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Mainar, Laura Baquedano, Leyre Ruiz Campo, Alberto Lanzon Laga, and Miguel Angel Ruiz Conde. "Endometrial cancer and hormonal therapy (HT)." Maturitas 81, no. 1 (May 2015): 198. http://dx.doi.org/10.1016/j.maturitas.2015.02.286.
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Mizowaki, T., Y. Norihisa, M. Ogura, T. Kamba, T. Inoue, Y. Shimizu, O. Ogawa, and M. Hiraoka. "Survival outcomes of neoadjuvant hormone therapy plus external-beam radiotherapy with relatively early initiation of salvage hormone therapy to patients with T3-4N0M0 prostate cancer." Journal of Clinical Oncology 29, no. 7_suppl (March 1, 2011): 95. http://dx.doi.org/10.1200/jco.2011.29.7_suppl.95.
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95 Background: Survival benefits of adding long-term adjuvant hormonal therapy (A-HT) on external beam radiation therapy (EBRT) had reported in patients with locally advanced prostate cancer. However, adverse effects of long-term hormonal therapy are also not negligible. If early initiation of salvage hormonal therapy (S-HT) to patents developed PSA failure after EBRT can realize comparable survival as to giving A-HT across the board, patients who maintain biochemical failure-free status after EBRT will receive hormonal-free benefit. We analyzed outcomes of EBRT combine with neoadjuvant hormonal therapy (NA-HT) to patients with T3-4N0M0 prostate cancer. Methods: Between April 1998 and Mar 2006, consecutive 173 Japanese patients with T3-4N0M0 adenocarcinoma of the prostate were definitively treated by 3D-CRT / IMRT. The median age was 72 years old (range 48-80). Pre-treatment PSA values ranged between 3.7 and 430 ng/ml (mean: 45.3). T-stage was distributed as follows: T3a: 122, T3b: 50 and T4: 1 case. NA-HT (3–17 months, median: 5 months) was given to all cases. Mean delivered dose was 74 Gy in 2 Gy per fraction to the prostate and seminal vesicles (range: 60-78). A-HT was not given to any patients and PSA values were monitored with one to 6 months interval after the treatment. S-HT was essentially started when PSA value exceeded 4 ng/ml. Results: Median follow-up period was 74 months (range: 8–152). So far, S-HT was initiated to 58 patients, and PSA values at the initiation of S-HT ranged 0.1 to 32.2 with a median value of 6.0 ng/ml. Biochemical relapse-free survival by the Phoenix definition and salvage hormonal therapy-free survival rates at 8 years were 60% (95% CI = 51-68) and 63% (95% CI = 56-71), respectively. Prostate cancer-specific and overall survival rates were 94% (95% CI = 89-99) and 85% (95% CI = 78-92), respectively. Conclusions: Survival rates of this cohort of patients treated by EBRT combined with NA-HT were excellent despite no A-HT was given, and more than two thirds of patients maintained hormone-free status at 8 years. This approach may be an alternative to giving long-term A-HT. No significant financial relationships to disclose.
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Wagner, Lynne I., Robert James Gray, George W. Sledge, Timothy Joseph Whelan, Daniel F. Hayes, Charles E. Geyer, Elizabeth Claire Dees, David Cella, and Joseph Sparano. "Patient-reported cognitive impairments among women with breast cancer randomly assigned to hormonal therapy (HT) alone versus chemotherapy followed by hormonal therapy (C+HT): Results from the Trial Assigning Individualized Options for Treatment (TAILORx)." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 9020. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.9020.
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9020 Background: Cognitive impairment is a complication of chemotherapy. Perceived cognitive impairments (PCI) were prospectively assessed among TAILORx participants randomized to HT alone versus chemotherapy followed by HT (C+HT). Methods: TAILORx participants with an OncoType DX Recurrence Score 11-25 were randomly assigned to HT or C+HT. PCI, fatigue, endocrine symptoms and health-related quality of life (HRQL) were assessed at baseline, 3, 6, 12, 24, and 36 months, using the Functional Assessment of Cancer Therapy (FACT) in 455 patients enrolled after 1/15/10. PCI change scores > 4.5 from baseline were defined a priori as clinically meaningful. Linear regression (LR) was used to model PCI scores on baseline PCI, treatment and other factors. Results: PCI scores were significantly worse at 3, 6, and 12 months compared to baseline for both groups (Table). The decline was greater for C+HT than HT at 3 months, but scores were similar at 12 months. Tests of an interaction between menopausal status and treatment were non-significant. PCI correlated with fatigue (r = 0.57-0.64) but not FACT Emotional well-being (EWB; r = 0.28-0.38); controlling for EWB did not account for differences in PCI change scores between treatment arms. Conclusions: Our study is the first to examine PCI among breast cancer patients randomized to receive C+HT vs. HT alone. C+HT was associated with greater declines in PCI at 3 months, but at 12 months PCI was similar in the C+HT and HT groups. PCI was associated with fatigue but not EWB. Pre- and post-menopausal groups demonstrated the same pattern of change. Since this study did not include a control group of patients not treated with HT, further study is required to determine if and to what extent HT contributes to PCI. [Table: see text]
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Lam, Lydia, Kenji Inaba, Bernardino Castelo Branco, Bradley Putty, Ali Salim, Donald J. Green, Peep Talving, and Demetrios Demetriades. "The Impact of Early Hormonal Therapy in Catastrophic Brain-Injured Patients and Its Effect on Organ Procurement." American Surgeon 78, no. 3 (March 2012): 318–24. http://dx.doi.org/10.1177/000313481207800340.
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The purpose of this study was to evaluate the impact of early hormonal therapy on organ procurement from catastrophic brain-injured patients. All catastrophic brain-injured patients admitted to a high-volume academic Level I trauma center who underwent successful organ procurement over a 3-year period (2006 to 2008) were reviewed. Patients were divided into two groups, those who received hormone therapy (HT) before brain death (BD) declaration and those who received HT after BD declaration. Thirty-two (60.4%) received HT before BD and 21 (39.6%) HTafter BD. Trauma was the most common cause of brain injury in both groups (before BD 96.9 vs after BD 90.5%, P = 0.324). There were no significant differences in demographics and clinical data. Patients receiving HT before BD were more hypotensive on admission (28.2 vs 9.5%, P = 0.048); however, they required vasopressors less frequently (62.5 vs 100.0%, P = 0.001), for a shorter duration (17.2 ± 16.3 hours vs 33.1 ± 34.9 hours, P = 0.043), and at a lower dosage. Time from admission to procurement did not differ between the two groups (109.8 ± 83.1 hours vs 125.0 ± 79.9 hours, P = 0.505). Patients receiving HT before BD had significantly more organs procured (4.5 ± 1.5 vs 3.5 ± 1.3, P = 0.023). Although catastrophic brain-injured patients receiving early hormonal therapy were more hypotensive, they required less vasopressors and had higher procurement rates. The early use of hormonal therapy may decrease the need for vasopressors and increase the salvage of potentially transplantable organs.
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Aizawa, Rihito, Kenji Takayama, Kiyonao Nakamura, Takahiro Inoue, Takashi Kobayashi, Shusuke Akamatsu, Toshinari Yamasaki, Osamu Ogawa, and Takashi Mizowaki. "Long-term outcomes of intensity-modulated radiation therapy combined with neoadjuvant hormonal therapy for Japanese patients with non-metastatic prostate cancer." Journal of Clinical Oncology 36, no. 6_suppl (February 20, 2018): 49. http://dx.doi.org/10.1200/jco.2018.36.6_suppl.49.
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49 Background: This study aimed to evaluate long-term outcomes of intensity-modulated radiation therapy (IMRT) combined with neoadjuvant (NA) hormonal therapy (HT) in Japanese patients with non-metastatic prostate cancer (NMPC). Methods: We retrospectively analyzed the data of 485 patients with T1-T4N0M0 adenocarcinoma of the prostate treated with IMRT combined with NA-HT. Of these patients, 32, 113, 250, and 90 patients were categorized into the low-, intermediate-, high-, and very high-risk groups, respectively, according to the NCCN risk classification. NA-HT was administered over a median duration of 6 months. In principle, 74 or 78 Gy in 2 Gy per-fraction were delivered to the prostate and seminal vesicles according to the risk. We did not administer adjuvant HT (A-HT) for any patient following the completion of IMRT. Salvage HT (S-HT) commenced when prostate-specific antigen (PSA) values exceeded 4 ng/mL. Results: The median follow-up period was 103.4 months, and the median PSA value at the initiation of S-HT was 5.1 ng/mL. In the low-risk group, the 8-year biochemical relapse-free survival, prostate cancer-specific survival, overall survival, and S-HT-free (SHTF) rates were 89.7%, 100.0%, 100.0%, and 96.7%, respectively. Those were 83.7%, 100.0%, 96.0%, and 94.3% for the intermediate-risk group, 64.5%, 97.8%, 87.0%, and 79.4% for the high-risk group, and 47.7%, 96.6%, 89.7%, and 53.3% for the very high-risk group, respectively. The estimated 8-year cumulative incidence rates of late gastrointestinal and genitourinary (grades 2–3) toxicity were 7.2% and 21.8%, respectively. We observed no grade 4 or higher toxicity. Conclusions: High-dose IMRT, combined with NA-HT and without A-HT under the early S-HT policy, achieved excellent survival outcomes with acceptable morbidities for a Japanese cohort with NMPC. Moreover, especially for high, and very high-risk patients, this approach could be a viable alternative to the uniform provision of long-term A-HT because more than the half of the patients maintained SHTF status over a period of 8-year after IMRT. Prospective trials are warranted to validate the findings of this study.
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Flanagan, J. R., C. Carney-Doebbeling, L. Jones, and C. Sweeney. "Metabolic syndrome predicts for shorter response to hormonal therapy in prostate cancer." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 4554. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.4554.
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4554 Background: Metabolic syndrome (MS) includes obesity, insulin resistance, dyslipidemia and hypertension. Recent studies have linked the individual components of MS to an increased risk for prostate cancer (PC) and worse PC outcomes. Methods: A retrospective chart review was performed on 100 consecutive patients treated for prostate cancer at a Veteran’s Administration oncology clinic between 1998–2005. MS was diagnosed according to Adult Treatment Panel III criteria, and was present with ≥3 of 5 components: hypertension (SBP ≥140 mmHg and/or DBP ≥90 mmHg on 2 outpatient visits; obesity (BMI ≥30); hypertriglyceridemia (>150 mg/dL on 2 fasting laboratories); LDL 110 mg/dL (2 outpatient am values while not on steroids). PC variables included baseline PSA at time of PC diagnosis, PSA at initiation of hormonal therapy (HT), presence of documented metastasis at time of HT, and primary PC treatment. We examined time to PSA progression (TTP) and median overall survival (OS) for PC among patients with and without MS using Kaplan-Meier curves and Cox proportional hazard models. Results: 83 patients treated with HT for PC were identified, and 41 (49%) met criteria for MS. Median age in both groups was 68. Median TTP was 16 months with MS vs. 46 months without MS (p = 0.001). In those patients with documented metastasis (DM) at time of HT, median TTP was 11 months with MS vs. 32 months without MS (p = 0.006). OS from time of HT was 40 months with MS, and median survival time for no MS was not reached. In multivariate regression analyses, the hazard ratio (HR) for increased TTP with MS was 3.49 (95% CI 1.86–6.54). HR for TTP with documented metastasis was 5.3 (95% CI 2.65–12.8). Conclusions: This retrospective analysis suggests patients with MS treated with HT for PC have significantly shorter time to PSA progression and worse overall survival. This analysis supports the need for a prospective evaluation of MS as a risk factor for early development of HRPC. [Table: see text] No significant financial relationships to disclose.
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Aberbach, Irit, Liliana Schliamser, Zeev Blumenfeld, Benjamin Brenner, and Galit Sarig. "Evaluation of ProC Global assay in women with a history of venous thromboembolism on hormonal therapy." Thrombosis and Haemostasis 96, no. 11 (2006): 578–83. http://dx.doi.org/10.1160/th06-05-0285.
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SummaryThe risk of thrombosis in women increases significantly during treatment with hormonal therapy (HT). The aim of this study was to evaluate ProC Global assay in women with a history of venous thromboembolism (VTE) while using HT. Protein C activation time normalized ratio (PCAT-NR) levels were significantly lower in 32 women with a history ofVTE while using HT (0.72 ± 0.1) compared with 56 healthy controls without HT, matched by age at blood sampling (0.99 ± 0.2) and 40 healthy controls with HT, matched by age and HT at VTE event (0.94 ± 0.2) (P<0.001 for both). PCAT-NR lower than the cut-off level of 0.8 was found in 23/32 (72%) patients compared with 5/56 (9%) age-matched controls (OR=26, 95%CI: 7-106, P<0.001) and 9/40 (22.5%) of HT-matched controls (OR=9, 95%CI: 2.7-30, P<0.001). Any thrombophilic risk factor was found in 20/32 (62.5%) of patients compared with 12/56 (21.4%) of agematched controls (OR=6, 95%CI: 2.1-10, P<0.001) and 12/40 (30%) of HT-matched controls (OR=4, 95%CI: 1.3-11.8, P=0.006).Out of the variables that are risk factors of VTE as age, HT or thrombophilic risk factor, ProC Global assay was found in the multivariate analysis - logistic regression, as the parameter that was the most associated with patient group [Exp(B)=15.8, 95% CI: 4.2-59.0, P<0.001]. In conclusion, abnormal PCAT-NR is associated with VTE in women using HT. ProC Global assay may potentially serve asa diagnostic tool for evaluating the risk of VTE in women prior to administration of HT.
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Olufade, Temitope O., Karen E. Skinner, Nicola Di Santo, Rahul A. Shenolikar, Mark Stephen Walker, and Lee Steven Schwartzberg. "Real-world effectiveness of fulvestrant monotherapy as first hormonal therapy in metastatic breast cancer patients." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): e12537-e12537. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e12537.
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e12537 Background: Fulvestrant is a selective estrogen receptor degrader approved as monotherapy for postmenopausal women with estrogen-receptor-positive metastatic breast cancer (MBC) who progress following anti-estrogen therapy. The recent Phase 3 FALCON study for hormone therapy (HT) naïve women showed increased median progression-free survival (PFS) (16.6 months) in fulvestrant treated patients (pts) compared with anastrozole (13.8 months), but real-world data are lacking. This study examined the real-world effectiveness of fulvestrant monotherapy as first (L1) or second line (L2) treatment after MBC diagnosis. Methods: This was a retrospective medical record review from 10 US community oncology practices. Female pts initiated fulvestrant monotherapy as the first HT after MBC diagnosis, administered as L1 or as L2 treatment following L1 chemotherapy. Fulvestrant was initiated between 1/1/2011 and 12/31/2015. Pts were classified as HT naïve; and HT relapse status: early relapse (≤12 months of adjuvant HT completion), late relapse (>12 months). Time to first chemotherapy (TTC), PFS, and overall survival (OS) were evaluated using Kaplan-Meier analyses. Results: The study included 121 pts: mean (SD) age 65.7 (11.4) years, 81.8% Caucasian, 94.2% postmenopausal/undocumented, and 92.0% HER2-/undocumented. Overall, 15.7% were de novo metastatic and 86.0% initiated fulvestrant in L1. At the start of fulvestrant, 40.5% had visceral metastasis. The study results (Table 1) suggest better outcomes (TTC, PFS, OS) in HT naïve and late relapse pts, than early relapse pts. Conclusions: First line fulvestrant in the real-world setting demonstrates comparable PFS benefit to clinical trial results and appeared successful in delaying chemotherapy initiation in HT naïve and late relapse pts. This finding supports the use of fulvestrant monotherapy as the first hormonal therapy in a metastatic setting. [Table: see text]
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Lin, Jenny J., Kathie-Ann P. Joseph, Kezhen Fei, Rebeca Franco, and Nina Bickell. "Adherence to hormone treatment for breast cancer and beliefs about treatment and screening." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e11004-e11004. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e11004.
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e11004 Background: Beliefs about medications, more than knowledge, have been found to affect medication adherence. For breast cancer patients, at least 5 years of daily adjuvant hormonal therapy (HT) improves survival but it is often difficult for women to sustain therapy. Qualitative studies suggest women take HT to prevent breast cancer recurrence. We sought to assess whether beliefs about HT and screening were associated with ongoing HT adherence. Methods: Patients with a new early-stage breast cancer enrolled in an IRB-approved RCT to reduce disparities in care in New York City were telephone surveyed 6 months after their surgical treatment for breast cancer to assess knowledge, attitudes and beliefs about breast cancer, its treatment and prevention. Adherence was defined as a positive response to “are you now taking hormonal therapy (e.g., tamoxifen, arimidex)?” Beliefs about HT and mammogram screening were assessed. Bivariate analyses were conducted with t tests, chi square or Wilcoxon rank sum tests; multivariate analysis used a stepwise logistic regression. Results: Of 333 enrolled women, 233 were recommended to take HT. Of these, 187 (80%) women were prescribed HT and 172 (92%) were still adherent 6 months after surgery. Fifty-three percent of women were bothered by side effects but all were adherent; however, of the 15 women who stopped HT, 6 (40%) stopped due to side effects. Sixteen percent of women expressed difficulty paying for HT but all were adherent. Patients adherent to HT had stronger beliefs in both HT as treatment and prevention and in the importance of regular mammograms to stay healthy. A multivariate model including race, insurance, HT knowledge and beliefs found that only beliefs about HT and mammogram screening were associated with adherence (belief about HT: OR=1.1; 95%CI: 1.03-1.11; belief about mammogram: OR=1.55; 95% CI: 1.06-2.27) [model c=.84; p<0.0001]. Conclusions: Ongoing HT adherence is related to beliefs about both treatment and screening.Adherence is not related to HT knowledge, side effects, cost, insurance or patient race. Understanding patients’ beliefs about screening and treatment may help physicians enable women to adhere to long-term therapy.
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Militello, Loredana, Paolo Carli, Vincenzo Di Lauro, Simon Spazzapan, Simona Scalone, Davide Lombardi, Alessandro Tuzi, et al. "Bevacizumab as maintenance therapy (mBev) in metastatic breast cancer (MBC)." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e22149-e22149. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e22149.
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e22149 Background: Preclinical models suggest that the anti-VEGF may improve the efficacy of anti-estrogen therapies in Hormonal Receptor positive (HR+) breast cancer, but there is lack of informations about the maintenance therapy with Bev (mBev) and Hormonal Therapy (HT). Methods: sixty-one pts with HER-2 negative MBC were treated, at our institution from 2007, with Bev+Taxanes (BT) as 1stline chemotherapy and with HT in HR+ pts as maintenance therapy. Primary endpoints were the evaluation of Progression Free Survival (PFS) and Overall Survival (OS). Secondary endpoint was the safety with HT in HR+ pts. Results: Hormonal status was positive in 52/61 (85%). Antracyclines were administered as adjuvant therapy in 26 pts (42%), antra+tax in 26 (42%) pts, no adjuvant therapy in 9 pts (14%). At the time of first relapse, median age was 50 y/o (range 33-72). First line HT was given to 12 pts. Metastatic sites were only bone in 20 pts (32%), visceral in 15 pts (25%), bone + visceral in 19 pts (31%), lymph nodes in 7 pts (11%). ECOG PS was 0 in 56 pts and 1 in 5. Median number of cycles of BT was 7 (1-14). All pts were evaluated for PFS and OS and 45 pts were evaluated for objective response: complete response (CR) was achieved in 5/45 pts (11%) (duration 12 months), partial response (PR) in 34/45 pts (75%) (duration 6-7 months), stable disease (SD) in 6/45 pts (14%) (6 months). After the assessment of the response, 34/61 pts received maintenance Bev (mBev); among this group, 24/34 pts with HR+ were also treated with HT until disease progression. The median number of cycles of mBev was 8 (1-42). Median PFS was 13.5 months (95%CI: 10.2-18.2) and median OS was 36 months (95%CI: 22-51). The BT regimen was well tolerated: 2 pts experienced cardiotoxicity with a reduction in left ventricular ejection fraction (LVEF); the most common side effects were hypertension (grade 1 in 11 pts e grade 2 in 16 pts), bleeding in 8 pts, proteinuria in 7 pts (grade 1 in 5 pts and grade 2 in 2 pts). Conclusions: Hormonalmaintenance and Bev can extend the overall benefit of therapy and it is well tolerated and associated with long-term clinical outcome. Our results are encouraging for prolonging Bev in association with HT as maintenance therapy until disease progression.
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Davis, S. R., I. Dinatale, L. Rivera-Woll, and S. Davison. "Postmenopausal hormone therapy: from monkey glands to transdermal patches." Journal of Endocrinology 185, no. 2 (May 2005): 207–22. http://dx.doi.org/10.1677/joe.1.05847.
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The climacteric is not a condition of the modern age, although with increased life expectancy over the centuries, more women will experience this physiological transition. As women are living longer there is a greater expectation that good health will be maintained through to the late decade. Thus the potential long-term adverse health consequences of using hormonal therapies (HTs) to alleviate menopausal symptoms are of considerable concern for women and medical practitioners. This concern is often the basis for a decision whether or not to use HT. We have reviewed the history of knowledge of the menopause and the development of HT for the treatment of climacteric complaints. We have also summarised the current evidence for specific benefits and risks of HT. Data indicate that postmenopausal HT is appropriate for the management of vasomotor symptoms, but that HT should not be prescribed for the prevention of cardiovascular disease or dementia. HT does prevent bone loss and osteoporotic fracture; however, use for this purpose remains controversial. The risk of breast cancer with HT varies according to the preparation used, such that oestrogen without concurrent progestin appears to convey little, or possibly even no significant breast cancer risk. There is insufficient information regarding the long-term use of non-oral HT, low-dose HT or novel compounds such as tibolone or the selective oestrogen receptor modulators with respect to breast cancer and cardiovascular risk for specific recommendations to be made.
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Ahmed, Mohamed E., Jack R. Andrews, Ayca Dundar, Masaya Jimbo, Vidhu B. Joshi, Giovanni Motterle, Jeffrey Karnes, et al. "Non-rising PSA disease progression on C-11 choline PET/CT imaging in patients receiving second generation hormone therapies (2nd-HT)." Journal of Clinical Oncology 38, no. 6_suppl (February 20, 2020): 144. http://dx.doi.org/10.1200/jco.2020.38.6_suppl.144.
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144 Background: Despite having well-recognized limitations, urologists often rely on serial PSA testing as a marker for treatment response or disease progression. To determine if PSA was indeed a reliable marker for treatment response or disease progression, we compared PSA levels against C-11 choline PET/CT in the evaluation of patients with advanced prostate cancer treated with second generation hormonal therapy (2nd-HT). Methods: We retrospectively identified 239 patients who were undergoing treatment with 2nd-HT (enzalutamide or abiraterone) for advanced prostate cancer. While on treatment, patients underwent serial PSA testing and C-11 choline PET/ CTs every 3 – 6 months. Paradoxical response was defined as increasing blood pool-corrected SUVmax of known choline-avid lesions and/or identification of new choline-avid lesions, despite stable or down-trending PSA. Results: Median (IQR) age was 70.4(64.3 – 75.7) years and median (IQR) primary Gleason Score was 8 (7 – 9). In our study, 19% of patients (n = 46/239) who were receiving 2nd-HT exhibited paradoxical response. Median (IQR) PSA and corrected SUVmax at baseline evaluation were 1.3 ng/mL (0.3 – 12.8 ng/mL) and 3.5 (1.8 – 5.8), respectively. Median (IQR) PSA and corrected SUVmax at the time of paradoxical response were 0.4 ng/mL (0.1 – 5.4 ng/mL) and 4.5 (2.8 – 6.8), respectively. The median duration of 2nd-HT treatment prior to detection of paradoxical response was 4.8 months (2.9 – 10.1 months). No significant difference was noted between patients receiving enzalutamide versus abiraterone (p = 0.35). Independent predictors of paradoxical response were prior primary systemic treatment (i.e. hormonal/chemo-hormonal therapy versus local therapy) and patient’s age at time of 2nd-HT initiation on univariate and multivariate analysis. Conclusions: Our retrospective review demonstrated prostate cancer disease progression discordant with PSA down-trending in 19% of patients receiving 2nd-HT. We conclude that in this subset of patients with advanced prostate cancer, PSA may not be a reliable marker of treatment response of disease progression, and routine radiographic evaluation in these patients is warranted.
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Nanda, Akash, Ming-Hui Chen, Brian Joseph Moran, Michelle H. Braccioforte, and Anthony Victor D'Amico. "Intermediate versus short-course hormone therapy and mortality in men with high-risk prostate cancer treated with radiation therapy." Journal of Clinical Oncology 31, no. 6_suppl (February 20, 2013): 83. http://dx.doi.org/10.1200/jco.2013.31.6_suppl.83.
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83 Background: Radiation therapy (RT) plus 28-36 months of hormonal therapy (HT) is standard-of-care for men with high-risk prostate cancer (HRPC) based on randomized trials comparing these HT durations to 4-6 months. However, it is unknown whether shorter durations of HT may also decrease mortality. We evaluate the impact of intermediate-course HT on the risk of all-cause mortality (ACM) in men with HRPC treated with RT. Methods: The study cohort comprised 554 men with HRPC (PSA > 20; Gleason score 8 or higher; or clinical stage T2c or higher) consecutively treated at the Chicago Prostate Cancer Center between 1997 and 2007. All men received brachytherapy with or without external beam RT and HT of intermediate (> 6 to 24; median 12 months) or short (up to 6; median 4 months) duration. A Cox regression multivariable analysis was performed assessing whether intermediate compared to short-course HT was associated with a decreased risk of ACM, adjusting for age, year and type of RT, treatment propensity score, and known PC prognostic factors. Results: After a median follow up of 4.3 years a total of 64 (11.6%) men died. Intermediate compared to short-course HT was associated with a significantly decreased risk of ACM (adjusted hazard ratio 0.44, 95% confidence interval 0.20 - 0.94, P = 0.03). Other significant covariates are shown in the table. The 5-year estimates of ACM for intermediate versus short-course HT were 7.0% and 15.7%, respectively. Conclusions: In men with HRPC treated with RT, a median HT duration of 12 months was associated with a significantly decreased risk of ACM when compared to a median HT duration of 4 months. This raises the hypothesis that HT durations shorter than 28-36 months may be sufficient to decrease mortality in men with HRPC. The ongoing RADAR trial by the Trans Tasman Radiation Oncology Group comparing 18 to 6 months of HT may provide level I evidence to validate this hypothesis. [Table: see text]
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Ismael, G., A. L. Coradazzi, C. A. Beato, P. Milhomem, J. Oliveira, C. Manzoni, and G. Segalla. "Adjuvant systemic therapy in elderly patients with breast cancer: A Brazilian single center experience." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e20711-e20711. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e20711.
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e20711 Background: Breast cancer is the leading cause of cancer in women in Brazil and in the western world. Despite the high incidence of breast cancer in elderly women, there is no solid information regarding the real impact of the adjuvant systemic therapy in this population, considering the underrepresentation of patients with 65 years of age or older in cancer-treatment trials. Moreover, elderly patients may face some difficulties to receive adequate adjuvant systemic treatment in the routine clinical practice. Methods: Two hundred fifty eight patients with 65 years of age or older at the time of diagnosis of operable breast cancer and treated in our Institution from February 2000 to December 2005 were retrospectively studied. Clinical and pathological data were recorded as well as the type of adjuvant systemic therapy: hormonal therapy (HT), chemotherapy (CT) or both. We evaluated the disease free survival and overall survival and compared the results between the group of patients treated with HT only and the group of patients treated with both HT and CT. Results: Ninety five (37.5%) patients were stage I, 150 (58.1%) were stage II and 6 (2.3%) were stage III, while 5 (1.9%) patients were diagnosed with DCIS. Ductal carcinoma was the most frequent histological type (81%) and grade II were reported in the majority of patients (47.3%). Mostly of patients were hormonal sensible (74.4% were ER+ and 64% were PR+) and HER 2 negative (81.8%). One hundred seventy eight (69%) patients received any kind of adjuvant HT while 91 (35.3%) received any kind of adjuvant CT. There was no statistical difference between patients treated with HT when compared with the group of patients treat with HT and CT, regarding disease free survival and overall survival. However, a higher rate of high risk patients were observed in the group treated with both HT and CT. Conclusions: Despite the age, a considerable part of this elderly breast cancer patient's population has received adjuvant systemic treatment. Benefits from HT and/or CT may be considered in this group of patients. No significant financial relationships to disclose.
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Quon, H. C., P. Cheung, D. A. Loblaw, G. Morton, E. Szumacher, C. Danjoux, R. Choo, G. Thomas, A. Kiss, and A. Deabreu. "Quality of life after pelvic radiotherapy with hypofractionated IMRT boost and long-term hormone therapy for locally advanced prostate cancer." Journal of Clinical Oncology 29, no. 7_suppl (March 1, 2011): 75. http://dx.doi.org/10.1200/jco.2011.29.7_suppl.75.
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75 Background: Combined radiotherapy (RT) and long-term hormonal therapy (HT) is a standard treatment option for high-risk prostate cancer. Dose escalated RT alone has been shown to improve disease free survival. Increased sensitivity of prostate cancer to high doses per fraction has led to hypofractionation as a method to radiobiologically escalate dose.We report on the quality of life of patients treated with combined hypofractionated RT and HT. Methods: A prospective phase I/II study enrolling patients with any of: clinical T3, PSA ≥20, or Gleason 8-10. Forty-five Gy (1.8 Gy/fraction) was delivered to the pelvic nodes with a concomitant 22.5 Gy intensity-modulated RT boost to the prostate, for a total of 67.5 Gy (2.7 Gy/fraction) in 25 fractions over 5 weeks. Hormonal therapy was administered for 2-3 years. Patient reported outcomes were measured at baseline and every 6 months using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, which measures urinary, bowel, sexual, and hormonal domains. Results: Sixty patients with a minimum 24 months of patient-reported outcomes were analyzed. Mean scores comparing baseline to 24 month values are reported. There were no statistically significant changes in the urinary summary scores (86.3 vs. 86.0, p=0.45) or any of the urinary subscales (function, bother, incontinence, irritative/obstructive). Domain summary score decreases were observed in: bowel by 4.4% (94.7 vs. 90.3, p<0.01), sexual by 27% (44.5 vs. 17.5, p<0.01), and hormonal by 11.9% (93.1 vs. 81.2, p<0.01). Examining time trends in outcomes, most changes occurred within the first 6 months with smaller changes thereafter. Conclusions: Hypofractionated RT combined with long-term HT is associated with good patient-reported urinary and bowel outcomes at 24 months. Sexual and hormonal summary scores are affected, largely due to continued androgen deprivation therapy. Further follow-up is needed to document patient reported outcomes after testosterone recovery. No significant financial relationships to disclose.
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Angelergues, Antoine, Denis Maillet, Aude Flechon, Mustafa Ozguroglu, Florence Mercier, Aline Guillot, Sylvestre Le Moulec, et al. "Duration of response to androgen-deprivation therapy (ADT) and efficacy of secondary hormone therapy, docetaxel (D), and cabazitaxel (C) in metastatic castration-resistant prostate cancer (mCRPC)." Journal of Clinical Oncology 32, no. 4_suppl (February 1, 2014): 282. http://dx.doi.org/10.1200/jco.2014.32.4_suppl.282.
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282 Background: Early CRPC (<12 months, m) with 1st hormonal therapy (HT) was found to predict poor efficacy of 2nd HT, but did not seem to impair the benefit of D-based chemotherapy. We evaluated the impact of this variable in our cohort of patients (pts) treated also with second-line chemotherapy C. Methods: Records of 132 consecutive mCRPC pts were retrospectively collected in 9 centers. PSA response ≥ 30% and time to biochemical progression (TTBP) with 1st- and 2nd-HT, D and C were evaluated according to time to progression to CRPC (<12 m and ≥12 m). PSA-response, TTBP and Overall Survival (OS) were compared using exact, Wilcoxon and log-rank tests, respectively. Results: All patients received first HT, D and C, and 94 of them received second HT. Time to CRPC <12 m was associated with a reduced OS and poor PSA-response and TTBP with second HT. Taxanes showed a similar PSA response whatever the time to CRPC but TTBP was slightly shorter in men with time to CRPC <12m. Conclusions: This retrospective analysis of 132 pts with mCRPC suggests that rapid progression to CRPC (<12 m) is associated with a poor prognosis and a low response to second-HT. PSA response to taxanes does not seem to be affected by time to CRPC, but TTBP is shorter in men with early CRPC. Prospective randomized trials are needed to confirm these results. [Table: see text]
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Tsai, Chi-Jui, Ho-Yin Huang, Fang-Ming Chen, Yi-Hsin Yang, Li-Chia Chen, and Kun-Pin Hsieh. "Investigating the effectiveness of adjuvant therapy for patients with hormone receptor-positive ductal carcinoma in situ." PLOS ONE 17, no. 1 (January 28, 2022): e0262934. http://dx.doi.org/10.1371/journal.pone.0262934.
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Background This study compared the recurrence risk of single versus dual adjuvant radiotherapy (RT) and hormonal therapy (HT) following breast-conserving surgery (BCS) in patients with hormone receptor-positive ductal carcinoma in situ (DCIS). Methods This retrospective cohort study used the Taiwan Cancer Registry database linking to the Taiwan National Health Insurance data from 2011 to 2016. We compared the recurrence risk between BCS-based regimens in Cox regressions and presented as adjusted hazard ratio (HR) and 95% confidence interval (95%CI). Results The 1,836 study cohort with a low-to-intermediate risk of recurrence was grouped into BCS alone (6.1%), BCS+RT (6.2%), BCS+HT (23.4%) and BCS+HT+RT (64.3%) according to the initial treatments. During the follow-up (median: 3.3 years), the highest 5-year recurrence-free survival rate was in BCS+RT (94.1%) group and followed by BCS+HT+RT (92.8%), BCS+HT (87.4%) and BCS alone (84.9%). Of the single adjuvant therapies, RT was more effective than HT. Both BCS+HT (HR: 1.52, 95%CI: 0.99–2.35) and BCS+RT (HR: 1.10, 95%CI: 0.50–2.41) did not significantly increase recurrence risk comparing against the BCS+HT+RT group. Conclusion Single adjuvant demonstrated a similar subsequent recurrence risk with dual adjuvant. This study supports the proposition to de-escalate adjuvant treatments in patients with low-to-intermediate risk of DCIS recurrence.
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Bartelink, H., R. D. Rubens, E. van der Schueren, and R. Sylvester. "Hormonal therapy prolongs survival in irradiated locally advanced breast cancer: a European Organization for Research and Treatment of Cancer Randomized Phase III Trial." Journal of Clinical Oncology 15, no. 1 (January 1997): 207–15. http://dx.doi.org/10.1200/jco.1997.15.1.207.
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PURPOSE To assess the long-term contribution of adjuvant chemotherapy (CT) and hormonal therapy (HT) in patients with locally advanced breast cancer, and to evaluate the impact of time of analysis on the results during accrual and up to 8 years after closure of a randomized phase III trial. MATERIALS AND METHODS In a trial using a factorial design, 410 patients were randomized between radiotherapy (RT) alone, RT plus CT, RT plus HT, and RT plus HT plus CT. RESULTS CT and HT each produced a significant prolongation of the time to locoregional tumor recurrence and to distant progression of disease, with the combined treatments providing the greatest therapeutic effect. At the time of trial closure, a significant improvement of survival was observed in patients who received CT (P = .004); however, with a longer follow-up duration, this effect disappeared (P > .05). HT did not initially appear to improve survival (P = .16); however, in the latest analysis with a long-term follow-up duration, a significant improvement of survival was seen (P = .02). A consistent 25% reduction in the death hazards ratio has been seen at all evaluations since trial closure in patients who received HT. The best survival results were observed in patients who received RT, HT, and CT (P = .02), with a reduction of 35% in the death hazards ratio. CONCLUSION An improvement in survival attributable to HT has been shown in patients with locally advanced breast cancer. The greatest therapeutic effect was seen in the treatment group that received both CT and HT. The improvement obtained with HT became apparent only after long-term follow-up evaluation.
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Sella, Tal, and Gabriel Chodick. "Adherence and Persistence to Adjuvant Hormonal Therapy in Early-Stage Breast Cancer Patients: A Population-Based Retrospective Cohort Study in Israel." Breast Care 15, no. 1 (May 29, 2019): 45–54. http://dx.doi.org/10.1159/000500318.
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Background: Adjuvant hormonal therapy (HT) has been consistently proven to improve multiple outcomes in early breast cancer yet rates of adherence and persistence are variable. Methods: We retrospectively identified women diagnosed with nonmetastatic breast cancer and initiating HT between January 2000 and December 2007 in a large Israeli health provider. Prescription records including the drug name, date of purchase, and the quantity of pills dispensed were collected. We used Cox proportional hazards and binary logistic models to analyze factors associated with early discontinuation (<5 years) and nonadherence (proportion of days covered, PDC <80%) of HT, respectively. Results: A total of 4,178 women with breast cancer were identified with nearly 95% of patients treated with tamoxifen as the initial HT. Over the 5-year follow-up period, early discontinuation was identified in 955 (23%) patients. The mean PDC was 82.9% (SD 0.004). Younger age and low BMI were both associated with an increased risk of early discontinuation and nonadherence. A history of hypertension was associated with a higher likelihood of both outcomes. Conclusion: Adherence and persistence with HT among Israeli breast cancer survivors are comparable to those in international reports. Interventions are necessary to identify and prevent suboptimal HT adherence.
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Jamy, Omer HASSAN, Namratha Reddy Vontela, Justin Gatwood, Mark Stephen Walker, Edward J. Stepanski, and Gregory A. Vidal. "Using patient-reported outcomes to assess the effectiveness of topical hormonal replacement therapy (THR) for vaginal complaints (VC) after anti-hormonal therapy (HT) treatment for breast cancer (BC)." Journal of Clinical Oncology 34, no. 26_suppl (October 9, 2016): 77. http://dx.doi.org/10.1200/jco.2016.34.26_suppl.77.
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77 Background: THR is sometimes used for treatment of VC in BC patients previously treated with HT. The safety of this practice remains a question but the effectiveness of this strategy has not been reported. Methods: We conducted a retrospective analysis of patient reported symptoms at the West Cancer Center (WCC) between 2002 and 2014. Early stage BC patients previously treated with HT with reported VC ± THR were statistically matched 1:1 using propensity score matching with calipers of 0.01. Demographics and clinical characteristics were extracted from electronic records and a proprietary patient-reported outcomes database: the Patient Care Monitor (PCM). A baseline PCM score for vaginal dryness and sexual dysfunction was noted at the initiation of THR and was followed for 12 months. Univariate statistics compared the resulting cohorts and repeated measures ANOVA assessed the impact of topical therapy. Results: We compared 74 THR patients to 74 controls (Table). The mean reported symptom scores were 3 fold higher in the active group with no statistical improvement in symptom scores noted at 6 or 12 months (Table). At the WCC, of the 5,479 patients with VC analyzed, only 5% received THR. The study was underpowered for survival analysis. Conclusions: In our study, increased severity of VC was associated with increased use of THR. However, there is no evidence that THR was effective in alleviating symptoms of vaginal dryness or sexual dysfunction. [Table: see text]
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Spain, Pamela, Stephanie Teixeira-Poit, Michael T. Halpern, Kathleen Castro, Irene Prabhu Das, Brenda A. Adjei, and Steven Clauser. "NCI Community Cancer Center Program (NCCCP): Understanding why hormonal therapy for breast cancer was considered but not administered." Journal of Clinical Oncology 34, no. 7_suppl (March 1, 2016): 74. http://dx.doi.org/10.1200/jco.2016.34.7_suppl.74.
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74 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) was designed to improve the quality of cancer care and reduce disparities at hospital-based community cancer centers. This study examined when guideline-concordant therapy was considered but not administered, who made the decision to not receive treatment. Methods: A retrospective analysis of patients diagnosed and receiving all or part of their initial cancer treatment at one of 12 NCCCP sites was conducted. We examined patients who were guideline-concordant with the hormonal therapy (HT) for breast cancer quality measure, but for whom treatment was considered but not administered. We compared patients diagnosed in the pre-NCCCP period (2006 – 2007) and during the NCCCP period (2008-2013). Results: Overall, a low proportion of cases had HT considered but not administered (4% in pre-NCCCP period; 5% in NCCCP period – difference not significant). In the pre-NCCCP period, white patients were twice as likely as Black patients to have HT considered but not administered, while there were no racial differences during the NCCCP period. In both time periods, older patients and Medicare patients were more likely to have HT considered but not administered. The most common reason for considering but not administering HT was refusal by the patient or patient’s family and this more likely for White patients, patients in the middle age groups (50-59 and 60 to 69), and Medicare patients. The second most common reason was that the physician determined it to be contraindicated due to patient risk factors. This was more likely to be a reason for Black and Medicaid patients. Conclusions: Results show that a large proportion of cases that had treatment considered but not administered did not receive treatment because of patient/family refusal or it was contraindicated due to other patient risk factors, both before and during the NCCCP period. Additional studies could inform the long-term outcomes of patients with comorbid conditions who were considered for guideline-concordant treatment but did not receive it (but the data were not available for this study).
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Lee, Anna, Daniel J. Becker, Ariel J. Lederman, Virginia W. Osborn, Meng S. Shao, Andrew T. Wong, David Schwartz, and David Schreiber. "Comparison of Neoadjuvant vs Concurrent/Adjuvant Androgen Deprivation in Men with High-risk Prostate Cancer Receiving Definitive Radiation Therapy." Tumori Journal 103, no. 4 (July 2017): 387–93. http://dx.doi.org/10.5301/tj.5000595.
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Purpose It is unknown whether there is a benefit to starting androgen deprivation therapy (ADT) prior to rather than concurrently with definitive radiation therapy in men with high-risk prostate cancer. We studied the National Cancer Data Base to determine whether the timing of ADT impacts survival. Methods Men diagnosed with high-risk prostate adenocarcinoma who received external beam radiation therapy (EBRT) to a dose of 70-81 Gy along with ADT from 2004-2011 were included. Those who started ADT 42-90 days before EBRT were identified as having received neoadjuvant hormonal therapy (N-HT) and those who received ADT from 14 days before their radiation until 84 days after the start of EBRT were categorized as receiving concurrent/adjuvant treatment (C-HT). We used the log-rank test to compare Kaplan-Meier survival curves and multivariable Cox regression to assess the impact of covariables on overall survival (OS). Results Among 11,491 included patients, those receiving N-HT were 1 year older ( p<0.001) and more likely to have Gleason 8-10 disease ( p = 0.01) and cT3-4 disease ( p = 0.002). Men receiving N-HT had a 5-year and median OS of 80.6% and 111.4 months, respectively, compared to 78.3% and 108.9 months, respectively, in those receiving C-HT ( p = 0.03). This benefit remained significant on multivariable analysis (hazard ratio 0.86, 95% confidence interval 0.77-0.96, p = 0.008). Duration of ADT was not available to report. Conclusions External beam radiation therapy with N-HT was associated with improved overall survival compared to C-HT. This study is hypothesis-generating and further studies are needed to best qualify the sequencing of hormone therapy with the duration of treatment.
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Loeb, Stacy, Meike Adam, Pierre Tennstedt, Wolfgang Huber, Juergen Bernard, Derya Tilki, Markus Graefen, Hartwig Huland, and Thorsten Schlomm. "Toxicity in a multimodality approach of radical prostatectomy with radiation and hormonal therapy." Journal of Clinical Oncology 34, no. 2_suppl (January 10, 2016): 107. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.107.
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107 Background: While the optimal use and timing of secondary therapy after radical prostatectomy remain controversial, there are limited data on the patient-reported outcomes following multimodality therapy. Our objective was to assess the impact of additional radiation and/or hormonal therapy on long-term urinary continence, quality of life and potency after radical prostatectomy. Methods: Among 13150 men treated by radical prostatectomy (RP) from 1992-2013, 905 underwent secondary radiation therapy (RP+RT), 407 received androgen deprivation therapy (RP+ADT) and 688 a combination of RT and ADT (RP+RT+ADT). Urinary function, sexual function and quality of life were evaluated annually using self-administrated validated questionnaires. Urinary function was assessed by the use of the number of pads in 24h (analyzed as 0 pads, safety only, 1-2, or ≥ 3 pads). Potency was defined as ≥ 3 points out of 5 on the question whether erections were hard enough for penetration. Quality of life was assessed using a score from 0-100%.The distribution of urinary function, sexual function and quality of life were plotted as a function of time after bootstrap analysis (n = 1000) of a propensity score matched cohort. Results: Urinary function. The distribution of 0 pads and 1 safety pad between patients with a) RP and RP+RT was 72.3% vs. 67.9% and 16.7% vs. 18.6%; b) between RP and RP+HT was 64.5% vs. 55.5% and 16.1% vs. 21.9%; c) between RP and RP+RT+ADT was 67.4% vs. 54.8% and 17.7% vs. 21.8% and d) between RP+RT and RP+RT+ADT was 64.5% vs. 55.5% and 16.1% vs. 21.9%. Potency. The distribution of potency between patients with a) RP and RP+RT was 62.9% vs. 40.0%; b) between RP and RP+HT was 59.1% vs. 29.3%; c) between RP and RP+RT+ADT was 57.4% vs. 24.0% and d) between RP+RT and RP+RT+ADT was 44.2% vs. 32.1%. Quality of life. The distribution of a score of 83.3%-100% between patients with a) RP and RP+RT was 67.9% vs. 57.4%; b) between RP and RP+HT was 57.8% vs. 41.7%; c) between RP and RP+RT+ADT was 59.3% vs. 48.2% and d) between RP+RT and RP+RT+ADT was 60.0% vs. 41.2%. Conclusions: Secondary therapy after radical prostatectomy has a negative influence on urinary function, potency and quality of life.
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Gartrell, Benjamin Adam, Giuseppe Del Priore, Avi S. Retter, Wen-Tien Chen, Gerald H. Sokol, Alexander G. Vandell, and Mack Roach. "Evaluating non-hormonal therapy in a phase II trial of SM-88 for rising PSA prostate cancer." Journal of Clinical Oncology 37, no. 7_suppl (March 1, 2019): 83. http://dx.doi.org/10.1200/jco.2019.37.7_suppl.83.
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83 Background: Absolute PSA change is an imperfect surrogate of clinical benefit; CTCs and PSA doubling time (DT) may also be used as a surrogate of progression (PD). Hormone therapy (HT) often leads to a rapid decline in PSA, however non-HT may be effective without causing a decline in absolute PSA or testosterone (T). SM-88, a non-HT novel combination Warburg effect therapy (amino acid analogue, CYP3a4 inducer, mTOR inhibitor and catalyst) does not affect T. We report outcomes leading to subsequent therapies of an ongoing PSA recurrent, non-metastatic PC trial. Methods: Prospective Phase II of rising PSA (per PCWG3), detectable CTCs, and no baseline lesions. Results: Since September 2016, 31 subjects enrolled with 17 on study for > 12 weeks. Mean age 68.9; BMI 28.7; 38% black and 62% post RT. Mean T increased 61 mg/dl from baseline 319 mg/dl (p=0.19). 82% (14/17) subjects experienced an improvement in PSA DT and 67% (10/15) experienced a decline in CTCs of >30%. Overall median PSA DT time on enrollment was 5.3 (1.4 – 37.6) and improved to 6.5 (Wilcoxon p=0.02) (see table). 3/4 subjects with PD failed to maintain a CTC drop >60% vs 2/17 without PD (p=.03); median time to nadir CTC was 3 cycles (1-7). Subjects avoiding subsequent therapy averaged a 50% CTC decline (15-100%). CTC and PSA DT effects were not correlated to T level. AEs possibly related to drug/unrelated were: No grade (G) 4 or 5; 0/1 G3; 1/7 G2; 13/19 G1. As reported elsewhere, typical HT-related side effects were not observed. Including all patients with >1 month of data, from initial diagnosis of PSA rise (median 9 months; 3-18), 96% (22/23) have remained metastases-free and 78% (18/23) remained free of additional HT (p<.05). Clinical trial information: NCT02796898. Conclusions: SM-88 may be a useful either before or as an additive to current PC treatments where normal T may be preferred. SM-88 might not worsen QOL parameters related to T level. An effect on PSA DT and CTCs were demonstrated even in an aggressive doubling time subgroup. Prospective trials are planned to confirm its utility.[Table: see text]
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Jerusalem, Guy Heinrich Maria, Patrick Neven, Nina Marinsek, Jie Zhang, Ravi Degun, Giancarlo Benelli, Stephen Saletan, and Fabrice Andre. "Patterns of resource utilization and cost for postmenopausal women with hormone-receptor–positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC) in Europe." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e17520-e17520. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e17520.
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e17520 Background: Healthcare resource utilization varies by disease stage and treatment choice. Notably, chemotherapy (CT) use is associated with extensive healthcare resource utilization and cost. This study reviews the direct and indirect cost implications of CT versus hormonal therapy (HT) in the ABC setting through the first 3 lines of treatment. Methods: A retrospective chart review of postmenopausal women diagnosed with HR+, HER2– ABC in 5 European countries was conducted. Patients must have progressed on at least 1 line of HT and completed at least 1 line of CT in the ABC setting. Patient cohorts based on therapy received in each line were constructed (cohort A: HT 1st-line, CT 2nd-line, and any treatment 3rd-line; cohort B: HT 1st- and 2nd-line with CT 3rd-line; and cohort C: CT 1st-line with any 2nd- and 3rd-line). Costs of care based on resource utilization and country-specific cost were calculated by patient cohort and line of therapy. Working status was also assessed. Results: A total of 355 eligible patient charts between 2008 and 2012 were included in the analysis: cohort A, 218 (61%) patients; cohort B, 26 (7%) patients; and cohort C 111 (31%) patients. Total direct costs over all 3 treatment lines were €14,362 higher for CT versus HT as 1st-line therapy (cohort C vs A) and €10,368 higher for CT versus HT as 2nd-line (cohort A vs B). Monthly direct costs were €2,536 higher for CT versus HT for 1st-line therapy and €1,713 higher for CT versus HT in 2nd-line. Increased costs for CT were due to treatments to manage side effects, use of concomitant targeted therapies, and increased frequency of hospitalizations, healthcare provider visits, and monitoring tests. On switching from HT to CT, there was a doubling of the proportion of patients on sick leaves in both cohorts A and B. Conclusions: These results suggest an increased direct cost of care for CT relative to HT in European postmenopausal women with HR+, HER2– ABC. Furthermore, CT-based therapy appears to be associated with lower productivity of working-age patients, potentially increasing overall indirect costs.
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Sitruk-Ware, Regine. "Progestins in hormonal therapy (HT) today, tomorrow and the next day: a roundtable discussion." Steroids 68, no. 10-13 (November 2003): 973–79. http://dx.doi.org/10.1016/j.steroids.2003.08.004.
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Sansone, Pasquale, Claudia Savini, Ivana Kurelac, Qing Chang, Laura Benedetta Amato, Antonio Strillacci, Anna Stepanova, et al. "Packaging and transfer of mitochondrial DNA via exosomes regulate escape from dormancy in hormonal therapy-resistant breast cancer." Proceedings of the National Academy of Sciences 114, no. 43 (October 11, 2017): E9066—E9075. http://dx.doi.org/10.1073/pnas.1704862114.
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The horizontal transfer of mtDNA and its role in mediating resistance to therapy and an exit from dormancy have never been investigated. Here we identified the full mitochondrial genome in circulating extracellular vesicles (EVs) from patients with hormonal therapy-resistant (HTR) metastatic breast cancer. We generated xenograft models of HTR metastatic disease characterized by EVs in the peripheral circulation containing mtDNA. Moreover, these human HTR cells had acquired host-derived (murine) mtDNA promoting estrogen receptor-independent oxidative phosphorylation (OXPHOS). Functional studies identified cancer-associated fibroblast (CAF)-derived EVs (from patients and xenograft models) laden with whole genomic mtDNA as a mediator of this phenotype. Specifically, the treatment of hormone therapy (HT)-naive cells or HT-treated metabolically dormant populations with CAF-derived mtDNAhi EVs promoted an escape from metabolic quiescence and HTR disease both in vitro and in vivo. Moreover, this phenotype was associated with the acquisition of EV mtDNA, especially in cancer stem-like cells, expression of EV mtRNA, and restoration of OXPHOS. In summary, we have demonstrated that the horizontal transfer of mtDNA from EVs acts as an oncogenic signal promoting an exit from dormancy of therapy-induced cancer stem-like cells and leading to endocrine therapy resistance in OXPHOS-dependent breast cancer.
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Barata, Pedro C., Hamid Emamekhoo, Prateek Mendiratta, Dharmesh Gopalakrishnan, Vadim S. Koshkin, Allison Janine Tyler, Moshe Chaim Ornstein, et al. "Treatment patterns for metastatic hormone-sensitive prostate cancer (mHSPC) progressing after up-front docetaxel in combination with androgen deprivation therapy (D-ADT)." Journal of Clinical Oncology 36, no. 6_suppl (February 20, 2018): 305. http://dx.doi.org/10.1200/jco.2018.36.6_suppl.305.
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305 Background: D-ADT increases overall survival (OS) in men with mHSPC. All patients (pts) however progress and develop castration-resistant prostate cancer (CRPC). Little is known about response to subsequent therapy and outcomes in this setting. Methods: Retrospective analysis of consecutive mHSPC pts treated with ≥3 cycles of D-ADT at Cleveland Clinic and University of Wisconsin-Madison. We aimed to describe baseline, progression characteristics, treatment choices, sequence and outcome of subsequent therapy. Results: A total of 146 mHSPC pts were treated with D-ADT (6% 1-2 cycles; 94% ≥3 cycles). Final analysis included 136 pts, median age 65 (range 35-86), 65% GS≥8, 79% high-volume disease. Median number of D cycles was 6 (1-6). PSA declined to “0” at 12 and 24 months in 32% and 25% of pts, respectively. Median time to CRPC (biochemical, clinical or radiographic) was 19.6 months (95% CI, 16.6-22.6). 57 pts (42%) received ≥1 subsequent treatment after CRPC [46 hormonal therapy (HT) (21 abiraterone acetate, 19 enzalutamide, 6 ASN-001); 4 Sipuleucel-T; 4 radium-223, 5 chemotherapy (2 carboplatin-based, 2 cabazitaxel, 1 D); 3 temsirolimus/bevacizumab]. Treatment response was independent from time to CRPC (≥12 months, p = 0.264). Pts receiving HT as the first subsequent treatment had a median rPFS of 13.3 months (95% CI, 10.1-16.5) compared with 3.1 months (95% CI, 0-15.8) for non-HT (p = 0.332). Treatment choice was independent of GS (p = 0.513), visceral disease (p = 0.374) and time to CRPC (p = 0.500). Most CRPC pts treated with ≥2 lines of therapy received one HT (n = 21) followed by a different HT (43%), chemo (38%), radium-223 (14%) or olaparib (10%). 57% of pts were alive at 2 years. Longer OS correlated with time to CRPC (p = 0.010) and first subsequent treatment with HT (p = 0.009) but not with visceral disease (p = 0.258), GS (p = 0.599) or sequence of therapies received (HT/HT vs HT/non-HT, p = 0.836). Conclusions: Prior D-ADT did not preclude subsequent treatment response in CRPC pts, independent of time to CRPC. The choice of first-line treatment for CRPC may impact survival in favor of those who start HT.
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Tassinari, Roberta, and Francesca Maranghi. "Rodent Model of Gender-Affirming Hormone Therapies as Specific Tool for Identifying Susceptibility and Vulnerability of Transgender People and Future Applications for Risk Assessment." International Journal of Environmental Research and Public Health 18, no. 23 (November 30, 2021): 12640. http://dx.doi.org/10.3390/ijerph182312640.
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Transgenders (TGs) are individuals with gender identity and behaviour different from the social norms; they often undergo gender-affirming hormone therapy (HT). HT for TG men involves testosterone treatment and, for TG women, oestrogen plus androgen-lowering agents. Due—but not limited—to the lifelong lasting HT, usually TG people experience several physical and behavioural conditions leading to different and specific susceptibility and vulnerability in comparison to general population, including the response to chemical contaminants present in daily life. In particular, the exposure to the widespread endocrine disrupters (EDs) may affect hormonal and metabolic processes, leading to tissue and organ damage. Since the endocrine system of TG people is overstimulated by HT and, often, the targets overlap with ED, it is reasonable to hypothesize that TG health deserves special attention. At present, no specific tools are available to study the toxicological effects of environmental contaminants, including EDs, and the potential long-term consequences of HT on TG people. In this context, the development of adequate and innovative animal models to mimic gender-affirming HT have a high priority, since they can provide robust data for hazard identification in TG women and men, leading to more reliable risk assessment.
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Santoro, Nanette, Cassandra Roeca, Brandilyn A. Peters, and Genevieve Neal-Perry. "The Menopause Transition: Signs, Symptoms, and Management Options." Journal of Clinical Endocrinology & Metabolism 106, no. 1 (October 23, 2020): 1–15. http://dx.doi.org/10.1210/clinem/dgaa764.
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Abstract Context Menopause, the permanent cessation of menses, reflects oocyte depletion and loss of gonadal steroids. It is preceded by a transition state, the perimenopause, which is characterized by the gradual loss of oocytes, altered responsiveness to gonadal steroid feedback, wide hormonal fluctuations, and irregular menstrual patterns. The goal of this mini-review is to discuss the basic pathophysiology of the menopausal transition and the hormonal and nonhormonal management of clinicopathology attributed to it. Evidence Acquisition A Medline search of epidemiologic, population-based studies, and studies of reproductive physiology was conducted. A total of 758 publications were screened. Evidence Synthesis The reproductive hormonal milieu of the menopausal transition precipitates bothersome vasomotor symptoms, mood disruption, temporary cognitive dysfunction, genitourinary symptoms, and other disease processes that reduce the quality of life of affected women. The endocrine tumult of the menopause transition also exposes racial and socioeconomic disparities in the onset, severity, and frequency of symptoms. Hormone therapy (HT) treatment can be effective for perimenopausal symptoms but its use has been stymied by concerns about health risks observed in postmenopausal HT users who are older than 60 and/or women who have been postmenopausal for greater than 10 years. Conclusions The menopause transition is a disruptive process that can last for over a decade and causes symptoms in a majority of women. It is important for clinicians to recognize early signs and symptoms of the transition and be prepared to offer treatment to mitigate these symptoms. Many safe and effective options, including HT, are available.
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Symmans, William Fraser, Eleni Andreopoulou, Daniel J. Booser, Christos Hatzis, Michael J. Wallace, Ya Zhang, Yun Gong, et al. "Progression of genomic signatures in local and metastatic estrogen receptor-positive (ER+) breast cancer: Relevance to palliative treatment." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 515. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.515.
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515 Background: Biological progression of ER+ breast cancer accelerates clinical progression and resistance to treatments. Methods: One laboratory used Affymetrix U133A gene expression microarrays to profile 588 biopsy samples from patients with ER+ breast cancer: 74 AJCC Stage I, 155 Stage IIA, 105 Stage IIB, 127 Stage III, 127 Stage IV (27 at presentation, 100 relapsed). We evaluated stage dependence of ER [ESR1, PGR, sensitivity to endocrine therapy (SET) index], proliferation [MKI67, AURKA, genomic grade index (GGI)], invasion [PLAU (uPA)], PI3-kinase (PIK3CA-GS), VEGF, genomic subtype [PAM50, 3-gene classifier (ESR1, ERBB2, AURKA)], and housekeeper control genes. Significance was evaluated through ordinal median regression (P < 0.002, for multiple testing) after adjusting for staging method (clinical or pathologic). Exploratory Cox regression analyses of progression-free survival (PFS) and overall survival (OS) were performed when treatment was hormonal therapy (HT, N=58) or chemotherapy (CT, N=27) after biopsy of metastatic ER+ breast cancer (MBC). Results: Stage progression was associated with reduced SET index and increased proliferation (GGI, MKI67, AURKA) and metabolism (GAPDH). These changes occurred between Stages IIB and III, and Stages III and IV. Luminal B and proliferation subtypes were more prevalent in Stage IV and less in Stage I. Interestingly, invasion (PLAU) genes were lower in MBC. Only SET index demonstrated a significant interaction with treatment (HT or CT) for MBC (PFS: p=0.018). SET was predictive of PFS and OS following HT, as a continuous score (PFS: HR=0.69, 95%CI 0.49 to 0.97, p=0.035; OS: HR=0.61, 95%CI 0.40 to 0.94, p=0.025) or dichotomized at median value (PFS: HR=0.43, 95%CI 0.24 to 0.76, p=0.003; OS: HR=0.37, 95%CI 0.18 to 0.77, p=0.006). Genomic subtype was prognostic for PFS irrespective of treatment type. High PIK3CA-GS expression predicted OS in the HT subset. Conclusions: Stage progression was associated with decreased ER-related transcription (SET) and increased proliferation, grade, higher risk subtype, and metabolism. In MBC samples, only SET index was predictive of PFS and OS with palliative hormonal therapy.
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Moleti, Mariacarla, Maria Di Mauro, Angela Alibrandi, Roberto Vita, Salvatore Benvenga, and Francesco Vermiglio. "Postpartum Thyroiditis in Women With Euthyroid and Hypothyroid Hashimoto’s Thyroiditis Antedating Pregnancy." Journal of Clinical Endocrinology & Metabolism 105, no. 7 (April 17, 2020): e2421-e2428. http://dx.doi.org/10.1210/clinem/dgaa197.
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Abstract Context Postpartum thyroiditis (PPT) is defined as the occurrence of de novo autoimmune thyroid disease accompanied by thyroid dysfunction in the first year postpartum. However, hormonal changes resembling the typical pattern of PPT have been reported to occur even in women with pregestational Hashimoto’s thyroiditis (HT) on levothyroxine (LT4). Objective To evaluate the risk of PPT in women with HT antedating pregnancy. Design/Setting Retrospective chart review of pregnant women with HT antedating pregnancy seen in a university hospital (2008-2017), who were followed from preconception up to 1 year after delivery. Patients 167 women preconceptionally diagnosed with HT and classified as hypothyroid HT (hypo-HT; n = 98) or euthyroid HT (eu-HT; n = 69), according to their thyroid status at the time of diagnosis. Outcome Measures PPT occurrence and associated clinical characteristics/risk factors. Results PPT occurred in 65/167 women, with a rate statistically greater in the eu-HT than in the hypo-HT group (68.1% vs 18.4%; odds ratio [OR] 9.49, 95% confidence interval [CI] 4.62-19.49). Most of the women experiencing PPT in both groups were euthyroid at the time of first-trimester evaluation (39/47 eu-HT [83%] and 16/18 hypo-HT [88.9%]). Multivariate regression analysis showed eu-HT group and first-trimester euthyroidism to be positively associated with PPT occurrence (ORs 10.71 and 3.89, respectively). Conclusion PPT may occur in hypo-HT women on LT4 therapy, although significantly less frequently than in eu-HT women. The 4-fold higher risk of PPT in HT women maintaining euthyroidism at first -trimester of gestation suggests that the risk of PPT could be related to the amount of unaffected thyroid tissue.
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Al-Saleh, Khalid A., Adda Bounedjar, Mohammed Oukkal, Hasen Mahfouf, Kamel Bouzid, Assia Bensalem, Prof Taha Fillali, et al. "Prediction of response to neoadjuvant hormonal therapy (NAHT) using upfront oncotype Dx recurrence score (RS): Results from the SAFIA phase III trial." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 594. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.594.
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594 Background: While hormonal therapy (HT) is a fundamental treatment in breast cancer therapy, neoadjuvant NAHT is not considered standard. The SAFIA trial is a prospective international neoadjuvant Phase III investigating the potential role of the addition of palbociclib (P) in patients (pts) sensitive to HT. We report the results of induction Faslodex (+/- zoladex) in pts initially selected by RS < 31, in order to assess their individual HT sensitivity before double-blind randomization HT vs HT + P followed by surgery. Materials and Methods: A total of 308 pts (stages II and IIIA Luminal A/B HER2 negative) in 24 centers and 6 countries (Middle-East/Maghreb) underwent upfront RS to select pts for induction HT. Pts with RS < 31 received induction neoadjuvant fulvestrant (500 mg i.m Day 1, 14, 28 then q.4 weeks) + goseriline (3.6 mg s.c q.4 w for pre and peri-menopausal pts) for 4 months, followed by clinical and radiological assessment of the disease response before randomization. Response was defined as no progression: Complete Response-CR/ Partial Response-PR: > 50% and Minor Response-MR: < 50% to > 0%/ No Response-NR: progression > 0%. Results: A total of 70 pts (22%) with RS > 31 were excluded, leaving 238 eligible pts for NAHT, age (25-84); pre-peri/ post menopause: 135 (57%)/103 (43%); Luminal A/B: 112 (49%)/114 (51%); Stage II/IIIA: 196 (87%) / 29 (13%). One hundred and seventy-seven pts (177) have validated responses to induction NAHT: CR: 9 pts (5%) / MR: 105 pts (59%) for major response rate: 64% / MR: 56 pts (32%) / NR: 7 pts (4%); available RS 0-10: 23 pts (16%) / RS 11-18: 67 pts (47%) / RS 19-25: 34 pts (24%) / RS 26-30: 18 pts (13%). Correlations between Response to NAHT and RS are shown in the table below (not statistically significant). Conclusions: In our population, upfront Oncotype DX RS < 31 allowed to select pts for induction NAHT without loss of chances with a no-progression rate (CR+PR = MR) of 96%. No significant correlation was found between RS and response to NAHT. Upfront RS > 31 (22%) is selecting pts candidates for neoadjuvant chemotherapy with a potential high risk of endocrine resistance. Clinical trial information: ICRG1201 .
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Safronova, E. Yu, A. A. Krasheninnikov, S. A. Sergienko, and A. A. Kostin. "THE USE OF MODERN ANALOGUES OF LUTEINIZING HORMONE RELEASING HORMONE IN THE HORMONAL THERAPY IN PATIENTS WITH PROSTATE CANCER." Research'n Practical Medicine Journal 4, no. 2 (June 17, 2017): 23–28. http://dx.doi.org/10.17709/2409-2231-2017-4-2-3.
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The urgency of the problem of prostate cancer (PC) remains extremely high due to the continued growth of morbidity and mortality from this disease. Despite the introduction of diagnostics with the use of prostate specific antigen (PSA) and the increase in the number of cases of detection of localized forms of the disease, frequency of detection in the primary treatment of patients with advanced and metastatic prostate cancer remains high. Therapy aimed at reducing testosterone levels in the body of the patient with metastatic prostate cancer is the gold standard of treatment, so surgical or pharmacological castration to reduce testosterone levels, are generally accepted methods of therapy. Hormone therapy (HT) using a pharmacological castration is the major and most commonly used method of treatment of patients with metastatic prostate cancer, the effectiveness of which is comparable with surgical castration. The article presents a review of studies that compared the effectiveness and side effects of HT with the use of surgical and medical castration, as well as the results of domestic studies evaluated the effectiveness of the application of the drug buserelin-domestic analogue of LHRH.
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Portokalidou, Zoi, Anna Huysse-Gaytandjieva, and Madelon L. Peters. "Experiences of Patients With Hashimoto Thyroiditis Through the Lens of Compassion." OBM Integrative and Complementary Medicine 7, no. 3 (January 9, 2022): 1. http://dx.doi.org/10.21926/obm.icm.2203027.
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Hashimoto thyroiditis (HT) is an autoimmune disease affecting mainly middle-aged women. Hormonal replacement is the most common therapy; however, it tackles only the functionality of the thyroid and not the autoimmunity components. Thus, patients experience persistent somatic and psychological symptoms, thereby affecting their quality of life. The cause of HT remains uncertain. Primary evidence suggests that adverse experiences in childhood are associated with autoimmune disease manifestation in adulthood; therefore, the effect of early adverse events on disease course needs to be explored. This paper explored patients’ early life events and everyday experiences through the lens of compassion, as defined in compassion-focused therapy (CFT). In this study, nine participants were interviewed, and the transcribed interviews were analyzed using Thematic Analysis. Qualitative analysis indicated that patients exhibited increased psychological distress and a lack of understanding from others. Common patterns of experiences and behaviors were identified, such as the lack of compassion and affiliation between significant others and themselves. Therefore, including psychological care in the therapeutic process of HT would improve patients’ well-being and quality of life. In particular, cultivating compassion could be a promising strategy for disease prevention and the healthy functioning of patients.
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Abdul Sater, Houssein Talal, Ramses F. Sadek, Li fang Zhang, Aaron Gopal, Jean-Pierre Blaize, David Yashar, Reena Patel, Swetha Aribindi, Hiral S. Patel, and Shou-Ching Tang. "Validity of 1% hormonal positivity cutoff by American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines at Georgia Cancer Center." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 1094. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.1094.
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1094 Background: Hormone Receptor Status (HS) in breast cancer (BC) is a universally accepted biomarker. ASCO/CAP 2010 guidelines set the threshold of Estrogen and Progesterone Receptor positivity to 1 %. BC with 1-9% HS expression remains controversial with recent data disputing these guidelines. The objective of this retrospective study was to validate these guidelines at Georgia Cancer Center (GCC) with high percentage of black race. Methods: All female patients with invasive BC diagnosed between 2005-2010 at GCC (11y follow-up) were chart reviewed. We used Cox proportional hazards model to explore survival among three HS groups ( < 1%, 1-9%, ≥10%) adjusting for standard prognostic factors. Hazard ratios (HR) and 95% confidence intervals (CI) were also reported. 1-9 %, and ≥10% groups were further explored using same method to test survival difference with or without hormone therapy (HT). Fischer’s Exact test was used to evaluate response to HT in these groups. Results: 400 patients (all stages) with mean age of 59, were 24.75% HS < 1%, 17.5% HS1-9%, and 57.75% HS≥10%. Race was 43.75% Black, and 54% White. Disease stages were 84.4% early (I-IIIA) and 15.56% late (IIIB-IV). Grades were 51.42% low (1-2) and 48.58% high (3). The 2 groups (1-9%, ≥10%) received chemotherapy (42.86%, 39.83%), and HT (58.57%, 80.52%) respectively while 70.71% of < 1% HS group had chemotherapy. Mortality in HS < 1% was significantly higher than HS ≥10% (HR 1.8, 95% CI 1.07-3.02), while mortality between HS 1-9% and HS ≥10% was not different (HR 1.05, 95% CI 0.48-2.30). Treated (HT) subjects had lower mortality than untreated subjects in the 1-9% group (HR 0.10, 95% CI 0.01-0.85). 100% of HT group had no evidence of tumor at last follow up compared to 87.5% in non-treatment group (p = 0.048). There was no significant difference in mortality between treated (HT) 1-9% and ≥10% groups. Conclusions: Hormone receptor expression as low as 1-9% was found to be equi-prognostic to ≥10% expression. It also predicted response to hormonal therapy. Whether other factors as lympho-vascular invasion, grade, and other parameters change the behavior of the 1-9% HS group remain to be explored.
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Goy, Barry W., and In-Lu Amy Liu. "Redefining the role of adjuvant versus salvage radiation therapy for prostate cancer after radical prostatectomy for T3 disease and/or positive margins." Journal of Clinical Oncology 38, no. 6_suppl (February 20, 2020): 367. http://dx.doi.org/10.1200/jco.2020.38.6_suppl.367.
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367 Background: SWOG 8794 recommends adjuvant radiation therapy (ART) after radical prostatectomy (RP) for T3 and/or positive margins. Our purpose was to assess 12-year outcomes on 862 RP patients who had either T3 and/or positive margins who underwent surveillance, salvage radiation therapy (SRT), or hormonal therapy (HT), while categorizing these patients into very low risk (VLR), low risk (LR), high risk (HR), and ultra high risk (UHR) groups. Methods: From 2004 - 2007, 862 RP patients had adverse factors of extracapsular penetration (T3a), seminal vesicle invasion (T3b), positive margins, and/or detectable post-operative PSA. Management included surveillance (54.8%), SRT (36.8%), and HT (8.5%) as first salvage therapy, and 21.5% eventually received hormonal therapy. Twenty patients underwent ART, and were excluded from this analysis. We assessed prognostic factors using multivariable analysis, and 12-year estimates of freedom from biochemical failure (FFBF), freedom from salvage therapy (FFST), distant metastases-free survival (DMFS), prostate cancer-specific survival (PCSS), and overall survival (OS). VLR were those with Gleason Score (GS) of 6. LR were GS 3+4 with only T3a or positive margins, but an undetectable postoperative PSA <0.1. HR were T3b with GS 7-10, any GS 7-10 with T3a/b and positive margins, but an undetectable PSA. UHR were those with a detectable PSA with a GS 7-10. Results: Median follow-up was 12.1 years. Median age was 61.6 years. Median time to first salvage treatment for VLR, LR, HR, and UHR were 10.8, 11.1, 5.3, and 0.6 years, p<0.001. 12-year estimates of FFBF for VLR, LR, HR, and UHR were 60.2%, 52.9%, 28.4%, and 0%, p<0.0001. For FFST, 70.9%, 68.6%, 40.5%, and 0%, p<0.0001. For DMFS, 99.1%, 97.8%, 88.6%, and 63.6%, p<0.0001. For PCSS, 99.4%, 99.5%, 93.5%, and 78.9%, p<0.0001. For OS, 91.8%, 91.8%, 81.0%, and 69.9%, p<0.0001. Conclusions: Outcomes of T3 and/or positive margins using surveillance or SRT as initial management yields excellent outcomes for VLR and LR groups, in which ART should be avoided. For HR, ART can be considered reasonable, since FFBF is only 28.4%. For VHR, these patients may benefit from combined hormonal therapy and ART.
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Jerez, Jose Manuel, Nuria Ribelles, Pablo Rodriguez-Brazzarola, Tamara Diaz Redondo, Begoña Jimenez Rodriguez, Alfonso Sanchez-Muñoz, Antonia Marquez, et al. "Prediction of early progression (EP) to CDKIs first line treatment in ER+/HER2- metastatic breast cancer (MBC) using machine learning." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e13040-e13040. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e13040.
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e13040 Background: The treatment of luminal MBC has undergone a substantial change with the use of cyclin dependent kinase 4/6 inhibitors (CDKIs). Nevertheless, there is not a clearly defined subgroup of patients who do not initially respond to CDKIs and show EP. Methods: MBC ER+/HER2- patients who have received at least one line of treatment were eligible. The event of interest was disease progression within 6 months of first line treatment according to the type of therapy administered. The first line treatments were categorized in chemotherapy (CT), hormonal therapy (HT), CT plus maintenance HT and HT plus CDKIs. Free text data from clinical visits registered in our Electronic Health Record were obtained until the date of first treatment in order to generate a feature vector composed of the word frequencies for each visit of every patient. Six different machine learning algorithms were evaluated to predict the event of interest and to obtain the risk of EP for every type of therapy. Area under the ROC curve (AUC), True Positive Rate (TPR) and True Negative Rate (TNR) were assessed using 10-fold cross validation. Results: 610 RE+/HER2- MBC treated between November 1991 and August 2019 were included. Median follow up for metastatic disease was 28 months. 17426 clinical visits were analyzed (per patient: range 1-173; median 30). 119 patients received CT as first line treatment, 311 HT, 117 CT plus maintenance HT and 63 HT plus CDKIs. There were 379 patients with disease progression, from which 126 were within 6 months from first line treatment (54 events with CT, 57 with HT, 4 with CT plus maintenance HT and 11 with HT plus CDKIs). The model that yields the best results was the GLMBoost algorithm: AUC 0.72 (95%CI 0.67-0.77), TPR 70.85% (95%CI 70.63%-71.06%), TNR 66.27% (95% 66.08%-66.46%). Conclusions: Our model based on unstructured data from real-world patients predicts EP and establishes the risk for each of the different types of treatment for MBC ER+/HER2-. Obviously an additional validation is needed, but a tool with these characteristics could help to select the best available treatment when that decision has to be made, avoiding those therapies that are probably not to be effective.
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Palomares, Melanie R., Michelle Banzet, Kelley Lu, Jacob Justus, Rebecca A. Ottesen, and Joyce C. Niland. "Breast cancer risk reduction among patients with DCIS." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 1562. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.1562.
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1562 Background: The incidence of ductal carcinoma in situ (DCIS) has dramatically increased with widespread mammographic screening. Although risk of recurrence of DCIS is low, it is associated with a higher risk for subsequent contralateral breast cancer (CBC), for which preventive measures are available. We evaluated the uptake of surgical and pharmacologic interventions to reduce CBC risk at our institution and investigated factors that may influence treatment choices for DCIS. Methods: City of Hope (COH) DCIS patients were identified using two sources, the Circulating Breast Tumor Marker (BrTM) Registry and the National Comprehensive Cancer Network (NCCN) database. Datasets were linked together, and treatment variables were cross-tabulated with patient and tumor characteristics. Results: Of 782 patients with breast malignancy diagnosed since 1997, 370 were excluded due to concurrent or prior invasive disease, 8 due to suspected misclassification based on therapies received, and 4 due to treatment on protocol. Of the remaining pure DCIS patients, treatment choices were recorded for 289. Of those, 40 (14%) chose bilateral risk reduction mastectomy (BRRM), 82 (28%) unilateral mastectomy, 165 (57%) lumpectomy, and 2 had no surgery. Hormonal therapy (HT) was recorded for 215 individuals who did not pursue BRRM: 124 (57%) took tamoxifen, 3 of whom switched to raloxifene, 5 (2%) started with raloxifene, and 7 (3%) took an unspecified hormonal agent, for a total HT uptake of 55%. This included 8 of 29 women with ER-negative DCIS who chose HT for CBC risk reduction. Younger age at diagnosis was associated with BRRM (24% of women diagnosed before age 50, 10% of those diagnosed 50-64, and 5% of women 65+ had BRRM, p<0.001) and HT (59% of women <65 chose HT compared to 40% of women 65+, p=0.009). Within ethnic minorities, more Asian women chose BRRM (22% vs 7% of other minorities, p=0.08). Interestingly, fewer high grade DCIS women opted for HT (39% vs 55% for low to intermediate grade, p=0.06). Conclusions: Young women tend to pursue surgical prophylaxis. Among women who keep their breasts, HT uptake was high across all age and ethnic groups, except for those older than 65 at diagnosis. It is unclear if this is due to patient choice or reflects age bias in physician recommendation.
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Ladha, Abdullah, and Josy Mathew. "Risk factors for fractures in patients on hormonal therapies for breast cancer and DCIS." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e19627-e19627. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e19627.
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e19627 Background: Hormonal therapy with aromatase inhibitors (AI) or tamoxifen (TAM) is standard of care for hormone receptor positive breast cancer and DCIS. Fractures are a complication of treatment with AI due to accelerated bone loss. Risk factors for fracture in patients on hormonal therapy (HT) for breast cancer and DCIS are poorly defined. Methods: All 71 patients with breast cancer or DCIS seen in the bone and mineral clinic of our institution from 2000 to 2010 were analyzed. Data on demographics, pathology, type and duration of HT, bone mineral density studies (BMD), number and site of fractures were collected. Statistical analysis: t test, chi square test and Fisher’s exact test for categorical data. Results: The age of the patients ranged 40 to 97 years. 65 patients had ER positive breast cancer, 6 patients had DCIS. 9 patients had fractures.41 patients were on an AI alone, 8 were on TAM alone and 14 were on both sequentially. Fractures involved: vertebral compression, femur, hip, distal radioulnar, rib, hand and feet bones. Patients who had osteoporosis at the femur, osteoporosis or osteopenia in the lumbar spine or forearm in the initial BMD study were found to have an increased risk of fracture (P<0.05). Patients who were on TAM and AI sequentially had an increased risk of fracture (P<0.05) compared AI alone. The use of bisphosphonates and the duration of use were significantly associated with fracture (P<0.05) as these patients already had osteoporosis. The age, race, duration of AI use and the use of calcium and vitamin D were not found to be significantly different in patients who had fractures compared to those who did not. In the 24 patients who had two BMD studies, there was no significant change in the BMD overall. Conclusions: Patients with osteoporosis or osteopenia at baseline have an increased risk of fracture with the use of hormonal therapies for breast cancer and DCIS. This risk was not eliminated by the use of bisphosphonates. Sequential use of tamoxifen and aromatase inhibitors increase the risk of fractures. Bone mineral density studies done prior to the initiation of hormonal therapy for breast cancer maybe useful estimating the risk of fracture while on treatment.
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Kling, Juliana M., N. Maritza Dowling, Heather A. Bimonte-Nelson, Carey E. Gleason, Kejal Kantarci, JoAnn E. Manson, Hugh S. Taylor, et al. "Impact of menopausal hormone formulations on pituitary-ovarian regulatory feedback." American Journal of Physiology-Regulatory, Integrative and Comparative Physiology 317, no. 6 (December 1, 2019): R912—R920. http://dx.doi.org/10.1152/ajpregu.00234.2019.
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Changes in pituitary-ovarian hormones across the menopausal transition have multiple physiological consequences. However, little is known about how the major types of postmenopausal hormone therapy (HT) affect pituitary-ovarian hormonal relationships. This study evaluated these relationships in recently menopausal women (52.45 ± 2.49 yr of age) in the Kronos Early Estrogen Prevention Study (KEEPS) who were compliant to randomized, double-blinded treatment with oral conjugated equine estrogen (o-CEE; n = 109), transdermal 17β-estradiol (t-E2; n = 107), or placebo ( n = 146). Androstenedione, testosterone, 17β-estradiol, estrone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum before (baseline) and 48 mo after randomization to treatment. Descriptive summaries of hormone levels were performed, and multiple regression analyses were used to examine the effects of o-CEE, t-E2, and placebo on these hormone levels at 48 mo, adjusting for baseline levels. A network analysis examined the covariance of changes in hormone levels over the 48 mo within treatment groups. As expected, at 48 mo of treatment, hormone levels differed between women in the two active treatment groups compared with placebo, and network analysis indicated stronger relationships among hormone levels in the t-E2 and o-CEE groups compared with placebo. Associations among testosterone, 17β-estradiol, FSH, and LH differed between the o-CEE group compared with t-E2 and placebo groups. Thus, two common HT regimens differentially alter pituitary-ovarian hormone levels, altering feedback cycles and interhormonal associations in recently menopausal women. These interactions provide the basis for future studies investigating the impact of hormonal modulation of aging, including cognitive decline in women.
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Schelbaum, Eva, Lacey Loughlin, Steven Jett, Cenai Zhang, Grace Jang, Niharika Malviya, Hollie Hristov, et al. "Association of Reproductive History With Brain MRI Biomarkers of Dementia Risk in Midlife." Neurology 97, no. 23 (November 3, 2021): e2328-e2339. http://dx.doi.org/10.1212/wnl.0000000000012941.
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Background and ObjectivesTo examine associations between indicators of estrogen exposure from women's reproductive history and brain MRI biomarkers of Alzheimer disease (AD) in midlife.MethodsWe evaluated 99 cognitively normal women 52 ± 6 years of age and 29 men 52 ± 7 years of age with reproductive history data, neuropsychological testing, and volumetric MRI scans. We used multiple regressions to examine associations among reproductive history indicators, voxel-wise gray matter volume (GMV), and memory and global cognition scores, adjusting for demographics and midlife health indicators. Exposure variables were menopause status, age at menarche, age at menopause, reproductive span, hysterectomy status, number of children and pregnancies, and use of menopause hormonal therapy (HT) and hormonal contraceptives (HC).ResultsAll menopausal groups exhibited lower GMV in AD-vulnerable regions compared to men, with perimenopausal and postmenopausal groups also exhibiting lower GMV in temporal cortex compared to the premenopausal group. Reproductive span, number of children and pregnancies, and use of HT and HC were positively associated with GMV, chiefly in temporal cortex, frontal cortex, and precuneus, independent of age, APOE ε4 status, and midlife health indicators. Although reproductive history indicators were not directly associated with cognitive measures, GMV in temporal regions was positively associated with memory and global cognition scores.DiscussionReproductive history events signaling more estrogen exposure such as premenopausal status, longer reproductive span, higher number of children, and use of HT and HC were associated with larger GMV in women in midlife. Further studies are needed to elucidate sex-specific biological pathways through which reproductive history influences cognitive aging and AD risk.
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Meyer, Nicole, Yanni Hao, Xue Song, Nianwen Shi, William Johnson, Jaqueline Willemann Rogerio, and Denise A. Yardley. "Healthcare Resource Use and Expenditures among Metastatic Breast Cancer Patients Treated with HER2-Targeted Agents." International Journal of Breast Cancer 2014 (2014): 1–12. http://dx.doi.org/10.1155/2014/475171.
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Objective. To compare healthcare utilization (HCU) and costs of women newly diagnosed with metastatic breast cancer (mBC) by receipt of HER2-targeted agents (H2T) and among H2T subgroups.Methods. Adult women newly diagnosed with mBC (index date) during 2008–2012 were followed until enrollment end or inpatient death. Study cohorts were antineoplastic ± H2Ts, and no treatment; and subgroups of H2T patients stratified by receipt of hormonal therapy (HT+/HT−), byde novoversus recurrent disease status, and by age group. All-cause (ALL) and breast cancer related (BCR) HCU and costs (in 2012 dollars) were estimated using a generalized linear model.Results. Of 18,059 women, 14.6% were H2T users 71.1% nonusers, and 14.3% untreated. No treatment patients had the highest ALL and BCR inpatient HCU, and ALL emergency room HCU. H2Ts users had the highest ALL and BCR office visits, lab and diagnostic radiology, radiation treatments, other outpatient services, and prescription antineoplastics. Adjusted ALL and BCR costs were the highest for H2T users and, in H2T subgroups, higher for HT—versus HT+ andde novoversus recurrent, and declined with older age.Conclusions. Receipt of H2Ts was associated with greater levels of ALL and BCR HCU and costs. H2T subgroups ofHT-,de novo, and younger age had higher HCU and costs, possibly indicating more aggressive treatments.
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Aggarwal, Sangeeta, Mingfeng Liu, Rishi Sharma, Fred Yang, Ankit Gupta, Divjot Singh, Rahul Sharma, Anirban Basak, and Alok Aggarwal. "Voice of Cancer Patients: Analysis of patient concerns regarding cognitive deficits associated with treatment for breast cancer." Journal of Clinical Oncology 33, no. 28_suppl (October 1, 2015): 82. http://dx.doi.org/10.1200/jco.2015.33.28_suppl.82.
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82 Background: Patients undergoing breast cancer treatment often report Symptoms of Cognitive Deficit (SCD). Many of them share their experiences on online forums, which contain millions of freely shared messages that can be used to analyze these SCD. Unfortunately, this data is unstructured, making it difficult to analyze. In this project we organize this data using methods from Big Data Science (BDS) and analyze it by creating a Decision Support System (DSS): an interface that can be used by patients and providers to understand how SCD are associated with specific types – hormonal only (HT), chemo only (CT), or both (CT/HT) – of breast cancer therapies. Methods: We collected 3.5 million unique messages from 20 unrestricted breast cancer forums that provide clinically relevant information. We next built custom ontologies for breast cancer treatments, SCD, and supportive therapies. Then, we created a DSS using methods from BDS, including topic modeling, information retrieval, and natural language processing to extract the relevant data from these messages. We also used token windows and co-occurrence-based algorithms to associate treatment with SCD and supportive therapies. To use this system, a user provides disease-related parameters and the treatment. The DSS then gives the percentage of messages discussing SCD for a similar cohort of patients and the percentage of messages that discuss supportive therapies for each of these SCD. Results: We found 15719 messages that had strong association of SCD with treatments. 3355 messages were from HT patients, 5740 messages were from CT patients, and 9095 messages were from CT/HT patients. Among HT, 28.18% patients taking aromatase inhibitors and 19.20% taking tamoxifen associated SCD to HT. Among CT, 35.26% patient receiving taxane containing chemo associated SCD to CT. SCD worsened during HT for CT/HT patients. Suggestive therapy: 80 messages found Vitamin B12 and B6 useful, 65 suggested Acetyle-L-Carnitine, and 50 suggested playing word games. Conclusions: Using methods from BDS, our DSS reliably associates SCD with HT, CT and CT/CT, and suggests supportive therapies. More research is needed to evaluate the role of supportive therapy for SCD.
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Bove, Riley, Liene Elsone, Enrique Alvarez, Nadja Borisow, Melissa M. Cortez, Farrah J. Mateen, Maureen A. Mealy, et al. "Female hormonal exposures and neuromyelitis optica symptom onset in a multicenter study." Neurology - Neuroimmunology Neuroinflammation 4, no. 3 (March 24, 2017): e339. http://dx.doi.org/10.1212/nxi.0000000000000339.
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Objective:To study the association between hormonal exposures and disease onset in a cohort of women with neuromyelitis optica spectrum disorder (NMOSD).Methods:Reproductive history and hormone use were assessed using a standardized reproductive survey administered to women with NMOSD (82% aquaporin-4 antibody positive) at 8 clinical centers. Using multivariable regression, we examined the association between reproductive exposures and age at first symptom onset (FS).Results:Among 217 respondents, the mean age at menarche was 12.8 years (SD 1.7). The mean number of pregnancies was 2.1 (SD 1.6), including 0.3 (SD 0.7) occurring after onset of NMOSD symptoms. In the 117 participants who were postmenopausal at the time of the questionnaire, 70% reported natural menopause (mean age: 48.9 years [SD 3.9]); fewer than 30% reported systemic hormone therapy (HT) use. Mean FS age was 40.1 years (SD 14.2). Ever-use of systemic hormonal contraceptives (HC) was marginally associated with earlier FS (39 vs 43 years, p = 0.05). Because HC use may decrease parity, when we included both variables in the model, the association between HC use and FS age became more significant (estimate = 2.7, p = 0.007). Among postmenopausal participants, 24% reported NMOSD onset within 2 years of (before or after) menopause. Among these participants, there was no association between age at menopause or HT use and age at NMOSD onset.Conclusions:Overall, age at NMOSD onset did not show a strong relationship with endogenous hormonal exposures. An earlier onset age did appear to be marginally associated with systemic HC exposure, an association that requires confirmation in future studies.
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Ravnik, M., A. Sadikov, N. Snoj, P. Nussdorfer, and T. Cufer. "Validation of Adjuvant!Online on Slovenian collective of early breast cancer patients." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e11532-e11532. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e11532.
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e11532 Background: Adjuvant!Online is a very useful tool for prognosis assessment of early breast cancer (EBC) patients. In the validation study, made on mostly untreated (45%) Canadian EBC patients, Adjuvant!Online proved to be a very reliable prognostic tool. The aim of our study was to validate Adjuvant!Online on EBC patients mainly treated with some kind of adjuvant systemic therapy. Methods: 753 EBC patients diagnosed and treated at the Institute of Oncology Ljubljana, Slovenia, with at least 10-year follow-up were included into the study. All patients received radical local therapy. Adjuvant chemotherapy (ChT) was either CMF or anthracycline-based schema and hormonal therapy (HT) was mainly tamoxifen. Adjuvant!Online 8.0 individual prediction of OS was calculated (with default value of “minor problems” as comorbidity for all patients). The average prediction over all patients was compared to the observed 10-year OS. Results: The predicted and observed 10-year OS of the whole group were 65.5% and 61.5%, respectively. The differences between predicted and observed OS did not differ substantially in the subgroups of patients stratified according to the classical prognostic factors, however, a large difference was found when stratifying by adjuvant systemic therapy. The puzzling difference in patients without systemic therapy (ST) can be both due to small group size and due to special selection of these patients (comorbidity). Conclusions: According to our observation, Adjuvant!Online is a reliable tool for prognosis assessment in EBC patients treated with HT, but it seems to overestimate prognosis in patients treated with ChT, alone or in combination with HT. This is evident even for our collective of EBC patients mainly treated with the first generation ChT - CMF or anthracyclines. Apparently, both Adjuvant!Online and Overview overestimate the positive effect of ChT, disregarding the biologic characteristics of the tumors and inherent effect of HT in HR+ patients. [Table: see text] No significant financial relationships to disclose.
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Sinibaldi, V. J., M. A. Carducci, K. Elza-Brown, E. Rosenbaum, S. Denmeade, R. Pili, J. Walczak, E. Garrett-Mayer, S. Moore-Cooper, and M. A. Eisenberger. "A phase II evaluation of imatinib mesylate (G) in stage M0 prostate cancer (PC) patients (pts) on hormonal therapy (HT) with evidence of biochemical relapse." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 14612. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.14612.
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14612 Background: Imatinib mesylate (Gleevec, G) is a potent inhibitor of the tyrosine kinases and other signaling mediated events. Preclinical models suggest that G inhibits platelet derived growth factor (PDGF) and stem cell factor (SCF) which are important for prostate cancer growth. This trial was designed to evaluate the safety and efficacy of G in PCA pts on HT with stage M0 disease. Methods: Eligible PCA pts included: stage M0 disease with rising PSA levels while on hormonal therapy, no prior chemotherapy. Planned treatment included G 400 mg PO BID given up to a maximum of 12 months. The statistical endpoint for this trial was the% of pts with a ↓ in prostate specific antigen (PSA) ≥ 50% lasting ≥ 4 wks. A 2 stage trial was designed where the study would terminate if the% of pts meeting the endpoint was not convincingly > 30% with 5% chance for error. Pts with a > 50% rise in PSA from baseline were removed from study. Follow-up included monthly toxicities and PSA (specimens frozen/stored until completion of each 3 months of therapy). Results: From 10/1/02–10/11/04, nine pts were enrolled. Pt characteristics included median: age of 67 years (range 52–80), ECOG performance status of 0 (range 0–1), baseline PSA of 29.6 ng/ml (range 2.69–39.52), # prior hormonal manipulations of 3 (1–5). Prior local therapies included: 1 status post (s/p) RP alone, 2 s/p RT alone, 2 s/p neoadjuvant HT plus RP, 2 s/p neoadjuvant HT plus RT. Two pts had no prior local therapy. Two pts had prior salvage RT, 1 had prior palliative RT. Eight of 9 pts evaluable for response and toxicity. One patient never received treatment. None of the pts had a decline 50% decline in PSA level lasting ≥ 4 weeks. Three of 8 pts (38%) had rapid increases in PSA and 4/8 pts (50%) developed metastatic disease after 3 months of therapy. Only one pt completed 12 months of planned therapy. Grade 3/4 toxicities included: fatigue (25%), rash (25%), arthralgias (12.5%), peripheral edema (25%), depression (12.5%), necessitating dose delays and/or discontinuation of G in 4/8 pts (50%). Conclusions: These data suggest significant toxicity and low clinical benefit. Further evaluation of Gleevec in this pt population is not warranted. No significant financial relationships to disclose.
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Mason, Jeremy, Yutao Gong, Laleh Amiri-Kordestani, Suparna Wedam, Jennifer J. Gao, Tatiana M. Prowell, Harpreet Singh, et al. "Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer." JCO Clinical Cancer Informatics, no. 5 (June 2021): 758–67. http://dx.doi.org/10.1200/cci.21.00025.
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PURPOSE Three cyclin-dependent kinase 4/6 inhibitors (CDKIs) are approved by the US Food and Drug Administration for the treatment of patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer in combination with hormonal therapy (HT). We hypothesized that on an individual basis, efficacy outcomes and adverse event (AE) development can be predicted using baseline patient and tumor characteristics. METHODS Individual-level data from seven randomized controlled trials submitted to the US Food and Drug Administration for new or supplemental marketing applications of CDKIs were pooled. Progression-free survival (PFS), overall survival (OS), and AE prediction models were developed for specific treatment regimens (HT v HT plus CDKI). An individual's characteristics were used in all models simultaneously to create a group of predicted outcomes that are comparable across treatment settings. RESULTS Accuracy of the PFS and OS prediction models for HT were 66% and 64%, respectively, with the strongest predictors being menopausal status and therapy line. The corresponding AE prediction models resulted in an average area under the curve of 0.613. Accuracy of the PFS and OS prediction models for HT plus CDKI were 62% and 63%, respectively, with the strongest predictors being histologic grade for both. The corresponding AE prediction models resulted in an average area under the curve of 0.639. CONCLUSION This exploratory analysis demonstrated that models of efficacy outcomes and AE development can be developed using baseline patient and tumor characteristics. Comparison of paired models can inform treatment selection for individuals on the basis of the patient's personalized goals and concerns. Although use of CDKIs is standard of care in the first- or second-line setting, this model provides prognostic information that may inform individual treatment decisions.
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Mattar, André, Guilherme R. Fonseca, Murilo B. A. Romão, Jorge Y. Shida, Vilmar M. de Oliveira, Maria C. S. Bastos, Fabio Bagnoli, et al. "Substantial Reduction in Adjuvant Chemotherapy With the Use of the 21-Gene Test to Manage Early Breast Cancer in a Public Hospital in Brazil." JCO Global Oncology, no. 7 (July 2021): 1003–11. http://dx.doi.org/10.1200/go.20.00609.
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PURPOSE We evaluated the impact of 21-gene test results on treatment decisions for patients with early-stage breast cancer treated under the public health care system in Brazil, Sistema Único de Saúde. METHODS Eligible patients treated at Hospital Pérola Byington and Santa Casa de Misericórdia de São Paulo in Brazil were required to have the following characteristics: postsurgery with hormone receptor–positive, human epidermal growth factor 2–negative, node-negative and node-positive, and T1/T2 breast cancer and patients with these characteristics were candidates for adjuvant systemic therapy. Treatment recommendations, chemotherapy plus hormonal therapy (CT + HT) or HT alone, were captured before and after 21-gene test results. RESULTS From August 2018 to April 2019, 179 women were enrolled. The mean age was 58 years (29-86 years), 135 (76%) were postmenopausal, and 58 (32%) had node-positive breast cancer. Most patients (61%) had a tumor > 2 cm, including 7% with tumors > 4 cm. Using Recurrence Score (RS) result cut points on the basis of the TAILORx trial, 40 (22%) had RS 0-10, 91 (51%) had RS 11-25, and 48 (27%) had RS 26-100. Before 21-gene testing, 162 of 179 (91%) patients were recommended for CT. After testing, 117 of 179 patients (65%) had changes in CT recommendation: 112 (63%) who were initially recommended CT received HT alone and five (3%) who were initially recommended HT alone received CT + HT. After 21-gene testing, 99% of physicians reported strong confidence in their treatment recommendations. CONCLUSION The change in clinical practice at these public hospitals was greater than expected: 66% of initial treatment recommendations were changed to omit CT with 21-gene test results. Clinicopathologic features did not correlate well with 21-gene test results and did not adequately identify those most likely to benefit from CT.
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Ellis, Peter G., Adam M. Brufsky, Sushil Beriwal, Kathleen G. Lokay, Hans O. Benson, Stephanie B. McCutcheon, and Melinda Krebs. "Pathways Clinical Decision Support for Appropriate Use of Key Biomarkers." Journal of Oncology Practice 12, no. 6 (June 2016): e681-e687. http://dx.doi.org/10.1200/jop.2015.010546.
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Purpose: Breast cancer diagnostics have the ability to predict disease recurrence and the benefit of chemotherapy. This study measures the use of a diagnostic assay, Oncotype DX, when embedded in a breast cancer decision support algorithm and, on the basis of the assay results, the use of chemotherapy in the adjuvant setting. Methods: UPMC CancerCenter retrospectively reviewed patients with estrogen receptor–positive, human epidermal growth factor receptor 2 (HER2)Neu–negative disease with zero to three positive nodes navigated in the Via Pathways decision support portal during a 12-month period. The breast algorithm prompted input of the assay recurrence score (RS) and then recommended hormonal therapy alone (HT) for low RS, or chemotherapy followed by HT for high RS. The patient’s RS was correlated with the treatment decision. Results: During this time period, 643 patients had ER-positive, HER2Neu-negative disease with zero to three positive nodes. Of those, 596 (92.7%) had diagnostic testing to determine chemotherapy plus HT versus HT alone, and 47 had chemotherapy followed by HT without an RS. For node-negative patients classified with low or high RS, pathway treatment adherence rates were 99.7% and 96.6%, respectively; node-positive patients had 95.7% and 87.5% adherence rates, respectively. Conclusion: This analysis demonstrates the use of a clinical pathway to measure the adoption of a diagnostic test, the Oncotype DX breast assay, and the use of the appropriate therapy on the basis of the RS. As more diagnostics are established to aid in the personalized treatment of diseases, pathways may be important in maintaining clinician awareness of the appropriate disease presentations where these tests should be used, measuring usage of these tests, and tracking the treatment decisions on the basis of test results.