Journal articles on the topic 'Chemotherapy (CT)'
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1
Tomaro, Maria, Paula Silverman, Wendy Rowehl Miano, Amy Wakeling, and Kathleen Gonzalez. "Chemotherapy safety initiative." Journal of Clinical Oncology 31, no. 31_suppl (November 1, 2013): 226. http://dx.doi.org/10.1200/jco.2013.31.31_suppl.226.
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226 Background: The 2006 Institute of Medicine report "Preventing Medication Errors," stated that “medication errors harm at least 1.5 million patients every year…” Chemotherapy (CT) has a narrow therapeutic index and safety margin which can and does lead to fatal errors. University Hospitals Seidman Cancer Center (UHSCC), an National Cancer Institute (NCI) designated Comprehensive Cancer Center, dispensed 10,500 CT doses in 2012 and has taken an active approach to enhance CT safety. Methods: In the last quarter of 2012, a nurse coordinator (NC) for chemotherapy orders and a Chemotherapy Safety Governance Committee (CSGC) was conceptualized. The NC’s role would be to incorporate CT safety best practices into order set development. The charter for the CSGC includes 1) to establish cancer CT standards and operating procedures across the adult and pediatric oncology population; 2) to develop and oversee cancer CT order set infrastructure applicable to our hybrid electronic/paper current state; and 3) to lead performance improvement initiatives related to CT safety. Leading organizations involved in oncology practice and medication safety standard-setting (ASCO, Oncology Nursing Society, Institute For Safe Medication Practices, National Comprehensive Cancer Network, Journal of Cancer Research) were reviewed for recommendations for standards for CT order sets. Results: Thirty standards for a CT order template were identified by the NC. A comprehensive gap analysis was completed to compare the current inpatient and ambulatory CT order sets to these standards. Results of the gap analysis were brought to the CSGC, a multi-disciplinary group of cancer and quality clinicians and leaders over 6 meetings. Consensus was achieved on the application of these standards to CT order sets. Our new orders will adopt 100% of all identified standards for CT orders. Conclusions: The gap analysis led to the development of a CT order set template that maximizes safety by applying best-practice standards. This template is designed to be applicable to electronic and paper-based order sets and with minor variation, appropriate to all disease-based order sets. This template is currently being utilized to revise 330 electronic and 398 paper CT order sets at UHSCC. [Table: see text]
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Robinson, S. I., J. Murray, and R. R. McWilliams. "Celiac disease and chemotherapy." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 19561. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.19561.
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19561 Background: Diarrhea is a common side effect of chemotherapy (CT). At times, often unpredictably, patients develop profound diarrhea during CT. Though the clinical diagnosis of celiac disease (CD) is relatively rare, (1/ 2000), the serologic prevalence is much higher (1/ 133), suggesting a large number of undiagnosed cases. Latent CD may be unmasked by stressors, such as CT. We hypothesized that undiagnosed CD may account for some cases of severe diarrhea from CT. Methods: We performed a retrospective chart review at the Mayo Clinic (1980–2006) for patients with diagnoses of cancer and CD that received CT at our center. CD cases were confirmed by biopsy (n= 25) or serologic studies. Data analyzed included severe (grade ≥ 3,) diarrhea while on CT, site of primary cancer, diagnosis of CD prior to or after CT, and specific CT agents received. Results: We identified 27 patients with CD and cancer (12 lymphoma, 6 gastrointestinal, 2 leukemia, 2 breast, 1 brain, bladder, lung, uterine, sarcoma) who received CT at our center. Fifteen were diagnosed with CD prior to receiving CT and 12 after, with the former group presumably on a gluten-free diet. One patient was excluded for lack of clinical data. Five of remaining 14 patients (35%) managed for their CD prior to CT had diarrhea, though 4 of these 5 had only mild diarrhea (gr. 1). One patient suffered gr. 3 diarrhea, though was reported to be poorly compliant with his diet. Three patients received treatment with 5- fluorouracil (5FU), and 2 had gr. 1 diarrhea. Five of the 12 patients (42%) with celiac disease undiagnosed prior to CT were reported to have diarrhea during treatment (3 gr. 4; 2 gr. 1). Of those receiving 5FU, 3 out of 4 had severe (gr. 4) diarrhea. The small numbers of patients precluded meaningful statistical analysis. Conclusion: Patients with known CD compliant with a gluten-free diet tolerated CT well. However, in a subset of undiagnosed patients, severe diarrhea developed during CT, most notably with 5FU-based regimens. We propose that when patients have diarrhea disproportionate to other effects, CD should be considered. Also, in malignancies with a high incidence of CD such as lymphoma and small bowel cancer, underlying CD should be considered before CT is given. No significant financial relationships to disclose.
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Rehan, Fareed A., Corinne Brillant, Holger Schulz, Ina Knauel, Julia Bohlius, Lena Specht, and Andreas Engert. "Chemotherapy Alone Versus Chemotherapy Plus Radiotherapy for Early Stage Hodgkin Lymphoma." Blood 110, no. 11 (November 16, 2007): 2320. http://dx.doi.org/10.1182/blood.v110.11.2320.2320.
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Abstract Both chemotherapy (CT) alone and combined modality therapy (CMT) are effective modalities for the treatment of early stages of Hodgkin lymphoma (HL). However, the optimal choice of treatment is still being discussed. Different research groups reported that ABVD-like CT followed by radiotherapy is highly effective for early favourable and early unfavourable (intermediate) stage HL. A recently conducted randomized trial aimed at determining whether CMT is superior to CT alone in early stages, showed no significant difference in 5 year overall survival (OS) and event-free survival in patients treated with either 4–6 cycles of ABVD alone or 2 cycles of ABVD plus radiotherapy. Thus, this systematic review and meta-analysis was performed for a more comprehensive comparison. Methods: Only randomized controlled trials (RCT) comparing CT alone with CMT in newly diagnosed adults with early stages of HL (CS IA, IB, IIA, IIB) were included. Medline and Cochrane Library were systematically searched for randomized controlled trials from 1975 to 2007. Patients who received CMT were considered as experimental group and patients who received ABVD-like CT alone were considered as control group. Data were collected from full text publications or abstracts and treatment effects for OS were calculated as hazard ratios (HR). Results: A total of 590 references were screened. Four eligible RCTs were identified, including 1207 patients with early-stage HL (early favourable and early unfavourable stages). Between 1983 and 2004, 765 patients where treated with CMT and 442 patients with CT alone. The OS for the CMT group was significantly better than the OS for the CT-alone group (HR: 0.54; 95% CI [0.35 - 0.84]; p = 0.006), but there was evidence for a substantial heterogeneity between the studies (I2 = 69%, p=0.02). Discussion: First results of this systematic review showed improved OS for patients treated with CMT in early-stage HL compared to patients treated with CT alone. The substantial heterogeneity between the trials should be clarified. Further comprehensive analyses are ongoing and will provide more detailed information.
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Debled, M., A. Trainaud, M. Durand, A. Floquet, V. Brouste, and L. Mauriac. "Administration of further chemotherapy (CT) after capecitabine as first-line chemotherapy (CT) for metastatic breast cancer (MBC)." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 1095. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.1095.
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1095 Background: Based on results of randomized trials of Xeloda (X) vs CMF or taxanes (T) as first-line CT for MBC, very favorable tolerability, and patients’ (pts) preference for oral therapy, front-line X is now often used in our institution, especially for slowly progressing disease. As other CT regimens, especially T, have demonstrated improved OS, we analyzed post-X CT in these pts. Methods: Analysis was restricted to pts who began X before Jan 05, all of whom have now discontinued because of progression or toxicity. Results: In 90 eligible pts, median TTF and OS from initiation of X are 9 [95% CI 7–11] and 26 [22–30] months, respectively. 75% of pts received second-line CT. Three subgroups can be analyzed: (A) 65 pts (median age 58y, range 34–84) received further CT (median 2 regimens, range 1–6) after stopping X, including T (85% of pts), anthracycline (a/c: 42%), vinorelbine (45%), or mitomycin C (20%). 24 pts received =2 regimens including a/c and T; 7 pts received neither T nor a/c (vinorelbine, n = 6; UFT, n = 1). Median OS from initiation of X was 30 months [95% CI 27–32]. 30 pts are alive after a 16-month median follow-up since X failure; they may receive another CT; (B) 3 pts are currently receiving endocrine therapy after X failure and may receive another CT later; (C) 22 pts (24%) (median age 77y, 19 =70y) died without receiving further CT. Median OS from initiation of X was 11 months (range 0.5–23). 4 of these pts (aged 57, 71, 74, and 84y) received endocrine therapy for 2–10 months. Ability to administer further CT varies with age: of pts <75y, 89% received subsequent CT (T: 75%), whereas 37% of pts =75y received second-line CT. Conclusions: TTF and OS indicate that capecitabine is very active as first-line CT for MBC. For a large majority of pts <75y, first-line X does not compromise administration of further CT including T. No significant financial relationships to disclose.
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Zhu, Yunshu, Sheng Yang, Shengyu Zhou, Jianliang Yang, Yan Qin, Lin Gui, Yuankai Shi, and Xiaohui He. "Nimotuzumab plus platinum-based chemotherapy versus platinum-based chemotherapy alone in patients with recurrent or metastatic nasopharyngeal carcinoma." Therapeutic Advances in Medical Oncology 12 (January 2020): 175883592095373. http://dx.doi.org/10.1177/1758835920953738.
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Background: Palliative chemotherapy has been the mainstay treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC). However, little is known about the efficacy and toxicity of nimotuzumab (NTZ) – a monoclonal antibody drug targeting epidermal growth factor receptor – plus chemotherapy (CT) versus CT alone for these patients. Methods: The database at Cancer Hospital of Chinese Academy of Medical Sciences was queried for patients diagnosed with NPC who received CT with or without NTZ between 2004 and 2018. Treatment compliance, survival outcomes, and adverse effects were compared among these groups. Results: Records of 70 patients with R/M-NPC were reviewed: 21 (30%) received NTZ plus CT (NTZ+CT) and 49 (70%) received CT. CT regimens included gemcitabine plus platinum, taxane plus platinum (TP), and fluorouracil plus platinum. Comparing the CT group with NTZ+CT group, the median follow up was 62 months (range = 3–133) versus 59 months (range = 9–117); median progression free survival was 7.5 [95% confidence interval (CI) 6.552–8.381] months versus 8.5 (95% CI 6.091–10.976) months, p = 0.424; median overall survival (OS) was 25.6 (95% CI 18.888–32.379) months versus 48.6 (95% CI 35.619–61.581) months, p = 0.017, respectively. Multivariable analysis established treatment group (CT versus NTZ+CT) as an independent prognostic factor for OS (hazard ratio, 0.5; 95% CI 0.255–0.979; p = 0.043). No significant difference with regard to toxicities was observed between the two groups. Among them, a subgroup analysis was performed in 53 (75.7%) patients who received TP with or without NTZ, which showed similar results. Conclusion: Our findings suggested that NTZ+CT provides a novel treatment option and prolongs survival significantly for R/M-NPC.
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Ali, Maria, M. Christine Cripps, Katelyn Balchin, Jennifer Spencer, and Paul Wheatley-Price. "Palliative inpatient chemotherapy: Clinical benefit or harm?" Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e19527-e19527. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e19527.
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e19527 Background: Palliative chemotherapy (CT) is given with the goals of palliating cancer symptoms and prolonging life. Patients with a poor performance status (PS) generally derive less benefit from CT and may experience greater toxicity. Advanced cancer patients admitted to hospital generally have a poor PS, and yet palliative CT is often administered to hospitalized patients. The evidence to support palliative CT in hospitalized patients is scarce. We hypothesize that palliative in-patient CT does not result in meaningful clinical benefit. Methods: With ethics approval, a retrospective chart review was undertaken to report outcomes from in-patient CT at the Ottawa Hospital Cancer Centre between April 2008- January 2010. From hospital pharmacy records, all advanced solid tumor patients receiving in-patient palliative CT were identified. Patients receiving radical, curative, neo- or adjuvant therapy, or those admitted for an inpatient regimen, were excluded. The primary endpoints were overall survival following CT, place of discharge from hospital, and whether further CT was received. Results: We report 199 in-patients (23% breast cancer, 22% small cell lung cancer, 16% NSCLC, 39% other) who received CT (median 1 cycle, range 1-5) during the study period. The median age was 61 (range 19-88); 59% were female. The main reasons for hospital admission were dyspnea (31%) or pain (29%). At baseline 25% were anemic, 36% had leucocytosis and 70% were hypoalbuminemic (<30g/l). 67% were receiving 1st line CT. The median overall survival was 4.5 months (95% CI: 3.2 - 5.8). Longest survival was seen in SCLC patients (7.3m). 77% of patients were discharged home, but 17% died during the admission. 72% of patients received further systemic therapy. Factors significantly associated with shorter survival were hypoalbuminemia (HR 1.52, 95% CI 1.06- 2.18, p=0.02), and therapy in 2nd line or beyond (HR 2.10, [1.37-3.23], p<0.001). Receiving treatment beyond 1st line, and baseline leucocytosis, were both significantly associated with patients being less likely to be discharged home or receive further CT. Conclusions: While in-patient palliative CT is associated with short survival, many patients remain well enough to be discharged home and receive further therapy.
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Landre, Thierry, Kader Chouahnia, Gaëtan Des Guetz, Boris Duchemann, Jean-Baptiste Assié, and Christos Chouaïd. "First-line immune-checkpoint inhibitor plus chemotherapy versus chemotherapy alone for extensive-stage small-cell lung cancer: a meta-analysis." Therapeutic Advances in Medical Oncology 12 (January 2020): 175883592097713. http://dx.doi.org/10.1177/1758835920977137.
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Introduction: Platin-based chemotherapy (CT) has long been the first-line standard-of-care for patients with extensive-stage small-cell lung cancer (ES–SCLC). Adding immune-checkpoint inhibitor(s) to CT (ICI+CT) in this setting is an option of interest, although its benefit is apparently modest. Methods: This meta-analysis was conducted on randomized trials comparing first-line ICI+CT versus CT alone for ES–SCLC. Outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), response at 12 months and adverse events (AEs). Subgroup analyses were computed according to the immunotherapy used, performance status (PS), age, platinum salt, liver metastases and brain metastases at diagnosis. Results: The literature search identified one randomized phase II (ECOG-ACRIN-5161) and four phase III trials (CASPIAN, IMPOWER-133, KEYNOTE-604 and Reck et al. 2016) that included 2775 patients (66% males, 95% smokers, median age: 64 years, PS = 0 or 1). ICI+CT was significantly associated (hazard ratio [95% confidence interval]) with prolonged OS [0.82 (0.75–0.89); p < 0.00001] and PFS [0.81 (0.75–0.87); p < 0.00001], with OS benefits for anti-PD-L1 [0.73 (0.63–0.85); p < 0.0001] or anti-PD-1 [0.76 (0.63–0.93); p < 0.006] but not for anti-CTLA-4 [0.90 (0.80–1.01), p = 0.07]. ORRs for ICI+CT or CT alone were comparable [odds ratio 1.12 (0.97–1.00); p = 0.12], but responses at 12 months favored ICI+CT [4.16 (2.81–6.17), p < 0.00001]. Serious grade-3/4 AEs were more frequent with ICI+CT [odds ratio 1.18 (1.02–1.37); p = 0.03]. Compared with CT, no ICI+CT benefit was found for ES–SCLC with brain metastases at diagnosis [HR 1.14 (0.87–1.50); p = 0.34]. Conclusions: First-line ICI+CT appears to be superior to CT alone for ES–SCLC except for patients with brain metastases at diagnosis.
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Lampe, H., A. Horwich, A. Norman, J. Nicholls, and D. P. Dearnaley. "Fertility after chemotherapy for testicular germ cell cancers." Journal of Clinical Oncology 15, no. 1 (January 1997): 239–45. http://dx.doi.org/10.1200/jco.1997.15.1.239.
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PURPOSE To analyze the probability of recovery of spermatogenesis after orchidectomy and cisplatin-based chemotherapy (CT) for testicular germ cell cancer. PATIENTS AND METHODS One hundred seventy-eight patients treated between 1979 and 1991 were selected by the requirement of sperm count both pre-CT and post-CT. Counts were classified as normospermic (NS) if more than 10 x 10(6)/mL, oligospermic (OS) if 1 to 9 x 10(6)/mL, and azoospermic (AS) if less than 1 x 10(6)/mL. The median follow-up time after CT before sperm analysis was 30 months. RESULTS Analysis of 170 patients whose spermatogenesis was reassessed at least 1 year after CT showed that of 89 patients whose pre-CT counts were NS, the post-CT count was NS in 64%, OS in 16%, and AS in 20%. There was clear evidence for continued recovery beyond 1 year; the probability of spermatogenesis increased to 48% by 2 years and 80% by 5 years. There was a significantly higher probability of recovery to OS and NS count levels in the 54 patients treated with carboplatin-rather than cisplatin-based therapy. There was an independent and similar effect of normal pre-CT count. There was a reduced probability to recover to OS in the 26 patients treated with more than four cycles of CT. A prognostic model identified three groups with 25%, 45%, and 82% probabilities of recovering spermatogenesis by 2 years after CT. CONCLUSION Analysis of pre-CT sperm count together with details of planned treatment can be used to predict recovery of spermatogenesis following germ cell CT.
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Refaie, Huda, Mohamed Sarhan, and Ashraf Hafez. "Role of CT in Assessment of Unresectable Wilms' Tumor Response after Preoperative Chemotherapy in Pediatrics." Scientific World JOURNAL 8 (2008): 661–69. http://dx.doi.org/10.1100/tsw.2008.96.
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The purpose of this study was to define the structural response of unresectable Wilms' tumor following preoperative chemotherapy by computed tomography (CT). We also compared CT changes in relation to histopathological nature. The study included 36 patients with 41 nephroblastomas. All were examined by CT before preoperative chemotherapy using multiphasic CT protocol study. The unresectability was diagnosed by CT imaging. All patients were subjected to fine-needle biopsy (FNB) to confirm the diagnosis and to define the histopathological type before preoperative chemotherapy. Five patients had unfavorable pathology and 31 patients with 36 nephroblastomas had favorable pathology. All patients received first line of treatment. Follow-up of these patients by CT at the 6th week was reviewed. All of our patients were diagnosed as unresectable Wilms' tumor by CT. Preoperative chemotherapy was started. Among our patients, 28 (77.8%) gave good response in the form of significant reduction in tumor size, disappearance of one tumor in two cases with bilateral WT and inferior vena cava (IVC) thrombus, and increased nonenhancing necrotizing content. Two patients with unfavorable pathology did not show any response. The remaining six patients gave partial response. CT can be used to evaluate tumor response and resectability after preoperative chemotherapy with high accuracy. The response to preoperative chemotherapy is not related to the histopathological classifications.
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Yoon, Choon Sik, Myung Jun Kim, Mi Hae Kim, and Ki Keun Oh. "Wilms' tumor:Changes of CT findings after chemotherapy." Journal of the Korean Radiological Society 29, no. 6 (1993): 1331. http://dx.doi.org/10.3348/jkrs.1993.29.6.1331.
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Aleixo, Gabriel, Stephanie A. Valente, Wei Wei, Po-Hao Chen, and Halle C. F. Moore. "CT scan versus bioelectrical impedance spectrometry sarcopenia assessment to predict chemotherapy toxicity in early breast cancer." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 12078. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.12078.
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12078 Background: There is growing literature on the impact of the progressive loss of skeletal muscle known as sarcopenia in women with early breast cancer (EBC). Imaging techniques such as Computed Tomography (CT) scans are the most studied methods to detect sarcopenia in patients with cancer; however, most patients with EBC do not require routine CT scans. Bioelectrical impedance spectrometry (BIS) is a method that does not expose patients to radiation and provides measurements to assess sarcopenia instantaneously. The extent to which BIS-assessed sarcopenia correlates with CT-assessed sarcopenia is uncertain. It is also unclear whether sarcopenia detected with either method can be associated with chemotherapy tolerance To address these questions, we evaluated the correlation between CT and BIS sarcopenia and associations of sarcopenia by each method with chemotherapy related outcomes in patients with EBC. Methods: This retrospective study identified patients with EBC who received chemotherapy (ACT, TC, TH, THP), underwent BIS analyses (ImpediMed) at any point between diagnosis and treatment completion and also received a CT abdomen including L3 level. Axial CT L3 segments were analyzed using Slice-O-Matic software. CT L3, and BIS generated the Skeletal Muscle (SM). Skeletal Muscle Index (SMI) was then calculated to assess for sarcopenia: BIS SMI= (SM in kg)/ (patient height, m2) and CT L3 SMI (SM cm2/ height m2). Patients were divided into normal SMI, and sarcopenia (if BIS was used SMI <6.75 kg/m2 and if CT SMI <40 cm2/m2). Patient medical records were reviewed for patient characteristics, grade 3 and 4 toxicity, including neuropathy symptoms, chemotherapy dose reductions, early treatment discontinuation or need for hospitalization during chemotherapy treatment. Spearman's rank coefficient was used to assess the correlation between CT SMI and BIS SMI. Multivariable logistic regression was used to associate sarcopenia with outcomes, controlling for age and BMI. Results: 361 patients received chemotherapy, underwent BIS; of those 171 had L3 CT scans. The correlation between L3 CT SMI and BIS SMI was r= 0.64 p<0.0001. In the multivariable model, sarcopenia assessed by L3 CT scan was associated with chemotherapy dose reduction (CI 0.04-0.60 p=0.01) and neuropathy (CI 0.10-0.95 P=0.04) but not with grade 3 or 4 chemotherapy toxicity (CI 0.13-1.09 p=0.07), early treatment discontinuation (p=0.3) or hospitalization (p=0.60). Sarcopenia assessed by BIS was associated with grade 3 or 4 chemotherapy toxicity (CI 0.2-0.83 p=0.01), neuropathy (CI 0.1-0.51 p=0.0003), early treatment discontinuation (OR 0.26 CI 0.11-0.80 p=0.001), and hospitalization (CI 0.12-0.68 p=0.004). Conclusions: There is a strong correlation between L3 CT scan and BIS screened sarcopenia in patients with EBC. Sarcopenia detected with either CT L3 or BIS is associated with worse chemotherapy tolerance.
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Liu, G., E. Franssen, M. I. Fitch, and E. Warner. "Patient preferences for oral versus intravenous palliative chemotherapy." Journal of Clinical Oncology 15, no. 1 (January 1997): 110–15. http://dx.doi.org/10.1200/jco.1997.15.1.110.
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PURPOSE To assess patient preference for oral versus intravenous (i.v.) palliative chemotherapy (CT). A strong preference would be an important quality-of-life issue. PATIENTS AND METHODS A structured interviewer-administered scenario-based questionnaire evaluated incurable cancer patients who would be likely to receive palliative CT in the future. Using probability trade-offs, the preference for route of administration was evaluated against diminishing treatment response. RESULTS Of 103 assessable patients, 92 preferred oral CT, 10 preferred i.v. CT, and one had no preference. Patient preferences were not associated with age, sex, site of primary cancer, or previous CT experiences. Major reasons for preferring oral CT were convenience, problems with i.v. access or needles, and a better CT-taking environment (outside of the clinic). Regardless of initial preference, 70% of patients were not willing to accept a lower response rate and 74% were not willing to accept a shorter duration of response to retain their initial preference. Although 99% of patients had a preference, 39% wanted the specific treatment decision made primarily by their physicians, 38% primarily by themselves, and 22% shared equally. CONCLUSION Patients with incurable cancer have a clear preference for oral CT, but are generally not willing to sacrifice efficacy for their preference. Almost 40% of patients did not want to make final treatment decisions themselves.
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Chen, Zhanhong, Xiaojia Wang, Jian Huang, Yabing Zheng, Xiying Shao, Wenming Cao, Junqing Chen, et al. "Apatinib combined with chemotherapy versus single chemotherapy in HER-2 negative advanced breast cancer: A randomized, controlled, open-label phase II study." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 1072. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.1072.
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1072 Background: Apatinib is an oral, highly potent tyrosine-kinase inhibitor targeting VEGFR2. A series of clinical studies have shown that anti-angiogenic drugs combined with chemotherapy enable to improve the efficacy of HER2-negative advanced/metastatic breast cancer(MBC). Methods: Patients with HER2-negative MBC with less than two lines of systemic therapy were enrolled in this open-label, controlled, phase II trial. Patients with measurable disease were randomly assigned, in a 1:1 ratio, to receive oral apatinib (250 mg once daily) combined with chemotherapy(A+CT) or chemotherapy(CT) alone (the physician’s choice) until disease progression or intolerable toxicity. The primary end point was progression-free survival(PFS), which was assessed by investigator and was analyzed on an intention-to-treat basis. Results: Between August 2017 and January 2021, of the 80 patients who underwent randomization, 40 were assigned to receive apatinib plus chemotherapy(A+CT) and 40 were assigned to receive standard therapy(CT). As of January 2022, 10 patient had not undergone response evaluation or dropout, 70 patients(36 patients in A+CT, 34 patients in CT were finally included with PFS events and 72 patients were included in safety set. Median PFS was significantly longer in A+CT than in CT (182 days vs 63 days; P = 0.043);The median PFS of TNBC subgroup (11 in A+CT group, 14 in CT) was longer in the aptinib group than in CT group (167 days vs 63 days; P = 0.637);The median PFS of HR+ subgroup(25 in apatinib group, 20 in chemotherapy group) was longer in the aptinib group than in CT group (259 days vs 56 days; P = 0.054);The median PFS of patients with liver metastases(19 in apatinib group, 17 in chemotherapy group) was longer in the aptinib group than in the CT group (151 days vs 54 days; P = 0.191); The severe adverse reactions (grade 3/4) were neutropenia(22.2% vs 13.9%), hypertension(11.1% vs 0.0%), leukopenia(8.3% vs 8,3%), hypokalemia(8.3% vs 2.8%), anemia(5.6% vs 11.1%), ALT(2.8% vs 8.3%), AST(0.0% vs 5.6%) in the apatinib group and the CT, respectively. Proteinuria did not occur in both groups. Treatment delay or dose reduction owing to adverse event was 16.7% and 11.1%, respectively. Treatment discontinuation owing to adverse event was 23.5% and 8.8%, respectively. Conclusions: Apatinib combined with chemotherapy showed a significant improvements in PFS and a manageable safety profile in HER2 negative MBC.
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Chirivella, I., B. Bermejo, A. Insa, A. Perez-Fidalgo, A. Magro, S. Rosello, E. Garcia-Garre, P. Martin, A. Bosch, and A. Lluch. "Impact of chemotherapy dose-related factors on survival in breast cancer patients treated with adjuvant anthracycline-based chemotherapy." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 668. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.668.
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668 Background: The relationship between chemotherapy (CT) dose intensity and patient (pt) outcome in the management of early stage breast cancer (EBC) is still controversial. Although randomised clinical trials have provided evidence that supports the delivery of full standard doses of CT on schedule, precise thresholds for CT dose-related factors and their impact on survival-related endpoints have not yet been fully defined. The objective of this project is to assess the impact of CT dose-related factors on event-free and overall survival in a large group of EBC pts treated with anthracycline-based chemotherapy. Methods: A total of 1056 EBC (stage I-II-IIIA) cases diagnosed and treated from January 1980 to December 2000 were retrospectively studied. All of them received adjuvant anthracycline non-taxanes-based CT. Consecutive charts from 793 pts that were fully completed were included in the analysis. Survival-related endpoints were analysed through Kaplan-Meier estimates, log-rank tests, and Cox proportional hazards models. Results: With a median follow-up of 10.0 years, pts exposed to either > 2 cycle-delay (delay at any cycle defined as ≥ 3 days vs. plan), or ≥ 15 day-delay across the whole CT regimen, or < 95% relative dose intensity (RDI) showed significantly worse 10-year Event-Free Survival (EFS) and Overall Survival (OS) as compared to pts with no dose delay/reduction (data shown below). Controlling for age at diagnosis, disease stage, histological grade, menopausal status and year of treatment did not modify these results. Conclusions: Based on this preliminary analysis, CT dose delays and reductions in EBC pts treated with adjuvant anthracycline-based regimens have a significantly negative impact on EFS and OS. [Table: see text] No significant financial relationships to disclose.
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Deniz, Gulhan Ipek, Ayten Can, and Sualp Tansan. "Chemotherapy and radiofrequency hyperthermia in advanced ovarian cancer." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): e17550-e17550. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e17550.
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e17550 Background: Ovarian cancer (OC) is the the leading cause of cancer death in females. Most cases present at advanced stage. Standard treatment is cytoreductive surgery before or after paclitaxel and carboplatin chemotherapy (CT) followed by maintenance treatment. Weekly CT is at least as effective as three weekly CT in OC, and may overcome resistance in some patients. Hyperthermia has been used alone or in combination with radiotherapy and chemotherapy in the treatment of advanced cancer. Radiofrequency hyperthermia (Oncothermia-OT) is theoretically more effective and comfortable form of hyperthermia due to its selective effects on tumor cells. Since most advanced patients have disease limited to the abdominal cavity, OT can be applied with a single electrode to cover the whole abdomen. Immediately following CT, OT may result in aggregation of DNA repair ezymes secreted in response to CT in cancer cells. Methods: We used weekly CT with paclitaxel or nab-paclitaxel with carboplatin followed immediately by OT. (Oncotherm-EHY 3010) to the whole abdomen for one hour for eighteen weeks in 22 consecutive patients with advanced (III or IV) ovarian/primary peritoneal cancer between 2016 and 2021. 19 patients received bevacizumab every three weeks in addition to chemotherapy.All pts had ECOG PS 0-1. Maintenance treatment was bevacizumab (19 patients) or olaparib (3 patients) for one year. Patients were followed by periodic CT/MRI/PET-CT and CA-125 levels. Results: All patients completed eighteen weeks of planned treatment. No unexpected or grade III-IV toxicity was observed. Complete response was obtained in 21 patients and partial response in one patient. Median follow up is 30 months (range 8-73 months).18 patients are alive, with 12 patients in ongoing remission and 6 patients receiving palliative treatment. 4 patients have died of cancer. Conclusions: Although this is a single center retrospective observation, the combination of weekly paclitaxel/nab-paclitaxel and carboplatin CT in combination with immediate weekly OT appears tolerable and feasible. Despite all of the limitations of this observation, activity of CT and OT appears promising. These findings should be confirmed with prospective randomized trials.
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Zander, A. R., N. Kroeger, C. Schmoor, W. Krueger, V. Moebus, N. Frickhofen, B. Metzner, et al. "Randomized trial of high-dose chemotherapy with autologous haematopoietic stem cell support vs. standard-dose chemotherapy in breast cancer patients with 10 or more positive lymph nodes: Overall survival after 6 years of follow up." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 672. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.672.
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672 Background: Investigation of high dose chemotherapy (HD-CT) supported by autologous hematopoietic stem cell transplantation compared with standard dose chemotherapy (SD-CT) as adjuvant treatment in patients with primary breast cancer and 10 or more axillary lymph nodes. Methods: Between November 1993 and September 2000 307 patients were randomized to receive the following cycles of Epirubicin (90 mg/m2), Cyclophosphamide (600 mg/m2) intervenously (every 21 days) either HD-CT of Cyclophosphamide (1500 mg/m2), Thiotepa (150 mg/m2) and Mitoxantrone (10 mg/m2) intervenously for 4 consecutive days followed by stem cell transplantation or standard dose chemotherapy SDCT in 3 cycles of Cyclophosphamide (500 mg/m2), Methotrexate (40 mg/m2) and Fluoruracil (600 mg/m2) intervenously on days 1 and 8 every 28 days. The primary end points were event-free survival and overall survival. Results: After a median follow-up of 6.1 years 166 events with respect to event-free survival (SD-CT: 91, HD-CT: 75) and 123 with respect to overall survival (SD-CT: 66 and HD-CT: 57) have been observed. The hazard ratio of HD-CT versus SD-CT is estimated as 0,80, p = 0,15. The hazard ratio for overall survival for high dose chemotherapy versus standard dose chemotherapy is estimated as 0,84, p = 0,33. Analysing the effect of treatment on event-free survival premenopausal patients, patients with tumor grade III and ER-positive patients had a better outcome with HD-CT with an interactive effect of 2.5 and 1.4. The significance was only shown in grade III patients in favour of HD-CT, (p = 0,049). The interactive effect of HD-CT with prognostic factors did not reach significance for overall survival. Conclusion: Even with a follow-up of 6.1 years there was only a trend in favour of high dose chemotherapy with respect to overall survival but without a statistical significance. A proper meta-analysis needs to be undertaken for an evaluation of subgroups of patients which might benefit from this treatment approach. No significant financial relationships to disclose.
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Boige, Valerie, Jean-Pierre Pignon, Mathilde Wagner, Eric Dupont Bierre, Samuel Le Sourd, Franck Audemar, Ayhan Ulusakarya, et al. "PRODIGE 53-UCGI 30 (SULTAN): A randomized phase II study comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy to systemic chemotherapy alone in patients with liver-only colorectal metastases considered still non resectable after at least two months of systemic induction chemotherapy." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): TPS3619. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps3619.
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TPS3619 Background: In the first-line setting, current combination chemotherapy (CT) achieve high objective response rates (ORR) ranging from 40% to 80% and leads to complete resection rate (CRR) of colorectal cancer liver metastasis (CRCLM) in 25% to 50% of patients with initially non-resectable CRLM. However, when patients with CRLM are still not amenable to resection after induction CT, ORRs (~5-30%) and CRRs ( < 10%) obtained with second-line systemic CT are much lower. Combining hepatic arterial infusion (HAI) and systemic (SYS) CT for unresectable CRLM lead to high ORR and the potential of cure in the second-line and further setting. Methods: This multicenter randomized phase II trial conducted in 20 centers in France plans to include 140 patients with CRLM still not amenable to a curative intent-treatment after at least two months of first-line induction SYS CT whatever the tumor response. Patients are randomized (1:1) between intensified biweekly regimen combining HAI oxaliplatin (100 mg/m²) and SYS FOLFIRI (leucovorin 400 mg/m², irinotecan 180 mg/m², and 5-FU 2.4 g/m²over 48 h) plus cetuximab 500 mg/m² or bevacizumab 5 mg/kg (according to RAS status and prior response/tolerance to SYS induction CT) or SYS CT alone according to current guidelines. The primary endpoint is to evaluate and compare the curative-intent (R0-R1) resection (and/or ablation) rate (CRR) of CRLM in both arms. A gain of 20% in CRR is expected (30% in the experimental arm vs. 10% in the control arm; α 5% [two-sided]; β 20%). Stratification factors at randomization are prior adjuvant or SYS induction oxaliplatin-based CT, tumor response to SYS induction CT, and center. Secondary endpoints include progression-free (overall, hepatic and extrahepatic) and overall survival, ORR, relative change in the sum of longest diameters of RECIST target lesions (DoR) and feasibility/tolerability. Since study start, 3 patients have been enrolled to date (planned accrual period: 3 years). Clinical trial information: NCT03164655.
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Yoh, Kiyotaka, Yasushi Goto, Yoichi Naito, Kazuma Kishi, Yasuo Ohashi, and Hideo Kunitoh. "Prospective observational cohort study of second-line chemotherapy administration after first-line platinum-based chemotherapy for patients with advanced NSCLC in Japan (SAPPHIRE study)." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 8058. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.8058.
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8058 Background: Maintenance therapy after first-line platinum-based chemotherapy (first-CT) is reported to be beneficial to patients with advanced non-small cell lung cancer (NSCLC). However, its impact on overall survival appears to be marginal or negligible, if those without maintenance receive active second-line chemotherapy (second-CT), which is initiated at disease progression. The purpose of this study is to investigate the proportion of second-CT administration after first-CT for patients with advanced NSCLC. Methods: From April 2010 to September 2011, 865 patients with advanced NSCLC who were initiated on first-CT at 30 institutions in Japan were enrolled in this prospective observational study. Baseline characteristics, regimens and responses to first-CT, whether or not they received second-CT, and if not, reasons for non-administration were recorded. This report describes from patients with at least 6 months of follow up. This study was supported by the Public Health Research Center Foundation CSPOR. Results: A total of 865 eligible patients with advanced NSCLC provided patient characteristics and details of first-CT. Of all patients, 70% had adenocarcinoma, 20% had squamous cell carcinoma, and 10% were positive for the EGFR mutation. At this data cut off, 225 patients were excluded from the analysis due to disease progression and loss of follow-up during first-CT, and 194 (22%) patients received maintenance therapy after first-CT. Among the 508 patients who were followed up for at least 6 months, 131 patients (26%) could not receive second-CT; the reasons were as follows: declined PS, 79 (60%); patient refusal, 28 (21%); death of any cause, 6 (5%); others, 18 (14%). Conclusions: Preliminary results of this large observational study in Japan suggested that around 20% of patients missed an opportunity to receive appropriate second-CT despite the follow-up of advanced NSCLC patients after first-CT. Further investigation is needed to elucidate the selection criteria of patients that may benefit the most from maintenance therapy, not second-CT at disease progression.
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Bergmann, L., A. Klima, A. Zoubek, S. Szepesi, C. v. Ilberg, and P. S. Mitrou. "Chemotherapy and radiotherapy (CT+RT) vs. chemotherapy alone (CT) in the treatment of advanced head and neck cancer (HNC)." Journal of Cancer Research and Clinical Oncology 111, S1 (February 1986): S123. http://dx.doi.org/10.1007/bf02580260.
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Carey, R. W., A. D. Hilgenberg, E. W. Wilkins, N. C. Choi, D. J. Mathisen, and H. Grillo. "Preoperative chemotherapy followed by surgery with possible postoperative radiotherapy in squamous cell carcinoma of the esophagus: evaluation of the chemotherapy component." Journal of Clinical Oncology 4, no. 5 (May 1986): 697–701. http://dx.doi.org/10.1200/jco.1986.4.5.697.
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Twenty-four patients with squamous cell cancer of the esophagus were entered into a treatment protocol consisting of preoperative chemotherapy (CT), surgical resection (SR), and possible postoperative CT or radiation therapy (RT) beginning August 1981. CT consisted of two cycles of 5-fluorouracil, 1,000 mg/m2, by continuous intravenous infusion for 4 days and cisplatin, 100 mg/m2, on day 4 with mannitol-induced diuresis at 4-week intervals. Postoperatively, RT was administered when resection margins were minimal or if paraesophageal nodes were abnormal; the RT consisted of 5,000 to 5,400 cGy to the tumor area plus a 800- to 1,200-cGy boost to known abnormal tumor margins. Nineteen of 24 patients were resectable (79%). There was one SR death (5%). One of 22 had a normal barium swallow post-CT, no visible tumor at SR, and no pathologic evidence of any residual disease. There was complete radiologic and gross clinical disappearance of tumor post-CT or post-SR in ten of 22 patients (45%). Four of 22 (18%) had greater than or equal to 50% regression, and five of 22 (23%) had no response. Toxicity of CT was mild. Eight of 19 patients (42%) received RT, and six of 19 (32%) received CT postoperatively. Sixteen of 24 (67%) are alive with a median duration of observation of 9.5 months. Eight of 24 (33%) are dead, five of whom had not responded to preoperative CT. Ten of 14 responders are alive and disease free. The mean survival time for nonresponders was 6.70 months and for responders, 20.40 months, with the longest survivor disease free at 45 months.
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Kalinka-Warzocha, Ewa, Javier Gallego Plazas, Laurent Mineur, Tomas Salek, Alain Hendlisz, Kate Bendall, Florian D. Vogl, and Rodolfo Passalacqua. "Chemotherapy (CT) treatment patterns and neutropenia management in gastric cancer patients (pts) receiving myelosuppressive chemotherapy in Europe." Journal of Clinical Oncology 31, no. 4_suppl (February 1, 2013): 128. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.128.
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128 Background: Granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP) is recommended for pts undergoing CT who are at overall high risk for febrile neutropenia (FN). No single CT regimen is recognized as standard in gastric cancer and few regimens are represented in G-CSF guidelines. We therefore evaluated neutropenia management in pts receiving CT for gastric cancer. Methods: This was a multicentre prospective observational study that enrolled pts sequentially from 11/2009 to 06/2011. Adult gastric cancer pts (any stage) with ≥3 cycles of myelosuppressive CT scheduled and an investigator-assessed overall FN risk ≥20% were eligible. The primary outcome was the proportion of pts who received PP G-CSF (G-CSF in days 1-7 of cycle 1). Secondary outcomes included FN incidence, chemotherapy administration, and G-CSF use. Posthoc analyses investigated the subgroup who received DCF, including modifications from standard DCF (Van Cutsem. JCO. 2006), and the G-CSF support given up to the first FN (G-CSF prophylaxis given per label in each cycle up to that in which FN occurred). Results: Of 209 pts enrolled, 199 were eligible and their data analyzed. The mean (±SD) age was 62 (±12) years, 76% were male, 17% were ECOG 2 and none ECOG 3-4; 47% were treatment naïve. Planned CT was palliative in 74% of pts; overall, 27 different backbone regimens were planned (10 triplet, 12 doublet, 5 single drug regimens). The most common regimen used was DCF (54 pts, 27%), predominantly given as modified DCF (41 pts). Despite being assessed as high risk for FN, G-CSF PP was administered to only 35% of pts overall (n=70; 54 pegfilgrastim, 16 daily G-CSF) and to 69% of pts who received DCF. FN occurred in 14 pts (10%), 9 of whom received DCF. A large majority of FN pts (12/14, 86%) had not received prophylactic G-CSF per label up to the first FN occurrence; furthermore, 86% of FN pts did not receive G-CSF prophylaxis in the cycle following the FN event. Conclusions: The variety of CT used, frequent modifications to standard CT, and presence of pt risk factors makes FN risk estimation difficult in gastric cancer. Improved risk assessment and appropriate targeting of G-CSF PP to high risk pts is needed.
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Samalin, Emmanuelle, Tien Tuan Nguyen, Simon Thezenas, Fabienne Portales, Thibault Mazard, Sophie Gourgou, Eric Assenat, and Marc Ychou. "Chemotherapy efficacy in metastatic colorectal cancer (mCRC) patients treated with adjuvant or first-line FOLFOX-based chemotherapy." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): e15048-e15048. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e15048.
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e15048 Background: Efficacy results of Folfox or Folfiri chemotherapies (CT) are not different as 1st line in mCRC patients, alone or with targeted therapies. No data reported on progression-free survival (PFS) of 1st line Folfiri after Folfox-based adjuvant CT and of 2nd line Folfiri-based CT after a Folfox-based 1st line. The objective was to evaluate the efficacy of a Folfiri-based CT after adjuvant or 1stline Folfox-based treatment. Methods: 210 of 568 pts from a mCRC database were retrospectively selected and divided in 2 cohorts: pts who received adjuvant Folfox then Folfiri as 1st line treatment (n = 76, AdjF) and those treated with Folfox as 1st line treatment then Folfiri 2nd line (n = 134, FFox). PFS1 was the time from beginning of Folfox to 1st progression and PFS2 the time from the Irinotecan-based CT to 2ndprogression. Results: Median age was 62 (22-80). 49.3% pts had synchronous liver (72%) metastases. Primary tumour was right and left colon in 22% and 70% patients. Primary tumour was resected in 91% pts (98.7% and 86.6% in the AdjF and FFox groups, p= 0.003). KRASand BRAF-mutated status were found in 21.8% and 4.7% pts. In the AdjF group, pts received Folfiri as 1st line combined with Bevacizumab (Beva) or anti-EGFR therapy (Cetuximab or Panitumumab) in 70% and 13% cases. In the FFox group, 1st line Folfox-based CT was associated with Beva and anti-EGFRs in 7 and 6% pts, and 2ndline Folfiri-based CT with Beva or Aflibercept in 51 and 4% pts, and with anti-EGFRs in 7.5%. Median duration of a therapeutic line was 5 months (0-29.8). Grade 3-4 toxicities were for the AdjF and FFox groups respectively, diarrhea 13/15%, neutropenia (febrile) 16(7)/37%(1%) and neuropathy 24/18%. Response rates were 55.3% and 68.7% in the AdjF and FFox groups. Median PFS1 were 14 (95%CI:10-16) and 10 (95%CI:8-11) months in the AdjF and FFox groups, and PFS2 10 (95%CI:8-11) and 7 (95%CI:6-9) months, respectively. Median overall survival was 43 (95%CI:39-50) and 33 months (95%CI:26-36) respectively. Conclusions: Results in terms of survival are in favor of the AdjFFox group. It would be interesting to identify a subgroup of pts rapidly progressing after adjuvant Folfox, who might show the same profile than pts in the FFox group.
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Wislez, Marie, Thibault Vieira, Mony Ung, Martine Antoine, Isabelle Monnet, Pierre Bonnette, Aurelie Cazes, et al. "Are sarcomatoid lung cancers resistant tumors to conventional chemotherapy?" Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e19036-e19036. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e19036.
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e19036 Background: Pulmonary sarcomatoid carcinomas (SC) account for about 0.4% of non-small cell lung carcinoma. These tumors have a poor prognosis due to high aggressiveness and maybe chemotherapy (CT) resistance. Methods: From 1995 to 2012, all consecutive patients with SC from 7 French hospitals and who underwent a 1st-line chemotherapy were included. Clinical characteristics and effect of CT (best response by RECIST 1.1 and progression-free survival [PFS]) as well as overall survival (OS) were collected. Results: Ninety-seven patients were included. Mean age was 62±1 years, 70% were men, 84% smokers, 84% symptomatic, 25% had a stage III and 75% a stage IV disease. At 1st-line, 73% received a platinum-based CT and 27% received a non-platinum-based CT. Progression (PR), stable disease (SD) and response (RR) rates were 69, 14.5 and 16.5%, respectively. For patients with platinum-based CT, PR, SD and RR rates were 69, 11 and 20%, respectively. RR rate was higher for platinum- than for non-platinum-based CT (p=0.018). Median PFS and OS were 2.0 mo [1.8 ; 2.3] and 6.7 mo [5.1 ; 8.2], respectively. No statistical difference in PFS (p=0.264) and OS (p=0.096) was observed between platinum and non-platinum based CT. In multivariate analysis, factors associated with better OS were disease control (HR=0.36 [0.21;0.59]), platinum-based CT (HR=0.92 [0.85;0.99]) and tobacco status (HR=0.92 [0.85 ; 0.99]). Conclusions: Two-thirds of patients with SC had early progression during 1st-line CT. Platinum-based regimen increased response rate for a few and was an independent factor for better OS with a 8% decreased risk of death. Overall, SC appear to be chemoresistant suggesting that new therapeutic strategies based on a better knowledge of its carcinogenesis should be tested for these patients.
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Rimassa, L., A. Chiti, C. Carnaghi, R. Doci, M. Zuradelli, G. Abbadessa, F. R. Lutman, M. C. Tronconi, T. Pressiani, and A. Santoro. "18F-FDG PET (PET) does not improve CT scan (CT) accuracy in the evaluation of colorectal cancer liver metastases after chemotherapy." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 13530. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.13530.
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13530 Background: Neoadjuvant chemotherapy has been successfully used in the treatment of patients (pts) affected by liver metastases from colorectal cancer unsuitable for surgery. We evaluated separately the diagnostic accuracy of PET and CT in this setting in a small series of pts. Methods: We retrospectively reviewed the data from 19 consecutive pts (12 males, 7 females; median age 62 years; range 41–79) affected by liver metastases from colorectal cancer. All of the pts underwent systemic chemotherapy and were evaluated with PET and CT at the end of the treatment. Whole-body PET scan was performed in 3D mode on a Siemens Ecat Accel LSO full-ring scanner, 60 minutes after the injection of 310–450 MBq of 18F-FDG. Contrast enhanced, 3 phases, liver CT was performed on a Philips Aura single slice system. Chemotherapy regimens were: FOLFOX (13 pts), FOLFIRI (2 pts), 5-FU-FA (2 pts), UFT-CPT-OXA (2 pts). Overall response rate was 68%. Median time interval between end of chemotherapy and CT was 6 wks (range 3–8), between end of chemotherapy and PET was 8 wks (range 5–13) and between end of chemotherapy and surgery was 10 wks (range 6–18). All pts underwent surgery to remove liver metastases and had histological confirmation of the lesions. Results: In 16 evaluable pts, 53 liver lesions were confirmed by histology. The table shows the results on a per-lesion basis. A complete agreement between PET or CT and histology was documented in 3 and 4 pts respectively. Conclusions: These results suggest that PET and CT had sub-optimal diagnostic accuracy in the post-chemotherapy evaluation of liver lesions from colorectal cancer. Moreover, the combined use of the two imaging techniques does not significantly increase the sensitivity of CT. Further data are needed to evaluate the metabolic changes induced by chemotherapy which may be the cause for inaccurate PET findings. [Table: see text] No significant financial relationships to disclose.
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Bokemeyer, C., C. Kollmannsberger, C. Meisner, A. Harstrick, J. Beyer, B. Metzner, J. T. Hartmann, et al. "First-Line High-Dose Chemotherapy Compared With Standard-Dose PEB/VIP Chemotherapy in Patients With Advanced Germ Cell Tumors: A Multivariate and Matched-Pair Analysis." Journal of Clinical Oncology 17, no. 11 (November 1999): 3450–56. http://dx.doi.org/10.1200/jco.1999.17.11.3450.
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PURPOSE: To compare first-line high-dose chemotherapy (HD-CT) with autologous blood stem-cell transplantation to standard-dose chemotherapy (SD-CT) in male patients with advanced germ cell tumors (GCTs), a matched-pair analysis was performed within a homogenous group of patients classified as having either Indiana advanced disease or a poor prognosis according to International Germ Cell Cancer Consensus Group (IGCCCG) criteria. PATIENTS AND METHODS: A multivariate analysis was performed that included 147 consecutive patients who had received sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) therapy (HD-CT) in a German multicenter trial between 1993 and 1997 and 309 patients who had been treated with standard-dose cisplatin, etoposide, and bleomycin (PEB) or VIP chemotherapy (SD-CT) within two randomized trials at Indiana University between 1984 and 1992. RESULTS: Multivariate analysis demonstrated HD-CT to be significantly superior to SD-CT when adjustments were made for prognostic factors (P = .021). Primary tumor site (mediastinal v retroperitoneal/gonadal, P = .035) and presence of visceral metastases (P = .0004) were shown to be significant prognostic factors for overall survival. On the basis of these factors, as well as on tumor marker levels (good, intermediate, or poor, according to IGCCCG criteria), 146 of 147 HD-CT patients were fully matched to an SD-CT patient. Median follow-up was 21 months (range, 0 to 70 months) for the HD-CT patients and 22 months (range, 0 to 90 months) for the SD-CT patients. Two-year progression-free survival (75% v 59%) and overall survival (82% v 71%) were significantly prolonged in HD-CT patients (P = .0056 and P = .0184, respectively). CONCLUSION: The results indicate that first-line HD-CT in patients with poor-prognosis GCT may result in a significant improvement of progression-free and overall survival as compared with SD-CT. Salvage HD-CT seems not to compensate this survival advantage.
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Cheung, Yin Ting, Maung Shwe Ham Guo, Wai Keung Chui, Rebecca Alexandra Dent, Yoon Sim Yap, Soo Kien Lo, Raymond C. H. Ng, and Alexandre Chan. "Effect of chemotherapy and psychosocial distress parameters on perceived cognitive disturbances in Asian breast cancer patients." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 9041. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.9041.
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9041 Background: A qualitative study has revealed that Asian breast cancer patients attributed their post-chemotherapy cognitive disturbances to psychosocial distress. To validate this claim, we aim to examine perceived cognitive disturbances, anxiety and quality of life (QoL) in Asian breast cancer patients and to identify clinical and psychosocial factors associated with perceived cognitive disturbances. Methods: A prospective, observational study was held at the largest cancer center in Singapore. Chemotherapy (CT) and non-chemotherapy (non-CT) receiving breast cancer patients completed self- reported questionnaires to assess the following domains: patients’ perceived impact of chemotherapy on cognitive disturbances (FACT-Cog), health-related QoL (EORTC QLQ-C30) and anxiety (Beck Anxiety Inventory). Multiple regression was conducted to delineate factors associated with perceived cognitive impairment. Results: A total of 166 (1:1 CT/non-CT) patients were recruited (age: 54.1±10.2 years; 78.9% Chinese; 53.6% post-menopausal). Most of the CT patients received anthracycline-based chemotherapy (93.1%) and anti-hormonal therapy (69.4%). Comparing to non-CT patients, CT patients experienced more fatigue (QLQ-C30 fatigue scores: 22.2 vs 33.3 points; p=0.005), more significant anxiety (8.6% vs 21.9%; p=0.002), and more cognitive disturbances (FACT-Cog scores: 110 vs 124 points; p<0.0001). Regression model identified chemotherapy, anti-hormonal therapy, emotional functioning and global health status to be strongly associated with cognitive disturbances in Asian breast cancer patients. The interacting effect between anxiety and fatigue, comparing to fatigue alone, was more associated with cognitive disturbances (β=-0.212; p=0.032 vs β=-0.07; p=0.25, respectively). Conclusions: This is the first study to demonstrate that Asian breast cancer patients experiencing both fatigue and anxiety are more predisposed to cognitive disturbances. Post-chemotherapy cognitive changes are observed in our patients, and our results suggest that psychosocial factors are impactful to identify cancer patients who are more susceptible to cognitive disturbances.
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Cohen, Bar, Nurith Hiller, Auryan Szalat, and Vladimir Vainstein. "OPPORTUNISTIC EVALUATION OF BONE MINERAL DENSITY BY PET-CT IN HODGKIN LYMPHOMA PATIENTS." Endocrine Practice 25, no. 9 (September 2019): 869–76. http://dx.doi.org/10.4158/ep-2019-0122.
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Objective: Bone density loss and increased risk for osteoporosis are of concern in Hodgkin lymphoma (HL) patients. Routinely performed positron emission tomography–computed tomography (PET-CT) scans could be informative in assessing bone mineral density (BMD). Methods: This retrospective study included 80 adults with newly diagnosed HL treated with standard first-line chemotherapy regimens. PET-CT scans performed at diagnosis (PET-CT1), at the end of chemotherapy (PET-CT2), and at follow-up after remission (PET-CT3) were used to assess BMD changes by measuring lumbar vertebrae CT attenuation. A CT attenuation threshold of 160 Hounsfield units was used to define abnormal BMD. Results: Following chemotherapy, comparison of PET-CT2 with PET-CT1 revealed a mean (standard deviation) 14.2% (10.4%) BMD reduction ( P<.001). On PET-CT3 performed at 14.6 (3.25) months after the last course of chemotherapy, a slight improvement (4.6% [10.4%]) in comparison to PET-CT2 was noted. Twelve patients (15%) converted from normal baseline BMD on PET-CT1 to abnormal BMD after chemotherapy on PET-CT2. Age, baseline BMD, and steroid cumulative dose were associated with BMD decline and risk for abnormal BMD after chemotherapy. No clinical fractures were reported, and only one rib fracture was incidentally captured (1.25%). Conclusion: HL patients treated with common first-line chemotherapies demonstrate a significant decline in bone density on routine PET-CT scans. Opportunistic use of PET-CT scan has the potential to detect HL patients at high risk for developing osteoporosis and to guide clinicians regarding monitoring and intervention. Abbreviations: BMD = bone mineral density; CT = computed tomography; DXA = dual-energy X-ray absorptiometry; HL = Hodgkin lymphoma; HU = Hounsfield units; L = lumbarvertebra; PET-CT = positron emission tomography-computed tomography; T = thoracic vertebra
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Ji, Xiang, Qiaoyun Yang, Hui Qin, Jie Zhou, and Wenming Liu. "Tumor blood supply may predict neoadjuvant chemotherapy response and survival in patients with gastric cancer." Journal of International Medical Research 47, no. 6 (May 1, 2019): 2524–32. http://dx.doi.org/10.1177/0300060519845491.
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Objectives We investigated the prognostic value of tumor blood supply in patients with advanced gastric cancer (GC) receiving neoadjuvant chemotherapy. Methods We retrospectively reviewed 53 patients with advanced GC treated with FLEEOX chemotherapy. The tumor computed tomography (CT) enhancement value was measured before chemotherapy (CT1; arterial phase CT–plain phase CT). The liver parenchyma CT enhancement value (CT2) was also measured using the same method, to eliminate individual differences. Tumor blood supply was defined as good or poor based on the median CT1/CT2 values. We evaluated the relationships between tumor blood supply and response to chemotherapy, clinicopathologic characteristics, and overall survival (OS). Results A good blood supply (GBS) was associated with significantly better clinical and pathological responses to chemotherapy than a poor blood supply (PBS). The 3-year OS was 65.8% for the entire cohort. Patients with a GBS had a significantly higher OS (78.57%) than those with a PBS (54.44%). Additionally, patients with Bormann type III GC had a better blood supply than those with type II GC. Conclusion Patients with advanced GC and a GBS are more likely to benefit from neoadjuvant chemotherapy than those with a PBS. Blood supply may thus be a predictor for chemotherapy response.
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Lai, Pamela, Shelly Sud, Tinghua Zhang, Timothy R. Asmis, and Paul Wheatley-Price. "Palliative chemotherapy in advanced colorectal cancer patients age 80 or older." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e14598-e14598. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e14598.
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e14598 Background: Colorectal cancer (CRC) is the second most common cancer worldwide, with a median age at diagnosis of 71 years. While there has been significant progress in chemotherapy (CT) options for metastatic CRC (mCRC) patients (pts) over the past decade, there is very little data on outcomes or toxicity from CT in mCRC pts aged ≥80 years. We investigated palliative CT in the 80+ mCRC population, hypothesizing that high rates of hospitalization and toxicity may be observed. Methods: With ethics approval, a retrospective chart review was conducted of pts ≥80 years with mCRC who initiated a CT course between June 2005 and November 2009 at our institution. Baseline data on pt demographics were collected, in addition to CT data. The endpoints included: rates of hospitalization, CT discontinuation due to toxicity, and overall survival (OS). Results: CT was initiated on 88 occasions during the study period. The median age was 83 (range 80-92) and 52% of pts were male. Where data were available, 60% of pts had a good performance status (PS) of ECOG 0-1, 20% PS 2 and 9% PS 3 (10% unknown). 63 pts (72%) lived with family and 23% lived alone. 76% had a Charlson Comorbidity Index (CCI) ≥7 and 31% were taking ≥6 baseline prescription medications. At baseline, 33% of pts were anemic (Hgb <100), 36% had leukocytosis (WBC>11) and 48% had renal impairment (eGFR <60). Palliation was the intent for 95% of cases and 47 pts (53%) were receiving first line CT. The initial CT dose was adjusted from standard of care in 67% of cases. The most common CT was capecitabine monotherapy (45%). In total 19 pts (22%) were hospitalized during or within 30 days of CT; 26 pts (30%) discontinued CT due to toxicity, and 48 pts (55%) required at least 1 dose reduction, delay or omission. The median OS was 14.6 months (95% CI 11.7-18.6). No baseline factors (age, sex, PS, CCI, line of CT, baseline dose adjustment, baseline blood work) were associated with hospitalization, CT discontinuation due to toxicity, or OS. Conclusions: Palliative CT for mCRC in the ≥80 population is feasible, but most pts will require dose adjustments, and a significant minority will be hospitalized or stop CT due to toxicity. Prospective research incorporating geriatric assessment tools is required.
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Beyhan Sagmen, Seda, Sevda Comert, Esra Turan Erkek, Aysun Küçüköz Uzun, Coşkun Doğan, Guven Yılmaz, Nesrin Kıral, Ali Fidan, Çağla Yılmaz Haksal, and Elif Torun Parmaksız. "Can We Predict Bleomycin Toxicity with PET-CT?" Acta Haematologica 142, no. 3 (2019): 171–75. http://dx.doi.org/10.1159/000502374.
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Aim: Bleomycin is an antitumor antibiotic used successfully to treat a variety of malignancies, predominantly germ cell tumors and Hodgkin’s lymphoma (HL). The major limitation of bleomycin therapy is the potential for life-threatening interstitial pulmonary fibrosis. Early identification of asymptomatic patients who may develop toxicity is important. We aimed to evaluate fluorodeoxyglucose positron-emission tomography (FDG-PET/CT) findings to predict bleomycin toxicity (BT) early after chemotherapy with doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy before clinical symptoms and radiological changes occur. Materials and Methods: HL patients who were treated with ABVD were evaluated. SUVmax values of lung parenchyma were analyzed in FDG-PET/CT at diagnosis and after 4 cycles of chemotherapy in all patients. At the end of the chemotherapy cycles, lung parenchymal SUVmax values of patients with BT and without BT were compared statistically. Results: Twenty (66.7%) male and 10 (33.3%) female patients with HL were included. Five (16.7%) HL patients developed BT. In 3 HL patients, BT was determined after 5 cycles and in 2 patients, BT was seen after 6 cycles. In all 5 of these patients with BT, FDG uptake in PET-CT was increased after 4 cycles of chemotherapy and BT was predicted before clinical and radiological findings by FDG-PET/CT. After 4 cycles of chemotherapy, lung parenchymal SUVmax of patients with BT (3.24 ± 0.76) was significantly higher than in patients without toxicity (1.84 ± 0.52) (p < 0.001). In patients with BT, a significant increase was established in lung parenchymal SUVmax after 4 cycles of chemotherapy when compared to the time of diagnosis (p = 0.043). Conclusion: BT can be fatal. Early detection of BT is essential in clinical practice. FDG-PET/CT can predict BT before clinical and radiological findings occur.
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Fenaux, Pierre, Claude Chastang, Sylvie Chevret, Miguel Sanz, Hervé Dombret, Eric Archimbaud, Martin Fey, et al. "A Randomized Comparison of All Transretinoic Acid (ATRA) Followed by Chemotherapy and ATRA Plus Chemotherapy and the Role of Maintenance Therapy in Newly Diagnosed Acute Promyelocytic Leukemia." Blood 94, no. 4 (August 15, 1999): 1192–200. http://dx.doi.org/10.1182/blood.v94.4.1192.
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Abstract All transretinoic acid (ATRA) followed by daunorubicin (DNR)-AraC chemotherapy (CT) has improved the outcome of acute promyelocytic leukemia (APL) by comparison to CT alone. In a randomized trial, (1) we compared 2 induction schedules (ATRA followed by CT [ATRA→CT] and ATRA plus CT [ATRA+CT, with CT added on day 3 of ATRA treatment]) and (2) we assessed the role of maintenance treatment. Four hundred thirteen patients ≤75 years of age and with newly diagnosed APL were included. Induction treatment was stratified on white blood cell (WBC) count and age: patients ≤65 years of age and with an initial WBC count of ≤5,000/μL (n = 208) were randomized between ATRA→CT and ATRA+CT (initially randomized patients); patients with a WBC count greater than (high WBC count group, n = 163) and patients 66 to 75 years of age with a WBC count greater than 5,000/μL (elderly group, n = 42) were not initially randomized and received ATRA+CT from day 1 and ATRA →CT, respectively. All patients achieving CR received 2 additional DNR-AraC courses (only 1 in patients 66 to 75 years of age) and were then randomized for maintenance between no treatment, intermittent ATRA (15 days every 3 months) for 2 years, continuous low-dose CT (6 mercaptopurine + methotrexate) for 2 years, or both, using a 2-by-2 factorial design. Overall, 381 (92%) of the patients achieved complete remission (CR), 31 (7%) suffered an early death, and only 1 patient had leukemic resistance. ATRA syndrome occurred in 64 patients (15%) and was fatal in 5 cases. The CR rate was similar in all induction treatment groups. Event-free survival (EFS) was significantly lower in the high WBC group (P = .0002) and close to significance in the elderly group (P = .086) as compared with initially randomized patients. Relapse at 2 years was estimated at 6% in the ATRA+CT group, versus 16% in the ATRA→CT group (P = .04, relative risk [RR] = .41). EFS at 2 years was estimated at 84% in the ATRA+CT group, versus 77% in the ATRA→CT group (P = .1, RR = .62). Two hundred eighty-nine patients were randomized for maintenance. The 2-year relapse rate was 11% in patients randomized to continuous maintenance CT and 27% in patients randomized to no CT (P = .0002) and 13% in patients randomized to intermittent ATRA and 25% in patients randomized to no ATRA (P= .02). An additive effect of continuous maintenance CT and intermittent ATRA was seen, and only 6 of the 74 patients who received both maintenance treatments had relapsed. Overall survival was improved in patients who received maintenance CT (P = .01), and there was a trend for better survival in patients who received maintenance ATRA (P = .22). Our findings strongly suggest that early addition of chemotherapy to ATRA and maintenance therapy combining continuous CT and intermittent ATRA can reduce the incidence of relapse in APL. This effect already translates into significantly better survival for maintenance treatment with continuous CT.
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Fenaux, Pierre, Claude Chastang, Sylvie Chevret, Miguel Sanz, Hervé Dombret, Eric Archimbaud, Martin Fey, et al. "A Randomized Comparison of All Transretinoic Acid (ATRA) Followed by Chemotherapy and ATRA Plus Chemotherapy and the Role of Maintenance Therapy in Newly Diagnosed Acute Promyelocytic Leukemia." Blood 94, no. 4 (August 15, 1999): 1192–200. http://dx.doi.org/10.1182/blood.v94.4.1192.416k07_1192_1200.
Full textAbstract:
All transretinoic acid (ATRA) followed by daunorubicin (DNR)-AraC chemotherapy (CT) has improved the outcome of acute promyelocytic leukemia (APL) by comparison to CT alone. In a randomized trial, (1) we compared 2 induction schedules (ATRA followed by CT [ATRA→CT] and ATRA plus CT [ATRA+CT, with CT added on day 3 of ATRA treatment]) and (2) we assessed the role of maintenance treatment. Four hundred thirteen patients ≤75 years of age and with newly diagnosed APL were included. Induction treatment was stratified on white blood cell (WBC) count and age: patients ≤65 years of age and with an initial WBC count of ≤5,000/μL (n = 208) were randomized between ATRA→CT and ATRA+CT (initially randomized patients); patients with a WBC count greater than (high WBC count group, n = 163) and patients 66 to 75 years of age with a WBC count greater than 5,000/μL (elderly group, n = 42) were not initially randomized and received ATRA+CT from day 1 and ATRA →CT, respectively. All patients achieving CR received 2 additional DNR-AraC courses (only 1 in patients 66 to 75 years of age) and were then randomized for maintenance between no treatment, intermittent ATRA (15 days every 3 months) for 2 years, continuous low-dose CT (6 mercaptopurine + methotrexate) for 2 years, or both, using a 2-by-2 factorial design. Overall, 381 (92%) of the patients achieved complete remission (CR), 31 (7%) suffered an early death, and only 1 patient had leukemic resistance. ATRA syndrome occurred in 64 patients (15%) and was fatal in 5 cases. The CR rate was similar in all induction treatment groups. Event-free survival (EFS) was significantly lower in the high WBC group (P = .0002) and close to significance in the elderly group (P = .086) as compared with initially randomized patients. Relapse at 2 years was estimated at 6% in the ATRA+CT group, versus 16% in the ATRA→CT group (P = .04, relative risk [RR] = .41). EFS at 2 years was estimated at 84% in the ATRA+CT group, versus 77% in the ATRA→CT group (P = .1, RR = .62). Two hundred eighty-nine patients were randomized for maintenance. The 2-year relapse rate was 11% in patients randomized to continuous maintenance CT and 27% in patients randomized to no CT (P = .0002) and 13% in patients randomized to intermittent ATRA and 25% in patients randomized to no ATRA (P= .02). An additive effect of continuous maintenance CT and intermittent ATRA was seen, and only 6 of the 74 patients who received both maintenance treatments had relapsed. Overall survival was improved in patients who received maintenance CT (P = .01), and there was a trend for better survival in patients who received maintenance ATRA (P = .22). Our findings strongly suggest that early addition of chemotherapy to ATRA and maintenance therapy combining continuous CT and intermittent ATRA can reduce the incidence of relapse in APL. This effect already translates into significantly better survival for maintenance treatment with continuous CT.
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Stomper, PC, MS Jochelson, EL Friedman, MB Garnick, and JP Richie. "CT evaluation of advanced seminoma treated with chemotherapy." American Journal of Roentgenology 146, no. 4 (April 1986): 745–48. http://dx.doi.org/10.2214/ajr.146.4.745.
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Aita, M., O. Belvedere, F. De Pauli, L. Deroma, L. Gurrieri, J. Menis, V. Merlo, F. Puglisi, L. Zanier, and G. Fasola. "Information technology (IT) and chemotherapy (CT) prescribing errors." Journal of Clinical Oncology 28, no. 15_suppl (May 20, 2010): 6080. http://dx.doi.org/10.1200/jco.2010.28.15_suppl.6080.
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Görich, J., N. Rilinger, R. Sokiranski, J. Vogel, M. Wikström, S. Krämer, E. Merkle, A. Rieber, and H. J. Brambs. "CT-guided intraarterial chemotherapy in locally advanced tumors." Radiology 199, no. 2 (May 1996): 567–70. http://dx.doi.org/10.1148/radiology.199.2.8668814.
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Ng, Y. Y., M. A. Hall-Craggs, C. Dicks-Mireaux, and J. Pritchard. "Wilms' tumour: Pre- and post-chemotherapy CT appearances." Clinical Radiology 43, no. 4 (April 1991): 255–59. http://dx.doi.org/10.1016/s0009-9260(05)80250-8.
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Azmy, Amir. "Wilms' tumours: Pre- and post-chemotherapy CT appearances." Journal of Pediatric Surgery 26, no. 11 (November 1991): 1354–55. http://dx.doi.org/10.1016/0022-3468(91)90654-c.
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Vernuccio, Federica, Marco Dioguardi Burgio, Filippo Barbiera, Silvestro Cusmà, Giuseppe Badalamenti, Massimo Midiri, Valérie Vilgrain, and Giuseppe Brancatelli. "CT and MR imaging of chemotherapy-induced hepatopathy." Abdominal Radiology 44, no. 10 (August 21, 2019): 3312–24. http://dx.doi.org/10.1007/s00261-019-02193-y.
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Rübe, Ch, M. Thomas, M. Semik, and D. Riesenbeck. "Chemotherapy (CT) and twice daily radio-chemotherapy (HA RT/CT) versus chemotherapy (CT) alone before surgery in stage III non small cell lung cancer (NSCLC): analysis of toxicity of a randomized trial." European Journal of Cancer 35 (September 1999): S249. http://dx.doi.org/10.1016/s0959-8049(99)81408-7.
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Cho, May Thet, Jonathan Kessler, John Park, Gagandeep Singh, Yi-Jen Chen, Philip HG Ituarte, and Marwan Fakih. "A single institute retrospective trial of concurrent chemotherapy with SIR-Sphere versus SIR-Sphere alone in patients with chemotherapy-resistant colorectal cancer liver metastases." Journal of Clinical Oncology 34, no. 4_suppl (February 1, 2016): 770. http://dx.doi.org/10.1200/jco.2016.34.4_suppl.770.
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770 Background: The use of selective internal radiation therapy (SIRT) with SIR-Spheres in chemotherapy-resistant colorectal cancer liver metastases (CRC-L) has been associated with favorable progression free survival (PFS) and overall survival (OS) when given alone or concurrently with chemotherapy. However, no prospective studies exist for concurrent SIRT and chemotherapy (SIRT-CT) vs. SIRT alone. We conducted a single institute retrospective trial to compare the effect of SIRT-CT to SIRT alone on liver PFS in patients with CRC-L. Methods: Patients (pts) with CRC-L treated with SIR-Spheres at City of Hope between 2009 and 2014 were identified. CRL-L patients treated with SIRT-CT or with SIRT were excluded if they received, following radioembolization, any chemotherapy/targeted regimen on which they did not previously progress. This strategy was adopted to minimize the impact of post-SIRT systemic therapy bias on SIRT-CT/SIRT liver PFS outcome. Pts characteristics included demographics, liver involvement pattern, and lines of prior chemotherapy. Liver PFS, response rate, and toxicities were compared between SIRT-CT and SIRT arms. Kaplan-Meier estimation was used for PFS analysis. Results: 48 CRC-L pts were treated with SIR-spheres; 27 satisfied the post-SIR-spheres systemic treatment criteria (14 SIRT-CT, 13 SIRT) and were included on this study. Pts characteristics included: age (median = 62; range 52-80), sex (18 males), primary site (colon: 23), hepatic disease burden (23 bilobar), 5-FU resistance/intolerance (25/2), and extrahepatic disease (22). Pts characteristics were similar between treatment arms, except for median prior therapies (SIRT-CT = 3, SIRT = 2). No SIRT-CT or SIRT associated ≥ grade 3 toxicities were noted. Disease control rates were 84% (2/13 PR; 9/13 SD) and 14% (2/14 SD on the SIRT-CT and SIRT arms, respectively (p = 0.001). Median PFS in the liver was 176 days in the SIRT-CT group vs. 91 days in the SIRT group (p = 0.0006). Conclusions: In patients with 5-FU refractory CRC-L, SIRT-CT is associated with an increased disease control rate and a prolonged DFS in comparison with SIRT alone.
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de Geus, Susanna W. L., Sameer Hirji, Sing Chau Ng, Teviah E. Sachs, and Jennifer F. Tseng. "First-line chemotherapy versus chemoradiation for resectable distal esophageal adenocarcinoma." Journal of Clinical Oncology 38, no. 4_suppl (February 1, 2020): 331. http://dx.doi.org/10.1200/jco.2020.38.4_suppl.331.
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331 Background: Multiple randomized controlled trials have shown that both neoadjuvant chemotherapy (CT) and chemoradiation (CRT) convey survival benefit as compared to upfront surgery in patients with esophageal adenocarcinoma. However, international practice remains variable. Therefore, the present study compares the outcomes of first-line CT to CRT for patients with adenocarcinoma arising from the distal esophagus. Methods: Patients with clinical stage T2-T3, N0-N+ esophageal adenocarcinoma originating from the distal esophagus who received first-line CT or CRT were identified from the National Cancer Data Base (2006-2014). Propensity-score were created for the odds of receiving CRT. Patients were matched 1:1 based on propensity score. Subset analysis was performed in patients who underwent esophagectomy. Pathological complete response was defined as ypT0N0M0. Results: In total, 709 and 8,877 patients who received first-line CT and CRT were identified, respectively. CT was associated with stage cT2 (27.2% vs. 23.3%; p = 0.017), and treatment at a high-volume center (27.2% vs. 20.2%; p < 0.001). After matching, resection rates were comparable for patients who received first-line CT and CRT (62.2% vs. 63.7%; p = 0.545). However, median overall survival was slightly lower for patients who receive CT compared to CRT (23.7 vs. 28.4 months; p = 0.044). Among patients who underwent esophagectomy, time to surgery (135 vs. 134 days; p = 0.689) and median overall survival (37.0 vs. 40.5 months; p = 0.630) was similar between matched cohorts. However, complete response (15.8% vs. 25.8%; p < 0.001) and negative margin (94.3% vs. 88.9%; p = 0.004) rates were significantly lower after CT compared to CRT. Conclusions: In patients with esophageal adenocarcinoma, first-line CRT results in significantly higher pathological complete response rates, negative resection margins rates, and improved survival. These findings suggest that first-line CRT is preferable over CT when tolerated in patients with esophageal adenocarcinoma.
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Ermacora, P., P. Driol, S. Russo, C. Andreetta, F. E. Pisa, B. Alessi, A. M. Minisini, M. Mansutti, G. Fasola, and F. Puglisi. "Predictors of tumor shrinkage after anthracycline-based preoperative chemotherapy." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e11531-e11531. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e11531.
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e11531 Background: Anthracyclines are currently included in several chemotherapy (CT) regimens for the treatment of breast cancer (BC). However, increasing evidence suggests that benefit from these agents is limited to some subgroups of patients (pts). Aim of this study was to identify potential predictors of tumor shrinkage (TS) in a retrospective series of pts receiving preoperative anthracycline-based CT for operable BC. Methods: The study population consisted of 94 pts with large (>2 cm), any N, operable BC treated with preoperative anthracycline-based CT. Association between clinico-biological factors and clinico-radiological TS (by caliper and MRI) was assessed. TS was calculated as the difference between the maximum tumor diameter at baseline and the maximum tumor diameter after preoperative CT/ the maximum tumor diameter at baseline x 100. Immunohistochemical analyses for biological variables (ER, PgR, HER2, MIB1, topoisomerase II alpha) were performed on pretreatment biopsies. Results: In univariate analysis, the following variables were associated with clinical TS: high MIB-1 [Odd ratio (OR) 2.6, p = 0.03], type of taxane (docetaxel vs paclitaxel: OR 0.3, p = 0.01) and number of cycles of CT (> 4 vs ≤ 4: OR 9.2, p < 0.0001). In multivariate analysis, number of cycles of CT was the only independent predictor of clinical TS (OR = 9.2, p = 0.05). In univariate analysis, the following variables were associated with MRI TS: high MIB-1 (OR 2.4, p = 0.06), tumor size (≥ 40 mm vs < 40 mm: OR 5.6, p 0 0.01), taxane CT (yes vs no: OR 4.3, p = 0.02) and number of cycles of CT (> 4 vs ≤ 4: OR 4.4, p = 0.002). In multivariate analysis, high MIB-1 was the only independent predictor of MRI TS (OR = 3.7, p = 0.03). Conclusions: High MIB-1 expression and number of cycles of chemotherapy significantly predicted tumor shrinkage in patients treated with preoperative anthracycline-based chemotherapy. Further studies are warranted to better identify patients who derive benefit from anthracyclines. No significant financial relationships to disclose.
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Moser, Justin, Benjamin Solomon, Christopher Duane Nevala-Plagemann, Glynn Weldon Gilcrease, Jonathan R. Whisenant, and Ignacio Garrido-Laguna. "Survival of patients with metastatic HER2 positive gastroesophageal cancer treated with second-line chemotherapy plus trastuzumab or ramucirumab after progression on frontline chemotherapy plus trastuzumab." Journal of Clinical Oncology 37, no. 4_suppl (February 1, 2019): 69. http://dx.doi.org/10.1200/jco.2019.37.4_suppl.69.
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69 Background: Optimal second line treatment for patients with metastatic HER2 positive gastroesophageal cancer (Her2GE) is unknown. A retrospective study has suggested continuation of chemotherapy with trastuzumab (CT), as compared to chemotherapy alone, may improve outcomes. However, CT has never been compared to the current standard second-line treatment of chemotherapy plus ramucirumab (CR). Methods: The Flatiron Health EHR-derived database, a nationally representative database comprising patient-level structured and unstructured data, curated via technology-enabled abstraction, was reviewed for patients with metastatic Her2GE who received CT in the first line setting, followed by either second line CT or CR. Survival from second line therapy (SST) and time to next therapy or death (TTNTD) were compared using Kaplan-Meier curves and Log-Rank analysis. Demographics between treatment groups were compared using standard T tests and chi-squared analysis. Results: 135 patients were identified, of whom 34 received second-line CR and 101 received CT. Median SST for patients treated with CT was 10.2 months (m) [interquartile range (IQR) 5.1-20.8] and 6.8 m (IQR 3.2-20.2) for those treated with CR, p = 0.39. Median TTNTD for patients treated with CT versus CR was 4.9 m (IQR 2.8-9.8) and 4.8 m (IQR 2.3-7.5), respectively (p = 0.53). There was no difference between patients who received CT or CR in regards to average age (63 vs. 62, p = 0.72), average duration of first-line therapy (7.8 m vs. 9.1 m, p = 0.36), or percentage of patients with ECOG > 1 (15% vs. 22%, p = 0.50). Patients who received CT were more likely to receive a multiagent chemotherapy backbone (76% vs. 3%, p ≤ 0.001). Conclusions: This data suggest a non-significant trend towards increased SST for patients treated with second line CT versus CR. Further studies are needed to clarify optimal second-line treatment for this patient population.
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Derks, Jules, Noémie Leblay, Robert Jan van Suylen, Erik Thunnissen, Michael den Bakker, Harry J. M. Groen, Egbert F. Smit, et al. "Genetic subtypes of large cell neuroendocrine carcinoma (LCNEC) to predict response to chemotherapy." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 9061. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.9061.
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9061 Background: To treat LCNEC with non-small cell lung carcinoma type chemotherapy (NSCLC-ct, i.e. gemcitabine/taxanes or pemetrexed) or small cell lung carcinoma type (SCLC-ct, i.e. platinum-etoposide) is subject of debate. Molecular studies have identified two mutually exclusive subtypes in LCNEC, the co-mutated TP53 and RB1and the STK11/ KEAP1 (predominantly RB1 wildtype(wt)) group. We investigated if overall survival (OS) and progression free survival (PFS) correlates with targeted next-generation sequencing (TNGS) results in LCNEC treated with NSCLC-ct or SCLC-ct. Methods: For this population based retrospective cohort study all diagnoses of stage IV ct treated high grade neuroendocrine carcinomas (NEC, not being SCLC) were retrieved from the Netherlands Cancer Registry and Pathology Registry (PALGA) (2003-2012). Panel-consensus pathology revision of original tumor slides was performed on (N = 230) and TNGS for genes TP53, RB1, STK11 and KEAP1 analyzed with a multi-sample variant caller (Needlestack). Results: LCNEC was consensus diagnosed in 146/230 and 77 passed quality control for TNGS. Mean coverage was 2832x, a mutation(mt) in TP53 was present in 87%, RB1mt in 46%, STK11mt in 13% and KEAP1mt in 18% of sequenced LCNEC. RB1 was co-altered with TP53 in 94% of LCNEC; mutually exclusive to STK11mt (100%) but not KEAP1mt (57%). NSCLC-ct or SCLC-ct was specified in 92% of patients and RB1wt LCNEC treated with NSCLC-ct (n = 22) showed a trend to better OS compared to SCLC-ct (n = 13) (8.5 months (95% confidence interval (CI): [6.3-10.6]) vs. 5.8 [5.5-6.1] months, p = 0.055). Due to reported resistance in NECs we analyzed NSCLC-ct without pemetrexed-ct; OS was significantly longer for NSCLC-ct (n = 15) compared to SCLC-ct (9.6 [7.7-11.6] vs. 5.8 [5.5-6.1] months, p = 0.026). PFS of RB1wt NSCLC-ct treated patients was significantly longer than SCLC-ct (p = 0.044), without pemetrexed (p = 0.018). In patients with RB1mt LCNEC OS/PFS was not significantly different for NSCLC-ct vs. SCLC-ct. Conclusions: In LCNEC with RB1wt, NSCLC-ct correlates with a more favorable outcome compared to SCLC-ct. However, RB1mt LCNEC treated with NSCLC-ct do similarly worse as SCLC-ct. Prospective studies should be initiated.
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Galsky, Matt D., Andrea Necchi, Srikala S. Sridhar, Osamu Ogawa, Natasha Angra, Stephan Hois, Feng Xiao, Erik Goluboff, and Joaquim Bellmunt. "A phase III, randomized, open-label, multicenter, global study of first-line durvalumab plus standard of care (SoC) chemotherapy and durvalumab plus tremelimumab, and SoC chemotherapy versus SoC chemotherapy alone in unresectable locally advanced or metastatic urothelial cancer (NILE)." Journal of Clinical Oncology 39, no. 6_suppl (February 20, 2021): TPS504. http://dx.doi.org/10.1200/jco.2021.39.6_suppl.tps504.
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TPS504 Background: Despite high response rates with first-Line (1L), standard, platinum-based chemotherapy (CT) (gemcitabine + cisplatin or gemcitabine + carboplatin) for patients (pts) with locally advanced or metastatic urothelial cancer (mUC), prognosis remains poor. Studies of immune checkpoint inhibitors + CT in 1L mUC have demonstrated mixed results. In IMvigor130, an improvement in progression-free survival (PFS) with atezolizumab + CT vs placebo + CT reached statistical significance, although overall survival (OS) had not reached statistical significance at the interim analysis. A subgroup analysis suggested a possible larger effect size for PFS and OS for pts with high PD-L1 expression. In KEYNOTE-361, no improvement in either PFS or OS was observed with pembrolizumab + CT vs CT alone. The combination of durvalumab (anti–PD-L1 antibody) and tremelimumab (anti–CTLA-4 antibody) has shown activity in previously treated mUC. In the DANUBE trial of 1L mUC, the co-primary endpoints were OS compared between durvalumab and CT in pts whose tumor cells and/or tumor-infiltrating immune cells express high levels of PD-L1 (≥25%) and between durvalumab + tremelimumab and CT regardless of PD-L1 expression. While neither co-primary endpoint was met, durvalumab + tremelimumab showed evidence of activity, particularly in the PD-L1–high population (hazard ratio: 0.74 [95% CI 0.59–0.93]). Collectively, these results led to an update to the NILE protocol, focusing on pts with PD-L1–high expression. Methods: NILE (NCT03682068) is a randomized, open-label, multicenter, phase III global trial that will randomize ~1215 previously untreated pts with histologically or cytologically documented, unresectable, locally advanced, or metastatic transitional cell carcinoma of the urothelium. Eligible pts aged ≥18 years will be randomized 1:1:1 to durvalumab + CT (Arm 1), durvalumab + tremelimumab + CT (Arm 2), or CT (Arm 3). A tumor tissue sample for biomarker analysis is mandatory as PD-L1 status is a stratification factor. The original co-primary endpoints were PFS and OS for durvalumab + CT vs CT in the intention-to-treat population. However, based on the DANUBE trial results, the primary endpoint was revised to a co-primary endpoint OS in pts with high PD-L1 expression for Arm 1 vs Arm 3 and Arm 2 vs Arm 3. Secondary endpoints will include OS, OS rate at 24 months, PFS, objective response rate, proportion of pts alive and progression free at 12 months, duration of response, disease control rate, time from randomization to second progression, health-related quality of life, and safety. Pharmacokinetics, immunogenicity, and biomarkers are exploratory endpoints. The study opened for enrollment in September 2018. Clinical trial information: NCT03682068.
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Suh, Byoung Jo. "A Case of Advanced Gastric Cancer with Para-Aortic Lymph Node Metastasis Treated with Preoperative FOLFOX Chemotherapy Followed by Radical Subtotal Gastrectomy and D2 Lymph Node Dissection." Case Reports in Oncology 10, no. 1 (February 15, 2017): 182–91. http://dx.doi.org/10.1159/000457791.
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We report the case of a 73-year-old female who was diagnosed with advanced gastric cancer. Esophagogastroduodenoscopy was used to diagnose Borrmann type 3 advanced gastric cancer located at the gastric antrum. A biopsy revealed poorly differentiated adenocarcinoma. Abdominopelvic computed tomography (CT) and 18F-fluorodeoxyglucose positron emission tomography-CT (FDG-PET-CT) scans demonstrated multiple lymph node metastases, including the para-aortic lymph nodes. Systemic chemotherapy with 5-fluoruracil (5-FU), oxaliplatin, and leucovorin (FOLFOX) was initiated. An abdominopelvic CT scan taken after 4 cycles of chemotherapy showed improvement in the ulceroinfiltrative gastric lesion and marked regression of several enlarged lymph nodes. Consequently, we performed a subtotal gastrectomy with D2 lymphadenectomy. The postoperative histopathological report was early gastric carcinoma with no lymph node metastasis in the 48 resected lymph nodes. Another 4 cycles of FOLFOX chemotherapy were performed after surgery. A FDG-PET-CT scan taken 12 months postoperatively showed no definite evidence of local recurrence or distant metastasis, and the previously noted retroperitoneal lymph nodes had disappeared. A FDG-PET-CT taken 16 months postoperatively showed multiple lymph node metastases, including the left supraclavicular lymph node. Despite 8 cycles of secondary chemotherapy with 5-FU, irinotecan, and leucovorin (FOLFIRI) and radiotherapy, the patient died 38 months after the operation.
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Glynne-Jones, Rob, and Peter Hoskin. "Neoadjuvant Cisplatin Chemotherapy Before Chemoradiation: A Flawed Paradigm?" Journal of Clinical Oncology 25, no. 33 (November 20, 2007): 5281–86. http://dx.doi.org/10.1200/jco.2007.12.3133.
Full textAbstract:
Effective chemotherapy (CT) treatment of solid tumors emerged with the introduction of anthracyclines and platinum CT in the late 1970s, at first with palliative intent, and later extended into the adjuvant setting. High response rates led to the belief that systemic CT might improve locoregional control and also decrease the risk of distant metastases. A new strategy advocated cisplatin-based neoadjuvant CT (NACT) before definitive local treatment—either surgery or radiotherapy (RT). Response to NACT was viewed as a favorable prognostic sign, which allows the selection of patients most likely to benefit from RT or chemoradiotherapy (CRT). The aim of this discussion is to raise the debate regarding NACT in reducing metastases, improving local control and selecting out good responders for nonsurgical treatment in the following sites: head and neck, esophagus, cervix, anus, nasopharynx, and bladder; as well as non–small-cell lung cancer. NACT has almost invariably failed to deliver an improved outcome in terms of disease-free survival (DFS) or overall survival (OS) when delivered before RT or CRT in all solid tumor sites. The evidence that NACT may improve outcome in terms of DFS or OS is strongest when it is administered before surgical resection, but remains scant before RT or CRT. Taxane-containing regimens look more promising than does cisplatin NACT, but have not been shown to improve on concurrent CRT. Future meta-analyses should compare induction CT followed by RT and induction followed by CRT versus RT or CRT alone.
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Liu, Feng, Shengnan Fu, Yanzhu Chen, Ouying Yan, Lili He, Cuihong Jiang, Xiangwei Wu, Yaqian Han, and Hui Wang. "A randomized phase II trial of diffusion-weighted MR imaging-guided radiotherapy plus chemotherapy versus standard chemoradiotherapy in locoregional advanced nasopharyngeal carcinoma." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 6018. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.6018.
Full textAbstract:
6018 Background: We hypothesized that diffusion-weighted MR imaging (DWI) guided dose-painting radiotherapy (DP-RT) was associated with improved tumor control and survival compared with standard CT-based radiotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC). The purpose of this randomized phase II trial was to compare the efficacy and toxicity of DWI guided DP-RT plus chemotherapy versus standard CT-based radiotherapy plus chemotherapy in locoregionally advanced NPC. Methods: Two hundred and fifty-six patients with stage III-IVa (8th AJCC) NPC were randomly assigned to receive DWI-guided dose-painting radiotherapy plus chemotherapy (DP-RT group, n = 128) or standard CT-based radiotherapy plus chemotherapy (CT-based RT group, n = 128). Patients in both groups received 3 cycles of induction chemotherapy followed by cisplatin-based concurrent chemoradiotherapy. In DP-RT group, subvolume GTVnx-DWI (gross tumor volume of nasopharynx in DWI) was defined as the areas within the GTVnx (gross tumor volume of nasopharynx) with an apparent diffusion coefficient (ADC) below the mean ADC (ADC < mean). The dose to GTVnx-DWI was escalated to DT 75.2 Gy/32 Fx in patients with T1-2 disease, and DT 77.55 Gy/33 Fx in those with T3-4 disease, in 2.35 Gy per fraction. In CT-based RT group (n = 128), PGTVnx was irradiated at DT 70.4-72.6 Gy/32-33 Fx in 2.2 Gy per fraction. This trial is registered with chictr.org.cn, number ChiCTR1800015779. Results: Compared with standard CT-based radiotherapy, DWI-guided DP-RT significantly improved 2-year local recurrence-free survival (LRFS, 100% vs. 95.4%; P = 0.024), distant metastasis-free survival (DMFS, 97.9% vs. 90.6%; P = 0.006), disease free survival (DFS, 93.2% vs. 86.8%; P = 0.021), and overall survival (OS, 100% vs. 95.2%; P = 0.038). No statistically significant differences in acute and late toxic effects were observed. Multivariate analysis showed that dose painting (DWI-guided DP-RT vs CT-based RT without DP) was a significant independent prognostic factor for DMFS and DFS (P = 0.021 and P = 0.020, respectively). Conclusions: Diffusion-weighted MR imaging guided dose-painting radiotherapy plus chemotherapy is associated with a considerable survival benefit, without increasing toxicity, as compared with standard CT-based radiotherapy plus chemotherapy, among patients with locoregionally advanced nasopharyngeal carcinoma. Clinical trial information: ChiCTR1800015779.
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Montravers, Françoise, Marc Tassart, Sophie Périé, Khaldoun Kerrou, Jean-NOËL Talbot, Bruno Angelard, and Jean Lacau St Guily. "Fluorodeoxyglucose Imaging Using a Coincidence Gamma Camera to Detect Head and Neck Squamous Cell Carcinoma and Response to Chemotherapy." Annals of Otology, Rhinology & Laryngology 111, no. 9 (September 2002): 763–71. http://dx.doi.org/10.1177/000348940211100901.
Full textAbstract:
This prospective study was performed to evaluate the ability of a dual-head gamma camera with fluorine-18 fluorodeoxyglucose coincidence detection emission tomography (FDG-CDET) to detect primary tumor and cervical lymph nodes in head and neck squamous cell carcinoma (HNSCC), and to show the response of the carcinoma to chemotherapy. The findings were compared with those of physical examination, computed tomography (CT), and histopathology, before treatment in 61 patients, and after induction chemotherapy in 34 of them. Before treatment, the primary was detected in 93%, 79%, and 95% of cases on panendoscopy, CT, and FDG-CDET, respectively. After chemotherapy, 34 patients were evaluable for response of the primary tumor. Surgical resection was performed in 23 of them: agreement with histopathologic results for response to treatment was 74%, 69%, and 78% for panendoscopy, CT, and FDG-CDET, respectively. No surgical resection was performed in 11 of the 34 patients, but biopsies were performed before radiotherapy, and their rates of agreement with histopathologic results for response to treatment were 75%, 75%, and 67% on panendoscopy, CT, and FDG-CDET, respectively. For cervical lymph nodes, 245 sites were resected in 41 patients, and FDG-CDET appeared competitive with CT in detecting metastatic neck disease, especially after neoadjuvant chemotherapy; the accuracy was 93%. These results demonstrated the ability of FDG-CDET to detect primary tumors and cervical lymph nodes in HNSCC and to show its response to chemotherapy, as compared to the ability of CT and panendoscopy. It may be a complementary tool to evaluate residual disease after induction chemotherapy, although higher sensitivity would be required for FDG-CDET to be considered as a staging modality.
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Cullen, M. H., L. J. Billingham, C. M. Woodroffe, A. D. Chetiyawardana, N. H. Gower, R. Joshi, D. R. Ferry, et al. "Mitomycin, Ifosfamide, and Cisplatin in Unresectable Non–Small-Cell Lung Cancer: Effects on Survival and Quality of Life." Journal of Clinical Oncology 17, no. 10 (October 1999): 3188–94. http://dx.doi.org/10.1200/jco.1999.17.10.3188.
Full textAbstract:
PURPOSE: Chemotherapy for non–small-cell lung cancer (NSCLC) remains controversial. We describe the two largest reported, randomized, parallel trials designed to determine whether the addition of chemotherapy influences duration and quality of life in localized, unresectable (mitomycin, ifosfamide, cisplatin [MIC]1 trial) and extensive (MIC2 trial) disease. PATIENTS AND METHODS: Ambulatory patients with NSCLC, aged 75 years or younger, with localized disease, were randomized in MIC1 to receive up to four cycles of chemotherapy (CT: mitomycin 6 mg/m2, ifosfamide 3 g/m2, and cisplatin 50 mg/m2) every 21 days, followed by radical radiotherapy (CT + RT) or radiotherapy (RT) alone. Extensive-stage patients were randomized in MIC2 to identical chemotherapy plus palliative care (CT + PC) or palliative care (PC) alone. Short-term change in quality of life (QOL) was assessed in a subgroup of patients. Data from the two trials were combined to allow multivariate and stratified survival analyses. RESULTS: Seven hundred ninety-seven eligible patients were randomized, 446 in MIC1 and 351 in MIC2. MIC CT improved survival in both trials (significantly in MIC2). The median survival time in MIC1 was 11.7 months (CT + RT) versus 9.7 months (RT alone) (P = .14); whereas in MIC2, median survival time was 6.7 months (CT + PC) compared with 4.8 months (PC alone) (P = .03). QOL, assessed in 134 patients from start of trial to week 6, showed improvement with chemotherapy and deterioration with standard treatment. In the combined analysis of 797 randomized patients, the positive effect of MIC on survival was significant overall (P = .01) and after adjusting for prognostic factors (P = .01). CONCLUSION: MIC chemotherapy prolongs survival in unresectable NSCLC without compromising QOL.