Journal articles: 'Adjuvant-free'

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Conrad, M. L., A. Ö. Yildirim, S. S. Sonar, A. Kılıç, S. Sudowe, M. Lunow, R. Teich, H. Renz, and H. Garn. "Comparison of adjuvant and adjuvant-free murine experimental asthma models." Clinical & Experimental Allergy 39, no. 8 (August 2009): 1246–54. http://dx.doi.org/10.1111/j.1365-2222.2009.03260.x.

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Hutchinson, Lisa. "Paclitaxel adjuvant therapy improves relapse-free survival." Nature Reviews Clinical Oncology 6, no. 8 (August 2009): 437. http://dx.doi.org/10.1038/nrclinonc.2009.100.

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Jones, Rachel S. "Adjuvant imatinib mesylate therapy improves recurrence-free survival." Nature Reviews Gastroenterology & Hepatology 6, no. 6 (June 2009): 320. http://dx.doi.org/10.1038/nrgastro.2009.80.

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Jin, Yining, Haoran Gao, Rick Jorgensen, Jillian Salloum, Dan Ioan Jian, Perry K. W. Ng, and Venugopal Gangur. "Mechanisms of Wheat Allergenicity in Mice: Comparison of Adjuvant-Free vs. Alum-Adjuvant Models." International Journal of Molecular Sciences 21, no. 9 (May 1, 2020): 3205. http://dx.doi.org/10.3390/ijms21093205.

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Wheat protein is considered a major type of food allergen in many countries including the USA. The mechanisms of allergenicity of wheat proteins are not well understood at present. Both adjuvant-based and adjuvant-free mouse models are reported for this food allergy. However, it is unclear whether the mechanisms underlying wheat allergenicity in these two types of models are similar or different. Therefore, we compared the molecular mechanisms in a novel adjuvant-free (AF) model vs. a conventional alum-adjuvant (AA) model of wheat allergy using salt-soluble wheat protein (SSWP). In the AF model, Balb/cJ mice were sensitized with SSWP via skin exposure. In the AA model, mice were sensitized by an intraperitoneal injection of SSWP with alum. In both models, allergic reactions were elicited using an identical protocol. Robust IgE as well as mucosal mast cell protein-1 responses were elicited similarly in both models. However, an analysis of the spleen immune markers identified strikingly different molecular activation patterns in these two models. Furthermore, a number of immune markers associated with intrinsic allergenicity were also identified in both models. Since the AF model uses skin exposure without an adjuvant, the mechanisms in the AF model may more closely simulate the human wheat allergenicity mechanisms from skin exposure in occupational settings such as in the baking industry.

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Felip, Enriqueta, Rafael Rosell, José Antonio Maestre, José Manuel Rodríguez-Paniagua, Teresa Morán, Julio Astudillo, Guillermo Alonso, et al. "Preoperative Chemotherapy Plus Surgery Versus Surgery Plus Adjuvant Chemotherapy Versus Surgery Alone in Early-Stage Non–Small-Cell Lung Cancer." Journal of Clinical Oncology 28, no. 19 (July 1, 2010): 3138–45. http://dx.doi.org/10.1200/jco.2009.27.6204.

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Purpose To address whether preoperative chemotherapy plus surgery or surgery plus adjuvant chemotherapy prolongs disease-free survival compared with surgery alone among patients with resectable non–small-cell lung cancer. Patients and Methods In this phase III trial, 624 patients with stage IA (tumor size > 2 cm), IB, II, or T3N1 were randomly assigned to surgery alone (212 patients), three cycles of preoperative paclitaxel-carboplatin followed by surgery (201 patients), or surgery followed by three cycles of adjuvant paclitaxel-carboplatin (211 patients). The primary end point was disease-free survival. Results In the preoperative arm, 97% of patients started the planned chemotherapy, and radiologic response rate was 53.3%. In the adjuvant arm, 66.2% started the planned chemotherapy. Ninety-four percent of patients underwent surgery; surgical procedures and postoperative mortality were similar across the three arms. Patients in the preoperative arm had a nonsignificant trend toward longer disease-free survival than those assigned to surgery alone (5-year disease-free survival 38.3% v 34.1%; hazard ratio [HR] for progression or death, 0.92; P = .176). Five-year disease-free survival rates were 36.6% in the adjuvant arm versus 34.1% in the surgery arm (HR 0.96; P = .74). Conclusion In early-stage patients, no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery. In this trial, in which the treatment decision was made before surgery, more patients were able to receive preoperative than adjuvant treatment.

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Eilber, F., A. Giuliano, J. Eckardt, K. Patterson, S. Moseley, and J. Goodnight. "Adjuvant chemotherapy for osteosarcoma: a randomized prospective trial." Journal of Clinical Oncology 5, no. 1 (January 1987): 21–26. http://dx.doi.org/10.1200/jco.1987.5.1.21.

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To determine the role of chemotherapy in the multidisciplinary treatment of patients with osteosarcoma, a randomized prospective trial of postoperative adjuvant chemotherapy was begun in 1981. Fifty-nine patients with nonmetastatic classic intramedullary osteosarcoma were randomized; 32 received postoperative adjuvant chemotherapy consisting of high-dose methotrexate, Adriamycin (Adria Laboratories, Columbus, OH), and BCD (bleomycin, cytoxan, actinomycin D), and 27 patients received no adjuvant chemotherapy. At a median follow-up of 2 years, there was a statistically significant improvement in both disease-free and overall survival in those who received adjuvant chemotherapy. In addition, there was no difference in the less than 20% disease-free or overall survival of patients treated in the 1970s who did not receive chemotherapy, as compared with the concurrent nontreatment controls. Therefore, with identical staging procedures, uniform surgical management, and standard pathologic evaluation, postoperative adjuvant chemotherapy definitely improves disease-free and overall survival in patients with osteosarcoma.

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Logothetis, C. J., D. E. Johnson, C. Chong, F. H. Dexeus, A. Sella, S. Ogden, T. Smith, D. A. Swanson, R. J. Babaian, and K. I. Wishnow. "Adjuvant cyclophosphamide, doxorubicin, and cisplatin chemotherapy for bladder cancer: an update." Journal of Clinical Oncology 6, no. 10 (October 1988): 1590–96. http://dx.doi.org/10.1200/jco.1988.6.10.1590.

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Seventy-one patients received adjuvant Cytoxan (cyclophosphamide; Bristol-Myers Co, Evansville, IN), Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and cisplatin (CISCA) chemotherapy between March 1981 and March 1986. Patients received adjuvant CISCA chemotherapy if they had pathological findings that were thought to predict for high likelihood of relapse. These included the presence of resected nodal metastases, extravesicular involvement of tumor, lymphatic/vascular permeation of the primary tumor, or pelvic visceral invasion. Sixty-two patients at a similar high risk for recurrence did not receive adjuvant CISCA chemotherapy because they refused, had medical contraindications to therapy, or were not referred for chemotherapy. Two-hundred six patients had a cystectomy performed during the same study period but had none of the poor prognostic features suggesting a high risk for relapse. Sixty-two percent of the patients receiving adjuvant chemotherapy are alive and disease-free for a mean follow-up of 118 weeks (range, 28 to 310 weeks). A survival advantage exists for the adjuvant-treated patients when compared with those with unfavorable pathological findings who did not receive adjuvant chemotherapy (70% v 37%) (P = .00012): no difference exists in long-term disease-free survival for those with favorable pathological findings (long-term disease-free survival 76%) v those who received adjuvant chemotherapy (70%) (P = .33). Adjuvant CISCA chemotherapy prolongs the disease-free survival of some patients following a cystectomy. Patients who benefitted from adjuvant CISCA chemotherapy included those with resected nodal metastases, extra-vesicular involvement of tumor, and direct invasion of the pelvic viscera. Patients not benefitting from adjuvant CISCA chemotherapy in this analysis included those with lymphatic/vascular invasion in their primary tumor as the sole manifestation of high risk for relapse.

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Meyers, Brandon Matthew, Humaid Obaid Al-Shamsi, and Alvaro Tell Figueredo. "Cochrane systematic review and meta-analysis of adjuvant chemotherapy for stage II colon cancer." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 3548. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.3548.

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3548 Background: Colon cancer is potentially curable by surgery in the early stages of the disease. Adjuvant chemotherapy improves disease-free and overall survival in patients with stage III disease, but the magnitude of benefit in stage II colon cancer is less clear. A previous Cochrane systematic review and meta-analysis (SR/MA) found improved disease-free, but not overall survival (Figueredo et al., 2008). An updated SR/MA was performed to determine the effects of adjuvant chemotherapy on disease-free and overall survival in patients with stage II colon cancer. Methods: Relevant databases (MEDLINE, EMBASE, and Cochrane) were independently searched by all authors, using the same search strategy employed in the original study (1/1988 to 9/2012). Randomized trials containing data on stage II colon cancer patients undergoing adjuvant 5-fluorouracil (5FU) chemotherapy versus observation were included. Pooled results were expressed as hazard ratios (HR) whenever possible, or risk ratios (RR), with 95% confidence intervals (95%CI) using a random effects model. Results: Seven studies were identified, and included in the final SR/MA. Six of the 7 studies were included in the disease-free survival analysis (n=4587). Adjuvant 5FU was associated with better disease-free survival (RR 0.84 (95%CI 0.75-0.94)). All 7 studies (n=5353) were included in the overall survival analysis showing an improvement with adjuvant 5FU (HR 0.87 (95%CI 0.78-0.97)). There was no evidence of heterogeneity across the studies (I2 = 0% for all analyses). Conclusions: In stage II colon cancer, adjuvant 5FU chemotherapy statistically improves both disease-free and overall survival. Our SR/MA demonstrates, for the first time, an overall survival advantage with adjuvant chemotherapy in stage II colon cancer.

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Li, Meichen, Xue Hou, Suxia Lin, Lie Zheng, Jianzhong Liang, Jing Chen, Na Wang, Baishen Zhang, and Likun Chen. "Efficacy of adjuvant EGFR inhibitors and impact of clinical factors in resected EGFR-mutated non-small-cell lung cancer: a meta-analysis." Future Oncology 18, no. 9 (March 2022): 1159–69. http://dx.doi.org/10.2217/fon-2021-0934.

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Background: The role of adjuvant EGFR tyrosine kinase inhibitors (TKIs) in resected EGFR-mutated non-small-cell lung cancer (NSCLC) remains unclear. Materials & methods: We evaluated pooled hazard ratio and 95% CI for disease-free survival, overall survival and prespecified subgroups. Results: Seven prospective studies with 1288 patients were included in the meta-analysis. Adjuvant EGFR TKIs significantly improved disease-free survival in EGFR-mutated resected NSCLC (HR: 0.41; 95% CI: 0.24–0.70) and in all subgroups. However, the overall survival benefit was not significant (HR: 0.65; 95% CI: 0.36–1.17). The benefit of adjuvant TKIs may be associated with TKI regimens, treatment duration, pathological stage and EGFR mutation type. Conclusion: Adjuvant EGFR TKIs significantly improved disease-free survival and nonsignificantly improved overall survival in resected EGFR-mutated NSCLC.

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Sakin, Abdullah, Nurgul Yasar, Suleyman Sahin, Serdar Arici, Saban Secmeler, Orcun Can, Caglayan Geredeli, Cumhur Demir, and Sener Cihan. "Efficacy and tolerability of adjuvant therapy in ≥70-year-old patients with T3N0M0 colorectal cancer: An observational study." Journal of Oncology Pharmacy Practice 26, no. 3 (August 1, 2019): 619–31. http://dx.doi.org/10.1177/1078155219865008.

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Background This study aimed to retrospectively investigate the efficacy and tolerability of adjuvant chemotherapy in ≥70-year-old patients with stage IIA (T3N0M0) colorectal cancer. Methods Lymphovascular invasion, perineural invasion, margin positivity, dissected lymph node count of <12, and presence of perforation/obstruction were accepted as risk factors. Those patients with at least one risk factor were regarded as having high risk. Results The study included 168 patients, among which 95 (56.5%) were male and 73 (43.5%) were female. The median age of patients was 73 years (range: 70–94). One hundred one (60.1%) patients were identified to have high risk. Eighty-one (87%) patients received 5-flourouracil+leucovorin and 12 (13%) patients received capecitabine regimens as adjuvant chemotherapy. The patients receiving capecitabine regimen had significantly higher rates of dose reduction at initiation and during the treatment. Among low-risk group, there was no statistically significant difference between patients with and without adjuvant chemotherapy in terms of disease-free survival or overall survival (p = 0.528 and p = 0.217, respectively). In high-risk group, patients receiving adjuvant chemotherapy significantly differed from those not receiving adjuvant chemotherapy in terms of median disease-free survival and overall survival (p = 0.009 and p < 0.001, respectively). While the grade, lymph node status, and adjuvant chemotherapy were identified as the most significant independent factors for disease-free survival, the most significant factors for overall survival were the age, Eastern Cooperative Oncology Group performance status, adjuvant chemotherapy, and recurrence. Conclusion The findings of our study showed improved disease-free survival and overall survival in high-risk ≥70-year-old patients who received adjuvant chemotherapy due to T3N0M0 colorectal cancer. We believe that 5-flourouracil+leucovorin or capecitabine regimens should be recommended for these older high-risk patients who could receive adjuvant chemotherapy regardless of age.

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Onal, Cem, Berna Akkus Yildirim, Sezin Yuce Sari, Guler Yavas, Melis Gultekin, Ozan Cem Guler, Ferah Yildiz, and Serap Akyurek. "Treatment outcomes of endometrial cancer patients with paraaortic lymph node metastasis: a multi-institutional analysis." International Journal of Gynecologic Cancer 29, no. 1 (January 2019): 94–101. http://dx.doi.org/10.1136/ijgc-2018-000029.

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ObjectiveTo analyze the prognostic factors and treatment outcomes in endometrial cancer patients with paraaortic lymph node metastasis.MethodsData from four centers were collected retrospectively for 92 patients with endometrial cancer treated with combined radiotherapy and chemotherapy or adjuvant radiotherapy alone postoperatively, delivered by either the sandwich or sequential method. Prognostic factors affecting overall survival and progression-free survival were analyzed.ResultsThe 5-year overall survival and progression-free survival rates were 35 % and 33 %, respectively, after a median follow-up time of 33 months. The 5-year overall survival and progression-free survival rates were significantly higher in patients receiving radiotherapy and chemotherapy postoperatively compared with patients treated with adjuvant radiotherapy alone (P < 0.001 and P < 0.001, respectively). In a subgroup analysis of patients treated with adjuvant combined chemotherapy and radiotherapy, the 5-year overall survival and progression-free survival rates were significantly higher in patients receiving chemotherapy and radiotherapy via the sandwich method compared with patients treated with sequential chemotherapy and radiotherapy (P = 0.02 and P = 0.03, respectively). In the univariate analysis, in addition to treatment strategy, pathology, depth of myometrial invasion, and tumor grade were significant prognostic factors for both overall survival and progression-free survival. In the multivariate analysis, grade III disease, myometrial invasion greater than or equal to 50%, and adjuvant radiotherapy alone were negative predictors for both overall survival and progression-free survival.ConclusionWe demonstrated that adjuvant combined treatment including radiotherapyand chemotherapy significantly increases overall survival and progression-free survival rates compared with postoperative pelvic and paraaortic radiotherapy.

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Ayhan, A., R. A. Al, C. Baykal, E. Demirtas, A. Ayhan, and K. YÜCE. "Prognostic factors in FIGO stage IB cervical cancer without lymph node metastasis and the role of adjuvant radiotherapy after radical hysterectomy." International Journal of Gynecologic Cancer 14, no. 2 (2004): 286–92. http://dx.doi.org/10.1136/ijgc-00009577-200403000-00015.

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Prognostic factors in FIGO stage IB cervical cancer without lymph node metastasis and the role of adjuvant radiotherapy after radical hysterectomy.ObjectivesThe aim of this study was to evaluate the clinical and pathologic prognostic variables for disease free survival, overall survival and the role of adjuvant radiotherapy in FIGO stage IB cervical carcinoma without lymph node metastasis.MethodsA retrospective review was performed of 393 patients with lymph node negative stage IB cervical cancer treated by type 3 hysterectomy and pelvic lymphadenectomy at the Hacettepe University Hospitals between 1980 and 1997.ResultsThe disease free survival and overall survival were 87.6 and 91.0%, respectively. In univariate analysis, tumor size, depth of invasion, vaginal involvement, lympho-vascular space involvement (LVSI) and adjuvant radiotherapy were found significant in disease free survival. Overall survival was affected by tumor size, LVSI, vaginal involvement and adjuvant radiotherapy. Tumor size, LVSI and vaginal involvement were found as independent prognostic factors for overall and disease free survival in multivariate analysis. Disease free survival, recurrence rate and site did not differ between patients underwent radical surgery and radical surgery plus radiotherapy.ConclusionTumor size, LVSI and vaginal involvement were independent prognostic factors in lymph node negative FIGO stage IB cervical cancer. Adjuvant radiotherapy in stage IB cervical cancer patients with negative nodes provides no survival advantage or better local tumoral control.

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Zeng, Erwei, Wei He, Jenny Bergqvist, and Kamila Czence. "Abstract P3-12-04: Extending therapy after 5-year adjuvant hormone therapy in breast cancer patients: A population-based study." Cancer Research 82, no. 4_Supplement (February 15, 2022): P3–12–04—P3–12–04. http://dx.doi.org/10.1158/1538-7445.sabcs21-p3-12-04.

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Abstract Background: Clinical guidelines have recommended breast cancer patients with certain characteristics to extend their therapy after 5-year adjuvant hormone therapy. However, no study thus far has described the prevalence, predictors, and outcomes of extending adjuvant hormone therapy in the real world. Methods: We identified 2,937 breast cancer patients who completed 5-year adjuvant hormone therapy during 2010-2019 in Stockholm, Sweden, by linking the Quality Register for Breast Cancer, Prescribed Drug Register, and Cause-of-death Register. We followed them until September 2020. Extended adjuvant hormone therapy was defined as having at least 2 prescriptions of tamoxifen and/or aromatase inhibitors after completing 5-year therapy. We used logistic regression to examine predictors of extended adjuvant hormone therapy and Cox regression to examine whether extended therapy is associated with distant metastasis-free survival, disease-free survival and all-cause mortality. Results: The proportion of extending therapy after 5-year adjuvant hormone therapy increased by 7 times during the past decade, from 8.8% in 2010 to 63.7% in 2019. Predictors of extended adjuvant hormone therapy included young age (≤50 years) at extension, positive lymph node status, high tumor grade and chemotherapy, among which chemotherapy was the strongest predictors [adjusted hazard ratio (HR), 4.64 (95% CI, 3.64-5.92)]. Among patients with chemotherapy, extended therapy improved distant metastasis-free survival [adjusted HR, 0.34 (95 CI%, 0.15-0.78)] and disease-free survival [adjusted HR, 0.61 (95 CI%, 0.39-0.95)]. Therapy discontinuation rates were similar during the first and second five years. Conclusion: Increasing number of breast cancer patients are extending adjuvant hormone therapy, even among patients without clear recommendations in clinical guidelines. Our findings support extended adjuvant hormone therapy in breast cancer patients with chemotherapy. Citation Format: Erwei Zeng, Wei He, Jenny Bergqvist, Kamila Czence. Extending therapy after 5-year adjuvant hormone therapy in breast cancer patients: A population-based study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-12-04.

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Edler, David, Bengt Glimelius, Marja Hallström, Anders Jakobsen, Patrick G. Johnston, Inger Magnusson, Peter Ragnhammar, and Henric Blomgren. "Thymidylate Synthase Expression in Colorectal Cancer: A Prognostic and Predictive Marker of Benefit From Adjuvant Fluorouracil-Based Chemotherapy." Journal of Clinical Oncology 20, no. 7 (April 1, 2002): 1721–28. http://dx.doi.org/10.1200/jco.2002.07.039.

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PURPOSE: We studied the prognostic value of thymidylate synthase (TS) expression in primary colorectal cancer (CRC) and the role of TS expression as a predictor of chemotherapeutic benefit in patients treated with adjuvant chemotherapy. PATIENTS AND METHODS: TS expression was immunohistochemically assessed on tumor sections from 862 patients with CRC Dukes’ stages B and C enrolled onto randomized trials evaluating fluorouracil (5-FU)-based adjuvant chemotherapy. RESULTS: TS expression was an independent prognostic factor for disease-free (P = .05) and overall survival (P = .05). In the subgroup treated with surgery alone, TS was an independent prognostic factor for disease-free (P < .001) and overall survival (P = .001), whereas this was not the case in the subgroup of adjuvantly treated patients. Patients whose tumors expressed high TS levels had a tendency to improved outcome after adjuvant therapy (not significant). The group whose tumors expressed the highest TS grade, grade 3 (34% of the patients), had a significantly longer disease-free survival if they were treated with adjuvant therapy compared with surgery alone (multivariate analyses, P = .02), whereas patients whose tumors expressed low TS levels (28% of the patients) had an impaired outcome after adjuvant therapy (multivariate analyses: disease-free survival, P = .01; overall survival, P = .01). CONCLUSION: TS expression predicts for survival independent of Dukes’ stage in patients with CRC treated with surgery alone. The study indicates that patients with high TS levels may benefit from adjuvant 5-FU–based chemotherapy. However, patients with low TS levels seem to have a worse outcome when treated with adjuvant chemotherapy.

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Colombo, N., and S. Pecorelli. "What have we learned from ICON1 and ACTION?" International Journal of Gynecologic Cancer 13, Suppl 2 (2003): 140–43. http://dx.doi.org/10.1136/ijgc-00009577-200311001-00002.

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Still, 20–30% of women with early-stage ovarian cancer eventually die from their disease. Adequate treatment for this subset of patients has not yet been identified, the greatest dispute being about the role of adjuvant therapy after surgical staging. No randomized trial has reliably demonstrated a survival advantage for one of the many approaches over another or over careful observation without immediate further adjuvant therapy. A combined analysis of two parallel randomized clinical trials in early ovarian cancer, ICON 1 and ACTION, comparing platinum-containing adjuvant chemotherapy to observation following surgery was performed, with survival as primary end point and time to recurrence as a secondary one. A total of 924 patients were randomized. With over 4 years median follow up for survivors, the hazard ratio for recurrence-free survival is 0.64 (95% CI, 0.50–0.82; P = 0.001) in favor of adjuvant chemotherapy, with an absolute difference of 11%. For overall survival, the hazard ratio is 0.67 (95% CI, 0.50–0.90; P = 0.008) in favor of adjuvant chemotherapy. These results translate into an absolute difference of 8% in the adjuvant chemotherapy group and indicate that adjuvant platinum-containing chemotherapy improves the survival and disease-free survival. Sub-group analysis demonstrated in the ACTION trial that completeness of surgical staging was an independent factor for prognosis, both for progression-free and for overall survival (along with histological type and tumor grade), while in suboptimally staged patients, adjuvant chemotherapy did improve the outcome.

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Bachelot, Thomas Denis, Sylvie Chabaud, Anne-Laure Martin, J. Lemonnier, Mario Campone, and Fabrice Andre. "UNIRAD: Multicenter, double-blind, phase III study of everolimus plus ongoing adjuvant therapy in ER+, HER2- breast cancer." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): TPS653. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.tps653.

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TPS653 Background: Advances in adjuvant treatment and highly effective endocrine therapies have resulted in better prognosis and survival among patients (pts) with hormone-receptor-positive (HR+; ER+ and/or PgR+) breast cancer (BC). Despite this, high risk pts (>3N+ and/or T3/4) are likely to relapse during/after adjuvant therapy. In a pivotal phase 3 trial (BOLERO-2), everolimus (EVE, an oral mammalian target of rapamycin [mTOR] inhibitor), plus exemestane demonstrated clinical efficacy in postmenopausal pts with HR+, human epidermal growth factor receptor-2–negative (HER2–) advanced BC progressing on non-steroidal aromatase inhibitors. Administering EVE earlier, concurrent with adjuvant endocrine therapy (ET) may lower relapse rates, especially in pts with high and/or persistent nodal involvement after neoadjuvant therapy. This study (UNIRAD) will evaluate the safety and effectiveness of adding EVE to adjuvant ET in pts with ER+, HER2–non-metastatic BC, who are disease-free following 3y of adjuvant ET. Methods: This multi-center, double-blind, phase 3 study will randomize adult (≥18y) women with non-metastatic ER+, HER2- BC, any T, pN+(≥4 if initial therapy and ≥1 after neoadjuvant therapy), who are disease-free following 3y of adjuvant ET to EVE (10mg/d) plus ongoing ET versus placebo (PBO) plus ongoing ET for a total adjuvant therapy duration of 5y. Stratification is by country, ET (tamoxifen or aromatase inhibitors), previous adjuvant versus neoadjuvant therapy, and age (≤70 versus >70y). Follow-up will continue for 5y after treatment. The primary endpoint is disease-free survival (DFS) with EVE versus PBO. Secondary endpoints include overall survival (OS), event-free survival, distant metastasis-free survival, DFS and OS in selected subgroups, safety, incidence of secondary cancers, quality of life, and predictive value of mTOR activation markers on DFS. Results: Accrual to the UNIRAD study will begin in March 2013 (planned N = 1984). Updated information will be presented. Clinical trial information: 2012-003187-44.

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Kumar, Ravinder, and Bhushan N. Kharbikar. "Lyophilized yeast powder for adjuvant free thermostable vaccine delivery." Applied Microbiology and Biotechnology 105, no. 8 (April 2021): 3131–43. http://dx.doi.org/10.1007/s00253-021-11259-1.

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&NA;. "Adjuvant breast cancer therapy - disease-free vs overall survival." Inpharma Weekly &NA;, no. 925 (February 1994): 5. http://dx.doi.org/10.2165/00128413-199409250-00007.

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Yamada, Ken-Ichi, Toshitaka Nakamura, and Hideo Utsumi. "Enhanced intraarticular free radical reactions in adjuvant arthritis rats." Free Radical Research 40, no. 5 (January 2006): 455–60. http://dx.doi.org/10.1080/10715760500440536.

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Silva, Sinara Figueiredo, Monique Celeste Tavares, Milton Jos De Barros E Silva, José Augusto Rinck, Joao Paulo SN Lima, Daniel Garcia, and Vinicius Fernando Calsavara. "Adjuvant therapy in non-metastatic melanoma result from a Brazilian cohort." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e22095-e22095. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e22095.

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e22095 Background: The PD-1–blocking antibodies, combination of target therapy and anti-CTLA4 have shown a favorable safety profile with better efficacy than high-dose interferon in the adjuvant setting. However, in Brazil only a minority of patients in private institutions have access to new therapies in adjuvants. Here, we describe the evolution of patients with non metastatic melanoma who received anti-PD1 or target therapy adjuvant or only followed. Methods: This is an observational, descriptive, retrospective cohort, which included patients diagnosed with cutaneous, mucous or acral melanoma (operated stage III or stage IVa) submitted or not they undergoing adjuvant chemotherapy between January 2013 and December 2019 at AC, São Paulo, Brazil. Results: We evaluated 82 patients with a median age of 54 years, 62.2% of the patients were male, the majority, 81.1%, white. In 29.3% had primary ulceration and presence of satellites was observed in 18.3% and the average Breslow value of the cases was 3,3mm. We found that 18.3% of patients were classified as stage IIIA, 4.9% IIIB, 22% IIIC, 8.5% IIID and 9.8% stage IV operated. The 44.6% of patients completed 1 year of adjuvant treatment. Related to the presence of ulceration, we observed a progression-free survival of 36.3 months for cases with ulceration versus 47.1 months for cases with absent ulceration, ( p= 0.449). Patients with satellite presence had a progression-free survival of 29.9 months versus 49.1 months for cases of missing satellite, ( p= 0.118). Patients who underwent lymph node dissection had a progression-free survival of 50.3 versus 36.4 months, those who did not undergo ( p= 0.201). Patients who completed 1 year of adjuvant therapy achieved a recurrence-free survival of 66.1 versus 27.9 months who did not complete, ( p= 0.003). Considering the tumor staging, patients classified T1a-T2a had a progression-free survival of 59.8 months, T2b-T3b of 42 months and those grouped as T4a, T4b, of 29.9 months, ( p = 0.021). The median progression-free survival was 44 months, 40.6 months for patients who received adjuvant treatment versus 27.2 months for those who did not ( p = 0.271) with a reduced risk of progression in the order of 33% for patients who received adjuvant. Conclusions: The presence of ulceration, satellites and advanced T staging were associated with a worse outcome with a greater chance of recurrence. Emptying of the lymph node chain, receiving adjuvant treatment and completing 1 year of adjuvant treatment were directly associated with improved survival

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Love, R. R., N. V. Dinh, T. T. Quy, N. D. Linh, E. M. Hade, G. S. Young, and D. Jarjoura. "Survival with adjuvant surgical oophorectomy and tamoxifen in premenopausal women with operable breast cancer." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 552. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.552.

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552 Background: Reports of randomized trials evaluating adjuvant ovarian suppression or ablation with and without tamoxifen are limited in number, useful comparative data and long-term follow-up. Methods: From 1993–99 we recruited 709 Vietnamese and Chinese premenopausal women with clinical stage II-III operable breast cancer to a multi-site randomized prospective clinical trial of immediate pre-mastectomy adjuvant surgical oophorectomy followed by tamoxifen for 5 years (n=356) or mastectomy alone with the same combined hormonal therapy on recurrence of disease (n=353).The primary study endpoints were disease-free and overall survival.This report provides analyses for an extended follow-up period after 5 years. Results: With a median follow up of 7 years, disease-free and overall survival were significantly better with adjuvant therapy (log-rank p-values of 0.0003 and 0.0002). Ten year DFS probabilities of 62% and 51% (95%CI 4–22%), and OS probabilities of 70% and 52% (95% CI 6–34%) between adjuvant and observation groups were observed. In the estrogen receptor positive patient subset, 5 and 10 year DFS probabilities were 83% and 61%, and 66% and 47%; and 5 and 10 year OS probabilities were 88% and 74% and 82% and 74% in adjuvant and observation groups respectively. Conclusions: In women with estrogen receptor positive operable breast cancers, 5 and 10 year disease free and overall survival rates following adjuvant oophorectomy and tamoxifen compare favorably with those from other adjuvant regimens. In estrogen receptor positive patients, the hazard function with adjuvant therapy increases after year six. No significant financial relationships to disclose.

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Berger, Arthur, Guillaume Perrod, Mathieu Pioche, Maximilien Barret, Elodie Cesbron-Métivier, Vincent Lépilliez, Marianne Hupé, et al. "Efficacy of Organ Preservation Strategy by Adjuvant Chemoradiotherapy after Non-Curative Endoscopic Resection for Superficial SCC: A Multicenter Western Study." Cancers 15, no. 3 (January 18, 2023): 590. http://dx.doi.org/10.3390/cancers15030590.

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Background. In case of high risk of lymph node invasion after endoscopic resection (ER) of superficial esophageal squamous cell carcinoma (SCC), adjuvant chemoradiotherapy (CRT) can be an alternative to surgery. We assessed long-term clinical outcomes of adjuvant therapy by CRT after non-curative ER for superficial SCC. Methods. We performed a retrospective multicenter study. From April 1999 to April 2018, all consecutive patients who underwent ER for SCC with tumor infiltration beyond the muscularis mucosae were included. Results. A total of 137 ER were analyzed. The overall nodal or metastatic recurrence-free survival rate at 5 years was 88% and specific recurrence-free survival rates at 5 years with and without adjuvant therapy were, respectively, 97.9% and 79.1% (p = 0.011). Independent factors for nodal and/or distal metastatic recurrence were age (HR = 1.075, p = 0.031), Sm infiltration depth > 200 µm (HR = 4.129, p = 0.040), and the absence of adjuvant CRT or surgery (HR = 11.322, p = 0.029). Conclusion. In this study, adjuvant therapy is associated with a higher recurrence-free survival rate at 5 years after non-curative ER. This result suggests this approach may be considered as an alternative to surgery in selected patients.

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Kiatbamrungpunt,, Chalermchai, Chaiyong Nualyong, Sittiporn Srinualnad, Sunai Leewansangtong, Tawatchai Taweemonkongsa, Bansithi Chaiyaprasith, Ekkarin Choti-kawanich, et al. "Long term outcomes between adjuvant radiotherapy and combined radiotherapy with hormonal treatment after radical prostatectomy in high risk prostate cancer." Insight Urology 42, no. 1 (June 1, 2021): 7–12. http://dx.doi.org/10.52786/isu.a.16.

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Objective: To determine the oncological outcome of adjuvant treatment between radiotherapy (RT) alone and combined radiotherapy with androgen deprivation therapy (ADT) in high risk prostate cancer patients after radical prostatectomy (RP). Materials and Methods: All medical records of high risk-prostate cancer patients (including PSA > 20 ng/ml, pT3-pT4 or Gleason score 8-10) who underwent RP in Siriraj Hospital between 2000 and 2016 were retrospectively reviewed. Demo-graphic data, pathological staging, types of adjuvant treatment, time to follow up and time to biochemical recurrence (BCR) were analyzed. Results: Undetectable PSA after RP was achieved in 1009 out of 1221 high risk prostate cancer patients who had been followed up at least 6 months after surgery. Pathological staging pT2, pT3, pT4 and N1 was 23.8%, 73%, 0.8% and 4.7%, respectively. Forty one percent received adjuvant treatment (41 adjuvant RT alone, 74 combined adjuvant RT and ADT, 303 ADT alone). Median follow up time in the adjuvant RT group and combined treatment group was 63.8 months (8.9 - 210.7). BCR rates were 22% (9 of 41) for adjuvant RT and 12.2% (9 of 74) for adjuvant combined treatment. 10-year BCR-free survival in the two groups was 70.2% and 83.8%, respectively. There was no statistical difference between adjuvant RT and adjuvant combined treatment in terms of survival benefit (Hazard Ratio 0.40; p = 0.057). Conclusion: Adjuvant radiotherapy after radical prostatectomy increases long term survival outcomes for high risk prostate cancer patients. This study shows that combined adjuvant RT and ADT may improve BCR-free survival.

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Figueredo, Alvaro, Manya L. Charette, Jean Maroun, Melissa C. Brouwers, and Lisa Zuraw. "Adjuvant Therapy for Stage II Colon Cancer: A Systematic Review From the Cancer Care Ontario Program in Evidence-Based Care’s Gastrointestinal Cancer Disease Site Group." Journal of Clinical Oncology 22, no. 16 (August 15, 2004): 3395–407. http://dx.doi.org/10.1200/jco.2004.03.087.

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Purpose To develop a systematic review that would address the following question: Should patients with stage II colon cancer receive adjuvant therapy? Methods A systematic review was undertaken to locate randomized controlled trials comparing adjuvant therapy to observation. Results Thirty-seven trials and 11 meta-analyses were included. The evidence for stage II colon cancer comes primarily from a trial of fluorouracil plus levamisole and a meta-analysis of 1,016 patients comparing fluorouracil plus folinic acid versus observation. Neither detected an improvement in disease-free or overall survival for adjuvant therapy. A recent pooled analysis of data from seven trials observed a benefit for adjuvant therapy in a multivariate analysis for both disease-free and overall survival. The disease-free survival benefits appeared to extend to stage II patients; however, no P values were provided. A meta-analysis of chemotherapy by portal vein infusion has also shown a benefit in disease-free and overall survival for stage II patients. A meta-analysis was conducted using data on stage II patients where data were available (n = 4,187). The mortality risk ratio was 0.87 (95% CI, 0.75 to 1.01; P = .07). Conclusion There is preliminary evidence indicating that adjuvant therapy is associated with a disease-free survival benefit for patients with stage II colon cancer. These benefits are small and not necessarily associated with improved overall survival. Patients should be made aware of these results and encouraged to participate in active clinical trials. Additional investigation of newer therapies and more mature data from the presently available trials should be pursued.

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Yang, Qiong, Ying Wei, Yan-Xian Chen, Si-Wei Zhou, Zhi-Min Jiang, and De-Rong Xie. "Indirect Comparison Showed Survival Benefit from Adjuvant Chemoradiotherapy in Completely Resected Gastric Cancer with D2 Lymphadenectomy." Gastroenterology Research and Practice 2013 (2013): 1–7. http://dx.doi.org/10.1155/2013/634929.

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Background. Little data on directly comparing chemoradiotherapy with observation has yet been published in the setting of adjuvant therapy for resected gastric cancer who underwent D2 lymphadenectomy. The present indirect comparison aims to provide more evidence on comparing the two approaches.Methods. We conducted a systematic review of randomized controlled trials, extracted time-to-event data using Tierney methods (when not reported), and performed indirect comparison to obtain the relative hazards of adjuvant chemoradiotherapy to observation on overall and disease-free survival.Results. seven randomized controlled trials were identified. Three trials compared adjuvant chemoradiotherapy with adjuvant chemotherapy, and 4 trials compared adjuvant chemotherapy with observation. Using indirect comparison, the relative hazards of adjuvant chemoradiotherapy to observation were 0.43 (95% CI: 0.33–0.55) in disease-free survival and 0.52 (95% CI: 0.38–0.71) in overall survival for completely resected gastric cancer with D2 lymphadenectomy.Conclusions. Postoperative chemoradiotherapy can prolong survival and decrease recurrence in patients with resected gastric cancer who underwent D2 gastrectomy. Molecular biomarker might be a promising direction in the prediction of clinical outcome to postoperative chemoradiotherapy, which warranted further study.

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Gavillet, Beatris Mastelic, Lucie Mondoulet, Véronique Dhelft, Christiane Sigrid Eberhardt, Floriane Auderset, Hong Thai Pham, Jean Petre, Paul-Henri Lambert, Pierre-Henri Benhamou, and Claire-Anne Siegrist. "Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: Preclinical proof of concept." Vaccine 33, no. 30 (July 2015): 3450–55. http://dx.doi.org/10.1016/j.vaccine.2015.05.089.

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Multinu, Francesco, Simone Garzon, Amy L. Weaver, Michaela E. McGree, Enrico Sartori, Fabio Landoni, Paolo Zola, et al. "Adjuvant chemotherapy in early-stage endometrioid endometrial cancer with >50% myometrial invasion and negative lymph nodes." International Journal of Gynecologic Cancer 31, no. 4 (February 19, 2021): 537–44. http://dx.doi.org/10.1136/ijgc-2020-002094.

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ObjectiveThe role of adjuvant chemotherapy as an addition or alternative to radiotherapy for early-stage high-risk endometrioid endometrial cancer is controversial. This study aimed to investigate the role of adjuvant chemotherapy in early-stage high-risk endometrioid endometrial cancer.MethodsWe identified patients with stage I or II endometrioid grade 2 or 3 endometrial cancer with myometrial invasion >50% and negative lymph nodes after pelvic with or without para-aortic lymphadenectomy at four institutions (USA and Italy). Associations between chemotherapy and cause-specific and recurrence-free survival were assessed with Cox proportional hazards models. Hematogenous, peritoneal, and lymphatic recurrences were defined as 'non-vaginal'.ResultsWe identified 329 patients of mean (SD) age 66.4 (9.8) years. The median follow-up among those alive was 84 (IQR 44–133) months. The 5-year cause-specific survival was 86.1% (95% CI 82.0% to 90.4%) and the 5-year recurrence-free survival was 82.2% (95% CI 77.9% to 86.8%). Stage II (vs stage IB) was associated with poorer cause-specific and recurrence-free survival. A total of 58 (90.6%) of 64 patients who had chemotherapy had 4–6 cycles of platinum-based regimen. In adjusted analysis, we did not observe a statistically significant improvement in cause-specific survival (HR 0.34; 95% CI 0.11 to 1.03; p=0.06) or non-vaginal recurrence-free survival (HR 0.36; 95% CI 0.12 to 1.08; p=0.07) with adjuvant chemotherapy. Sixteen of 18 lymphatic recurrences (88.9%; 3/5 pelvic, all 13 para-aortic) were observed in the 265 patients who did not receive adjuvant chemotherapy. Among stage II patients, no deaths (100% 5-year recurrence-free survival) were observed in the eight patients who received adjuvant chemotherapy compared with 66% 5-year recurrence-free survival in the 34 patients who did not.ConclusionAlthough we observed that adjuvant chemotherapy was associated with improved oncologic outcomes in early-stage high-risk endometrioid endometrial cancer, the associations did not meet conventional levels of statistical significance. Further research is warranted in this relatively uncommon subgroup of patients.

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Choi, Yoon Young, Hyunki Kim, Han-Kwang Yang, Woo Ho Kim, Young Woo Kim, Myeong-Cherl Kook, Young-Kyu Park, et al. "Clinical impact of microsatellite instability in patients with stage II and III gastric cancer: Results from the CLASSIC trial." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 4022. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.4022.

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4022 Background: The clinical implications of microsatellite instability (MSI) in gastric cancer are unclear. We investigated the usefulness of MSI status as a predictor of prognosis and responsiveness to adjuvant chemotherapy in patients with stage II and III gastric cancer. Methods: Tumor specimens and clinical information were collected from patients enrolled in the CLASSIC trial, a randomized controlled study of capecitabine plus oxaliplatin-based adjuvant chemotherapy. Five mononucleotide markers were used to assess tumor MSI status. Results: Of 592 specimens, 36 (6.1%) were MSI-high (MSI-H), whereas others were MSI-low or microsatellite-stable (MSS). Among 286 patients not treated with adjuvant therapy, those with MSI-H tumors had a better 5-year disease-free survival rate than did those with MSI-low/MSS tumors (hazard ratio adjusted by age, sex, tumor grade, disease stage, tumor location: 0.244 [95% confidence interval, 0.069–0.867]; p = 0.0292). Among 306 patients who received adjuvant chemotherapy, MSI-H status did not correlate with better disease-free survival (adjusted hazard ratio: 0.561 [95% confidence interval, 0.190–1.654]; p = 0.2946). Benefits from adjuvant chemotherapy differed by MSI status; although adjuvant chemotherapy improved disease-free survival among patients with MSI-low/MSS (adjusted hazard ratio: 0.634 [95% confidence interval, 0.485–0.828]; p = 0.0008), no benefit was observed in the MSI-H group (adjusted hazard ratio: 1.877 [95% confidence interval, 0.284–12.390]; p = 0.5130). Conclusions: Among patients with stage II and III gastric cancer, a MSI-H status correlated with a favorable prognosis, and adjuvant chemotherapy benefited those with MSI-L/MSS tumors but not those with MSI-H tumors.

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Smithy, James W., and Alexander N. Shoushtari. "Adjuvant PD-1 Blockade in Resected Melanoma: Is Preventing Recurrence Enough?" Cancer Discovery 12, no. 3 (March 1, 2022): 599–601. http://dx.doi.org/10.1158/2159-8290.cd-21-1593.

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Summary: Grossmann and colleagues report the results of a large randomized trial demonstrating improved recurrence-free survival with adjuvant pembrolizumab in resected melanoma compared with adjuvant ipilimumab or IFNα2b. However, it remains unclear whether adjuvant immunotherapies extend overall survival as outcomes for patients with advanced melanoma continue to improve. See related article by Grossmann et al., p. 644 (1).

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Tom, Martin, Deborah Park, Surabhi Tewari, Wei Wei, Samuel Chao, Jennifer Yu, John Suh, et al. "NCOG-30. ADJUVANT VERSUS SALVAGE MANAGEMENT FOR IDH-MUTANT LOW GRADE GLIOMA." Neuro-Oncology 22, Supplement_2 (November 2020): ii135. http://dx.doi.org/10.1093/neuonc/noaa215.568.

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Abstract PURPOSE Timing of postoperative treatment in low-grade glioma (LGG) remains controversial. We sought to evaluate outcomes between adjuvant versus salvage management among patients with IDH-mutant molecularly-defined LGG. METHODS We analyzed a single-institutional database of adults diagnosed with LGG (grade II) with an IDH-mutation and either 1p19q-codeletion (oligodendroglioma) or 1p19q-intact (astrocytoma). Cox multivariable analysis (MVA) accounting for age, sex, and extent-of-resection, was used to compare adjuvant versus salvage approaches on overall survival (OS), progression free survival (PFS), next-intervention free survival (NIFS, defined as intervention subsequent to either adjuvant or salvage treatment), and malignant-transformation free survival (MTFS). Adjuvant treatment was defined as immediate postoperative treatment with radiotherapy (RT) and/or temozolomide (TMZ) prior to progression. Salvage management was defined as postoperative observation followed by surgery or RT and/or TMZ at progression. RESULTS Of 162 patients with oligodendroglioma, median follow-up was 8.5 years (range, 0.03-25.7). Adjuvant treatment was given to 97 (59.9%) patients, with 65 (40.1%) undergoing a salvage approach. On MVA, adjuvant treatment was not associated with OS, PFS, NIFS, or MTFS (p > 0.05 each). Among 82 patients with astrocytoma, median follow-up was 6.1 years (range, 0.5–25.7), and adjuvant treatment was administered to 41 (50.0%) patients, while 41 (50.0%) received salvage management. On MVA, adjuvant treatment was associated with improved PFS (HR 0.42, 95% CI 0.24-0.73, p < 0.001) and NIFS (HR 0.35, 95% CI 0.18–0.65, p < 0.001), but was not associated with OS or MTFS (p > 0.05 each). CONCLUSIONS Among grade II, IDH-mutant oligodendrogliomas, initial postoperative observation followed by salvage treatment at progression may be appropriate, as immediate adjuvant therapy was not associated improved outcomes. However, a more individualized postoperative management approach is required for grade II, IDH-mutant astrocytomas, as adjuvant treatment was associated with improved PFS and NIFS, but not OS. Further validation and prospective studies are required.

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Dimopoulos, M. A., and L. A. Moulopoulos. "Role of adjuvant chemotherapy in the treatment of invasive carcinoma of the urinary bladder." Journal of Clinical Oncology 16, no. 4 (April 1998): 1601–12. http://dx.doi.org/10.1200/jco.1998.16.4.1601.

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PURPOSE The standard treatment for patients with muscle-invasive carcinoma of the urinary bladder is radical cystectomy. While radical cystectomy cures many patients with this tumor, almost 50% of them will develop metastatic disease. Adjuvant chemotherapy has been proposed for these patients in an attempt to reduce the probability of relapse and to improve survival. To assess whether adjuvant chemotherapy does benefit patients with muscle-invasive bladder cancer, we reviewed all phase II and III studies published in the English literature over the last 20 years. METHODS A review of all published reports was facilitated by the use of Medline computer search and by manual search of the Index Medicus. RESULTS Several comparative, nonrandomized studies have indicated that adjuvant chemotherapy may prolong disease-free survival. Four randomized studies have been conducted and all had a suboptimal patient accrual. Three studies used a cisplatin-containing combination chemotherapy and included primarily patients with non-organ-confined transitional-cell carcinoma (TCC) of the bladder. All three studies indicated that adjuvant chemotherapy improved disease-free survival and two of them also showed improvement in event-free survival and overall survival, respectively. CONCLUSION Published series have been unable to establish an undisputed benefit of adjuvant chemotherapy over radical cystectomy alone for muscle-invasive bladder cancer. The interpretation of the available data is compromised by several methodologic and statistical problems. Thus, adjuvant chemotherapy cannot be considered as a standard treatment for all patients with muscle-invasive carcinoma of the bladder. Well-designed prospective randomized studies are needed to clarify the role of adjuvant chemotherapy in this disease. However, outside a protocol setting, there is some evidence that patients with extravesical disease or with lymph node involvement may benefit from adjuvant treatment with cisplatin-based combination chemotherapy. No data support such an approach for patients with muscle-invasive but organ-confined bladder cancer.

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Collette, Laurence, Jean-Francois Bosset, Marcel den Dulk, France Nguyen, Laurent Mineur, Philippe Maingon, Ljiljana Radosevic-Jelic, Marianne Piérart, and Gilles Calais. "Patients With Curative Resection of cT3-4 Rectal Cancer After Preoperative Radiotherapy or Radiochemotherapy: Does Anybody Benefit From Adjuvant Fluorouracil-Based Chemotherapy? A Trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group." Journal of Clinical Oncology 25, no. 28 (October 1, 2007): 4379–86. http://dx.doi.org/10.1200/jco.2007.11.9685.

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Purpose European Organisation for Research and Treatment of Cancer (EORTC) trial 22921 compared adjuvant fluorouracil-based chemotherapy (CT) to no adjuvant treatment in a 2 × 2 factorial trial with randomization for preoperative (chemo)radiotherapy in patients with resectable T3-4 rectal cancer. The results showed no significant impact of adjuvant CT on progression-free or overall survival, although a difference seemed to emerge at approximately, respectively, 2 and 5 years after the start of preoperative treatment. We further explored the data with the aim of refining our understanding of the long-term results. Patients and Methods Data of 785 of the 1,011 randomly assigned patients who whose disease was M0 at curative surgery were used. Using meta-analytic methods, we investigated the homogeneity of the effect of adjuvant CT on the time to relapse or death after surgery (disease-free survival [DFS]) and survival in patient subgroups. Results Although there was no statistically significant impact of adjuvant CT on DFS for the whole group (P > .5), the treatment effect differed significantly between the ypT0-2 and the ypT3-4 patients (heterogeneity P = .009): only the ypT0-2 patients seemed to benefit from adjuvant CT (P = .011). The same pattern was observed for overall survival. Conclusion Exploratory analyses suggest that only good-prognosis patients (ypT0-2) benefit from adjuvant CT. This could explain why, in the whole group, the progression-free and overall survival diverged only after the poor-prognosis patients (ypT3-4) had experienced treatment failure. Patients in whom no downstaging was achieved did not benefit. This also suggests that the same prognostic factors may drive both tumor sensitivity for the primary treatment and long-term clinical benefit from further adjuvant CT.

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Hajibandeh, Shahab, and Shahin Hajibandeh. "Systematic Review: Adjuvant Chemotherapy for Locally Advanced Rectal Cancer with respect to Stage of Disease." International Scholarly Research Notices 2015 (February 8, 2015): 1–10. http://dx.doi.org/10.1155/2015/710569.

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Background. Recent meta-analysis of 21 randomised controlled trials (RCTs) supports the use of adjuvant chemotherapy for nonmetastatic rectal carcinoma. In order to define a subgroup of patients who can potentially benefit from postoperative adjuvant chemotherapy, this study aims to review trials investigating adjuvant chemotherapy with respect to stage of disease in patients with locally advanced rectal cancer who had undergone surgery for cure (stage II and stage III). Methods. We searched electronic information sources to identify randomised trials evaluating adjuvant chemotherapy in patients with stages II and III rectal cancer with overall survival or disease-free survival as outcomes. Scottish Intercollegiate Guidelines Network notes on methodology were used to assess the methodological quality of the selected studies. Random-effects models were applied to calculate pooled outcome data. Results. Eight studies reporting total of 5527 patients were selected for analysis. Adjuvant chemotherapy was associated with statistically significant improvement in disease-free survival and overall survival compared to surgery alone in both stage II and stage III cancer. Conclusions. This study indicates that both stage II and stage III rectal cancer patients may benefit from postoperative adjuvant chemotherapy. However, the benefits of adjuvant chemotherapy for patients who already had neoadjuvant chemoradiation still remain unknown.

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Luke, Jason J., Paolo A. Ascierto, Matteo S. Carlino, Jeffrey E. Gershenwald, Jean-Jacques Grob, Axel Hauschild, John M. Kirkwood, et al. "KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma." Future Oncology 16, no. 3 (January 2020): 4429–38. http://dx.doi.org/10.2217/fon-2019-0666.

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Patients with high-risk stage II melanoma are at significant risk for recurrence after surgical resection. Adjuvant treatment options to lower the risk for distant metastases are limited. Although adjuvant IFN-α2b is associated with improved relapse-free survival in patients with high-risk melanoma, toxicity and limited overall survival benefits limit its use. Adjuvant treatment with the PD-1 inhibitor pembrolizumab significantly improved recurrence-free survival, compared with placebo, in patients with resected stage III melanoma in the Phase III KEYNOTE-054 trial; efficacy in patients with stage II disease has not been established. This article describes the design and rationale of KEYNOTE-716 (NCT03553836), a two-part, randomized, placebo-controlled, multicenter Phase III study of adjuvant pembrolizumab in patients with surgically resected high-risk stage II melanoma. Clinical trial registry & ID: ClinicalTrials.gov, NCT03553836

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Beets, G. L., M. Maas, P. J. Nelemans, V. Valentini, C. H. Crane, C. Capirci, C. Roedel, L. Kuo, J. Garcia-Aguilar, and R. Glynne-Jones. "Evaluation of response after chemoradiation for rectal cancer as a predictive factor for the benefit of adjuvant chemotherapy: A pooled analysis of 2,724 individual patients." Journal of Clinical Oncology 29, no. 4_suppl (February 1, 2011): 361. http://dx.doi.org/10.1200/jco.2011.29.4_suppl.361.

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361 Background: Neoadjuvant chemoradiation (CRT) for rectal cancer increasingly results in pathologic response. It has been suggested that patients with different degrees of response might not have the same benefit of adjuvant chemotherapy. The aim was to determine whether patients with a pathologic complete response (pCR), ypT1-2 or ypT3-4 tumor after CRT for rectal cancer have different benefits of adjuvant chemotherapy for disease-free survival. Methods: Authors from studies evaluating different degrees of response to CRT were contacted to share individual patient data. The collected individual patient data were pooled into one dataset. To evaluate the effect of adjuvant chemotherapy on disease-free survival multivariate analyses according to the Cox proportional hazards model were performed. Hazard ratios (HR) with 95% confidence intervals (CI) were calculated for 3 subgroups: patients with pCR(ypT0N0), ypT1-2 tumor and ypT3-4 tumor after CRT. To determine benefit of adjuvant chemo for different pathologic N-stages we performed subgroup analyses. Results: 2,724 patients were included. 811 had pCR (28%), 863 had ypT1-2 (30%) and 1050 had ypT3-4 (37%). Median follow-up was 50 months (range 0-277). 41% underwent adjuvant chemotherapy, which consisted mostly of 5-FU based chemotherapy. The HR with 95%CI for disease-free survival for adjuvant chemotherapy was 0.94 (0.50-1.78) for patients with pCR, 0.61 (0.40-0.92) for patients with ypT1-2 tumors and 0.97 (0.75-1.25) for patients with ypT3-4 tumors. ypT1-2N0 patients benefited most from adjuvant chemo: HR 0.45 (0.27-0.75) vs. 0.79 (0.31-1.95) for patients with ypT1-2N+. For ypT3-4 patients pN-stage did not alter benefit of adjuvant chemo. Conclusions: Patients with pCR or ypT3-4 residual tumor after CRT do not seem to benefit from adjuvant chemo. This might be due to the already good prognosis of patients with pCR and less responsiveness to 5-FU based chemotherapy in the poor responders (the ypT3-4 tumors). Possibly adjuvant chemotherapy can be omitted or adapted for these patients. Patients with ypT1-2N0 benefit most from adjuvant chemo. No significant financial relationships to disclose.

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Gao, Min, Naiyi Zhang, Nan Song, Hong Zheng, Xin Yan, and Yunong Gao. "Chemotherapy as Adjuvant Treatment for Early Stage Endometrial Cancer With High Intermediate Risk Factors." International Journal of Gynecologic Cancer 28, no. 7 (September 2018): 1285–89. http://dx.doi.org/10.1097/igc.0000000000001295.

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ObjectiveThe aim of this study was to explore the role of chemotherapy as adjuvant treatment for early-stage endometrial cancer (EC) with high-intermediate-risk (HIR) factors.MethodsA prospective study of patients with early-stage EC with HIR factors for recurrence was performed between 2006 and 2014. A total of 96 patients were enrolled, and 50 patients received 3 cycles of platinum-based chemotherapy after surgery. Five-year disease-free survival and overall survival were evaluated.ResultsA total of 11 (11.5%) of the 96 patients had recurrence, with a median recurrent time of 15.4 months. Of these 11 patients with recurrence, 2 received adjuvant chemotherapy after surgery, whereas 9 did not receive any treatment. Patients without adjuvant chemotherapy exhibited a significantly higher recurrence rate than those with adjuvant chemotherapy (19.6% vs 4%; P = 0.024). Meanwhile, patients with adjuvant chemotherapy had significantly higher 5-year disease-free survival compared with the control group (92.1% vs 70.0%, P = 0.024).ConclusionsChemotherapy is feasible and safe as adjuvant treatment for early-stage EC with HIR factors. Three cycles of platinum-based chemotherapy are sufficient for reducing the risk of recurrence. Further, large sample randomized studies are needed to confirm these results.

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Lipkus, Isaac M., Ellen Peters, Gretchen Kimmick, Vlayka Liotcheva, and Paul Marcom. "Breast Cancer Patients’ Treatment Expectations after Exposure to the Decision Aid Program Adjuvant Online: The Influence of Numeracy." Medical Decision Making 30, no. 4 (February 16, 2010): 464–73. http://dx.doi.org/10.1177/0272989x09360371.

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The decision aid called ‘‘Adjuvant Online’’ (Adjuvant! for short) helps breast cancer patients make treatment decisions by providing numerical estimates of treatment efficacy (e.g., 10-y relapse or survival). Studies exploring how patients’ numeracy interacts with the estimates provided by Adjuvant! are lacking. Pooling across 2 studies totaling 105 women with estrogen receptor—positive, early-stage breast cancer, the authors explored patients’ treatment expectations, perceived benefit from treatments, and confidence of personal benefit from treatments. Patients who were more numerate were more likely to provide estimates of cancer-free survival that matched the estimates provided by Adjuvant! for each treatment option compared with patients with lower numeracy (odds ratios of 1.6 to 2.4). As estimates of treatment efficacy provided by Adjuvant! increased, so did patients’ estimates of cancer-free survival (0.37 > rs > 0.48) and their perceptions of treatment benefit from hormonal therapy (rs = 0.28) and combined therapy (rs = 0.27). These relationships were significantly more pronounced for those with higher numeracy, especially for perceived benefit of combined therapy. Results suggest that numeracy influences a patient’s ability to interpret numerical estimates of treatment efficacy from decision aids such as Adjuvant!.

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Lipkus, I. M., G. G. Kimmick, S. Y. Chui, D. L. Fifield, L. A. Werner, and P. K. Marcom. "Relationship between numeracy and breast cancer patients’ estimates of adjuvant treatment benefit." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 586. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.586.

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586 Background: Based on clinical anecdotes and existing literature, the general population has trouble understanding and making use of statistical information. We explored the accuracy of breast cancer patients’ (pts) estimates of treatment outcomes (probabilities of remaining cancer free versus recurring) relative to data provided by ‘Adjuvant! Online‘ decision aid program, and whether accuracy differed by pts numeracy skills (i.e. use of mathematical concepts and operations). Methods: 43 ER+ women with early stage, node-negative breast cancer were recruited (mean age 56, 72% Caucasian). After signing an informed consent and completing an assessment of numeracy (Lipkus et al., 2001), pts discussed case-specific Adjuvant! print-outs with an oncologist. Pts then estimated their chances of being cancer free after receiving no further treatment, hormonal therapy only, chemotherapy only, or both. Pts also were asked to select the treatment option that afforded their best chance of remaining cancer free. Results: Compared to the estimates provided by Adjuvant! Online, pts underestimated their chance of being cancer free after receiving no further treatment (M=62 vs. 48 out of 100), hormonal therapy only (M=72 vs. 45), chemotherapy only, (M=71 vs.42), and combined therapy (M=78 vs. 54). 63% correctly selected the treatment option that afforded the highest estimate of being cancer free. More numerate patients were more likely to correctly specify which treatment option provided the best chance of being cancer free (OR=0.67, 95% CI: 0.50, 0.89, p<.006); and less likely to give personal estimates of being cancer free inconsistent with estimates provided by Adjuvant! for hormonal therapy (OR=0.17, 95% CI: 0.04, 0.72, p<.02), chemotherapy (OR=0.62, 95% CI: 0.39, 0.99, p<.05) and combined therapy (OR=0.44, 95% CI: 0.23, 0.85, p<.02). Conclusions: Findings suggest that pt numeracy skills are important in comprehending statistical data about adjuvant treatment outcomes. Numeracy skills may have implications for how statistical information about treatment is presented and discussed, affecting processes of informed decision-making and pt quality of life. No significant financial relationships to disclose.

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Chang, Wenju, Jianmin Xu, Ye Wei, Li Ren, Tianshu Liu, Jingwen Chen, Dexiang Zhu, Qi Lin, and Xinyu Qin. "Improved disease-free survival with intraportal chemotherapy plus adjuvant chemotherapy (mFOLFOX6) as adjuvant treatment in colon cancer." Journal of Clinical Oncology 32, no. 15_suppl (May 20, 2014): 3616. http://dx.doi.org/10.1200/jco.2014.32.15_suppl.3616.

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Fuerst, Mark L. "Adjuvant Olaparib Improves Disease-Free Survival in Early Breast Cancer." Oncology Times 43, S15 (August 5, 2021): 11. http://dx.doi.org/10.1097/01.cot.0000771908.13436.7c.

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Goodman, Alice. "Exemestane after Adjuvant Tamoxifen Increases Breast Cancer Relapse-Free Survival." Oncology Times 29, no. 4 (February 2007): 53–54. http://dx.doi.org/10.1097/01.cot.0000266142.00815.96.

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Clegg, Christopher H., Richard Roque, Lucy A. Perrone, Joseph A. Rininger, Richard Bowen, and Steven G. Reed. "GLA-AF, an Emulsion-Free Vaccine Adjuvant for Pandemic Influenza." PLoS ONE 9, no. 2 (February 14, 2014): e88979. http://dx.doi.org/10.1371/journal.pone.0088979.

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Parvataneni, Sitaram, Babu Gonipeta, Robert J. Tempelman, and Venu Gangur. "Development of an Adjuvant-Free Cashew Nut Allergy Mouse Model." International Archives of Allergy and Immunology 149, no. 4 (2009): 299–304. http://dx.doi.org/10.1159/000205575.

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44

Pont, Luis Parra, Stefano Marcelli, Manuel Robustillo, Dajiang Song, Daniel Grandes, Marcos Martin, Israel Iglesias, Jorge Aso, Iñaki Laloumet, and Antonio J. Díaz. "Immediate Breast Reconstruction with Abdominal Free Flap and Adjuvant Radiotherapy." Plastic and Reconstructive Surgery 140, no. 4 (October 2017): 681–90. http://dx.doi.org/10.1097/prs.0000000000003664.

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45

Bonomi, Stefano, Laura Sala, and Umberto Cortinovis. "Immediate Breast Reconstruction with Abdominal Free Flap and Adjuvant Radiotherapy." Plastic and Reconstructive Surgery 142, no. 1 (July 2018): 91e—92e. http://dx.doi.org/10.1097/prs.0000000000004521.

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46

Schneider, J., M. Martin, F. Erasun, J. C. Matia, and F. J. Rodriguez-Escudero. "Cisplatin-Containing versus Cisplatin-Free Adjuvant Chemotherapy in Ovarian Carcinoma." Oncology 47, no. 2 (1990): 109–11. http://dx.doi.org/10.1159/000226799.

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47

Chesson, Charles B., Erica J. Huelsmann, Andrew T. Lacek, Frederick J. Kohlhapp, Matthew F. Webb, Arman Nabatiyan, Andrew Zloza, and Jai S. Rudra. "Antigenic peptide nanofibers elicit adjuvant-free CD8+ T cell responses." Vaccine 32, no. 10 (February 2014): 1174–80. http://dx.doi.org/10.1016/j.vaccine.2013.11.047.

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48

Nochi, Tomonori, Yoshikazu Yuki, Haruko Takahashi, Shin-ichi Sawada, Mio Mejima, Tomoko Kohda, Norihiro Harada, et al. "Nanogel antigenic protein-delivery system for adjuvant-free intranasal vaccines." Nature Materials 9, no. 7 (June 20, 2010): 572–78. http://dx.doi.org/10.1038/nmat2784.

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Nochi, Tomonori, Yoshikazu Yuki, Haruko Takahashi, Shinichi Sawada, Mio Mejima, Tomoko Kohda, Norihiro Harada, et al. "Nanogel antigen delivery system for adjuvant-free intranasal vaccines (46.16)." Journal of Immunology 184, no. 1_Supplement (April 1, 2010): 46.16. http://dx.doi.org/10.4049/jimmunol.184.supp.46.16.

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Abstract:

Abstract Nanotechnology is an innovative method of freely controlling nanometer-sized materials. The recent outbreak of mucosal infectious diseases have increased the demands for development of mucosal vaccines because they induce antigen-specific both mucosal and systemic immune responses. However because of lacking the effective antigen delivery system to aero-digestive mucosa, co-administration of mucosal adjuvant mediating protective but also undesired immunity is continuously needed. Here we developed a novel intranasal vaccine-delivery system with a nanometer-sized hydrogel (“nanogel”) consisting of a cationic type of cholesteryl group-bearing pullulan (cCHP). A nontoxic subunit fragment of Clostridium botulinum type-A neurotoxin BoHc/A administered intranasally with cCHP nanogel (cCHP-BoHc/A) continuously adhered to the nasal epithelium and was effectively taken up by mucosal dendritic cells (DCs) after its release from the cCHP nanogel. Vigorous botulinum neurotoxin A (BoNT/A)-neutralizing serum IgG and secretory IgA antibody responses were induced without co-administration of mucosal adjuvant. Importantly, intranasally administered cCHP-BoHc/A did not accumulate in the olfactory bulbs or brain. Moreover, intranasally immunized tetanus toxoid (TT) with cCHP nanogel induced strong TT-specific systemic and mucosal immune responses. These results indicate that cCHP nanogel can be used as a universal protein-based antigen-delivery vehicle for adjuvant-free intranasal vaccination.

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Wu, Mei, Dilip Shah, Xinyuan Chen, and Richard Anderson. "Non-inflammatory and additive-free adjuvant for cutaneous vaccination (113.29)." Journal of Immunology 188, no. 1_Supplement (May 1, 2012): 113.29. http://dx.doi.org/10.4049/jimmunol.188.supp.113.29.

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Abstract Skin has been considered an attractive site for vaccine delivery for more than 3000 years, but it is still not commonly used today, because of technical difficulties and a lack of inflammation-free adjuvant. Considerable progress made in generating convenient intradermal (i.d.) injection devices in the past decade raises an urgent need of developing potent vaccine adjuvants that introduce little skin inflammation. Many current vaccine adjuvants cause severe skin inflammation that jeopardizes the integrity of the skin and thus cannot be accepted for cutaneous vaccination. We develop a laser-based vaccine adjuvant (LVA) capable of boosting immune responses without incurring inflammation. LVA was induced by brief (2 min) illumination of a small area of the skin with a safe laser prior to i.d. administration of vaccines at the site of laser illumination. The pre-illumination augmented the hemagglutination inhibition (HAI) titers against seasonal or 2009-pandemic influenza vaccine by 10~20-folds when compared to i.m. immunization. And, while i.d. immunization blocked viral production in the lung by 2-fold over i.m. vaccination, i.d. immunization after laser illumination increased the blockade to 186-fold. In comparison with all current vaccine adjuvants that are either chemical compounds or biological agents, LVA is a risk- and additive-free adjuvant and has distinct advantages over traditional vaccine adjuvants for cutaneous vaccination.

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Journal articles on the topic 'Adjuvant-free'

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