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Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2- negative breast cancer: A trajectory analysis of adverse events

التفاصيل البيبلوغرافية
العنوان: Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2- negative breast cancer: A trajectory analysis of adverse events
المؤلفون: Ip, Edward H., Saldana, Santiago, Miller, Kathy D., Carlos, Ruth C., Gareen, Ilana F., Sparano, Joseph A., Graham, Noah, Zhao, Fengmin, Lee, Ju-Whei, O’Connell, Nathaniel S., Cella, David, Peipert, John D., Gray, Robert J., Wagner, Lynne I.
بيانات النشر: Wiley Periodicals, Inc.
سنة النشر: 2021
المجموعة: University of Michigan: Deep Blue
مصطلحات موضوعية: breast cancer, adverse events, drug treatment, early treatment discontinuation, patient- reported outcome, peripheral neuropathy, Oncology and Hematology, Public Health, Health Sciences
الوصف: Peer Reviewed ; http://deepblue.lib.umich.edu/bitstream/2027.42/171125/1/cncr33992_am.pdfTest ; http://deepblue.lib.umich.edu/bitstream/2027.42/171125/2/cncr33992.pdfTest
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: unknown
تدمد: 0008-543X
1097-0142
العلاقة: Ip, Edward H.; Saldana, Santiago; Miller, Kathy D.; Carlos, Ruth C.; Gareen, Ilana F.; Sparano, Joseph A.; Graham, Noah; Zhao, Fengmin; Lee, Ju-Whei; O’Connell, Nathaniel S.; Cella, David; Peipert, John D.; Gray, Robert J.; Wagner, Lynne I. (2021). "Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2- negative breast cancer: A trajectory analysis of adverse events." Cancer (24): 4546-4556.; https://hdl.handle.net/2027.42/171125Test; Cancer; Thanarajasingam G, Leonard JP, Witzig TE, et al. Longitudinal toxicity over time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial. Lancet Haematol. 2020; 7: e490 - e497.; Miller KD, O- Neill A, Gradishar W, et al. Double- blind phase III trial of adjuvant chemotherapy with and without bevacizumab in patients with lymph node- positive and high- risk lymph node- negative breast cancer (E5103). J Clin Oncol. 2018; 36: 2621 - 2629.; Miles DW, Chan A, Dirix LY, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first- line treatment of human epidermal growth factor receptor 2- negative metastatic breast cancer. J Clin Oncol. 2010; 28: 3239 - 3247.; Robert NJ, Diéras V, Glaspy J, et al. RIBBON- 1: randomized, double- blind, placebo- controlled, phase III trial of chemotherapy with or without bevacizumab for first- line treatment of human epidermal growth factor receptor 2- negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011; 29: 1252 - 1260.; Miles D, Cameron D, Bondarenko I, et al. Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first- line therapy for HER2- negative metastatic breast cancer (MERiDiAN): a double blind placebo- controlled randomised phase III trial with prospective biomarker evaluation. Eur J Cancer. 2017; 70: 146 - 155.; von Minckwitz G, Puglisi F, Cortes J, et al. Bevacizumab plus chemotherapy versus chemotherapy alone as second- line treatment for patients with HER2- negative locally recurrent or metastatic breast cancer after first- line treatment with bevacizumab plus chemotherapy (TANIA): an open- label, randomised phase 3 trial. Lancet Oncol. 2014; 15: 1269 - 1278.; Brufsky AM, Hurvitz S, Perez E, et al. RIBBON- 2: a randomized, double- blind, placebo- controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second- line treatment of human epidermal growth factor receptor 2- negative metastatic breast cancer. J Clin Oncol. 2011; 29: 4286 - 4293.; Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007; 357: 2666 - 2676.; Jubb AM, Miller KD, Rugo HS, et al. Impact of exploratory biomarkers on the treatment effect of bevacizumab in metastatic breast cancer. Clin Cancer Res. 2011; 17: 372 - 381.; Roviello G, Generali D, Sobhani N. The combination of bevacizumab with chemotherapy is more beneficial in the metastatic setting rather than in the adjuvant setting for the treatment of HER2- negative breast cancer- a commentary on the E5103 randomized phase III clinical study. Transl Cancer Res. 2019; 8 ( suppl 2 ): S94 - S96.; Schneider BP, Shen F, Jiang G, et al. Impact of genetic ancestry on outcomes in ECOG- ACRIN- E5103. JCO Precis Oncol. 2017; 2017: PO.17.00059. doi:10.1200/PO.17.00059; Coster S, Poole K, Fallowfield LJ. The validation of a quality of life scale to assess the impact of arm morbidity in breast cancer patients post- operatively. Breast Cancer Res Treat. 2001; 68: 273 - 282.; Ip EH, Zhang Q, Rejeski WJ, Harris TB, Kritchevsky S. Partially ordered mixed hidden Markov model for the disablement process of older adults. J Am Stat Assoc. 2013; 108: 370 - 380.; Ip EH, Zhang Q, Schwartz R, et al. Multi- profile hidden Markov model for mood, dietary intake, and physical activity in an intervention study of childhood obesity. Stat Med. 2013; 32: 3314 - 3331.; Rejeski WJ, Ip EH, Bertoni A, et al. Lifestyle change and mobility in aging obese adults with type 2 diabetes. N Engl J Med. 2012; 366: 1209 - 1217.; Gressett SM, Shah SR. Intricacies of bevacizumab- induced toxicities and their management. Ann Pharmacother. 2009; 43: 490 - 501.; Gullo G, Eustace AJ, Canonici A, et al. Pilot study of bevacizumab in combination with docetaxel and cyclophosphamide as adjuvant treatment for patients with early- stage HER- 2 negative breast cancer, including analysis of candidate circulating markers of cardiac toxicity: ICORG 08- 10 trial. Ther Adv Med Oncol. 2019; 11: 1 - 9. doi:10.1177/1758835919864236; Wong ML, Gao J, Thanarajasingam G, et al. Expanding beyond maximum grade: chemotherapy toxicity over time by age and performance status in advanced non- small cell lung cancer in CALGB 9730 (Alliance A151729). Oncologist. Published online September 20, 2020. doi:10.1002/onco.13527; Basch E, Jia X, Heller G, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst. 2009; 101: 1624 - 1632.; Basch E, Abernethy AP, Mullins D, et al. Recommendations for incorporating patient- reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol. 2012; 30 ( 34 ): 4249 - 4255.; Basch E, Rogak LJ, Dueck AC. Methods for implementing and reporting patient- reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials. Clin Ther. 2016; 38: 821 - 830.; Di Maio M, Gallo C, Leighl NB, et al. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015; 33: 910 - 915.; Basch E, Iasonos A, McDonough T, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire- based study. Lancet Oncol. 2006; 7: 903 - 909.; Basch E, Wilfong L, Schrag D. Adding patient- reported outcomes to Medicare’s oncology value- based payment model. JAMA. 2020; 323: 213 - 214.; Kluetz PG, Kanapuru BK, Lemery S, et al. Informing the tolerability of cancer treatments using patient- reported outcome measures: summary of an FDA and Critical Path Institute workshop. Value Health. 2018; 21: 742 - 747.; Eton DT, Cella D, Yost KJ, et al. A combination of distribution- and anchor- based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol. 2004; 57: 898 - 910.
DOI: 10.1002/cncr.33992
الإتاحة: https://doi.org/10.1002/cncr.33992Test
https://doi.org/10.1200/PO.17.00059Test
https://doi.org/10.1177/1758835919864236Test
https://doi.org/10.1002/onco.13527Test
https://hdl.handle.net/2027.42/171125Test
حقوق: IndexNoFollow
رقم الانضمام: edsbas.F08BD6E6
قاعدة البيانات: BASE
الوصف
تدمد:0008543X
10970142
DOI:10.1002/cncr.33992