Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Catherine M KellyAman U Buzdar

Abstract

We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer. In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m(2) for 12 weeks followed by fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m(2) on day 1 and capecitabine (XT) 1,500 mg/m(2) on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens. After enrollment of 601 patients and a median follow-up of 50 months, we observed no improvement in RFS between XT (87.5%; 95% CI, 82.7% to 91.1%) and WP (90.7%; 95% CI, 86.4% to 93.7%; P = .51). In the preoperative group, the pathologic complete response rate was 19.8% and 16.4% in the XT and WP arms, respectively ...Continue Reading

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Citations

Sep 26, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Justin N Bottsford-MillerAnil K Sood
Dec 30, 2015·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J TruongK K W Chan
Apr 18, 2014·Clinical Reviews in Allergy & Immunology·Matthieu Picard, Mariana C Castells
Jan 8, 2014·The Breast : Official Journal of the European Society of Mastology·N McCarthyUNKNOWN Australia and New Zealand Breast Cancer Trials Group
Jul 16, 2013·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·B E P J VriensUNKNOWN Breast Cancer Trialists' Group of the Netherlands (BOOG)
Apr 5, 2014·Journal of Biopharmaceutical Statistics·Kristine R BroglioScott M Berry
Feb 15, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Gunter von MinckwitzSibylle Loibl
Oct 29, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Alfredo BerrutiMaria Pia Sormani
Mar 6, 2019·Therapeutic Advances in Medical Oncology·Rafael CaparicaMartine Piccart
Aug 2, 2017·NPJ Breast Cancer·Jo Anne Zujewski, Lawrence Rubinstein
Nov 9, 2019·Therapeutic Advances in Medical Oncology·Amanda Fitzpatrick, Andrew Tutt
Feb 2, 2020·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Karama AslehSaranya Chumsri
Jul 3, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·David Kudlowitz, Franco Muggia
Apr 11, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Junjie LiUNKNOWN CBCSG010 Study Group
May 27, 2021·The Cochrane Database of Systematic Reviews·Siao-Nge HoonAndrew D Redfern

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