Efficacy and Safety of Ixabepilone and Capecitabine in Patients With Advanced Triple-negative Breast Cancer: a Pooled Analysis From Two Large Phase III, Randomized Clinical Trials

Clinical Breast Cancer
Hope S RugoLinda Vahdat

Abstract

The purpose of this study was to evaluate the safety and efficacy of ixabepilone plus capecitabine in patients with metastatic or locally advanced triple-negative breast cancer (TNBC). We conducted a pooled analysis of patients with TNBC enrolled in 2 phase III trials (NCT00080301 and NCT00082433), pretreated or resistant to an anthracycline and a taxane. In each study, patients were randomized to receive ixabepilone 40 mg/m2 (3-hour intravenous infusion, day 1), plus oral capecitabine 1000 mg/m2 twice daily (days 1-14), or capecitabine alone 1250 mg/m2 twice daily (days 1-14), every 3 weeks. Treatment was continued until disease progression or unacceptable toxicity. In the subset of patients with TNBC (N = 443), the addition of ixabepilone to capecitabine compared with capecitabine alone prolonged median progression-free survival from 1.7 months to 4.2 months (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.52-0.78; P < .0001), and doubled the objective response rate from 15% (95% CI, 10.4%-20.5%) to 31% (95% CI, 24.4%-38.0%). The median overall survival was similar (9.0 vs. 10.4 months; HR, 0.88; 95% CI, 0.72-1.08; P = .1802). A similar pattern of efficacy between arms was observed in the overall pooled population (N...Continue Reading

Citations

Apr 5, 2020·Breast Cancer Research and Treatment·Takehiro HiraiMasaaki Matsuura
Oct 7, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Fakhrossadat EmamiSimmyung Yook
Dec 15, 2020·Journal of Oncology·Vito LorussoFrancesco Giotta
Jan 27, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·David S HongManish R Patel
May 13, 2021·Seminars in Cancer Biology·Chakrabhavi Dhananjaya MohanKanchugarakoppal S Rangappa
Oct 16, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Jan ŠkubníkSilvie Rimpelová

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