Hope S Rugo1, Henri Roche2, Eva Thomas3, Hyun C Chung4, Guillermo L Lerzo5, Igor Vasyutin6, Amit Patel7, Linda Vahdat8. 1. Department of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA. Electronic address: Hope.Rugo@ucsf.edu. 2. Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France. 3. Department of Oncology and Hematology, Kaiser Permanente, Oakland, CA. 4. Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea. 5. Division of Oncology, Hospital of Oncologia Maria Curie, Cuidad de Buenos Aires, Argentina. 6. R-Pharm JSC, Moscow, Russian Federation. 7. R-Pharm US, Princeton, NJ. 8. Breast Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Abstract
INTRODUCTION: 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). PATIENTS AND METHODS: 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. RESULTS: 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 = 1973). The safety profile was comparable between the pooled TNBC subset and the overall pooled population. Adverse events observed with combination therapy were generally manageable and consistent with the safety profiles of the individual agents. CONCLUSION: Adding ixabepilone to capecitabine is effective in prolonging progression-free survival and improving objective response rate compared with capecitabine alone in patients with advanced TNBC previously treated withanthracyclines and taxanes.
RCT Entities:
INTRODUCTION: 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). PATIENTS AND METHODS: 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. RESULTS: 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 = 1973). The safety profile was comparable between the pooled TNBC subset and the overall pooled population. Adverse events observed with combination therapy were generally manageable and consistent with the safety profiles of the individual agents. CONCLUSION: Adding ixabepilone to capecitabine is effective in prolonging progression-free survival and improving objective response rate compared with capecitabine alone in patients with advanced TNBC previously treated with anthracyclines and taxanes.
Authors: Elaine M Walsh; Ayca Gucalp; Sujata Patil; Marcia Edelweiss; Dara S Ross; Pedram Razavi; Shanu Modi; Neil M Iyengar; Rachel Sanford; Tiffany Troso-Sandoval; Mila Gorsky; Jacqueline Bromberg; Pamela Drullinsky; Diana Lake; Serena Wong; Patricia Ann DeFusco; Nicholas Lamparella; Ranja Gupta; Tasmila Tabassum; Leigh Ann Boyle; Artavazd Arumov; Tiffany A Traina Journal: Breast Cancer Res Treat Date: 2022-08-20 Impact factor: 4.624
Authors: Hope S Rugo; Sara M Tolaney; Delphine Loirat; Kevin Punie; Aditya Bardia; Sara A Hurvitz; Joyce O'Shaughnessy; Javier Cortés; Véronique Diéras; Lisa A Carey; Luca Gianni; Martine J Piccart; Sibylle Loibl; David M Goldenberg; Quan Hong; Martin Olivo; Loretta M Itri; Kevin Kalinsky Journal: NPJ Breast Cancer Date: 2022-08-29