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RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer

J. Baselga, C. Zamagni, P. Gómez, B. Bermejo, SE. Nagai, B. Melichar, A. Chan, L. Mángel, J. Bergh, F. Costa, HL. Gómez, WJ. Gradishar, CA. Hudis, BL. Rapoport, H. Roché, P. Maeda, L. Huang, G. Meinhardt, J. Zhang, LS. Schwartzberg,

. 2017 ; 17 (8) : 585-594.e4. [pub] 20170522

Language English Country United States

Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc18033766

INTRODUCTION: Sorafenib is a multikinase inhibitor with antiangiogenic/antiproliferative activity. In this randomized, double-blind, placebo-controlled phase III trial, we assessed first- or second-line capecitabine with sorafenib or placebo in patients with locally advanced/metastatic HER2-negative breast cancer resistant to a taxane and anthracycline and with known estrogen/progesterone receptor status. PATIENTS AND METHODS: A total of 537 patients were randomized to capecitabine 1000 mg/m2 orally twice per day for days 1 to 14 every 21 days with oral sorafenib 600 mg/d or placebo. The primary end point was progression-free survival (PFS). Patients were stratified according to hormone receptor status, previous chemotherapies for metastatic breast cancer, and geographic region. RESULTS: Treatment with sorafenib with capecitabine, compared with capecitabine with placebo, did not prolong median PFS (5.5 vs. 5.4 months; hazard ratio [HR], 0.973; 95% confidence interval [CI], 0.779-1.217; P = .811) or overall survival (OS; 18.9 vs. 20.3 months; HR, 1.195; 95% CI, 0.943-1.513; P = .140); or enhance overall response rate (ORR; 13.5% vs. 15.5%; P = .515). Any grade toxicities (sorafenib vs. placebo) included palmar-plantar erythrodysesthesia syndrome (PPES; 79.2% vs. 59.6%), diarrhea (47.3% vs. 37.8%), mucosal inflammation (15.4% vs. 6.7%), and hypertension (26.2% vs. 5.6%). Grade 3/4 toxicities included PPES (15.4% vs. 7.1%), diarrhea (4.2% vs. 6.4%), and vomiting (3.5% vs. 0.7%). CONCLUSION: The combination of sorafenib with capecitabine did not improve PFS, OS, or ORR in patients with HER2-negative advanced breast cancer. Rates of Grade 3 toxicities were higher in the sorafenib arm.

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$a INTRODUCTION: Sorafenib is a multikinase inhibitor with antiangiogenic/antiproliferative activity. In this randomized, double-blind, placebo-controlled phase III trial, we assessed first- or second-line capecitabine with sorafenib or placebo in patients with locally advanced/metastatic HER2-negative breast cancer resistant to a taxane and anthracycline and with known estrogen/progesterone receptor status. PATIENTS AND METHODS: A total of 537 patients were randomized to capecitabine 1000 mg/m2 orally twice per day for days 1 to 14 every 21 days with oral sorafenib 600 mg/d or placebo. The primary end point was progression-free survival (PFS). Patients were stratified according to hormone receptor status, previous chemotherapies for metastatic breast cancer, and geographic region. RESULTS: Treatment with sorafenib with capecitabine, compared with capecitabine with placebo, did not prolong median PFS (5.5 vs. 5.4 months; hazard ratio [HR], 0.973; 95% confidence interval [CI], 0.779-1.217; P = .811) or overall survival (OS; 18.9 vs. 20.3 months; HR, 1.195; 95% CI, 0.943-1.513; P = .140); or enhance overall response rate (ORR; 13.5% vs. 15.5%; P = .515). Any grade toxicities (sorafenib vs. placebo) included palmar-plantar erythrodysesthesia syndrome (PPES; 79.2% vs. 59.6%), diarrhea (47.3% vs. 37.8%), mucosal inflammation (15.4% vs. 6.7%), and hypertension (26.2% vs. 5.6%). Grade 3/4 toxicities included PPES (15.4% vs. 7.1%), diarrhea (4.2% vs. 6.4%), and vomiting (3.5% vs. 0.7%). CONCLUSION: The combination of sorafenib with capecitabine did not improve PFS, OS, or ORR in patients with HER2-negative advanced breast cancer. Rates of Grade 3 toxicities were higher in the sorafenib arm.
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$a Zamagni, Claudio $u S. Orsola Malpighi Hospital, Bologna, Italy.
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$a Gómez, Patricia $u Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
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$a Bermejo, Begoña $u Hospital Clínico Universitario de Valencia, Valencia, Spain.
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$a Nagai, Shigenori E $u Saitama Cancer Center, Saitama, Japan.
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$a Melichar, Bohuslav $u Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.
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$a Chan, Arlene $u Curtin Health Innovation Research Institute, Curtin University, Perth, Australia.
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$a Gómez, Henry L $u Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
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$a Gradishar, William J $u Northwestern University Feinberg School of Medicine, Chicago, IL.
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$a Hudis, Clifford A $u Memorial Sloan Kettering Cancer Center, New York, NY.
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$a Roché, Henri $u Institut Claudius Régaud, Toulouse, France.
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$a Maeda, Patricia $u Bayer HealthCare Pharmaceuticals, Whippany, NJ.
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$a Huang, Liping $u Bayer HealthCare Pharmaceuticals, Whippany, NJ.
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$a Schwartzberg, Lee S $u The West Clinic, Memphis, TN.
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