Title |
Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1
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Published in |
Breast Cancer Research, April 2017
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DOI | 10.1186/s13058-017-0839-0 |
Pubmed ID | |
Authors |
Masakazu Toi, Zhimin Shao, Sara Hurvitz, Ling-Ming Tseng, Qingyuan Zhang, Kunwei Shen, Donggeng Liu, Jifeng Feng, Binghe Xu, Xiaojia Wang, Keun Seok Lee, Ting Ying Ng, Antonia Ridolfi, Florence Noel-baron, Francois Ringeisen, Zefei Jiang |
Abstract |
The current exploratory analysis was performed to evaluate the efficacy and safety of everolimus for treatment of human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer in the Asian subset of patients in the BOLERO-1 trial. Postmenopausal women with HER2+ advanced breast cancer, who had not received systemic therapy for advanced disease, were randomized 2:1 to receive everolimus or placebo, plus trastuzumab and paclitaxel. The two primary end points were investigator-assessed progression-free survival (PFS) in the full population and in the hormone receptor-negative (HR-) subpopulation. Secondary end points included assessment of the objective response rate, the clinical benefit rate, and safety. In the Asian subset, median PFS was similar in the everolimus (n = 198) and placebo (n = 105) arms in the full analysis set (hazard ratio = 0.82 (95% CI 0.61-1.11)). In the HR- subpopulation, everolimus prolonged median PFS by 10.97 months vs placebo (25.46 vs 14.49 months; hazard ratio = 0.48 (95% CI 0.29-0.79)). In the everolimus arm of the Asian subset, the most common adverse events of any grade were stomatitis (62.2%), diarrhea (48.0%), rash (43.4%) and neutropenia (42.3%). Neutropenia (grade 3: 27.6%; grade 4: 4.6%) and decreased neutrophil count (grade 3: 11.2%; grade 4: 3.6%) were the most frequent grade 3/4 adverse events. Serious adverse events included pneumonia (5.1%), pneumonitis (3.1%), and interstitial lung disease (3.1%). There were three deaths (1.5%) during treatment in the everolimus arm vs none in the placebo arm. The efficacy and safety of everolimus plus trastuzumab and paclitaxel as first-line treatment for HER2+ advanced breast cancer in the Asian subset was consistent with that reported previously in the overall population. ClinicalTrials.gov, NCT00876395 . Registered on 2 April 2009. |
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Geographical breakdown
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 107 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 13 | 12% |
Researcher | 13 | 12% |
Student > Bachelor | 13 | 12% |
Student > Ph. D. Student | 12 | 11% |
Lecturer | 6 | 6% |
Other | 18 | 17% |
Unknown | 32 | 30% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 29 | 27% |
Nursing and Health Professions | 13 | 12% |
Pharmacology, Toxicology and Pharmaceutical Science | 7 | 7% |
Psychology | 5 | 5% |
Immunology and Microbiology | 4 | 4% |
Other | 11 | 10% |
Unknown | 38 | 36% |