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- Title
Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1.
- Authors
Masakazu Toi; Zhimin Shao; Hurvitz, Sara; Ling-Ming Tseng; Qingyuan Zhang; Kunwei Shen; Donggeng Liu; Jifeng Feng; Binghe Xu; Xiaojia Wang; Keun Seok Lee; Ting Ying Ng; Antonia Ridolfi; Noel-baron, Florence; Ringeisen, Francois; Jiang, Zefei; Toi, Masakazu; Shao, Zhimin; Tseng, Ling-Ming; Zhang, Qingyuan
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov, NCT00876395 . Registered on 2 April 2009.
- Subjects
BREAST cancer patients; EVEROLIMUS; TRASTUZUMAB; PACLITAXEL; NEUTROPENIA; ANTINEOPLASTIC agents; BREAST tumors; CELL receptors; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; METASTASIS; REOPERATION; RESEARCH; TUMOR classification; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; PROPORTIONAL hazards models; KAPLAN-Meier estimator
- Publication
Breast Cancer Research, 2017, Vol 19, p1
- ISSN
1465-5411
- Publication type
journal article
- DOI
10.1186/s13058-017-0839-0