Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1

Breast Cancer Research

卷:19

Zefei Jiang¹  Keun Seok Lee²  Zhimin Shao³  Masakazu Toi⁴  Ting Ying Ng⁵  Xiaojia Wang⁶  Binghe Xu⁷  Donggeng Liu⁸  Qingyuan Zhang⁹  Jifeng Feng¹⁰  Florence Noel-baron¹¹  Francois Ringeisen¹¹  Antonia Ridolfi¹²  Kunwei Shen¹³  Ling-Ming Tseng¹⁴  Sara Hurvitz¹⁵ 

[1] Beijing 307 Hospital of PLA;

[2] Center for Breast Cancer, National Cancer Center;

[3] Department of Breast Surgery, Cancer Hospital of Fudan University;

[4] Department of Breast Surgery, Graduate School of Medicine, Kyoto University;

[5] Department of Clinical Oncology, Tuen Mun Hospital;

[6] Department of Medical Oncology, Affiliated Zhejiang Cancer Hospital of Zhejiang Chinese Medical University Hangzhou;

[7] Department of Medical Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College;

[8] Department of Medical Oncology, Sun Yat-sen University Cancer Center;

[9] Department of Medical Oncology, Tumor Hospital of Harbin Medical University;

[10] Jiangsu Cancer Hospital;

[11] Novartis Pharma AG;

[12] Novartis Pharma SAS;

[13] Ruijin Hospital Shanghai Jiao Tong University School of Medicine;

[14] Taipei Veterans General Hospital, National Yang Ming University;

[15] University of California, Los Angeles (UCLA);

关键词: Advanced breast cancer;    BOLERO-1;    Everolimus;    HER2;    Metastatic breast cancer;    Asian;   

DOI  :  10.1186/s13058-017-0839-0

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods 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. Results 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. Conclusions 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. Trial registration ClinicalTrials.gov, NCT00876395 . Registered on 2 April 2009.

【 授权许可】

Unknown