机构:[1]Kyoto Univ, Grad Sch Med, Dept Breast Surg, Sakyo Ku, 54 Shogoin Kawara Cho, Kyoto 6068507, Japan;[2]Fudan Univ, Canc Hosp, Dept Breast Surg, Shanghai, Peoples R China;[3]Univ Calif Los Angeles, Los Angeles, CA USA;[4]Natl Yang Ming Univ, Taipei Vet Gen Hosp, Taipei, Taiwan;[5]Harbin Med Univ, Tumor Hosp, Dept Med Oncol, Harbin, Peoples R China;[6]Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Shanghai, Peoples R China;[7]Sun Yat Sen Univ, Canc Ctr, Dept Med Oncol, Guangzhou, Peoples R China;临床科室内科中山大学肿瘤防治中心[8]Jiangsu Canc Hosp, Nanjing 210009, Peoples R China;[9]Chinese Acad Med Sci, Canc Hosp & Inst, Dept Med Oncol, Beijing, Peoples R China;[10]Peking Union Med Coll, Beijing, Peoples R China;[11]Zhejiang Chinese Med Univ Hangzhou, Affiliated Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou, Zhejiang, Peoples R China;[12]Natl Canc Ctr, Ctr Breast Canc, Gyeunggi Do, South Korea;[13]Tuen Mun Hosp, Dept Clin Oncol, Tuen Mun, Hong Kong, Peoples R China;[14]Novartis Pharma SAS, Rueil Malmaison, France;[15]Novartis Pharma AG, Basel, Switzerland;[16]Beijing 307 Hosp PLA, Beijing, Peoples R China
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.
基金:
Novartis Pharmaceuticals CorporationNovartis
语种:
外文
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2017]版:
大类|2 区医学
小类|2 区肿瘤学
最新[2023]版:
大类|1 区医学
小类|2 区肿瘤学
第一作者:
第一作者机构:[1]Kyoto Univ, Grad Sch Med, Dept Breast Surg, Sakyo Ku, 54 Shogoin Kawara Cho, Kyoto 6068507, Japan;
通讯作者:
通讯机构:[1]Kyoto Univ, Grad Sch Med, Dept Breast Surg, Sakyo Ku, 54 Shogoin Kawara Cho, Kyoto 6068507, Japan;
推荐引用方式(GB/T 7714):
Toi Masakazu,Shao Zhimin,Hurvitz Sara,et al.Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+advanced breast cancer in BOLERO-1[J].BREAST CANCER RESEARCH.2017,19(1):-.doi:10.1186/s13058-017-0839-0.
APA:
Toi, Masakazu,Shao, Zhimin,Hurvitz, Sara,Tseng, Ling-Ming,Zhang, Qingyuan...&Jiang, Zefei.(2017).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,19,(1)
MLA:
Toi, Masakazu,et al."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 19..1(2017):-