Peng Yuan1, Xichun Hu2, Tao Sun3, Wei Li4, Qingyuan Zhang5, Shude Cui6, Ying Cheng7, Quchang Ouyang8, Xiaojia Wang9, Zhendong Chen10, Masahide Hiraiwa11, Kenichi Saito11, Setsuo Funasaka11, Binghe Xu12. 1. National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China. 2. Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. 3. Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China. 4. Cancer Center, The First Hospital of Jilin University, Changchun City, China. 5. Department of Medical Oncology, The Third Affiliated Hospital of Harbin Medical University, Harbin, China. 6. Department of Breast Surgery, Henan Cancer Hospital, Zhengzhou, China. 7. Department of Thoracic Oncology, Jilin Province Tumor Hospital, Changchun, China. 8. Oncology Division of Breast Cancer, Hunan Cancer Hospital, Changsha, China. 9. Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China. 10. Department of Oncology, The Second Hospital of Anhui Medical University, Hefei, China. 11. Eisai Co., Ltd., Tokyo, Japan. 12. National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China. Electronic address: bhxu@hotmail.com.
Abstract
INTRODUCTION: The objective of this study was to evaluate the efficacy and safety of eribulin monotherapy, relative to vinorelbine, in Chinese women with locally recurrent/metastatic breast cancer (MBC). METHODS: This phase III open-label, randomised, parallel-group, multicentre clinical trial enrolled patients with locally recurrent or MBC who had had 2-5 prior chemotherapy regimens, including an anthracycline and taxane) from September 26, 2013, to May 19, 2015. Women were randomised 1:1 to receive eribulin (1.4 mg/m2, intravenously, on day 1 and day 8) or vinorelbine (25 mg/m2, intravenously, on day 1, day 8 and day 15) every 21 days. The primary end-point was progression-free survival (PFS). Secondary end-points included objective response rate (ORR), duration of response and overall survival (OS). RESULTS:Five hundred thirty women were randomised to receive eribulin (n = 264) or vinorelbine (n = 266). Improvement in PFS was observed with eribulin compared with vinorelbine (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.65-0.98, P = 0.036); median PFS was 2.8 months in both treatment arms. The median OS was 13.4 months with eribulin and 12.5 months with vinorelbine (HR: 1.03, 95% CI: 0.80-1.31, P = 0.838). The ORR was 30.7% (95% CI: 25.2%-36.6%) with eribulin and 16.9% (95% CI: 12.6%-22.0%) with vinorelbine (P < 0.001). Treatment-emergent adverse events leading to treatment discontinuation were less frequent with eribulin (7.2%) than with vinorelbine (14.0%). CONCLUSIONS:Eribulin achieved statistically significantly superior PFS (and response rate) compared with vinorelbine in previously treated women with locally recurrent or MBC. Eribulin appeared to be better tolerated than vinorelbine, with no new safety signals observed. TRIAL REGISTRATION: National Institutes of Health ClinicalTrials.gov registry, NCT02225470. Registered 05 August 2014- Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02225470?term=NCT02225470&rank=1.
RCT Entities:
INTRODUCTION: The objective of this study was to evaluate the efficacy and safety of eribulin monotherapy, relative to vinorelbine, in Chinese women with locally recurrent/metastatic breast cancer (MBC). METHODS: This phase III open-label, randomised, parallel-group, multicentre clinical trial enrolled patients with locally recurrent or MBC who had had 2-5 prior chemotherapy regimens, including an anthracycline and taxane) from September 26, 2013, to May 19, 2015. Women were randomised 1:1 to receive eribulin (1.4 mg/m2, intravenously, on day 1 and day 8) or vinorelbine (25 mg/m2, intravenously, on day 1, day 8 and day 15) every 21 days. The primary end-point was progression-free survival (PFS). Secondary end-points included objective response rate (ORR), duration of response and overall survival (OS). RESULTS: Five hundred thirty women were randomised to receive eribulin (n = 264) or vinorelbine (n = 266). Improvement in PFS was observed with eribulin compared with vinorelbine (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.65-0.98, P = 0.036); median PFS was 2.8 months in both treatment arms. The median OS was 13.4 months with eribulin and 12.5 months with vinorelbine (HR: 1.03, 95% CI: 0.80-1.31, P = 0.838). The ORR was 30.7% (95% CI: 25.2%-36.6%) with eribulin and 16.9% (95% CI: 12.6%-22.0%) with vinorelbine (P < 0.001). Treatment-emergent adverse events leading to treatment discontinuation were less frequent with eribulin (7.2%) than with vinorelbine (14.0%). CONCLUSIONS:Eribulin achieved statistically significantly superior PFS (and response rate) compared with vinorelbine in previously treated women with locally recurrent or MBC. Eribulin appeared to be better tolerated than vinorelbine, with no new safety signals observed. TRIAL REGISTRATION: National Institutes of Health ClinicalTrials.gov registry, NCT02225470. Registered 05 August 2014- Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02225470?term=NCT02225470&rank=1.
Authors: Min Ho Park; Soo Jung Lee; Woo Chul Noh; Chang Wan Jeon; Seok Won Lee; Gil Soo Son; Byung-In Moon; Jin Sun Lee; Sung Soo Kang; Young Jin Suh; Geumhee Gwak; Tae Hyun Kim; Young Bum Yoo; Hyun-Ah Kim; Min Young Kim; Ju Yeon Kim; Joon Jeong Journal: Breast Date: 2020-09-16 Impact factor: 4.380
Authors: I E de Kruijff; A M Sieuwerts; N Beije; W J C Prager-van der Smissen; L Angus; C M Beaufort; M N Van; E Oomen-de Hoop; A Jager; P Hamberg; F E de Jongh; J Kraan; J W M Martens; S Sleijfer Journal: Front Oncol Date: 2021-06-25 Impact factor: 6.244