欧洲癌症杂志发表中国乳腺癌研究
对于蒽环类和紫杉类化疗失败的局部复发或转移性乳腺癌女性患者，同属细胞有丝分裂微管抑制剂的艾日布林或长春瑞滨均为美国国家综合癌症网络（NCCN）乳腺癌临床实践指南推荐的后续化疗候选药物。
2019年3月28日，欧洲癌症治疗研究组织、欧洲癌症组织、欧洲乳腺癌专科医师学会《欧洲癌症杂志》在线发表中国医学科学院北京协和医学院肿瘤医院（国家癌症中心、国家肿瘤临床医学研究中心）袁芃和徐兵河、复旦大学附属肿瘤医院胡夕春、中国医科大学附属肿瘤医院（辽宁省肿瘤医院）孙涛、吉林大学第一医院李薇、哈尔滨医科大学附属第三医院（黑龙江省肿瘤医院）张清媛、河南省肿瘤医院（郑州大学附属肿瘤医院）崔树德、吉林省肿瘤医院程颖、湖南省肿瘤医院（中南大学湘雅医学院附属肿瘤医院）欧阳取长、浙江省肿瘤医院王晓稼、安徽医科大学第二附属医院陈振东的随机对照研究报告，头对头比较了艾日布林或长春瑞滨治疗中国女性局部复发或转移性乳腺癌的有效性和安全性。
NCT02225470: Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes (An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane)
该多中心非盲随机平行对照III期临床研究于2013年9月26日～2015年5月19日入组既往2～5种化疗方案（包括蒽环类和紫杉类）失败的局部复发或转移性乳腺癌女性患者530例，按1∶1随机分配，每21天静脉注射艾日布林（1.4mg/m²，第1、8天，264例）或长春瑞滨（25mg/m²，第1、8、15天，266例）。主要终点为无进展生存。次要终点包括客观缓解率、缓解持续时间、总生存。
结果，艾日布林与长春瑞滨相比：
中位无进展生存：2.8比2.8个月（95%置信区间：2.8～4.1、2.7～2.8个月）
复发死亡风险比：0.80（95%置信区间：0.65～0.98，P=0.036）
中生总生存：13.4比12.5个月（95%置信区间：11.5～16.2、10.6～16.6个月）
死亡风险比：1.03（95%置信区间：0.80～1.31，P=0.838）
客观缓解率：30.7%比16.9%（95%置信区间：25.2%～36.6%、12.6%～22.0%，P<0.001）
治疗所致不良事件引起治疗中止：7.2%比14.0%
因此，该研究结果表明，对于既往化疗失败的局部复发或转移性乳腺癌女性，艾日布林与长春瑞滨相比，复发死亡风险显著减少，客观缓解率显著较高，治疗所致不良事件引起治疗中止发生率显著较低。
Eur J Cancer. 2019 Mar 28;112:57-65.
Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial.
Peng Yuan, Xichun Hu, Tao Sun, Wei Li, Qingyuan Zhang, Shude Cui, Ying Cheng, Quchang Ouyang, Xiaojia Wang, Zhendong Chen, Masahide Hiraiwa, Kenichi Saito, Setsuo Funasaka, Binghe Xu.
National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Fudan University Shanghai Cancer Center, Shanghai, China; Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China; Cancer Center, The First Hospital of Jilin University, Changchun City, China; The Third Affiliated Hospital of Harbin Medical University, Harbin, China; Henan Cancer Hospital, Zhengzhou, China; Jilin Province Tumor Hospital, Changchun, China; Hunan Cancer Hospital, Changsha, China; Zhejiang Cancer Hospital, Hangzhou, China; The Second Hospital of Anhui Medical University, Hefei, China; Eisai Co., Ltd., Tokyo, Japan.
HIGHLIGHTS
A study of eribulin versus vinorelbine in Chinese women with metastatic breast cancer.
Significant improvements in progression-free survival and objective response rate were seen with eribulin versus vinorelbine.
Toxicity profiles for both were as expected, with no new safety signals observed.
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
KEYWORDS: Progression-free survival, Tolerability, Locally recurrent or metastatic breast cancer, Eribulin
DOI: 10.1016/j.ejca.2019.02.002
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