艾日布林用于至少接受过一次化疗转移性乳腺癌患者的汇总分析

　　2016年5月13日，欧洲肿瘤内科学会（ESMO）官方期刊、牛津大学出版社旗下的《肿瘤学年鉴》在线发表了法国、德国、奥地利、美国、瑞士的研究报告。

　　该研究根据两项多中心Ⅲ期临床研究（与卡培他滨1∶1对照的301研究，与医师自选方案2∶1对照的305研究）1644例（艾日布林组946例，对照组698例）至少接受过一次化疗（包括蒽环类和紫杉类）转移性乳腺癌患者的意向治疗人群以及亚组汇总分析，强调了按照欧盟批准适应症使用艾日布林的生存获益，无论在总的转移性乳腺癌人群（总生存，P＜0.01；无进展生存、临床获益率，P＜0.05），还是在各个亚组，包括HER2阴性或三阴性乳腺癌（P＜0.05）。

Ann Oncol. 2016 May 13. [Epub ahead of print]

Pooled analyses of eribulin in metastatic breast cancer patients with at least 1 prior chemotherapy.

Pivot X, Marmé F, Koenigsberg R, Guo M, Berrak E, Wolfer A.

• Centre Hospitalier Universitaire de Besancon, Service d'Oncologie Médicale, Besancon cedex, France.

• National Centre for Tumour Diseases, Heidelberg, Department of Gynecologic Oncology, University Hospital, Heidelberg, Germany.

• Ludwig Boltzmann Institute for Applied Cancer Research (LBI-ACR VIEnna) - LB Cluster Translational Oncology, 3rd Medical Department - Centre for Oncology and Haematology, Kaiser Franz Josef-Spital, Kundratstr. 3, A-1100, Vienna, Austria; Ludwig Boltzmann Institut für angewandte Krebsforschung (LBI-ACR VIEnna), 3. Med. Abt. - Zentrum für Onkologie und Hamatologie, Kaiser Franz Josef-Spital, Kundratstr. 3, 1100 Wien, Osterreich.

• Biostatistics, Oncology PCU, Eisai Inc., Woodcliff Lake, NJ, USA.

• Oncology, Eisai Inc., Woodcliff Lake, NJ, USA.

• Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.

BACKGROUND: Based on data from two multicentre, phase 3 clinical trials (studies 301 and 305), eribulin (a microtubule dynamics inhibitor) is indicated in the European Union (EU) for patients with locally advanced or metastatic breast cancer (MBC) after ≥1 prior chemotherapy for advanced disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting. Data from Studies 305 and 301 were pooled to investigate the efficacy of eribulin in various subgroups of patients who matched the EU label, including those with human epidermal growth factor receptor 2 (HER2)-negative and triple-negative disease.

PATIENTS AND METHODS: In Study 305 (NCT00388726), patients were randomized 2:1 to eribulin (1.23 mg/m2 intravenously [equivalent to 1.4 mg/m2 eribulin mesylate] on days 1 and 8 every 21 days) or treatment of physician's choice after 2-5 prior chemotherapies (≥2 for advanced disease), including an anthracycline and a taxane (in early/advanced setting). In Study 301 (NCT00337103), patients were randomized 1:1 to eribulin (as above) or capecitabine (1.25 g/m2 orally twice daily on days 1-14 every 21 days) following ≤3 prior chemotherapies (≤2 for advanced disease), including an anthracycline and a taxane. Efficacy endpoints were investigated in the intent-to-treat population and subgroups, pooled as discussed above.

RESULTS: Overall, 1644 patients were included (eribulin: 946; control: 698); baseline characteristics were well matched. Overall survival was significantly longer with eribulin versus control (p<0.01), as were progression-free survival and clinical benefit rate (both p<0.05). Significant survival benefits with eribulin versus control were observed in a wide range of patient subgroups including HER2-negative or triple-negative disease (all p<0.05).

CONCLUSION: Our findings underline the survival benefit achieved by eribulin used according to EU label in the overall MBC population and in various subgroups of interest, including patients with HER2-negative and triple-negative disease.

KEYWORDS: Metastatic breast cancer; clinical trial; eribulin; pooled analysis; survival; triple-negative breast cancer

PMID: 27177860

PII: mdw203