Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI)

ESMO Open

article

M. De Laurentiis¹  M. Giuliano²  S. De Placido²  G. Arpino²  C. De Angelis²  D. Bruzzese³  A. Bernardo⁴  E. Baldini⁵  L. Leo⁶  A. Fabi⁷  T. Gamucci⁸  P. De Placido²  F. Poggio⁹  S. Russo^1,10  V. Forestieri²  R. Lauria²  I. De Santo²  A. Michelotti^1,11  L. Del Mastro⁹ 

[1] Breast Oncology Department, Istituto Nazionale Tumori Fondazione G. Pascale;Department of Clinical Medicine and Surgery, University of Naples “Federico II”;Department of Public Health, University of Naples “Federico II”;Oncologia Medica;Department of Oncology, S. Luca Hospital;Unit of Oncology;Medical Oncology 1, IRCCS Regina Elena National Cancer Institute;Medical Oncology Unit;UO Breast Unit, IRCCS Ospedale Policlinico San Martino;Department of Oncology, Azienda Sanitaria Universitaria Integrata di Udine;Azienda Ospedaliera Universitaria Pisana, Ospedale Santa Chiara;University of Genova, Dipartimento di Medicina Interna e Specialità Mediche

关键词: eribulin;    bevacizumab;    HER2-negative;    metastatic breast cancer;   

DOI  :  10.1016/j.esmoop.2021.100054

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background We evaluated the efficacy and safety of the nontaxane microtubule dynamics inhibitor eribulin plus the humanized anti-VEGF monoclonal antibody bevacizumab in a novel second-line chemotherapy scheme in HER2-negative metastatic breast cancer (MBC) patients progressing after first-line paclitaxel and bevacizumab.Patients and methods This is a multicenter, single-arm, Simon's two-stage, phase II study. The primary endpoint was the overall response rate, considered as the sum of partial and complete response based on the best overall response rate (BORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and clinical benefit rate.Results A total of 58 of the 61 patients enrolled in the study were evaluable for efficacy. The BORR was 24.6% (95% CI 14.5-37.3). The clinical benefit rate was 32.8% (95% CI 21.3-46.0). The median PFS was 6.2 months (95% CI 4.0-7.8), and median OS was 14.8 months (95% CI 12.6-22.8). Overall, adverse events (AEs) were clinically manageable and the most common AEs were fatigue, paresthesia, and neutropenia. Quality of life was well preserved in most patients.Conclusions The results of this study suggest that second-line therapy with bevacizumab in combination with eribulin has a meaningful clinical activity and may represent a potential therapeutic option for patients with HER2-negative MBC.

【 授权许可】

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