PMID- 33601296 OWN - NLM STAT- MEDLINE DCOM- 20211029 LR - 20211029 IS - 2059-7029 (Electronic) IS - 2059-7029 (Linking) VI - 6 IP - 2 DP - 2021 Apr TI - 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). PG - 100054 LID - S2059-7029(21)00008-9 [pii] LID - 10.1016/j.esmoop.2021.100054 [doi] LID - 100054 AB - 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. CI - Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - De Angelis, C AU - De Angelis C AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. FAU - Bruzzese, D AU - Bruzzese D AD - Department of Public Health, University of Naples "Federico II", Naples, Italy. FAU - Bernardo, A AU - Bernardo A AD - Oncologia Medica, Fondazione S. Maugeri IRCCS, Pavia, Italy. FAU - Baldini, E AU - Baldini E AD - Department of Oncology, S. Luca Hospital, Lucca, Italy. FAU - Leo, L AU - Leo L AD - Unit of Oncology, A.O.R.N. dei Colli, Napoli, Naples, Italy. FAU - Fabi, A AU - Fabi A AD - Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, Rome, Italy. FAU - Gamucci, T AU - Gamucci T AD - Medical Oncology Unit, ASL Frosinone, Frosinone, Italy. FAU - De Placido, P AU - De Placido P AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. FAU - Poggio, F AU - Poggio F AD - UO Breast Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy. FAU - Russo, S AU - Russo S AD - Department of Oncology, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy. FAU - Forestieri, V AU - Forestieri V AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. FAU - Lauria, R AU - Lauria R AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. FAU - De Santo, I AU - De Santo I AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. FAU - Michelotti, A AU - Michelotti A AD - Azienda Ospedaliera Universitaria Pisana, Ospedale Santa Chiara, Pisa, Italy. FAU - Del Mastro, L AU - Del Mastro L AD - UO Breast Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy; University of Genova, Dipartimento di Medicina Interna e Specialita Mediche (DIMI), Genova, Italy. FAU - De Laurentiis, M AU - De Laurentiis M AD - Breast Oncology Department, Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy. FAU - Giuliano, M AU - Giuliano M AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. Electronic address: m.giuliano@unina.it. FAU - De Placido, S AU - De Placido S AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. FAU - Arpino, G AU - Arpino G AD - Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20210216 PL - England TA - ESMO Open JT - ESMO open JID - 101690685 RN - 0 (Furans) RN - 0 (Ketones) RN - 2S9ZZM9Q9V (Bevacizumab) RN - LR24G6354G (eribulin) RN - P88XT4IS4D (Paclitaxel) SB - IM EIN - ESMO Open. 2021 Apr;6(2):100097. PMID: 33926709 MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Bevacizumab/therapeutic use MH - *Breast Neoplasms/drug therapy MH - Female MH - Furans MH - Humans MH - Ketones MH - Paclitaxel/adverse effects MH - Quality of Life MH - Treatment Outcome PMC - PMC7900694 OTO - NOTNLM OT - HER2-negative OT - bevacizumab OT - eribulin OT - metastatic breast cancer COIS- Disclosure CDA is a consultant/advisory board member for Novartis, Eli Lilly, and Pfizer. FP has received travel, accommodations, expenses supported by Takeda, Ely Lilly, and received honoraria from Merck Sharp & Dohme, Ely Lilly, and Novartis outside the submitted work. AM is a consultant/advisory board member for EISAI, Novartis, Astra Zeneca, Teva, Pfizer, Celgene; has received travel accommodations supported by Eisai, Celgene, Novartis, and Ipsen. LDM is a consultant/advisory board member for Roche, Novartis, Celgene, Pfizer, MSD, Genomic Health, Ipsen, Takeda, Eli Lilly, Seattle Genetics, Pierre Fabre, and Eisai. MG, GA, and SDP have declared honoraria from Roche, Pfizer, Astra-Zeneca, Novartis, Celgene, Eli Lilly, Amgen, and Eisai. MDL has declared consulting fees from Pfizer, Novartis, Eli Lilly, Roche, Eisai, and Celgene. The remaining authors have declared no conflicts of interest. Data sharing The data sets obtained and/or analyzed during this study are available from the corresponding author on reasonable request. EDAT- 2021/02/19 06:00 MHDA- 2021/10/30 06:00 PMCR- 2021/02/16 CRDT- 2021/02/18 20:19 PHST- 2020/11/15 00:00 [received] PHST- 2021/01/03 00:00 [revised] PHST- 2021/01/12 00:00 [accepted] PHST- 2021/02/19 06:00 [pubmed] PHST- 2021/10/30 06:00 [medline] PHST- 2021/02/18 20:19 [entrez] PHST- 2021/02/16 00:00 [pmc-release] AID - S2059-7029(21)00008-9 [pii] AID - 100054 [pii] AID - 10.1016/j.esmoop.2021.100054 [doi] PST - ppublish SO - ESMO Open. 2021 Apr;6(2):100054. doi: 10.1016/j.esmoop.2021.100054. Epub 2021 Feb 16.