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Clinical Trial
. 2020 Dec:54:256-263.
doi: 10.1016/j.breast.2020.09.011. Epub 2020 Sep 30.

First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study

Anne-Claire Hardy-Bessard  1 , Fabien Brocard  2 , Florian Clatot  3 , Alain Lortholary  4 , Benoît You  5 , Julien Grenier  6 , Jérôme Martin-Babau  7 , Brigitte Lucas  8 , Jérôme Meunier  9 , Jean-Marc Ferrero  10 , Aude-Marie Savoye  11 , Adina Marti  12 , Raymond Despax  13 , Isabelle Moullet  14 , George Emile  15
Affiliations
Clinical Trial

First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study

Anne-Claire Hardy-Bessard et al. Breast. 2020 Dec.

Abstract

Purpose: Combining bevacizumab with paclitaxel significantly improves progression-free survival (PFS) versus paclitaxel alone in HER2-negative metastatic breast cancer (MBC). Eribulin is active and tolerable in pretreated MBC. To assess whether eribulin may offer a more tolerable yet effective combination partner for bevacizumab, we evaluated a bevacizumab/eribulin combination regimen as first-line therapy for MBC.

Methods: In this single-arm phase II study, patients with histologically confirmed HER2-negative MBC and no prior chemotherapy for MBC received eribulin 1.23 mg/m2 on days 1 and 8 every 3 weeks for ≥6 cycles plus bevacizumab 15 mg/kg on day 1 every 3 weeks until disease progression. The primary endpoint was non-progression rate at 1 year. Secondary endpoints included objective response rate (ORR), PFS, and safety.

Results: The median age of the 61 treated female patients was 59 years, 16% had triple-negative MBC, 30% had ≥3 metastatic sites, and 71% had received prior (neo)adjuvant chemotherapy. Patients received a median of six eribulin and nine bevacizumab cycles. The non-progression rate at 1 year was 32% (95% confidence interval [CI]: 20-43%), ORR was 47% (95% CI: 34-60%), and median PFS was 8.3 months (95% CI: 7.0-9.6 months). The only grade ≥3 clinical adverse events in >5% of patients were hypertension (39%), neutropenia (26%), thrombosis (10%), and paresthesia/dysesthesia (7%).

Conclusion: First-line eribulin/bevacizumab combination therapy showed interesting activity in MBC with an acceptable safety profile, including a particularly low incidence of high-grade neuropathy.

Keywords: Bevacizumab; Combination therapy; Eribulin; Metastatic breast cancer; Neuropathy.

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Conflict of interest statement

Declaration of competing interest FC reports grants, personal fees, and non-financial support from AstraZeneca, grants from Roche Diagnostics, and personal fees and non-financial support from Roche and Lilly, outside the submitted work. BY reports consulting/advisory roles for AstraZeneca and advisory boards for Roche, GSK/Tesaro, Clovis, Novartis, MSD, BMS, Amgen, and ECS Progastrin, all outside the submitted work. GE reports personal fees and research support from Roche and Novartis, personal fees from Pfizer and Amgen, and research support from MSD, Odonate, Dompé Farmaceutici, AstraZeneca, and MacroGenics, outside the submitted work. A–CH–B, FB, AL, JG, JM-B, BL, JM, J-MF, A-MS, AMa, RD, and IM have nothing to disclose.

Figures

Fig. 1
Fig. 1
Treatment exposure by cycle.
Fig. 2
Fig. 2
Progression-free survival. Median OS was 28.3 months (95% CI: 22.8–33.9 months) after deaths in 35 patients (57%) (Fig. 3).
Fig. 3
Fig. 3
Overall survival.
See this image and copyright information in PMC

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