235P - Phase II trial evaluating the combination of eribulin (E)+ bevacizumab (BEV) as first line chemotherapy in patients with metastatic Her2-negative b...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer, Metastatic
Presenter Anne-Claire Hardy-Bessard
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors A. Hardy-Bessard1, F. Brocard2, M. Leheurteur3, A. Melis4, J. Dauba5, A. Lortholary6, B. You7, E. Guardiola8, J. Grenier9, J. Martin-Babau10, J. Meunier11, P. Follana12, A. Savoye13, A. Mercier-Blas14, A. Marti15, R. Despax16, N. Barbier17, N. Gane18, P. Ardisson19, C. Segura-Djezzar20
  • 1Oncologie Médicale, Centre CARIO - HPCA, 22190 - Plerin-sur-Mer/FR
  • 2Oncologie Médicale, ORACLE - Centre d'Oncologie de Gentilly, Nancy/FR
  • 3Oncologie Médicale, Centre Henri Becquerel, Rouen/FR
  • 4Oncologie Médicale, Hôpital Privé Sainte-Marie, Chalon-sur-Saône/FR
  • 5Oncologie Médicale, Hôpital de Mont-de-Marsan, Mont de Marsan/FR
  • 6Oncologie, Centre Catherine de Sienne, Nantes/FR
  • 7Oncologie Médicale, Centre Hospitalier Lyon Sud, Pierre Bénite/FR
  • 8Oncologie Médicale, CH de la Dracénie-Draguignan, Draguignan/FR
  • 9Cancérologie Clinique, Institut Ste Catherine, Avignon/FR
  • 10Institut De Cancérologie Et D'hématologie, C.H.U. Brest - Hôpital Morvan, Brest/FR
  • 11Oncologie Médicale, C.H.R. Orleans - La Source, Orleans/FR
  • 12Oncologie Médicale, Centre Antoine Lacassagne, Nice/FR
  • 13Service Rubis - Oncologie Médicale, Institut Jean Godinot, Reims/FR
  • 14Oncologie Médicale, Centre Hospitalier Privé de Saint-Grégoire, Saint-Grégoire/FR
  • 15Service Oncologie, CH Auxerre, Auxerre/FR
  • 16Oncologie - Hématologie, Clinique Pasteur - ONCOSUD, Toulouse/FR
  • 17Oncologie Médicale, Centre Catalan d'Oncologie Clinique St. Pierre, Perpignan/FR
  • 18Service De Biostatistique, Arcagy-Gineco, Paris/FR
  • 19Service De Chimiothérapie, Clinique de la Sauvegarde, Lyon/FR
  • 20Oncologie Médicale, Centre Francois Baclesse, Caen/FR

Abstract

Background

Phase III combination of chemotherapy with BEV versus chemotherapy alone in first line MBC showed a benefit in favour of the combination in terms of PFS. Moreover, paclitaxel + BEV is a standard of care in Europe, and the main toxicity is sensory neuropathy (23.5 % of grade >= 3). The efficacy of E is well established in MBC pre-treated with taxanes and anthracyclines with a favourable safety profile. Therefore, our group initiated a study to assess the efficacy and safety of E + BEV combination in first-line MBC.

Methods

In this prospective, open-label, phase II study, patients with histologically confirmed HER2-negative MBC received as initial chemotherapy E every 3 weeks 1.23 mg/m2 on day 1 and day 8 for 6 cycles or more with BEV 15 mg/kg on day 1, until progression. The primary end point was non-progression rate at 1 year. Secondary end points were progression free survival (PFS) and safety.

Results

Of the 62 patients enrolled, 61 received the treatment. Median age was 59, 16% were triple negative, 30% had 3 metastatic sites or more. 71% of patients received prior chemotherapy, as adjuvant or neo-adjuvant treatment and 36% received hormonotherapy for MBC before enrolment. Median number of E cycles was 6 and 9 for BEV. The non-progression rate at 1 year was 32% (95% CI: 20%-43%), overall response rate (ORR) was 46%, and PFS was 8.3 months (95%CI: 7-9.6 months). Grade 3 or 4 neutropenia was observed in 26% patients only. Grade 3 HTA and thrombosis were observed in 39% and 8% of patients respectively. Grade 3 or 4 neuropathy occurred in 11% of patients. Other non-haematological adverse events were mild in severity.

Conclusions

This trial shows that E plus BEV has antitumor activity similar to paclitaxel plus BEV as first line chemotherapy in MBC, with an acceptable safety profile, notably a lower rate of neuropathy than expected with paclitaxel. This combination might be beneficial for patients with HER2-negative MBC what should be confirmed by further comparative study.

Clinical trial identification

NCT01341407

Legal entity responsible for the study

ARCAGY-GINECO

Funding

Eisai

Disclosure

All authors have declared no conflicts of interest.