Efficacy and safety of eribulin in taxane-refractory patients in the ‘real world’

Abstract

Aim: Recent clinical, randomized and observational studies showed that eribulin, an analogous of Halichondrin B, was beneficial and well-tolerated in heavily pretreated metastatic breast cancer patients. Here, we aim to evaluate the effectiveness and safety of eribulin in taxane-refractory metastatic breast cancer patients. Patients & methods: In this subanalysis of the ESEMPIO study database, we selected 91 subjects with well-defined taxane refractoriness and complete data available. Results: 41 patients (45.2%) showed clinical benefit; one complete response (2.2%) and 16 partial responses (17.6%) were observed. Median progression-free survival and median overall survival were 3.1 and 11.6 months, respectively. The most experienced adverse event was asthenia/fatigue (58%), followed by neutropenia (30%). The treatment-related toxicity led to eribulin-dose reduction in 19 patients and suspension in nine. Conclusion: This study shows that eribulin is effective and well tolerated also in taxane-refractory patients in clinical practice.

Keywords:

• eribulin
• metastatic breast cancer
• taxane-refractory

Author contributions

V Lorusso and S Barni performed study setting and design. All authors performed data collection and analysis, did manuscript editing and provided final approval of the manuscript. V Lorusso performed manuscript drafting.

Acknowledgements

Study group thanks the following centers for their contribution: ES Lutrino (Ospedale A Perrino, Brindisi), A Pellegrino (Ospedale San Pietro FBF, Roma), L Pizzuti (Regina Elena NCI Oncologia Medica B, Roma), M Ciccarese (PO Vito Fazzi, Lecce), L Mentuccia (Unità di Oncologia Medica, ASL Frosinone), M Airoldi (ASO Molinette Torino), L Molteni (Ospedale Multimedica, Castellanza), M Pistelli (Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona), A Latorre (Istituto Tumori Giovanni Paolo II, Bari), Z Coccorullo (Ospedale G Borea, Sanremo), A Michelotti (Azienda Ospedaliera Universitaria Pisana, Pisa), A Musolino (Azienda Ospedaliero Universitaria di Parma, Parma), F Petrelli (ASST Bergamo Ovest Ospedale Treviglio, Treviglio), A Bertolini (Azienda Ospedaliera Valtellina e Valchiavenna, Sondrio), I Meattini (Azienda Ospedaliera Universitaria Careggi, Firenze), S Quercia (Ospedale S Orsola – Malpighi, Bologna), C Fontanella (Azienda Ospedaliero-Universitaria di Udine, Udine), K Cagossi (Azienda USL di Modena - Oncologia Ospedali Carpi e Mirandola), L Cecconetto (IRST - Meldola FC), S Quadrini (Ospedale Santissima Trinità, Sora), E Baldini (Ospedale San Luca, Lucca), L Iezzi (PO SS Annunziata, Chieti), D Amoroso (PO Versilia, Lido di Camaiore), S Saracchini (Azienda Ospedaliera Santa Maria degli Angeli, Pordenone), F Martella (Ospedale S Maria Annunziata, Firenze), L Livraghi (Azienda Ospedaliera ‘Papa Giovanni XXIII’, Bergamo), M Morritti (IRCSS Casa Sollievo della Sofferenza, S Giovanni Rotondo FG), O Garrone (AO S Croce e Carle, Cuneo), L D’Onofrio (Università Campus Biomedico, Roma), L Blasi (Ospedale Civico, Palermo), N La Verde (AO Fatebenefratelli e Oftalmico, Milano), F Tuccia (Ospedale Civile, Belluno), A Gennari (EO Ospedali Galliera, Genova), E Cretella (A S dell’Alto Adige, Bolzano), A Fabi (INT Regina Elena, Roma), S Gori (Ospedale Sacro Cuore Don Calabria, Negrar), V Gambi (Ospedale Niguarda Ca’ Granda, Milano), A Gambaro (Ospedale L Sacco, Milano), A Bernardo (Fondazione S Maugeri, Pavia), C Ficorella (Ospedale S Salvatore, L’Aquila), I Falco (Ospedale S Bassiano, Bassano del Grappa), C Oliani (Azienda ULSS 5, Ovest Vicentino) and C Cappelletti (AO Ospedali Riuniti Marche Nord, Fano).

Disclaimer

The sponsoring company was not offered the opportunity to revise the data or the manuscript, and had no role in the decision to submit.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Editorial assistance for the preparation of this manuscript was provided by L Giacomelli, PhD, and S Parodi, PhD, on behalf of Content Ed Net; this assistance was funded by Eisai.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.