A Real-World Multicentre Retrospective Study of Paclitaxel-Bevacizumab and Maintenance Therapy as First-Line for HER2-Negative Metastatic Breast Cancer.

Teresa Gamucci,Cecilia Nisticò,Alessandra Fabi,Claudia De Angelis,Patrizia Vici,Luigi Di Lauro,Simonetta Buglioni,Antonino Grassadonia,Maddalena Barba,Valentina Sini,Franco Angelini,Domenica Pellegrini,Laura Pizzuti,Emanuela Magnolfi,Antonio Giordano,Ernesto Rossi,Luca Moscetti,Michela Palleschi,Andrea Michelotti,Ilaria Bertolini,Angela Vaccaro,Paolo Marchetti,Isabella Sperduti,Domenico Sergi,Alessandra Cassano,Clara Natoli,Lucia Mentuccia,Marcello Maugeri‐Saccà,A Pellegrino ,Maria Giuseppina Sarobba ,A Astone

doi:10.1002/jcp.25685

Abstract

Bevacizumab in combination with taxanes in HER2‐negative metastatic breast cancer (MBC) patients has shown improved progression‐free survival (PFS), despite the lack of clear overall survival (OS) benefit. We performed a retrospective analysis to evaluate the impact of paclitaxel‐bevacizumab and of maintenance therapy with bevacizumab (BM) and endocrine therapy (ET) in the real‐world practice. We identified 314 HER2‐negative MBC patients treated in 12 cancer centers. Overall, the median PFS and OS were 14 and 40 months, respectively. Among the 254 patients potentially eligible for BM, 183 received BM after paclitaxel discontinuation until progression/toxicity. PFS and OS were improved in patients who had received BM in comparison with those potentially eligible but who did not receive BM (P< 0.0001 and P = 0.001, respectively). Results were confirmed when adjusting for propensity score. Among the 216 hormone‐receptor positive patients eligible for BM, a more favorable PFS and OS were observed when maintenance ET was administered (P < 0.0001). Multivariate analysis showed that PS, BM, number of disease sites and maintenance ET were related to PFS, while response and maintenance ET were related to OS. In hormone‐receptor positive patients, BM produced a significant PFS and a trend towards OS benefit only in absence of maintenance ET (P = 0.0007 and P = 0.06, respectively). In the triple‐negative subgroup, we observed a trend towards a better OS for patients who received BM (P = 0.06), without differences in PFS (P = 0.21). Our results confirmed the efficacy of first‐line paclitaxel‐bevacizumab in real‐world practice; both BM and maintenance ET significantly improved PFS and OS compared to no maintenance therapies. J. Cell. Physiol. 232: 1571–1578, 2017. © 2016 Wiley Periodicals, Inc.

Highlights

The majority of the patients had visceral metastasis (61.7%), bone exclusive disease was recorded in 41 patients (13.1%), and 193 patients (61.5%) had multiple metastatic sites
In the first-line setting, the E2100 trial demonstrated significant progressionfree survival (PFS) and response rate (RR) improvements with paclitaxel-bevacizumab compared with paclitaxel alone in patients with HER2-negative metastatic breast cancer (MBC) (Miller et al, 2007)
The AVADO trial, evaluating bevacizumab-docetaxel as first-line therapy (Miles et al, 2010), showed a small improvement in median PFS compared with the control arm, and RR was increased in the experimental arm