title: A Real-World Multicentre Retrospective Study of Paclitaxel-Bevacizumab and Maintenance Therapy as First-Line for HER2-Negative Metastatic Breast Cancer.
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.
authors.affiliation: Medical Oncology Unit, Frosinone, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Gamucci
authors.affiliation: Medical Oncology Unit, Frosinone, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Mentuccia
authors.affiliation: Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell' Invecchiamento e Medicina Traslazionale - CeSI-MeT, Chieti, Italy.
authors.forename: Clara
authors.initials: C
authors.lastname: Natoli
authors.affiliation: Bio-Statistics Unit, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Isabella
authors.initials: I
authors.lastname: Sperduti
authors.affiliation: Department of Medical Oncology, Policlinico Universitario A. Gemelli, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Cassano
authors.affiliation: Oncology Unit I, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Michelotti
authors.affiliation: Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Lauro
authors.affiliation: Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Sergi
authors.affiliation: Division of Medical Oncology 1, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Fabi
authors.affiliation: Medical Oncology Unit, Nuoro, Italy.
authors.forename: Maria G
authors.initials: MG
authors.lastname: Sarobba
authors.affiliation: Department of Clinical and Molecular Medicine, "Sapienza" University of Rome, Azienda Ospedaliera Sant'Andrea, Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Marchetti
authors.affiliation: Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy.|Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Maddalena
authors.initials: M
authors.lastname: Barba
authors.affiliation: Medical Oncology Unit, Frosinone, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Magnolfi
authors.affiliation: Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy.|Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Maugeri-Saccà
authors.affiliation: Department of Medical Oncology, Policlinico Universitario A. Gemelli, Rome, Italy.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Rossi
authors.affiliation: Department of Clinical and Molecular Medicine, "Sapienza" University of Rome, Azienda Ospedaliera Sant'Andrea, Rome, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Sini
authors.affiliation: Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell' Invecchiamento e Medicina Traslazionale - CeSI-MeT, Chieti, Italy.
authors.forename: Antonino
authors.initials: A
authors.lastname: Grassadonia
authors.affiliation: Division of Medical Oncology 1, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Domenica
authors.initials: D
authors.lastname: Pellegrini
authors.affiliation: Department of Medical Oncology, Policlinico Universitario A. Gemelli, Rome, Italy.
authors.forename: Antonino
authors.initials: A
authors.lastname: Astone
authors.affiliation: Division of Medical Oncology 1, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nisticò
authors.affiliation: Medical Oncology Unit, Regina Apostolorum Hospital, Albano, Rome, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Angelini
authors.affiliation: Medical Oncology Unit, Frosinone, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Vaccaro
authors.affiliation: Medical Oncology Unit, Ospedale San Pietro Fatebenefratelli, Rome, Italy.
authors.forename: Arianna
authors.initials: A
authors.lastname: Pellegrino
authors.affiliation: Oncology Unit I, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: De Angelis
authors.affiliation: Medical Oncology Unit, Policlinico Umberto I, Rome, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Palleschi
authors.affiliation: Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy.|Department of Medical and Surgical Sciences for Children and Adults, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Moscetti
authors.affiliation: Oncology Unit I, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Bertolini
authors.affiliation: Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Buglioni
authors.affiliation: Sbarro Institute for Cancer Research and Molecular Medicine and Center for Biotechnology, College of Science and Technology, Temple University, Philadelphia, Pennsylvania.
authors.forename: Antonio
authors.initials: A
authors.lastname: Giordano
authors.affiliation: Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Pizzuti
authors.affiliation: Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vici
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068258:Bevacizumab / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008875:Middle Aged; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000068258:Bevacizumab; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases