title: Efficacy of biological agents in metastatic triple-negative breast cancer.
abstract: Metastatic triple-negative breast cancer (mTNBC) represents 15% of invasive breast cancers. Prognosis is poor, and there is no specific target therapy but biological agents combined with chemotherapy may be effective. To assess the role of biological agents in metastatic triple-negative breast cancer we performed a systematic review of phase III randomized controlled trials published from January 2006 to February 2013 and presentations at ESMO, ASCO, and SABCS congresses in 2010-2012. We consulted PubMed and ClinicalTrials.gov. Only studies comparing biological agents and chemotherapy versus chemotherapy alone were considered. Relevant statistical variables were log of the hazard ratio and relative variance for progression-free survival (PFS) and overall survival (OS). Of 353 PubMed publications and 229 studies registered on ClinicalTrials.gov, 10 trials were selected and 5293 patients were analyzed: 1546 had mTNBC. Biological agents considered were bevacizumab, sunitinib, sorafenib, lapatinib, iniparib and cetuximab. In addition, a meta analysis of the four studies containing bevacizumab was performed and it showed a PFS improvement with a relative risk reduction of 35% (95% CI: 25-43%). No effect on OS was observed. No PFS and OS benefit was detected with the other agents. No improvement of OS was detected in patients treated with biological agents plus chemotherapy, while a significant PFS improvement was observed only for bevacizumab and cetuximab. The overall impact of these agents on patient survival was not as great as expected, probably because the molecular basis of this illness needs to be better understood so that treatment can be more appropriately tailored.
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: annalisa.bramati@fbf.milano.it.
authors: Annalisa
authors: A
authors: Bramati
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: datamanager@fbf.milano.it.
authors: Serena
authors: S
authors: Girelli
authors: IRCCS - Istituto di ricerche farmacologiche Mario Negri, Lab of Methodology of Biomedical research, Department of Oncology, via La Masa 19, 20156 Milan, Italy. Electronic address: valter.torri@marionegri.it.
authors: Valter
authors: V
authors: Torri
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: gabriella.farina@fbf.milano.it.
authors: Gabriella
authors: G
authors: Farina
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: elena.galfrascoli@gmail.com.
authors: Elena
authors: E
authors: Galfrascoli
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: sheila.piva@fbf.milano.it.
authors: Sheila
authors: S
authors: Piva
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: anna.moretti@fbf.milano.it.
authors: Anna
authors: A
authors: Moretti
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: chiara.dazzani@fbf.milano.it.
authors: Maria Chiara
authors: MC
authors: Dazzani
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: paola.sburlati@fbf.milano.it.
authors: Paola
authors: P
authors: Sburlati
authors: Department of Oncology, Fatebenefratelli e Oftalmico, Corso di Porta Nuova, 23, 20121 Milan, Italy. Electronic address: nicla.laverde@fbf.milano.it.
authors: Nicla Maria
authors: NM
authors: La Verde
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000068258:Bevacizumab; D000068818:Cetuximab; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009389:Neovascularization, Pathologic / Q000517:prevention & control*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000187:drug effects* / Q000235:genetics; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D000068818:Cetuximab; D018719:Erb-b2 Receptor Tyrosine Kinases
keywords: Bevacizumab; Biological agents (BA); Metastatic triple-negative breast cancer (mTNBC)