Human epidermal growth factor receptor 2 dual blockade with trastuzumab and pertuzumab in real life: Italian clinical practice versus the CLEOPATRA trial results

• Published in: Breast (Edinburgh) 2018-04, Vol.38, p.86-91
• Main Authors: De Placido, Sabino, Giuliano, Mario, Schettini, Francesco, Von Arx, Claudia, Buono, Giuseppe, Riccardi, Ferdinando, Cianniello, Daniela, Caputo, Roberta, Puglisi, Fabio, Bonotto, Marta, Fabi, Alessandra, Bilancia, Domenico, Ciccarese, Mariangela, Lorusso, Vito, Michelotti, Andrea, Bruzzese, Dario, Veneziani, Bianca Maria, Locci, Mariavittoria, De Laurentiis, Michelino, Arpino, Grazia
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Breast cancer; Breast Neoplasms - chemistry; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Bridged-Ring Compounds - administration & dosage; Clinical practice; Disease-Free Survival; Docetaxel; Female; HER2; Humans; Italy; Middle Aged; Observational study; Paclitaxel; Pertuzumab; Randomized Controlled Trials as Topic; Real life; Receptor, ErbB-2 - analysis; Receptor, ErbB-2 - antagonists & inhibitors; Retrospective Studies; Taxoids - administration & dosage; Trastuzumab; Trastuzumab - administration & dosage; Treatment Outcome; Young Adult
• ISSN: 0960-9776; 1532-3080
• DOI: 10.1016/j.breast.2017.12.012

Given their inclusion and exclusion criteria, randomized clinical trials (RCT) might not include a population that truly mirrors real life (RL). This raises concerns about the applicability of RCT results in clinical practice. We evaluated the efficacy of anti-HER2 treatment with pertuzumab combined with trastuzumab and a taxane as first-line treatment for HER2-positive metastatic breast cancer in a RL setting, and compared the safety results obtained in our population versus the experimental cohort of the CLEOPATRA RCT, which led to the approval of this therapy. Patients treated with trastuzumab, pertuzumab and a taxane were enrolled in this retrospective study. We compared the tumor features and the patients' characteristics of the RL cohort to those of the CLEOPATRA cohort. We also compared the median progression-free survival (PFS) in the RL population versus specific patients' subgroups. RL patients were more frequently HR-positive, less likely to have visceral metastases (P