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

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...

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Bibliographic Details
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
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Summary: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 
ISSN:0960-9776
1532-3080
DOI:10.1016/j.breast.2017.12.012