Back to Search Start Over

Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study.

Authors :
Arpino, Grazia
Michelotti, Andrea
Truini, Mauro
Montemurro, Filippo
Russo, Stefania
Palumbo, Raffaella
Zamagni, Claudio
Latorre, Agnese
Bruzzese, Dario
Riccardi, Ferdinando
De Laurentiis, Michelino
Beano, Alessandra
Biganzoli, Laura
Zaniboni, Alberto
Laudadio, Lucio
Malagoli, Maria
Bilancia, Domenico
Schettini, Francesco
Giuliano, Mario
Cazzaniga, Marina
Source :
Journal of Cancer Research & Clinical Oncology; Mar2016, Vol. 142 Issue 3, p669-678, 10p
Publication Year :
2016

Abstract

Background: Several randomized clinical trials (RCTs) have demonstrated the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancer (BC). However, RCT patients may not invariably be representative of patients routinely seen in clinical practice (CP). To address this issue, we compared the clinical and tumor features of RCT and CP patients with HER2-positive BC. Patients and methods: From January to December 2012, 650 consecutive patients with HER2-positive early BC, treated in 36 different types of Italian healthcare facilities, were enrolled in this study. Age, treatment, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status were prospectively collected in these CP patients. The same data were extracted from the main adjuvant trastuzumab RCTs and pooled using the random-effects model of DerSimonian and Laird. RCT and CP patients were compared by using the Cochran Q statistics. Results: Versus RCT patients, CP patients were more likely to be older than 50 years (65 vs. 49 %; p < 0.0001) and to have HR (ER and/or PgR)-positive (72 vs. 54 %; p < 0.0001) BC and less likely to have tumor >2 cm ( T ≥ 2 cm 39 vs. 59 %; p < 0.0001), positive N (47 vs. 89 %; p < 0.0001) and a high G (61 vs. 67 %; p = 0.0241). CP patients more frequently received adjuvant endocrine therapy (70 vs. 57 %; p < 0.0003) and less frequently adjuvant chemotherapy (97 vs. 99.7 %; p < 0.0001). Conclusions: Most tumor and clinical features differed significantly between CP and RCT patients. These data raise concerns about the applicability of RCT results to CP patients. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01715216
Volume :
142
Issue :
3
Database :
Complementary Index
Journal :
Journal of Cancer Research & Clinical Oncology
Publication Type :
Academic Journal
Accession number :
112926797
Full Text :
https://doi.org/10.1007/s00432-015-2033-z