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

G. Arpino, A. Michelotti, Mauro Truini, Filippo Montemurro, Stefania Russo, Raffaella Palumbo, Claudio Zamagni, Agnese Carmela Latorre, Dario Bruzzese, Fernando Riccardi, Michelino De Laurentiis, Alessandra Beano, Laura Biganzoli, Alberto Zaniboni, Lucio Laudadio, Maria Malagoli, D. Bilancia, Francesco Schettini, M. Giuliano, Marina CazzanigaS. De Placido

Research output: Contribution to journalArticle

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 2 cm (T ≥ 2 cm 39 vs. 59 %; p

Original languageEnglish
Pages (from-to)669-678
Number of pages10
JournalJournal of Cancer Research and Clinical Oncology
Volume142
Issue number3
DOIs
Publication statusPublished - Mar 1 2016

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Keywords

  • Adjuvant therapy
  • Clinical practice
  • Early breast cancer
  • HER2
  • Trastuzumab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Arpino, G., Michelotti, A., Truini, M., Montemurro, F., Russo, S., Palumbo, R., Zamagni, C., Latorre, A. C., Bruzzese, D., Riccardi, F., De Laurentiis, M., Beano, A., Biganzoli, L., Zaniboni, A., Laudadio, L., Malagoli, M., Bilancia, D., Schettini, F., Giuliano, M., ... De Placido, S. (2016). Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study. Journal of Cancer Research and Clinical Oncology, 142(3), 669-678. https://doi.org/10.1007/s00432-015-2033-z