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

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.

• Authors: Grazia Arpino, Andrea Michelotti, Mauro Truini, Filippo Montemurro, Stefania Russo, Raffaella Palumbo, Claudio Zamagni, Agnese Latorre, Dario Bruzzese, Ferdinando Riccardi, Michelino De Laurentiis, Alessandra Beano, Laura Biganzoli, Alberto Zaniboni, Lucio Laudadio, Maria Malagoli, Domenico Bilancia, Francesco Schettini, Mario Giuliano, Marina Elena Cazzaniga, Sabino De Placido
• Journal: Journal of cancer research and clinical oncology (J Cancer Res Clin Oncol) Vol. 142 Issue 3 Pg. 669-78 (Mar 2016) ISSN: 1432-1335 [Electronic] Germany
• PMID: 26531187 (Publication Type: Journal Article, Multicenter Study, Observational Study)

Chemical References

• Receptor, ErbB-2

Topics

• Adult
• Aged
• Aged, 80 and over
• Breast Neoplasms (epidemiology, genetics, pathology, therapy)
• Female
• Humans
• Italy (epidemiology)
• Meta-Analysis as Topic
• Middle Aged
• Practice Patterns, Physicians' (statistics & numerical data)
• Randomized Controlled Trials as Topic
• Receptor, ErbB-2 (genetics, metabolism)