Survher: A retrospective multicenter study comparing demographic and tumor characteristics of clinical trials versus clinical practice patients with HER2-positive breast cancer.
2014; Lippincott Williams & Wilkins; Volume: 32; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2014.32.15_suppl.640
ISSN1527-7755
AutoresGrazia Arpino, Mauro Truini, Filippo Montemurro, Francesco Schettini, Andrea Michelotti, Stefania Russo, R. Palumbo, Marina Elena Cazzaniga, Claudio Zamagni, Vito Lorusso, Dario Bruzzese, Ferdinando Riccardi, Michelino De Laurentiis, Angelo Di Leo, Alessandra Beano, Alberto Zaniboni, Antonio Nuzzo, Maria Malagoli, Domenico Bilancia, Sabino De Placido,
Tópico(s)HER2/EGFR in Cancer Research
Resumo640 Background: Several clinical trials (CT) have shown remarkable efficacy of trastuzumab-based adjuvant therapy in human epidermal growth factor receptor 2 (HER2)-positive breast cancers (BC). However, CT patient population may not always be representative of patients routinely seen in clinical practice (CP). The aim of this study was to compare clinical and tumoral features between CT and CP patients with HER2 positive BC. Methods: From January to December 2012, 696 consecutive patients with HER2+ early BC, treated in 36 Italian Hospitals were enrolled in our study. Age, treatment information, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status, were prospectively collected in CP patients. In parallel, the same data were extracted from the adjuvant trastuzumab trials FNCLCC-PACS-04, BCIRG-006, FinHER, HERA, NSABP B31-NCCTG N9831 and pooled using the random-effects model of DerSimonian and Laird. CT and CP groups were compared by using the Cochran Q statistics. Results: Compared to CT patients, CP patients were more likely to be older than 50 years (65% vs 48%, respectively, p<0.0001) and have ER positive (71% vs 51%, p<0.0001) and PgR positive (60% vs 39%; p<0.0001) BC and were less likely to have tumor bigger than 2 cm (T ≥2 cm 39% vs 59%; p<0.0001), with positive N (47% vs 89%, p<0.0001) and high G (61% vs 67%, p=0.0241). Additionally, CP patients received more frequently adjuvant endocrine therapy (70% vs 57% p<0.0003) and less frequently adjuvant chemotherapy (97% vs 99.7%; p<0.0001). Among chemo-treated patients there was no difference in the type of administered chemotherapy. Conclusions: Most tumor and clinical characteristics significantly differed among CP and CT patients. These data raise doubts about the applicability of CT results to the CP patient population. Therefore, assessing the efficacy and tolerability of anti-cancer treatments also in a clinical scenario closer to the routine CP may be needed to further validate CT results.
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