Observational GHEA study: Adjuvant trastuzumab treatment of HER2-positive breast carcinomas in the Italian clinical setting compared to HERA trial.

Abstract

672 Background: GHEA (Group Herceptin in Adiuvant Treatment), an Italian multicentric observational study, was designed with the aim to investigate on adjuvant trastuzumab therapy of HER2-positive breast carcinomas in conventional clinical setting. Methods: Eligible patients should have been treated with trastuzumab in adjuvant setting and were collected among 35 oncologic Italian centers. Results: The 516 patients registered in the GHEA database had a median age of 52 years and 50% were in post-menopause at the time of trastuzumab therapy, similarly to the patients enrolled in HERA (median age of 49 years and postmenopause status in 46%). Primary breast tumors in GHEA were mainly of ductal type (93%) of high grade (53% were GIII) and small in size (50% T1); moreover, 7% of the samples were classified as N- negative and T1micro, T1a and T1b, and around 4% were T4, four categories not included in HERA. ER-PgR-positive tumors were 42%, thus higher than in HERA (31%). Negative lymph nodes were present in 42% of cases compare to 32% in HERA. Thus, in GHEA study are included earlier breast cancers than in HERA. Moreover, some GHEA cases are not fitting selection criteria of HERA trial, therefore the follow-up of those patients will give us indication of trastuzumab efficacy that are lacking in those categories, right now. In the Italian clinical practice 96% of patients completed 1-year trastuzumab-treatment with around 2% of patients registered cardiac toxicity. GHEA DFS at 21 months of FU resulted similar to the one of HERA DFS at 23.5 months of FU. To date, half of patients progressed during trastuzumab treatment with some distant metastasis (i.e., bones, liver, lung, SNC). Conclusions: The purpose of the present study is to gather information from a large number of patients related to the effect of adjuvant trastuzumab treatment in conventional clinical setting. Furthermore, the inclusion of patients' categories not included in clinical trials can be used to design further clinical trials to better define guideline for trastuzumab adjuvant therapy and for the treatment of these patients at relapse. Supported by AIRC and Roche. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche