Observational GHEA Study: Adjuvant-Trastuzumab-Treatment of HER2-Positive Breast Carcinoma.

Abstract

Abstract 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.Material and Methods: Eligible patients should have been treated with trastuzumab in adjuvant setting and were collected among 35 oncologic Italian centers.Results: The patient registered so far in the GHEA database (500 pts) had a median age of 52 years and 64% were in post-menopause at the time of trastuzumab therapy. Primary breast tumor were mainly of ductal type (93%) of high grade (59% were GIII) and small in size (58% T1, 35% T2, 4% T3 and 3% T4). 12% of the samples included in GHEA were classified as T1micro, T1a and T1b, three categories generally not included in clinical trials. ER and PgR positive tumors were 58% and 51%, respectively and more than 53% presented in situ component. Positive lymph-nodes were present in 53% of cases. 15% of the patients received neo-adjuvant therapy prior surgery and adjuvant treatment. In the neo-adjuvant therapy, 95% of patients received anthracycline–based regimens and 72% were treated with taxanes. In adjuvant setting 89% of patients received anthracycline–based regimens and only 43% were treated with taxanes. 88% of the patients completed 1-year-trastuzumab treatment. Median exposure time of the series was 26 months. To date, 6% of the patients presented distant metastasis (i.e. bones, liver, lung, SNC) and half of them progressed during trastuzumab treatment.Discussion: 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, the treatment of tumor categories not included in clinical trails and the therapies used at the relapse of these patients. All together, these data are warranted to design further clinical trials to better define guide-line for trastuzumab adjuvant therapy and for the treatment of these patients at relapse.Supported by AIRC and Roche. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5112.