10566 Background: In Argentina, before 2003 few pathologists performed HER2 testing, using different non-standardized Inmuno-Histo-Chemical (IHC) methods with dubious and non-reproducible results and also leaving some parts of the country without HER2 diagnosis Objective: HER2 has a key role in breast cancer management, so the aim of the study was to settle a National HER2 testing Program to permit access to standardized HER2 detection all over the country, and whenever possible, to determine hormonal receptors. Methods: In August 2003, 13 pathologists formed a cooperative group and created a national framework to train and set HER2 diagnostic centres in each country region. A coordinator responsible for coaching and evaluating centres and two technical consultants in charge of quality control and technique standardization were designated. In February 2004, the program was launched. Tumors were received from 82 oncologists and breast surgeons, using a private courier created “ad hoc”. HER2 was analyzed by IHC test between February 2004 and November 2005 and performed using policlonal antibody anti Her 2 (DAKO), microwave antigenic recovery, detection system EnVision (Dako) and developed with diaminobenzidine. Results were interpreted as HercepTest guidelines. ER/PR were screened by IHC analyses. Results: 2285 HER2 tests were performed: HER2 was over-expressed (score 3+) in 18% of tumors (408). 136 (6%) samples were score 2+, 407 (18%) score 1+ and 1334 (58%) score 0. In 1532/2285 (67%) of tumor specimens ER and PR status could be determined. Conclusions: Founding HER2 National Program allowed access to HER2 testing all over the country with a standardized and reproducible technique. HER2 prevalence in our sample (18%) is similar to those previously published. Although international algorithms recommend FISH assay to HER2 2+ tumors, our Program can not afford it. ER/PR expression were decreased significantly in HER2 3+ vs. HER2 - tumors: 53% vs. 64%: p = 0.002. HER2 3+ were associated with higher levels ER/PR: 38% vs. 24% in HER2 - tumors (p < 0.001). [Table: see text] No significant financial relationships to disclose.
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