HER-2/neu assessment in primary chemotherapy treated breast carcinoma: no evidence of gene profile changing.

HER-2/neu protein expression and gene amplification were analyzed in a series of 85 consecutive breast carcinoma patients entered into an adriamicin/taxol primary chemotherapy trial followed by surgery, 45 of whom underwent pre-treatment fine needle aspirate (FNA). Dual color FISH (fluorescent in situ hybridization) assay revealed high-level HER-2/neu gene amplification in the immunocytochemistry (ICC) indicated 3+ cases and no, low or moderate amplification in the ICC 2+ group, consistent with previous findings in untreated patients series. Results obtained with the ICC assay CB 11 showed higher overall concordance with FISH than did the Herceptest ICC assay, but CB 11 was less accurate than Herceptest in terms of selecting patients suitable for Herceptin treatment, which is currently restricted to ICC 3+/FISH amplified patients. The only ICC 3+ low-level amplified case (non-amplified according the two more stringent criteria applied) was found with the CB 11 assay. Comparison between pre-treatment smears and post-treatment sections by FISH revealed no significant changes in the HER-2/neu gene profile. In the clinical setting these findings point to the usefulness of HER-2/neu assessment in chemotherapy-treated patients, when pre-treatment material is unavailable.