PMID- 15668276 OWN - NLM STAT- MEDLINE DCOM- 20050712 LR - 20200203 IS - 0923-7534 (Print) IS - 0923-7534 (Linking) VI - 16 IP - 2 DP - 2005 Feb TI - Serum HER2 extracellular domain in metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel: association with HER2 status by immunohistochemistry and fluorescence in situ hybridization and with response rate. PG - 234-9 AB - PURPOSE: We explored the relationship between circulating HER2 extracellular domain (ECD) and tissue HER2 status as determined by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). We also examined its predictive value in a cohort of metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel. METHODS: Eligible patients had pre- and post-treatment stored serum specimens and were treated on a previously reported phase II trial. Retrospective analysis evaluated: the association between pretreatment serum HER2 ECD and tissue HER2 status by IHC and FISH; and the association between change in serum HER2 ECD after 12 weeks of therapy and response proportion. RESULTS: Stored serum samples were available for 55/95 (58%) patients. Statistically significant associations were found between HER2 status as assessed by IHC and FISH, and baseline serum HER2 ECD level. Patients whose ECD normalized after 12 weeks of therapy had a higher response proportion compared with patients with persistently high ECD levels (68% versus 15%, P=0.005). A relative decline of over 55% from baseline HER2 ECD predicted response to therapy. CONCLUSION: A statistically significant association was observed between pretreatment serum HER2 ECD and tissue HER2 status as assessed by IHC and FISH. A decrease in serum HER2 ECD level was a significant predictor of response to trastuzumab-based therapy. FAU - Fornier, M N AU - Fornier MN AD - Breast Cancer Medicine Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA. fornierm@mskcc.org FAU - Seidman, A D AU - Seidman AD FAU - Schwartz, M K AU - Schwartz MK FAU - Ghani, F AU - Ghani F FAU - Thiel, R AU - Thiel R FAU - Norton, L AU - Norton L FAU - Hudis, C AU - Hudis C LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Ann Oncol JT - Annals of oncology : official journal of the European Society for Medical Oncology JID - 9007735 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Adult MH - Aged MH - Antibodies, Monoclonal/administration & dosage MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Biomarkers, Tumor/*analysis MH - Breast Neoplasms/*drug therapy/*genetics/pathology MH - Cohort Studies MH - Female MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Middle Aged MH - *Neoplasm Metastasis MH - Paclitaxel/administration & dosage MH - Receptor, ErbB-2/*blood MH - Retrospective Studies MH - Tissue Distribution MH - Trastuzumab EDAT- 2005/01/26 09:00 MHDA- 2005/07/13 09:00 CRDT- 2005/01/26 09:00 PHST- 2005/01/26 09:00 [pubmed] PHST- 2005/07/13 09:00 [medline] PHST- 2005/01/26 09:00 [entrez] AID - S0923-7534(19)48416-0 [pii] AID - 10.1093/annonc/mdi059 [doi] PST - ppublish SO - Ann Oncol. 2005 Feb;16(2):234-9. doi: 10.1093/annonc/mdi059.