registHER: A prospective, longitudinal cohort study of women with HER2 positive metastatic breast cancer
2005; Lippincott Williams & Wilkins; Volume: 23; Issue: 16_suppl Linguagem: Inglês
10.1200/jco.2005.23.16_suppl.670
ISSN1527-7755
AutoresElizabeth Tan-Chiu, PA Kaufman, Sun-Sook Paik, M. Ulcickas-Yood, M Mayer, Debu Tripathy, H. S. Rugo, Adam Brufsky,
Tópico(s)Cancer Treatment and Pharmacology
Resumo670 Background: Human Epidermal Receptor 2 (HER2) is gene amplified in approx 25% of patients with breast cancer and is an unfavorable prognostic factor for survival. Both NCCN and ASCO recommend that all breast tumor samples be tested for HER2 status by either immunohistochemistry (ICH) or fluorescent in situ hybridization (FISH). Methods: RegistHER is a prospective, longitudinal cohort study of HER2 positive MBC designed to understand treatment practice and outcomes. Eligible patients are HER2 + with MBC diagnosed within 6 months and receive treatments according to standard of care. HER2 testing data collection includes tissue source (primary vs metastatic tumor) and test Method: All treatment information is collected from the time of initial diagnosis to study discontinuation or death. Study endpoints include time to treatment failure, time to progression, tumor response, cardiac safety and survival. All data are obtained through an internet-based data collection system. Results: 273 of 291 eligible patients have been enrolled over 11 months, of a planned n=1,000. Patient characteristics: median age 54 yrs (range 22 - 91), race (white 83%), PS 0–1 64%, DFI 20 mos (range 0 - 263 mos). Tumor characteristics: ER and/or PR + 46%, ductal histology 86%. HER2 testing results were available in 264 patients. The tissue source for HER2 testing was primary tissue samples only (67%), metastatic tissue only (13%) or both 17%. Positive HER2 results were considered to be either IHC 3+ or FISH positive in >90% of patients. In those with results from both primary and metastatic tissue sources (n=46), HER2 results were confirmed by the same testing method in 23/46 (50%). IHC results were confirmed by FISH in 11/46 (24%). Discordant HER2 results (discrepant IHC-IHC or IHC- FISH results) between primary and metastatic tissue samples were reported in 7/46 (15%). Conclusion: The pace of enrollment suggests that this study design represents a feasible approach in HER2+ MBC. The predominant HER2 test reported was IHC performed on primary tissue samples. The number of patients with confirmatory metastatic biopsy findings and discrepant HER2 results was higher than anticipated and highlight the importance of accurate HER2 testing practices. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech Genentech Genentech
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