Abstract
706 Background: Phase II studies of T with D have demonstrated encouraging response rates in women with HER2/neu overexpressing (HER2+) MBC. Because there are no studies comparing this combination to the efficacy of the well-studied combination of Paclitaxel (P) and T, we undertook a MA to obtain a summary estimate of the response rate and toxicity, and to derive aggregate measures of other efficacy parameters. Methods: The project was designed in 2 phases: An LBMA and an IPDMA. Studies were included in the LBMA if they were prospective clinical trials of D + T in women with HER2+ MBC containing ≥ 10 patients. Studies were identified by an electronic literature search of 8 medical databases (Medline and Premedline, Embase, Cancerlit, CINAHL, Biological Abstracts, HealthStar, ACP Journal Club, and Cochrane Database of Systematic Reviews) for the years 1966–2002 using the following criteria; “trastuzuamab”, “herceptin”, “docetaxel” and “taxotere”. This was supplemented by hand searches of abstracts from proceedings of the European Society of Medical Oncology, American Society for Clinical Oncology and San Antonio Breast Cancer meetings for the years 1995 - 2002. Summary estimates of the objective response rates (OR) (intent to treat) were obtained using methods described by Laird and Mosteller (Int J Technol Assess in Health Care 6:5–30, 1990) for random effects adjustment.Results: 7 phase II trials with a total of 165 patients were identified. The overall estimated response rate was 60% (95% CI 52%–68%). Major grade 3/4 toxicities are presented. The IPDMA is currently underway and is to be completed in the spring of 2004. Conclusions: Results of the LBMA and IPDMA will be presented and their clinical implication discussed in light of known outcome with P + T and subsequent clinical implications. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis; Roche Canada
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