The combination of gemcitabine, carboplatin and a platin drug has significant supporting literature. Hussain and associates from the Wayne State University had previously reported on the combination of carboplatin dosed to a targeted area under the concentration x time curve (AUC), gemcitabine, and paclitaxel, in which the objective response rate was 68%. In that study, 32% of patients experienced a complete response and the median survival was 14.7 months. At ASCO 2002, this group reported the preliminary results of the same three-drug regimen plus trastuzumab in patients with HER2 protein overexpression. Forty-one patients were evaluated for HER2 overexpression; 19 of them (46%) had 3+ expression by immunohistochemistry. Only 16% of patients had HER2 gene amplification and 26% had serum assays positive for HER2 by ELISA. Nine of the 10 patients evaluable for response to the 4-drug regimen experienced a major response. One complete response was observed. The trial is designed to accrue approximately 40 patients to assess the overall response rate and survival, and accrual to the trial is still in progress. At this time, however, the approach of combining the 3-drug combination appears to be feasible.
Hussain M, Vaishampayan U, Du W, et al. Combination paclitaxel, carboplatin, and gemcitabine is an active treatment for advanced urothelial cancer. J Clin Oncol. 2001;19:2527.
Hussein M, Smith D, Al-Sukhum S, et al. Preliminary results of Her-2/neu screening and treatment with trastuzumab, paclitaxel, carbplatin and gemcitabine in patients with advanced urothelial cancer. Program and abstracts of the American Society of Clinical Oncology 38th Annual Meeting; May 18-21, 2002; Orlando, Florida. Abstract 800.
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