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Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer

Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer,10.1038/sj.bjc.6603196,British Journal of Cancer,K Yamaguchi,T Shimamur

Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer   (Citations: 32)
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K Yamaguchi, T Shimamura, I Hyodo, W Koizumi, T Doi, H Narahara, Y Komatsu, T Kato, S Saitoh, T Akiya, M Munakata, Y Miyatahttp://academic.research.microsoft.com/io.ashx?type=5&id=28803083&selfId1=0&selfId2=0&maxNumber=12&query=
The aims of this phase I/II study of docetaxel and S-1 were to determine the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and recommended dose (RD) in the phase I part and to explore the tumour response, survival and safety in the phase II part. Patients with histologically- or cytologically confirmed unresectable or recurrent gastric cancer were eligible. Treatment consisted of intravenous docetaxel on day 1 (starting dose 50 mg m−2) and oral S-1 at a fixed dose of 40 mg m−2 twice daily on days 1–14, every 4 weeks up to six cycles. Nine patients took part in the phase I portion of the study. The MTD of docetaxel was determined to be 50 mg m−2, with the DLTs of grade 3 infection associated with grade 3 neutropenia and grade 4 neutropenia during S-1 administration. The RD of docetaxel was 40 mg m−2 in combination with S-1 40 mg m−2 b.i.d. The efficacy and safety of this regimen was therefore assessed in 46 patients with at least one measurable lesion. The overall response rate and estimated median overall survival were 46% (95% CI, 31–61%) and 14.0 months (8.3–17.3 months), respectively. The most common grade 3/4 toxicity was neutropenia (67% of patients), which was predictable and manageable. This regimen showed promising activity with moderate toxicities in advanced gastric cancer.
Journal: British Journal of Cancer - BRIT J CANCER , vol. 94, no. 12, pp. 1803-1808, 2006
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