Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4218
© 2005 American Society of Clinical Oncology

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Abstract

Phase I/II study of docetaxel, CDDP and S-1 in unresectable advanced gastric cancer

Sapporo Medcl Univ, Sapporo, Japan

4218

Purpose: Recently it has been reported that the combination of docetaxel, CDDP and 5-FU was effective in advanced gastric cancer. It has also been reported that S-1, a new oral fluorinated pyrimidine compound consisting of tegafur, 5-chloro-2, 4-dihydroxypyridine, and potassium oxonate, was significantly more effective as compared to 5-FU in advanced gastric cancer. Therefore, we conducted a phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer. Methods: Eligibility criteria were pathologically proven unresectable gastric cancer (stage IIIb - IV), PS 0 - 1, normal organ functions, and no prior treatment. Doses of S-1 (80mg/m2, d 1 - 14) and CDDP (60 mg/m2, d 8) were fixed. Docetaxel (d 8) was dose-escalated from 60mg/m2 (level 1) to 70 mg/m2 (level 2), and then 80mg/m2 (level 3). This treatment was repeated more than 3 times every 3 wks. Patients who achieved down staging underwent surgical resection. Results: Eleven patients were enrolled. Toxicity and efficacy data of all the patients are available. At level 1 (n=3), no patient developed grade 3/4 toxicity. At level 2 (n=5), two patients developed grade 4 neutropenia, and one patient developed grade 3 nausea /vomiting. At level 3 (n=3), two patients developed grade 4 neutropenia and grade 3 nausea/vomiting. Dose limiting toxicities (DLT) were neutropenia and nausea /vomiting. Recommended dose (RD) was determined as docetaxel 60mg/m2 (level 1). 91% of the patients achieved objective response consisting of 1 complete response and 9 partial responses, and only 1 patient showed disease stabilization. Three out of the 10 patients who achieved objective response underwent down staging, and received subsequent gastrectomy. On the other hand, 5 out of the 7 patients, who did not undergo down staging, have survived, and currently survival time is 10 - 16 months (median 14). One out of the 3 patients who received gastrectomy achieved complete response that was proven by histological examination. All the patients who received gastrectomy have survived, and currently survival time is 15 - 23 months (median 18). Conclusion: RD of this regimen was determined to be level 1. Our regimen is feasible and very effective with a high response rate (91%).

No significant financial relationships to disclose.