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Combination Phase I Trial of a Novel Oral Fluorouracil Derivative S-1 with Low-Dose Cisplatin for Unresectable and Recurrent Gastric Cancer (JFMC27–9902)

¹ Department of Surgical Oncology (First Department of Surgery), Osaka City University Graduate School of Medicine, Osaka, Japan; ² Department of Gastroenterology, Sendai Kosei Hospital, Miyagi, Japan; ³ Department of Internal Medicine, Kochi Municipal Central Hospital, Kochi, Japan; ⁴ Sapporo Tsukisamu Hospital, Sapporo, Japan; ⁵ First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan; and ⁶ Laboratory of Pathogenic Biochemistry in Medicine, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan

Purpose: The Japanese Foundation for Multidisciplinary Treatment of Cancer conducted a Phase I study of a novel oral fluorouracil derivative, S-1, combined with a low dose of cisplatin in unresectable and recurrent gastric cancer.

Experimental Design: S-1 was administered orally at 80–120 mg/body/day, depending on body surface area. One course consisted of consecutive administration for 28 days followed by a rest of 14 days. Low-dose cisplatin was given i.v. on days 1–5, 8–12, 15–19, and 22–26 of each course. The dose escalation of cisplatin began with an initial dose of 1 mg/m²/day as level 1 and was stepped up to 2, 3, 4, and 6 mg/m²/day as level 2, 3, 4, and 5, respectively. The regimen was repeated for at least two courses.

Results: A total of 24 patients was entered in the study. There was no treatment-related death. At level 5, consisting of 5 evaluable patients, dose-limiting toxicity was experienced as grade 3 appetite loss in 2 patients and grade 4 neutropenia in 1 patient. The maximum-tolerated dose of cisplatin was estimated to be 6 mg/m²/day. We decided on a recommended dose of cisplatin of 4 mg/m²/day because the dosage was one level under the maximum-tolerated dose. All 3 patients at level 4 showed partial response, suggesting promising clinical efficacy with this dosage. The serum concentration of cisplatin at level 4 was 918 ± 92 ng/ml on day 26 of the first course.

Conclusions: S-1 with low-dose cisplatin may become an effective regimen with acceptable toxicity for gastric cancer.

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