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Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer

Authors' Affiliations: Departments of ¹ Surgical Oncology and ² Translational Cancer Research, Research Institute for Radiation Biology and Medicine, Hiroshima University; ³ Department of Surgery, Hiroshima City Hospital; ⁴ Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan; ⁵ Department of Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan; ⁶ First Department of Surgery, Fukushima Medical University, Fukushima, Japan; and ⁷ Department of Epidemiological and Clinical Research Information Management, Kyoto University, Graduate School of Medicine, Kyoto, Japan

Requests for reprints: Masahiko Nishiyama, Department of Translational Cancer Research, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima University Biomedical Research Building, 1-2-3 Kasumi, Minami-ku, 734-8551 Hiroshima, Japan. Phone: 81-82-257-5839; Fax: 81-82-256-7105; E-mail: yamacho{at}hiroshima-u.ac.jp.

Purpose: To evaluate the efficacy and toxicity of docetaxel in combination with a novel oral 5-fluorouracil analogue S-1 for patients with advanced or recurrent gastric cancer.

Experimental Design: Patients with advanced or recurrent adenocarcinoma of the stomach and up to one previous chemotherapy regimen were treated with i.v. docetaxel 40 mg/m² on day 1 and oral S-1 80 mg/m²/d on days 1 to 14 every 3 weeks.

Results: Forty-eight patients (median age, 65 years; range, 25-75 years) received a total of 272 treatment cycles (median, 4; range, 1-17). No complete responses and 27 partial responses were observed for an overall response rate of 56.3% [95% confidence interval (95% CI), 38-66%]. Eighteen patients (37.5%) had stable disease and three patients (6.3%) had progressive disease as best response. The tumor control rate (complete response + partial response + stable disease) was 93.8% (95% CI, 83-98%). Median overall survival was 14.3 months (95% CI, 10.7-20.3 months) and median time to tumor progression was 7.3 months (95% CI, 4.3-10.0 months). The most common grade 3 to 4 hematologic toxicities were neutropenia (58.3%), leukopenia (41.7%), febrile neutropenia (8.3%), and anemia (8.3%). The most common grade 3 nonhematologic toxicities included anorexia (14.6%), stomatitis (8.3%), and nausea (6.3%). No grade 4 nonhematologic toxicities were reported and all treatment-related toxicities were resolved.

Conclusion: Docetaxel/S-1 combination is highly active and well tolerated in advanced or recurrent gastric cancer. Further investigation in randomized studies is warranted.

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