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Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer

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Abstract

Purpose

We evaluated the activity and toxicity of docetaxel, cisplatin, and S-1 (DCS) combination chemotherapy in patients with unresectable metastatic gastric cancer.

Methods

Patients with histologically proven, unresectable metastatic gastric adenocarcinoma, performance status (PS) 0–2, and no prior chemotherapy were eligible. Patients received oral S-1 (40 mg/m2 b.i.d.) on days 1–14 and intravenous cisplatin (60 mg/m2) and docetaxel (60 mg/m2) on day 8 every 3 weeks.

Results

Thirty-four patients were enrolled between March 2005 and April 2007. Three patients were considered ineligible and did not receive the DSC therapy. Clinical characteristics were as follows: median age, 63 years (range, 44–77); PS, 0/1/2: 23/8/0; women/men, 8/23; and well-differentiated/undifferentiated adenocarcinoma, 10/21. The objective response rate was 87.1% with 1 complete response (3.2%) and 26 partial responses (83.9%) in 31 assessable patients. Four had stable disease (12.9%) but none had progressive disease. Of these 27 responders, 8 (25.8%) achieved downstaging and 7 (22.6%) underwent curative surgery. The median survival time and progression-free survival were 687 days [confidence interval (95% CI), 600.0–1,138.1] and 226 days (95% CI, 182.5–379.3), respectively. Most common grade 3/4 hematologic toxicity was neutropenia (77.4%). Most common grade 3 nonhematologic toxicities included anorexia (35.5%) and nausea (32.3%). All treatment-related toxicities resolved, and no toxic deaths were observed.

Conclusions

DCS combination chemotherapy is highly active against unresectable metastatic gastric cancer and can be given safely with proper management of adverse events. Further studies of this combination are warranted.

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Acknowledgments

We thank the following doctors for their assistance in this study. Hiroyuki Nagashima, M.D., Gangi Kuroiwa, M.D., Michiaki Hirayama, M.D., Shinichi Katsuki, M.D., Hiroshi Muramatsu, M.D., Hiroyuki Kuroda, M.D., Fourth Department of Internal Medicine, Sapporo Medical University, School of Medicine, Sapporo, Japan and Tomoko Sonoda, M.D., Department of Public Health, Sapporo Medical University, School of Medicine, Sapporo, Japan.

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Authors and Affiliations

  1. Fourth Department of Internal Medicine, School of Medicine, Sapporo Medical University, South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan

    Yasushi Sato, Tamotsu Sagawa, Shingo Tanaka, Koji Miyanishi, Tsutomu Sato, Rishu Takimoto, Masayoshi Kobune & Junji Kato

  2. Department of Gastroenterology and Oncology, Tokushima University, Tokushima, Japan

    Tetsuji Takayama

  3. Department of Gastroenterology, Hokkaido Cancer Center, Sapporo, Japan

    Yasuo Takahashi, Hiroyuki Ohnuma, Syunichi Okubo & Naoaki Shintani

  4. Department of Gastroenterology, Chitose City Hospital, Chitose, Japan

    Masaya Kida

  5. Department of Gastroenterology, Oji General Hospital, Tomakomai, Japan

    Yasuhiro Sato & Hidetoshi Ohta

  6. First Department of Surgery, School of Medicine, Sapporo Medical University, Sapporo, Japan

    Koji Yamaguchi & Koichi Hirata

  7. Department of Molecular Target Exploration, School of Medicine, Sapporo Medical University, Sapporo, Japan

    Yoshiro Niitsu

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  1. Yasushi Sato
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Correspondence to Junji Kato.

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Sato, Y., Takayama, T., Sagawa, T. et al. Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Cancer Chemother Pharmacol 66, 721–728 (2010). https://doi.org/10.1007/s00280-009-1215-2

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  • DOI: https://doi.org/10.1007/s00280-009-1215-2

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