Japanese Journal of Clinical Oncology Advance Access originally published online on October 6, 2009
Japanese Journal of Clinical Oncology 2009 39(11):713-719; doi:10.1093/jjco/hyp099
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© The Author (2009). Published by Oxford University Press. All rights reserved
Second-line Chemotherapy with Biweekly Paclitaxel after Failure of Fluoropyrimidine-based Treatment in Patients with Advanced or Recurrent Gastric Cancer: a Report from the Gastrointestinal Oncology Group of the Tokyo Cooperative Oncology Group, TCOG GC-0501 Trial
1 Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa
2 Division of Gastroenterology, Gunma Prefectural Cancer Center, Ohta, Gunma
3 Division of Medical Oncology, Department of Internal Medicine, Showa University School of Medicine, Tokyo
4 Department of Gastroenterology, Saitama Cancer Center, Saitama
5 Division of Clinical Oncology/Hematology Department of Internal Medicine, The Jikei University School of Medicine, Tokyo
6 Division of Gastroenterology, Kanagawa Cancer Center Hospital, Kanagawa
7 Department of Internal Medicine, Toyosu Hospital, Showa University School of Medicine, Tokyo, Japan
For reprints and all correspondence: Wasaburo Koizumi, Department of Gastroenterology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. E-mail: koizumi{at}med.kitasato-u.ac.jp
Received May 11, 2009; accepted July 21, 2009
Objective: A multicenter trial was conducted to evaluate the efficacy and safety of paclitaxel every 2 weeks in patients with advanced or recurrent gastric cancer who had previously received fluoropyrimidine-based chemotherapy.
Methods: The subjects were patients with gastric cancer who had disease progression or recurrence while receiving fluoropyrimidine-based chemotherapy. All patients had adequate major organ functions with an Eastern Cooperative Oncology Group performance status (PS) of 0–2. Paclitaxel 140 mg/m2 was administered intravenously on days 1 and 15 of a 4-week cycle. The primary endpoint was the response rate. Secondary endpoints were progression-free survival (PFS), overall survival and safety.
Results: Response was assessable in 40 of 41 enrolled patients. Their median age was 63 (range: 48–77) years, and PS was 0 in 22 patients, 1 in 13 and 2 in 5. Previous treatment included S-1 (1 M tegafur–0.4 M gimestat–1 M otastat potassium) monotherapy in 32 patients and S-1-based combination therapy in 5. The median number of administered courses of paclitaxel was 3.5 (1–14). The response rate was 17.5% (95% confidence interval: 7.3–32.8%, partial response: 7, stable disease: 21, progressive disease: 10 and not evaluable: 2). The disease control rate was 70.0%, the median PFS was 111 days and the median overall survival was 254 days. Major adverse events of Grade 3 or 4 were neutropenia (27.5%), anemia (12.5%), diarrhea (2.5%) and sensory neuropathy (2.5%).
Conclusions: Biweekly paclitaxel seemed to be one of the useful chemotherapies after failure of fluoropyrimidine-based treatment in patients with advanced or recurrent gastric cancer.
Key Words: advanced gastric cancer • biweekly paclitaxel • second-line chemotherapy