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Japanese Journal of Clinical Oncology

Year: 2009  |  Volume: 39  |  Issue: 11  |  Page No.: 713 - 719

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

W Koizumi, T Akiya, A Sato, K Yamaguchi, T Sakuyama, N Nakayama, S Tanabe, K Higuchi, T Sasaki, T Sekikawa and The Tokyo Cooperative Oncology Group (TCOG GI Group)



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.


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.


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%).


Biweekly paclitaxel seemed to be one of the useful chemotherapies after failure of fluoropyrimidine-based treatment in patients with advanced or recurrent gastric cancer.

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