Japanese Journal of Clinical Oncology 32:248-254 (2002)
© 2002 Foundation for Promotion of Cancer Research
Docetaxel 75 mg/m2 is Active and Well Tolerated in Patients with Metastatic or Recurrent Gastric Cancer: a Phase II Trial
1 Department of Internal Medicine, Seoul National University Hospital, Seoul, 2 Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Centre, Seoul, 3 Department of Internal Medicine, Korea Cancer Center Hospital, Seoul and 4 Department of Hematology and Oncology, Ajou University Hospital, Suwon, Korea and 5 Aventis Pharma, Bridgewater, NJ, USA
Objective: The aim of the present study was to confirm the efficacy and tolerability of docetaxel 75 mg/m2 in a population of Korean patients with advanced gastric cancer.
Methods: Patients with metastatic or locally recurrent gastric cancer received docetaxel 75 mg/m2 by intravenous infusion every 3 weeks. Objective response rate was the primary endpoint.
Results: Forty-five patients were enrolled. Most showed adenocarcinomas of the gastric antrum and/or body of the stomach. All showed metastases and two-thirds retained the primary tumour. Forty-four patients received at least one docetaxel infusion (‘treated’ population), with 40 patients evaluable for response. A total of 159 cycles (median three cycles) were administered, with mean duration of treatment 10.9 weeks. The objective response rate in the treated population was 15.9% (17.5% in the per protocol population), with stable disease in 25.0% of patients and progressive disease in 50.0%. Grade 3–4 neutropenia occurred in 36 (81.8%) patients and 36.1% of cycles. However, febrile neutropenia occurred in only two (4.5%) patients and 1.3% of cycles. Grade 3 anorexia, experienced by two patients (4.5%) and during 1.9% of cycles, was the most frequent non-haematological adverse event possibly or probably related to docetaxel. No grade 4 non-haematological events occurred.
Conclusion: This study suggests that docetaxel 75 mg/m2 is active in metastatic or locally recurrent adenocarcinoma with a low incidence of grade 3–4 adverse events. Docetaxel warrants further study in combination regimens for advanced gastric cancer.
+ For reprints and all correspondence: Yung-Jue Bang, Department of Internal Medicine, Seoul National University Hospital, 28 Yongon-dong, Chongno-gu, Seoul 110–744, Korea. E-mail: bangyj@plaza.snu.ac.kr
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