Phase II study of first-line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer.

Purpose: Previous studies have shown that docetaxel and cisplatin, as single agents, are effective and relatively well tolerated in patients with advanced gastric cancer. The aim of this study was to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer.
Patients/methods: Fifty-five patients with histologically proven advanced gastric cancer with at least 1 measurable lesion and ECOG PS ≤ 2 were enrolled. Patients received docetaxel 50 mg/m(2) and cisplatin 50 mg/m(2) every 2 weeks until progression disease, unbearable toxicity or a maximum of 12 cycles.
Results: In total, 426 cycles were administered (median 8.5 cycles) to 52 evaluable patients. One patient (1.9 %) showed a complete response, while 21 (40.4 %) had partial responses. The objective response rate was 42.3 % (95 % CI 28.9-55.7), the median time to progression was 5.5 months (95 % CI 4.0-7.0), and the median overall survival was 8.9 months (95 % CI 6.0-11.9). The most common grade 3-4 toxicities per cycle were haematological [neutropenia (5.9 %)].
Conclusions: Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable toxicity profile and shows a promising antitumour activity as a first-line therapy.