The efficacy of docetaxel and cisplatin combination chemotherapy for the treatment of advanced gastric cancer after failing to 5-fluorouracil based chemotherapy.

PURPOSE: This study was conducted to confirm the efficacy and toxicity of docetaxel and cisplatin combination chemotherapy (DP) in patients with advanced gastric cancer.
MATERIALS AND METHODS: Patients with measurable gastric adenocarcinoma received intravenous docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) with premedication on day 1, which was repeated every 3 weeks. All patients received DP as a second-line treatment after failing to 5-FU based chemotherapy.
RESULTS: 34 patients were enrolled in this study between January 1998 and August 2003. A total of 112 cycles (median 3 cycles) were administered. Responses were evaluable in 30 patients. The objective response rate was 16.7% (95% CI: 3.5 approximately 30.3), with a stable disease in 56.7% (95% CI: 40.0 approximately 74.4) and a progressive disease in 26.7% (95% CI: 10.9 approximately 42.5) of patients, with a median follow up duration of 20 months for all the patients, The median duration of response, time to progression and overall survival were 2.1 months (95% CI: 0.4 approximately 3.9), 4.2 months (95% CI: 2.3 approximately 6.1) and 6.8 months (95% CI: 1.3 approximately 12.3), respectively, with a 1-year survival rate of 32%. The toxicity was evaluated in 30 patients, with neutropenia being most common. Renal impairment was seen in two patients with grade 3 creatinine elevation and liver enzyme elevation in four with grades 3 and 4.
CONCLUSION: Although DP was an active combination regimen, with a tumor control rate of about 73% and with moderate tolerance, adjustment of the administration schedule, with further evaluation of other combination chemotherapies of docetaxel with new agents, other than cisplatin, seem warranted.