Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic gastric cancer.

PURPOSE: Docetaxel, as a single agent, has demonstrated activity in patients with advanced gastric cancer and cisplatin has shown lack of overlapping toxicities with docetaxel. Therefore, we conducted a phase II study to assess the efficacy and the toxicity of a combination regimen of docetaxel plus cisplatin in patients with advanced gastric cancer who have never been treated with palliative chemotherapy.

METHODS

Ninety-two patients with metastatic gastric cancer were enrolled from April 2000 to March 2004. Patients with histologically confirmed gastric adenocarcinoma, at least one bi-dimensionally measurable lesion, no prior palliative chemotherapy and at least 6 months from the end of adjuvant chemotherapy were eligible for study entry. Docetaxel 75 mg/m(2 )and cisplatin 75 mg/m(2) were given on day 1. The cycle was repeated every 3 weeks. The objective response was evaluated after three cycles of chemotherapy. Toxicity was assessed according to the National Cancer Institute common toxicity criteria scale version 2.0.

RESULTS

In total, 401 cycles were administered, with a median of 5 cycles per patient (range 1-9 cycles). The median age was 56 years (range 31-76). Eighty-six patients were evaluable for treatment response. The objective response rate was 43.5% (95% CI, 33.4-53.6) with one complete response and 39 partial responses. Twenty patients (21.7%) had stable disease and 26 patients (28.3%) had a progression. The median time to progression was 7.0 months (95% CI, 5.0-9.0) and the median overall survival was 11.5 months (95% CI, 9.5-13.4). The chemotherapy was generally well tolerated and the most common grade 3-4 toxicities were neutropenia (17.4%), nausea/vomiting (13.0%) and diarrhea (7.6%).

CONCLUSION

The combination chemotherapy of docetaxel with cisplatin in advanced gastric cancer was tolerable for most patients and showed a promising antitumor activity as a first-line therapy.