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  • Title: Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic gastric cancer.
    Author: Park KW, Ahn JS, Park YS, Lee J, Kang JH, Park JO, Lim HY, Im YH, Kang WK, Park K, Lee SI.
    Journal: Cancer Chemother Pharmacol; 2007 Jan; 59(1):17-21. PubMed ID: 16721549.
    Abstract:
    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.
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