Home Neoplasma 2012 Neoplasma Vol.59, No.4, p.370-375, 2012

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Neoplasma Vol.59, No.4, p.370-375, 2012

Title: Phase I study of docetaxel, cisplatin and concurrent radiotherapy for locally advanced gastric adenocarcinoma
Author: L. XING, H. LU, J. ZHANG, J. YU, F. WANG, X. YU, H. YU, L. XIA

Abstract: This phase I study is designed to determine the maximal tolerated dose and the dose-limiting toxicity of docetaxel with cisplatin and concurrent radiotherapy in patients with unresectable locally advanced gastric adenocarcinoma.
Docetaxel was given once a week with the dosage escalated from 5 mg/m2 to 15 mg/m2 in increments of 2.5 mg/m2. Cisplatin were administered at 20 mg/m2 once a week. Radiotherapy was delivered to 50.4Gy at 1.8Gy/day. At least three patients were enrolled at each level. The maximal tolerated dose (MTD) and dose-limiting toxicity (DLTs) was determined. The DLTs were defined as grade 3 or 4 hematologic and nonhematologic toxicity.
Twenty-one patients with locally advanced gastric adenocarcinoma were enrolled. Grade 1-2 neutropenia and nausea/vomiting were the most common side effects. The first DLT (grade-3 neutropenia) was observed in one of three patients at 12.5 mg/m2 docetaxel. Three more patients were enrolled, but DLT was not observed and 6 patients were enrolled into 15 mg/m2 group, DLT occurred in 3 patients (1 Grade 3 neutropenia, 1 Grade 4 neutropenia and 1 Grade 3 nausea/vomiting). Overall tumor response rate was 66.7% with 28.6% complete and 38.1% partial response.
In conclusion, the MTD of docetaxel was 15 mg/m2, and the recommended dose of docetaxel for Phase II study was 12.5 mg/m2 weekly. The docetaxel and cisplatin with concurrent radiotherapy were tolerable and feasible in treating locally advanced gastric adenocarcinoma.

Keywords: adenocarcinoma, phase I trail, docetaxel, cisplatin, radiotherapy
Published online: 10-Apr-2012
Year: 2012, Volume: 59, Issue: 4 Page From: 370, Page To: 375

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