1. Phase II Study of Paclitaxel, Cisplatin, and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer
- Author
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Sang-Hee Cho, Se Ryeon Lee, Hyeoung Joon Kim, D.-H. Yang, Jae Sook Ahn, Hyun Jeong Shim, Je-Jung Lee, Ik Joo Chung, Yeo Kyeoung Kim, and Junyl Hwang
- Subjects
Adult ,Male ,Oncology ,medicine.medical_specialty ,Paclitaxel ,Phases of clinical research ,Adenocarcinoma ,Neutropenia ,Gastroenterology ,Disease-Free Survival ,Stomach Neoplasms ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Progression-free survival ,Aged ,Cisplatin ,business.industry ,Combination chemotherapy ,General Medicine ,Middle Aged ,medicine.disease ,Regimen ,Fluorouracil ,Female ,Original Article ,business ,Febrile neutropenia ,medicine.drug - Abstract
This phase II study evaluated the efficacy and safety of combination chemotherapy with paclitaxel, cisplatin, and 5-fluorouracil (5-FU) in advanced gastric cancer. Patients with histologically confirmed gastric adenocarcinoma were eligible for the study. Paclitaxel (175 mg/m(2)) and cisplatin (75 mg/m(2)) were given as a 1-hr intravenous infusion on day 1, followed by 5-FU (750 mg/m(2)) as a 24-hr continuous infusion for 5 days. This cycle was repeated every 3 weeks. Forty-five eligible patients (median age, 56 yr) were treated in this way. Of the 41 patients in whom efficacy was evaluable, an objective response rate (ORR) was seen in 51.2% (95% CI, 0.35-0.67), a complete response in two, and a partial response in 19 patients. The median progression free survival was 6.9 months (95% CI, 5.86-7.94 months), and the median overall survival was 12.7 months (95% CI, 9.9-15.5). The main hematological toxicity was neutropenia and greater than grade 3 neutropenia was observed in twelve patients (54%). Febrile neutropenia developed in three patients (6.8%). The major non-hematological toxicities were asthenia and peripheral neuropathy, but most of patients showed grade 1 or 2. In conclusion, combination chemotherapy with paclitaxel, cisplatin, and 5-FU is a promising regimen, and was well tolerated in patients with advanced gastric cancer.
- Published
- 2008