A phase II study of infusional 5-fluorouracil and low-dose leucovorin with docetaxel for advanced gastric cancer |
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Authors: | Jeung H-C Rha Sun Young Kim Yong Tae Noh Sung Hoon Roh Jae Kyung Chung Hyun Cheol |
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Affiliation: | Cancer Metastasis Research Center, Yonsei Cancer Center, Seoul, Korea. |
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Abstract: | BACKGROUND: The standard chemotherapy regimen for advanced gastric cancer has not yet been established. We investigated the efficacy and the safety of the combination of docetaxel with infusional 5-fluorouracil (5-FU) and leucovorin (FLT) in advanced gastric cancer. METHODS: Patients received docetaxel 75 mg/m(2) (1-hour infusion) followed by a leucovorin bolus 20 mg/m(2) and a 24-hour infusion of 5-FU 1,000 mg/m(2) (day 1-3) every 3 weeks. The response was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and the toxicity was evaluated by National Cancer Institute common toxicity criteria (NCI-CTC). RESULTS: Sixty-six patients were enrolled. Median relative dose intensity was 86%. Of 57 evaluable patients, the overall response rate was 25.7%. The response rate was 34.2% in chemona?ve patients and 14.2% in the patients who had previously received treatment. Median time to progression and overall survival duration were 5.2 and 9.7 months, respectively. The most frequent grade 3-4 toxicity was neutropenia, which was the major cause of treatment delay. Other hematological and nonhematological toxicities were rare. CONCLUSIONS: The FLT regimen showed a comparable efficacy with other second-generation regimens. Because of the low nonhematological toxicity, this could be a potential alternative to the cisplatin-containing regimens in gastric cancer. |
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