A phase II study of infusional 5-fluorouracil and low-dose leucovorin with docetaxel for advanced gastric cancer

Hei Cheul Jeung, Young Rha Sun, Tae Kim Yong, Hoon Noh Sung, Kyung Roh Jae, Cheol Chung Hyun

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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 chemonaïve 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.

Original languageEnglish
Pages (from-to)63-70
Number of pages8
Issue number1
Publication statusPublished - 2006 Mar 1


All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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