Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer

S. H. Park, E. Nam, J. Park, E. K. Cho, D. B. Shin, J. H. Lee, W. K. Lee, M. Chung, S. I. Lee

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Background: Irinotecan, in combination with 5-fluorouracil (5-FU) or cisplatin, has demonstrated efficacy against advanced gastric cancer (AGC). Patients and methods: Chemotherapy-naive AGC patients were randomly assigned to receive irinotecan 150 mg/m2 on day 1, leucovorin 20 mg/m2 and a 22-h infusion of 5-FU 1000 mg/m2 on days 1 and 2 (ILF) or ILF plus cisplatin 30 mg/m2 on day 2 (PILF). Treatment was repeated every 2 weeks. Results: Of 91 registered patients, 45 patients were treated with ILF and 45 with PILF. For both arms, 687 chemotherapy cycles were delivered (median = 7 for ILF and 8 for PILF). Both ILF and PILF were generally well tolerated and there was no relevant difference in the occurrence of overall grade 3/4 toxic effects between the two arms. Four patients died during treatment: one in the ILF and three in the PILF arm. The objective response rate was 42% for both arms. There was no significant difference in therapeutic efficacy between ILF and PILF with respect to progression-free survival (4.8 versus 6.2 months; P = 0.523) and overall survival (10.7 versus 10.5 months; P = 0.850). Conclusion: Both ILF and PILF are active as first-line chemotherapy for AGC. The addition of cisplatin, however, has no clear advantage over ILF.

Original languageEnglish
Pages (from-to)729-733
Number of pages5
JournalAnnals of Oncology
Issue number4
Publication statusPublished - 2008 Apr 1


All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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