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Annals of Oncology Advance Access originally published online on December 13, 2007
Annals of Oncology 2008 19(4):729-733; doi:10.1093/annonc/mdm502
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© The Author 2007. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

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

S. H. Park1, E. Nam1, J. Park1, E. K. Cho1, D. B. Shin1,*, J. H. Lee1, W. K. Lee2, M. Chung2 and S. I. Lee3

1 Division of Hematology and Oncology, Department of Internal Medicine
2 Department of General Surgery, Gachon University Gil Medical Center, Incheon
3 Department of Internal Medicine, Dankook University Hospital, Cheonan, Korea

* Correspondence to: Dr D. B. Shin, Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon 405-760, Korea. Tel: +82-32-460-3817; Fax: +82-32-460-3233; E-mail: dbs{at}gilhospital.com

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.

Key words: chemotherapy, cisplatin, 5-fluorouracil, irinotecan, stomach cancer

Received for publication July 16, 2007. Revision received September 27, 2007. Accepted for publication September 28, 2007.


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