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Japanese Journal of Clinical Oncology Advance Access originally published online on October 8, 2007
Japanese Journal of Clinical Oncology 2007 37(10):744-749; doi:10.1093/jjco/hym103
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© 2007 Foundation for Promotion of Cancer Research

A Phase II Study of Irinotecan with Bi-weekly, Low-dose Leucovorin and Bolus and Continuous Infusion 5-fluorouracil (Modified FOLFIRI) as Salvage Therapy for Patients with Advanced or Metastatic Gastric Cancer

Seong-Geun Kim, Sung Yong Oh, Hyuk-Chan Kwon, Suee Lee, Jung Hwan Kim, Sung-Hyun Kim and Hyo-Jin Kim

Departments of Internal Medicine, Dong-A University College of Medicine, Busan, Korea

For reprints and all correspondence: Hyo-Jin Kim, Department of Internal Medicine, Dong-A University College of Medicine, 3-1 Dongdaeshin-dong, Seo-gu, Busan, 602-715, Korea. E-mail: kimhj{at}dau.ac.kr

Received April 22, 2007; accepted June 22, 2007

Objective: This phase II study was designed to assess the safety and efficacy of a modified FOLFIRI regimen (irinotecan with bi-weekly, low dose leucovorin (ldLV) and bolus and continuous infusion with 5-fluorouracil (5-FU)) as a salvage therapy for patients with advanced or metastatic gastric cancer.

Methods: Patients were treated with irinotecan 150 mg/m2 on day 1 and received ldLV 20 mg/m2 followed by 5-FU 400 mg/m2 (bolus) and 5-FU 600 mg/m2 (22 h continuous infusion) on days 1 and 2 every 14 days.

Results: A total of 36 patients were assigned to treatment. The median patient age was 55 years (range 31–70), and 55.6% (20/36) of the patients had performance status (ECOG) of 0 or 1.The median follow-up duration was 15.5 (range 2.6–36.4) months. Of the 30 patients evaluated for their tumor response, three achieved a partial response, with an overall response rate of 10.0% (95% CI 0.0–21.0%). Eleven patients (36.7%) showed stable disease. The median time to progression was 3.3 (95% CI 2.0–4.6) months, and the median overall survival time was 10.9 (95% CI 6.1–15.7) months. The median number of cycles of modified FOLFIRI treatment was 3 (range 1–9 cycles). Grade III or IV neutropenia was observed in 23 cycles (17.6%), and febrile neutropenia occurred in three cycles (2.3%). Grade III nausea/vomiting was found in one patient (2.8%). There was one episode of UGI bleeding, but there were no treatment-related deaths.

Conclusion: The modified FOLFIRI regimen described here appears a safe and feasible salvage therapy in advanced gastric cancer patients.

Key Words: irinotecan • low-dose leucovorin • 5-fluorouracil • advanced gastric cancer


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M.-D. Seo, K.-W. Lee, J. H. Lim, H. G. Yi, D.-Y. Kim, D.-Y. Oh, J. H. Kim, S.-A. Im, T.-Y. Kim, J. S. Lee, et al.
Irinotecan Combined with 5-Fluorouracil and Leucovorin as Second-line Chemotherapy for Metastatic or Relapsed Gastric Cancer
Jpn. J. Clin. Oncol., September 1, 2008; 38(9): 589 - 595.
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