Safety of irinotecan and infusional fluorouracil/leucovorin (FOLFIRI) in Japan: A retrospective review of 48 patients with metastatic colorectal cancer

Nozomu Fuse, Toshihiko Doi, Atsushi Ohtsu, Tomonori Yano, Yasuo Hamamoto, Keiko Minashi, Makoto Tahara, Manabu Muto, Masahiro Asaka, Shigeaki Yoshida

Research output: Contribution to journalArticlepeer-review

14 Citations (Scopus)


Background. A combination of irinotecan and infusional fluorouracil/ leucovorin (FOLFIRI) has become one of the global standard chemotherapy regimens for metastatic colorectal cancer. The aim of this study was to evaluate the feasibility of FOLFIRI in a Japanese population with metastatic colorectal cancer. Methods. This retrospective analysis included 48 patients with unresectable metastatic colorectal cancer who received FOLFIRI between May 2004 and June 2005. Evaluation points included adverse events, dose intensity, response rate, progression-free survival, and overall survival. Results. Thirty-eight (79%) patients received FOLFIRI as first-line chemotherapy. Eighteen patients received original full-dose FOLFIRI and 30 patients received reduced FOLFIRI with irinotecan at 150mg/m2. Eighteen (38%) of the 48 patients experienced grade 3 or 4 neutropenia, 5 (10%) had grade 3 vomiting and 5 (10%) had grade 3 diarrhea. Toxicity was tolerable, with appropriate dose reduction if necessary. There were no treatment-related deaths or early deaths within the first 60 days of treatment. Median dose intensities (with relative dose intensities in parentheses) in all patients and in patients who received full-dose FOLFIRI were 129mg/m2 per 2 weeks (71%) and 144mg/m 2 per 2 weeks (80%) for irinotecan and 2349mg/m2 per 2 weeks (84%) and 2376mg/m2 per 2 weeks (85%) for fluorouracil, respectively. The response rate in patients with measurable lesions was 37% (13/35; 95% confidence interval [CI], 21.1%-53.2%), and median progression-free survival was 8.4 months (95% CI, 6.4-10.3). Conclusion. The dose intensity of irinotecan was relatively low, and toxicity was tolerable with appropriate dose reduction; efficacy was comparable to that previously reported. FOLFIRI is feasible and can be one of the standard treatment options for Japanese patients with metastatic colorectal cancer.

Original languageEnglish
Pages (from-to)144-149
Number of pages6
JournalInternational Journal of Clinical Oncology
Issue number2
Publication statusPublished - 2008 Apr
Externally publishedYes


  • Colorectal cancer
  • Feasibility
  • Irinotecan
  • Safety

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology


Dive into the research topics of 'Safety of irinotecan and infusional fluorouracil/leucovorin (FOLFIRI) in Japan: A retrospective review of 48 patients with metastatic colorectal cancer'. Together they form a unique fingerprint.

Cite this