• Yoshito Komatsu, Satoshi Yuki, Susumu Sogabe, Hiraku Fukushima, Hiroshi Nakatsumi, Yoshimitsu Kobayashi, Ichiro Iwanaga, Michio Nakamura, Kazuteru Hatanaka, Takuto Miyagishima, Mineo Kudo, Masaki Munakata, Takashi Meguro, Miki Tateyama, and Yuh Sakata.
• Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan. ykomatsu@med.hokudai.ac.jp
• Acta Oncol. 2012 Sep 1; 51 (7): 867-72.

BackgroundIn Japan, a study comparing the effectiveness and safety of irinotecan plus S-1 (IRIS) with those of a combination of 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) as second-line treatment in patients with advanced or recurrent colorectal cancer demonstrated that IRIS was non-inferior to FOLFIRI. We previously reported that IRIS is also effective as first-line treatment.Patients And MethodsEligibility criteria included inoperable recurrent colorectal cancer with a confirmed diagnosis of adenocarcinoma, age ≥20 years, and no history of prior chemotherapy. S-1 (40-60 mg twice daily) was given orally on Days 1 to 14, and irinotecan (100 mg/m(2)) and bevacizumab (5 mg/kg) were given intravenously on Days 1 and 15 of a 28-day cycle. The primary endpoint was safety. The secondary endpoints included overall response (OR), progression-free survival (PFS), and overall survival (OS).ResultsA total of 52 eligible patients were enrolled from October 2007 through March 2009. In safety analysis, the incidences of grade 3 or 4 adverse reactions were as follows: neutropenia, 27%; hypertension, 21%; and diarrhea, 17%. The overall response rate was 57.7%. Median progression-free survival was 16.7 months.ConclusionIRIS plus bevacizumab is a well-tolerated, highly effective chemotherapeutic regimen that is easy to administer.

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