Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer

• Published in: Acta oncologica 2012-09, Vol.51 (7), p.867-872
• Main Authors: Komatsu, Yoshito, Yuki, Satoshi, Sogabe, Susumu, Fukushima, Hiraku, Nakatsumi, Hiroshi, Kobayashi, Yoshimitsu, Iwanaga, Ichiro, Nakamura, Michio, Hatanaka, Kazuteru, Miyagishima, Takuto, Kudo, Mineo, Munakata, Masaki, Meguro, Takashi, Tateyama, Miki, Sakata, Yuh
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - epidemiology; Adenocarcinoma - pathology; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - epidemiology; Colorectal Neoplasms - pathology; Diarrhea - chemically induced; Drug Administration Schedule; Drug Combinations; Female; Humans; Hypertension - chemically induced; Japan - epidemiology; Kaplan-Meier Estimate; Male; Middle Aged; Neoplasm Staging; Neutropenia - chemically induced; Oxonic Acid - administration & dosage; Severity of Illness Index; Tegafur - administration & dosage; Treatment Outcome
• ISSN: 0284-186X; 1651-226X
• DOI: 10.3109/0284186X.2012.682629

Abstract Background. In 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 methods. Eligibility 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/m2) 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). Results. A 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. Conclusion. IRIS plus bevacizumab is a well-tolerated, highly effective chemotherapeutic regimen that is easy to administer.