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Japanese Journal of Clinical Oncology 33:28-32 (2003)
© 2003 Foundation for Promotion of Cancer Research

A Phase II Study of Irinotecan in Combination with 120-h Infusion of 5-Fluorouracil in Patients with Metastatic Colorectal Carcinoma: Japan Clinical Oncology Group Study (JCOG9703)

Atsushi Ohtsu1, Narikazu Boku1, Takashi Yoshioka2, Ichinosuke Hyodo3, Kuniaki Shirao4, Yasuhiro Shimada4, Soh Saitoh5, Akira Nakamura6, Noboru Yamamichi7, Seiichiro Yamamoto8 and Shigeaki Yoshida1,+

1 Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, 2 Department of Clinical Oncology, Tohoku University Hospital, Sendai, 3 Department of Internal Medicine, National Shikoku Cancer Center, Matsuyama, 4 Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, 5 Department of Gastroenterology, Aomori Prefectural Central Hospital, Aomori, 6 Department of Internal Medicine, Asahi General Hospital, Asahi, Chiba, 7 Department of Surgery, Fukui Prefectural Center for Adult Disease, Fukui and 8 JCOG Data Center, Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo, Japan

Purpose: To evaluate the antitumor effect and feasibility of a combination of irinotecan (CPT-11) and 5-day infusional 5-fluorouracil (5-FU) in a sequential schedule based on our previous combination phase I studies in patients with metastatic colorectal cancer.

Patients and Methods: Forty chemotherapy-naive patients with metastatic colorectal cancer received 90-min infusion of CPT-11 at a dose of 150 mg/m2 on days 1 and 15 and 120-h protracted infusion of 5-FU at 600 mg/m2/day on days 3–7, which were repeated every 4 weeks.

Results: The median number of actually administered courses was five, ranging from one to 14. There were 16 (40%) patients who developed grade 3 or 4 neutropenia. Grade 3 or 4 nausea/vomiting and diarrhea were seen in three (8%) and seven (18%) patients, respectively. Only one early death not related to treatment occurred during the study. There was one complete response and 17 partial responses with a response rate of 45% (95% confidence interval: 29.3–61.5%). With a median follow-up period of 22.5 months for survivors, the median survival and median progression-free survival times were 15.9 and 7.0 months, respectively.

Conclusions: Although the toxicities were modest, this sequentially combined regimen is active and feasible in patients with metastatic colorectal cancer.

+ For reprints and all correspondence: Atsushi Ohtsu, 6–5–1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: aohtsu@east.ncc.go.jp


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