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World J Gastroenterol. Oct 28, 2006; 12(40): 6522-6526
Published online Oct 28, 2006. doi: 10.3748/wjg.v12.i40.6522
Phase II study of protracted irinotecan infusion and a low-dose cisplatin for metastatic gastric cancer
Hiroshi Imamura, Masataka Ikeda, Hiroshi Furukawa, Toshimasa Tsujinaka, Kazumasa Fujitani, Kenji Kobayashi, Hiroyuki Narahara, Michio Kato, Haruhiko Imamoto, Arimichi Takabayashi, Hideaki Tsukuma
Hiroshi Imamura, Masataka Ikeda, Hiroshi Furukawa, Department of Surgery, Sakai Municipal Hospital, Osaka, Japan
Toshimasa Tsujinaka, Kazumasa Fujitani, Department of Surgery, Osaka National Hospital, Osaka, Japan
Kenji Kobayashi, Department of Surgery, Kinki Central Hospital, Hyogo, Japan
Hiroyuki Narahara, Hideaki Tsukuma, Department of Internal Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
Michio Kato, Department of Surgery, Kinki University School of Medicine, Osaka, Japan
Haruhiko Imamoto, Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan
Arimichi Takabayashi, Department of Surgery, Kitano Hospital & Research Institute, Osaka, Japan
Correspondence to: Hiroshi Imamura, Department of Surgery, Sakai Municipal Hospital, 1-1-1, Minamiyasui-cho, Sakai, Osaka 590-0064, Japan. imamura-h@city.sakai.osaka.jp
Telephone: +81-72-2211700 Fax: +81-72-2253303
Received: June 21, 2006
Revised: July 10, 2006
Accepted: July 18, 2006
Published online: October 28, 2006
Abstract

AIM: To test protracted irinotecan infusion plus a low-dose cisplatin in this Phase II trial to decrease its toxicity.

METHODS: The eligibility criteria were: (1) histologically proven measurable gastric cancer; (2) performance status of 0 or 1; (3) no prior chemotherapy or completion of prior therapy at least 4 wk before enrollment; (4) adequate function of major organs; (5) no other active malignancy; and (6) written informed consent. The regimen consisted of irinotecan (60 mg/m2) on d 1 and 15 by 24-h infusion and cisplatin (10 mg/m2) on d 1, 2, 3, 15, 16, and 17. Treatment was repeated every 4 wk.

RESULTS: Thirty-one patients were registered between April 2000 and January 2001. The response rate for all 31 patients, 20 patients without prior chemotherapy, and 11 patients with prior chemotherapy was 52% (16/31), 60% (12/20), and 36% (4/11), respectively. The median survival time was 378 d. The median number of courses given to all patients was 2. Grade 4 neutropenia occurred in 11 (35%) patients, while grade 3 to 4 diarrhea or nausea occurred in 1 (3%) and 3 (10%) patients, respectively. Fatigue was minimal as grade 1 fatigue was found only in 3 (10%) patients. Other adverse events were mild and no treatment-related deaths occurred.

CONCLUSION: This regimen showed a high level of activity and acceptable toxicity in patients with metastatic gastric cancer.

Keywords: Gastric cancer; CPT-11; CDDP; Protracted Irinotecan; Chemotherapy