Phase I/II study of combination therapy with S-1 and CPT-11 for metastatic colorectal cancer

Nakafusa,Yuji; Tanaka,Masayuki; Ohtsuka,Takao; Miyoshi,Atsushi; Kohya,Naohiko; Kitajima,Yoshihiko; Sato,Seiji; Mochinaga,Sakiko; Dohi,Sawako; Miyazaki,Kohji

doi:10.3892/mmr_00000051

November-December 2008 Volume 1 Issue 6

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November-December 2008 Volume 1 Issue 6

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Article

Phase I/II study of combination therapy with S-1 and CPT-11 for metastatic colorectal cancer

Authors:
- Yuji Nakafusa
- Masayuki Tanaka
- Takao Ohtsuka
- Atsushi Miyoshi
- Naohiko Kohya
- Yoshihiko Kitajima
- Seiji Sato
- Sakiko Mochinaga
- Sawako Dohi
- Kohji Miyazaki
View Affiliations / Copyright

Affiliations: Department of Surgery, Saga University Faculty of Medicine, Saga 849-8501, Japan. nakafusy@cc.saga-u.ac.jp
Pages: 925-930
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Published online on: November 1, 2008

https://doi.org/10.3892/mmr_00000051
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Abstract

We conducted a Phase I/II study of combination therapy using CPT-11 and S-1 as a first-line treatment for metastatic colorectal cancer. The 28-day treatment cycle consisted of S-1 administered orally from day 1 to 21 and CPT-11 administered intravenously on days 1 and 15. In the Phase I portion, the dose of S-1 was fixed at 80 mg/m2/day, while CPT-11 was administered at a starting dose of 60 mg/m2 then stepped up in 20 mg/m2 increments. The maximum-tolerated dose was achieved at 80 mg/m2 of CPT-11, and the recommended dose was determined to be 60 mg/m2 of CPT-11. In the Phase II portion, this therapy exhibited a response rate of 58%, a median progression-free survival of 8.4 months, and a median overall survival of 18.7 months. Toxicity was generally mild and manageable. No patient showed grade 4 toxicity, and grade 3 toxicity was observed in only 18% of patients. The most frequently observed grade 3 toxicity was diarrhea, at a rate of 6%. The mean relative dose intensity of CPT-11 and S-1 was as high as 98 and 97%, respectively. In conclusion, combination therapy with CPT-11 and S-1 according to our treatment schedule is effective, safe and highly feasible for metastatic colorectal cancer patients. These data suggest that assessing this combination therapy in a Phase III study would be worthwhile.

Journals

International Journal of Molecular Medicine

International Journal of Oncology

Molecular Medicine Reports

Oncology Reports

Experimental and Therapeutic Medicine

Oncology Letters

Biomedical Reports

Molecular and Clinical Oncology

World Academy of Sciences Journal

International Journal of Functional Nutrition

International Journal of Epigenetics

Medicine International

Phase I/II study of combination therapy with S-1 and CPT-11 for metastatic colorectal cancer

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Abstract

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