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Phase I/II study of sequential therapy with irinotecan and S-1 for metastatic colorectal cancer

2009; Springer Nature; Volume: 101; Issue: 12 Linguagem: Inglês

10.1038/sj.bjc.6605432

1532-1827

Takashi Yoshioka, Shunsuke Kato, Makio Gamoh, Natsuko Chiba, Takao Suzuki, Nobuyuki Sakayori, Shunsuke Kato, Hiroyuki Shibata, Hiroshi Shimodaira, Keita Otsuka, Yuichi Kakudo, Shin Takahashi, Chikashi Ishioka,

Hepatocellular Carcinoma Treatment and Prognosis

Both irinotecan (CPT-11) and S-1 are active against colorectal cancer; however, as S-1 is a prodrug of 5-fluorouracil (5-FU), 5-FU and its metabolites might inhibit the antitumour effect of CPT-11. Therefore, we designed a sequential combination, in which CPT-11 infusion was given on day 1 and S-1 was given orally at 80 mg m−2 per day on days 3–16 every 3 weeks. Twelve patients entered the phase I study, and the recommended doses were determined as a CPT-11 dose of 150 mg m−2 and an S-1 dose of 80 mg m−2. In all, 36 patients entered the phase II study, of whom 4 and 16 had complete and partial responses. The overall response rate was 55.6% (95% confidence interval, 38.1–72.1%), and median progression-free survival was 7.7 months (95% confidence interval, 4.8–12.6 months). Grade 3 neutropenia was the most common haematological toxicity and occurred in 6.5% of 215 treatment courses. Grade 3 non-haematological toxicities included anorexia (1.4%) and diarrhoea (0.9%). There was no grade 4 toxicity of any kind. Our results suggest that this regimen is convenient, safe and promising, compared with conventional regimens for patients with metastatic colorectal cancer.