et al.

Sch\uf6ffski, P.

Schellens, J.H.M.

van den Brande, Jan

Vermorken, Jan Baptist

Abstract: Cancer of the colon and rectum is one of the most frequent malignancies both in the US and Europe. Standard palliative therapy is based on 5-fluorouracil/folinic acid combinations, with or without oxaliplatin or irinotecan, given intravenously, Oral medication has the advantage of greater patient convenience and acceptance and potential cost savings. S-1 is a new oral fluorinated pyrimidine derivative. In a nonrandomised phase II study, patients with advanced/metastatc colorectal cancer were treated with S-1 at 40 mg m(-2) b.i.d. for 28 consecutive days, repeated every 5 weeks, but by amendment the dose was reduced to 35 mg m-2 during the study because of a higher than expected number of severe adverse drug reactions. In total 47 patients with colorectal cancer were included. In the 37 evaluable patients there were nine partial responses (24%), 17 stable diseases (46%) and II patients had progressive disease (30%). Diarrhoea occurred frequently and was often severe: in the 40 and 35 mg m(-2) group, respectively, 38 and 35% of the patients experienced grade 3-4 diarrhoea. The other toxicites were limited and manageable. S-1 is active in advanced colorectal cancer, but in order to establish a safer dose the drug should be subject to further investigations. (C) 2003 Cancer Research UK

EORTC Early Clinical Studies Group early phase II trial of S-I in patients with advanced or metastatic colorectal cancer

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