EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer
| Autor: | Patrick Schöffski, K Weigang-Köhler, J. Van den Brande, Pierre Fumoleau, F Reinke, Jan H.M. Schellens, Jantien Wanders, Florence Duffaud, Jan B. Vermorken, Arnaud Roth, R F de Boer |
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| Rok vydání: | 2003 |
| Předmět: |
Male
Antimetabolites Antineoplastic Cancer Research medicine.medical_specialty Pyridines Colorectal cancer Phases of clinical research Rectum colorectal cancer Antimetabolites Antineoplastic/adverse effects/therapeutic use fluoropyrimidines Gastroenterology Tegafur/adverse effects/therapeutic use Clinical oral Folinic acid Pyridines/adverse effects/therapeutic use Internal medicine medicine Humans Neoplasm Metastasis Oxonic Acid/adverse effects/therapeutic use Aged Tegafur ddc:616 business.industry Cancer S-1 phase II Middle Aged medicine.disease Surgery Oxaliplatin Irinotecan Drug Combinations Oxonic Acid Treatment Outcome medicine.anatomical_structure Oncology Colorectal Neoplasms/drug therapy/pathology Female Colorectal Neoplasms business Progressive disease medicine.drug |
| Zdroj: | British Journal of Cancer British Journal of Cancer, Vol. 88, No 5 (2003) pp. 648-53 |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | 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 nonrandomized phase II study, patients with advanced/metastatic 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 11 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 toxicities 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. |
| Databáze: | OpenAIRE |
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