Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: The IGCS-COL multicentre, randomised, phase III study

S. De Placido, M. Lopez, C. Carlomagno, G. Paoletti, S. Palazzo, L. Manzione, C. Iannace, G. P. Ianniello, F. De Vita, C. Ficorella, A. Farris, G. Pistillucci, M. Gemini, E. Cortesi, V. Adamo, N. Gebbia, S. Palmeri, C. Gallo, F. Perrone, G. PersicoA. R. Bianco

Research output: Contribution to journalArticlepeer-review

Abstract

The aims of this multicentre, randomised phase III trial were to evaluate: (1) the role of levamisol (LEV); and (2) the role of folinic acid (FA), added to 5-fluorouracil (5FU) in the adjuvant treatment of colorectal cancer. Patients with histologically proven, radically resected stage II or III colon or rectal cancer were eligible. The study had a 2 × 2 factorial design with four treatment arms: (a) 5FU alone, (b) 5FU+LEV, (c) 5FU+FA, (d) 5FU+LEV+FA, and two planned comparisons, testing the role of LEV and of FA, respectively. From March 1991, to September 1998, 1327 patients were randomised. None of the two comparisons resulted in a significant disease-free (DFS) or overall (OAS) survival advantage. The hazard ratio (HR) of relapse was 0.89 (95% confidence intervals (CI): 0.73-1.09) for patients receiving FA and 0.99 (95% CI 0.80-1.21) for those receiving LEV; corresponding HRs of death were 1.02 (95% CI: 0.80-1.30) and 0.94 (95% CI 0.73-1.20). Nonhaematological toxicity (all grade vomiting, diarrhoea, mucositis, congiuntivitis, skin, fever and fatigue) was significantly worse with FA, while all other toxicities were similar. In the present trial, there was no evidence that the addition of FA or LEV significantly prolongs DFS and OAS of radically resected colorectal cancer patients.

Original languageEnglish
Pages (from-to)896-904
Number of pages9
JournalBritish Journal of Cancer
Volume93
Issue number8
DOIs
Publication statusPublished - Oct 17 2005

Keywords

  • 5-fluorouracil modulation
  • Adjuvant chemotherapy
  • Colorectal cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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