TY - JOUR
T1 - “Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer:the IGCS-COL multicentre, randomised, phase III study”
AU - Palmeri, Sergio
AU - Gebbia, Nicolo'
AU - De Vita, Fernando
AU - Cortesi, null
AU - Bianco, Angelo Raffaele
AU - Carlomagno, null
AU - Gemini, null
AU - Pistillucci, null
AU - Iannace, null
AU - Carlomagno, null
AU - Ianniello, Giovanni Pietro
AU - Ficorella, Corrado
AU - Paoletti, Giancarlo
AU - Adamo, Vincenzo
AU - Persico, Giovanni
AU - Palazzo, Salvatore
AU - Farris, null
AU - Manzione, Luigi
AU - De Placido, null
AU - Perrone, Francesco
AU - Gallo, Ciro
AU - Lopez, Massimo
AU - Lopez, Manuela
PY - 2005
Y1 - 2005
N2 - 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 2x2 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.
AB - 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 2x2 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.
UR - http://hdl.handle.net/10447/2216
M3 - Article
VL - 93
SP - 896
EP - 904
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
ER -