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

Clinical Study British Journal of Cancer (2005) 93, 896–904. doi:10.1038/sj.bjc.6602800 www.bjcancer.com Published online 11 October 2005 Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study S De Placido1, M Lopez2, C Carlomagno1, G Paoletti2, S Palazzo3, L Manzione4, C Iannace5, G P Ianniello6, F De Vita7, C Ficorella8, A Farris9, G Pistillucci10, M Gemini11, E Cortesi12, V Adamo13, N Gebbia14, S Palmeri15, C Gallo16, F Perrone17, G Persico18 and A R Bianco1 1Dipartimento di Endocrinologia ed Oncologia Molecolare e Clinica, Università Federico II, Napoli, Italy 2Struttura Complessa, Oncologia Medica B, Istituto Nazionale Tumori Regina Elena, Roma, Italy 3Divisione di Oncologia, Ospedale Mariano Santo, Cosenza, Italy 4U.O. di Oncologia Medica, Ospedale San Carlo, Potenza, Italy 5Divisione di Chirurgia Generale, Ospedale Moscati, Avellino, Italy 6U.O. di Oncologia, ASL-1, Benevento, Italy 7Divisione di Oncologia Medica, Seconda Università, Napoli, Italy 8Divisione di Oncologia Medica, Università de L'Aquila, Italy 9Divisione di Oncologia Medica, Università di Sassari, Italy 10Divisione di Oncologia, Ospedale S. Maria Goretti, Latina, Italy 11U.O. di Oncologia, Ospedale Belcolle, Viterbo, Italy 12U.O. Complessa Oncologia 'B' Università La Sapienza, Roma, Italy 13Dipartimento di Oncologia medica, A.O.U. Policlinico, Messina, Italy 14U.O. di Oncologia, Dipartimento di Oncologia Clinica, Università di Palermo, Italy 15Cattedra di Oncologia, Dipartimento di Oncologia Clinica, Università di Palermo, Italy 16Dipartimento di Medicina Pubblica, Clinica e Preventiva, Seconda Università, Napoli, Italy 17Unità Operativa Sperimentazioni Cliniche, Istituto Nazionale Tumori, Napoli, Italy 18Dipartimento Universitario di Chirurgia Generale, Geriatrica, Oncologica e Tecnologie Avanzate, Università Federico II, Napoli, Italy Correspondence: Professor S De Placido, Dipartimento di Endocrinologia ed Oncologia Molecolare e Clinica, Università Federico II, Via Sergio Pansini, 5, Napoli 80131, Italy. E-mail: sdponco@unina.it Revised 2 August 2005; Accepted 25 August 2005. Top of pageAbstract 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. Keywords: adjuvant chemotherapy, colorectal cancer, 5-fluorouracil modulation Extra navigationHomeFor authorsServicesABSTRACT NAVIGATION - ABSTRACT Previous | Next Table of contents Full text Download PDF Send to a friend Rights and permissions Order Commercial Reprints Scopus lists 5 articles citing this article Save this link Abstract Export citation Papers by De Placido Papers by Bianco nature jobs Assistant Professor of Surgery University of Pittsburgh Medical Center Fellowships for Biomedical Science in India The Wellcome Trust / DBT India Alliance More science jobs Post a job for freenature events 2nd Max Planck Freiburg Epigenetics Meeting 05 December 2012 — 08 December 2012 Stuebeweg 51, Freiburg im Breisgau, Germany Naturejobs Career Expo- London 20 September 2012 — 20 September 2012 London, United Kingdom More science events