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

Author

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

Published
2005
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7. Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study

Author

Sergio Palmeri, F. De Vita, G Persico, F. Perrone, Corrado Ficorella, Luigi Manzione, Chiara Carlomagno, Massimo Lopez, Vincenzo Adamo, Ciro Gallo, Angelo Raffaele Bianco, Enrico Cortesi, Antonio Farris, C Iannace, G P Ianniello, Silvano Palazzo, G Pistillucci, G Paoletti, S. De Placido, M Gemini, Nicolo' Gebbia, DE PLACIDO, Sabino, Lopez, M, Carlomagno, Chiara, Paoletti, G, Palazzo, S, Manzione, L, Iannace, C, Ianniello, Gp, DE VITA, F, Ficorella, C, Farris, A, Pistillucci, G, Gemini, M, Cortesi, E, Adamo, V, Gebbia, N, Palmeri, S, Gallo, C, Perrone, F, Persico, G, Bianco, ANGELO RAFFAELE, DE PLACIDO, S, Carlomagno, C, DE VITA, Ferdinando, Gallo, Ciro, and Bianco, Ar

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Randomization, 5-fluorouracil modulation, adjuvant chemotherapy, colorectal cancer, medicine.drug_class, Colorectal cancer, Leucovorin, Antimetabolite, Gastroenterology, Disease-Free Survival, Folinic acid, RECTAL CANCER, COLON, Internal medicine, Clinical Studies, Antineoplastic Combined Chemotherapy Protocols, medicine, Mucositis, Humans, Aged, business.industry, Hazard ratio, Middle Aged, medicine.disease, Surgery, Treatment Outcome, Levamisole, Oncology, Chemotherapy, Adjuvant, Fluorouracil, Vomiting, Female, medicine.symptom, Colorectal Neoplasms, business, medicine.drug
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 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..

Published
2005

8. [Sequential therapy with methotrexate and 5-fluorouracil in patients with advanced colorectal cancer pretreated with 5-fluorouracil plus folinic acid].

Author

Paoletti G, Di Lauro L, Gionfra T, Venturo I, Belli F, Squilloni E, Mariotti S, Fioretti G, Gemini M, Tersigni R, and Lopez M

Subjects
Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols toxicity, Colorectal Neoplasms drug therapy, Fluorouracil toxicity, Humans, Leucovorin toxicity, Liver Neoplasms secondary, Methotrexate toxicity, Neoplasm Staging, Stomatitis chemically induced, Colorectal Neoplasms pathology, Fluorouracil therapeutic use, Leucovorin therapeutic use, Methotrexate therapeutic use
Abstract

Purpose: To evaluate the efficacy and toxicity of a sequential low-dose methotrexate (MTX) and 5-fluorouracil (5FU) regimen in the palliative treatment of patients with advanced colorectal cancer., Patients and Methods: Enrolled in the study were patients with advanced colorectal cancer, refractory to 5FU + FA. Patients were treated with MTX 40 mg/m2 i.v. bolus d 1 and 8, 5FU 700 mg/m2 i.v. bolus d 2 and 9 (24 hours after MTX bolus). The cycle was repeated every 4 weeks., Results: 48 patients entered the study, and 45 are evaluable. The overall response rate was 15% with 1 complete response and 6 partial responses. Eight patients obtained disease stabilization. Median time to progression was 9 months. Toxicity was mild. Grade 3 stomatitis was observed in 7 (15%) patients., Conclusions: Sequential MTX/5FU is a well tolerated regimen with mild antitumor activity in refractory advanced colorectal patients.

Published
1998

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