Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma: a randomised study by the Southern Italy Cooperative Oncology Group

Autor: F. Del Gaizo, S. Mancarella, Antonio Farris, S. Palmeri, Annunziato Iannelli, G. De Cataldis, Salvatore Tafuto, Pasquale Comella, L. De Lucia, E. Crucitta, F. De Vita, F. Buzzi, Luigi Maiorino
Rok vydání: 2002
Předmět:
Zdroj: Annals of oncology : official journal of the European Society for Medical Oncology. 13(6)
ISSN: 0923-7534
Popis: Purpose: The purpose of this study was to compare the activity and toxicity of the combination of irinotecan (IRI) plus folinic acid (FA)-modulated 5-fluorouracil (5-FU) i.v. bolus with a regimen of double modulation of 5-FU with methotrexate (MTX) and FA in patients with advanced colorectal carcinoma. Patients and methods: Two-hundred and thirty-four patients were enrolled: 118 patients received IRI 200 mg/m 2 (90-min i.v. infusion) on day 1, followed by levo-FA 250 mg/m 2 (2-h i.v. infusion) and 5-FU 850 mg/m 2 (i.v. bolus) on day 2(IRIFAFU), and 116 patients received MTX 750 mg/m 2 (2-h i.v. infusion) on day 1, followed by levo-FA 250 mg/m 2 (2-h i.v. infusion) and FU 800 mg/m 2 (i.v. bolus) on day 2 (MTXFAFU). Both cycles were repeated every 2 weeks until progression or to a maximum of 16 cycle. Response rate (RR) was the main end point of the study; responses were assessed every four cycles and confirmed after 2 additional months of treatment. Results: RR was significantly greater with IRIFAFU (36%) than with MTXFAFU (20%) (P
Databáze: OpenAIRE