OPTIMOX1: A Randomized Study of FOLFOX4 or FOLFOX7 With Oxaliplatin in a Stop-and-Go Fashion in Advanced Colorectal Cancer—A GERCOR Study

作者: Christophe Tournigand , Andres Cervantes , Arie Figer , Gérard Lledo , Michel Flesch

DOI: 10.1200/JCO.2005.03.0106

关键词: Randomized controlled trialRegimenFluorouracilFOLFOXGastroenterologySurvival analysisColorectal cancerRandomizationOxaliplatinInternal medicineMedicine

摘要: Purpose In metastatic colorectal cancer, a combination of leucovorin (LV) and fluorouracil (FU) with oxaliplatin (FOLFOX) 4 is standard first-line regimen. The cumulative neurotoxicity often requires therapy to be stopped in patients who are still responding. This study evaluates new strategy intermittent treatment that based on FOLFOX7, simplified regimen high-dose oxaliplatin. Patients Methods Previously untreated were randomly assigned either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7 for six cycles, maintenance without 12 reintroduction B). Results Six hundred twenty enrolled, including an exploratory cohort 95 elderly poor prognosis patients. Median progression-free survival times 9.0 19.3 months, respectively, allocated arm A compared 8.7 21.2 patients...

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