title: A Phase II Study of Oxaliplatin Combined with 5-Fluorouracil and Leucovorin (Mayo Clinic Regimen) in 5-Fluorouracil Refractory Colorectal Cancer.
abstract: OBJECTIVE
  There are few therapeutic options in patients with colorectal cancer that have progressed or recurred following 5-fluorouracil (5-FU) based therapy. We evaluated the efficacy and toxicity of oxaliplatin, 5-FU, leucovorin (Mayo clinic regimen) in 5-FU pretreated advanced colorectal cancer patients. MATERIALS AND METGODS: Twenty-eight patients were enrolled in this study between January 1999 and May 2001. Patients were treated with oxaliplatin 150 mg/m2 on day 1 as a 2-hr infusion and 5-FU 425 mg/m2, leucovorin 20 mg/m2, bolus for 5 days. Treatment courses were repeated in 4-week intervals.
  
  
  RESULTS
  The objective response rate was 25% for 28 assessable patients, all cases registered a partial response. Eleven patients (39%) demonstrated stable disease, and ten (36%) progressed. The median response duration was 5.5 months, and the median time to progression was 6.3 months. The median overall survival time was 13.5 months from the start of the chemotherapy. From the 120 cycles analyzed, grade 3,4 hematologic toxicities included neutropenia: 1.6%, and thrombocytopenia: 1.6%. The frequent grade 3.4 non-hematologic adverse reactions were nausea/vomiting (25.0%), diarrhea (14.3%), stomititis (3.6%), and neuropathy (3.6%). There were no treatment-related deaths.
  
  
  CONCLUSIONS
  This phase II study had relatively higher toxicity than previous studies, and did not show an increased significant response rate. These high levels of toxicity suggest that the study treatment combination of oxaliplatin with a full dose Mayo clinic regimen arm is no feasible. Therefore, this regimen will be discontinued and a safer regimen will be adopted.
authors.forename: Yee Zee
authors.initials: YZ
authors.lastname: Bae
authors.forename: Jae Hyuk
authors.initials: JH
authors.lastname: Jung
authors.forename: Chang Hoon
authors.initials: CH
authors.lastname: Moon
authors.forename: Seong Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Hyuk Chan
authors.initials: HC
authors.lastname: Kwon
authors.forename: Jae Seok
authors.initials: JS
authors.lastname: Kim
authors.forename: Hyo Jin
authors.initials: HJ
authors.lastname: Kim
keywords: 5-FU; Colorectal neoplasm; Combination chemotherapy; Leucovorin; Oxaliplatin