Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer
- Study type
- Clinical trial
- Study name
- MOSAIC
- Phase
- Phase 3
- Design
- International multicentre randomised trial
- Sample size
- 2246 patients
- Source
- N Engl J Med · 2004
In plain words
In this large study, patients with stage 2 or 3 colon cancer whose tumour had been removed by surgery received six months of chemotherapy: some had only fluorouracil and leucovorin, and some had these two drugs plus oxaliplatin. Adding oxaliplatin lowered the chance of the disease coming back, and more patients were disease-free at three years. The main side effect of this drug was sensory neuropathy (numbness and nerve pain in the hands and feet), which became severe in some patients during treatment but eased a great deal in most of them within a year after treatment.
Key results
Treatment arms and regimens
FOLFOX4 every 2 weeks, 12 cycles (6 months): day 1: oxaliplatin 85 mg/m² (2-hour infusion) + leucovorin 200 mg/m² (2-hour infusion), then fluorouracil 400 mg/m² bolus and 600 mg/m² as a 22-hour infusion; day 2: leucovorin 200 mg/m² (2-hour), then fluorouracil 400 mg/m² bolus and 600 mg/m² over 22 hours (1123 patients).
LV5FU2 every 2 weeks, 12 cycles (6 months): on days 1 and 2, leucovorin 200 mg/m² (2-hour infusion), then fluorouracil 400 mg/m² bolus and 600 mg/m² as a 22-hour infusion (1123 patients).
Source of the regimen details: FDA label for oxaliplatin (Clinical Studies section, Table 14: dosing regimens in the MOSAIC adjuvant trial)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with stage 2 or 3 colon cancer who had undergone curative-intent surgical resection.
Endpoints
Primary endpoint: disease-free survival.
Safety and side effects
In the FL plus oxaliplatin group, febrile neutropenia occurred in 1.8% and gastrointestinal toxicity was low. Grade 3 sensory neuropathy occurred in 12.4% during treatment and fell to 1.1% at one year of follow-up. Six patients in each group died during treatment (mortality 0.5%).
Clinical significance and place in guidelines
According to the abstract, adding oxaliplatin to FL improved disease-free survival in the adjuvant treatment of stage 2 and 3 colon cancer. The exact status of guideline recommendations and drug approvals should be checked in current sources.
Limitations
The abstract reports only follow-up with a median of 37.9 months, and the primary endpoint was disease-free survival. Overall survival results are not given in this abstract. Grade 3 sensory neuropathy during treatment occurred in 12.4% of patients in the oxaliplatin group.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.