Improved Overall Survival With Oxaliplatin, Fluorouracil, and Leucovorin As Adjuvant Treatment in Stage II or III Colon Cancer in the MOSAIC Trial
- Study type
- Clinical trial
- Study name
- MOSAIC
- Design
- Randomised trial comparing LV5FU2 with FOLFOX4 as adjuvant therapy (final report including 6-year overall survival and updated 5-year disease-free survival)
- Sample size
- 2,246 patients
- Source
- JCO · 2009
In plain words
In this large study, patients with stage II or III colon cancer received 6 months of chemotherapy after surgery to lower the risk of the cancer returning: some had only fluorouracil and leucovorin, and some also had oxaliplatin. Adding oxaliplatin raised the chance of staying free of the disease after 5 years, and in stage III patients it also improved survival at 6 years. In stage II patients no difference in survival was seen. Oxaliplatin can cause sensory neuropathy (numbness and tingling in the hands and feet), but its most severe form became less common over time.
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 II or III colon cancer who had undergone curative-intent resection. Other inclusion criteria are not given in the abstract.
Endpoints
Primary endpoint: disease-free survival (DFS). Secondary endpoints: overall survival (OS) and safety.
Safety and side effects
In patients who received oxaliplatin, the frequency of grade 3 peripheral sensory neuropathy was 1.3% at 12 months after treatment and 0.7% at 48 months. Other adverse events are not reported in the abstract.
Clinical significance and place in guidelines
According to this final report, adding oxaliplatin to LV5FU2 (the FOLFOX4 regimen) improved 5-year disease-free survival and 6-year overall survival in the adjuvant treatment of colon cancer, and the authors recommend that it be considered after surgery for stage III patients. No overall survival benefit was shown in stage II. Its exact status in current clinical guidelines should be checked separately, as the abstract does not address it.
Limitations
The abstract does not state the study's limitations. No overall survival difference was seen in stage II, and the upper bound of the confidence interval for the overall survival HR in the whole population was 1.00. A full appraisal of limitations requires the full text.
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.