MOSAIC (colon cancer)
Trial question
What is the role of addition of oxaliplatin with fluorouracil and leucovorin in patients who had undergone resection for stage II or III colon cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 2246
2246 patients (1028 female, 1218 male).
Inclusion criteria: patients who had undergone resection with curative intent for stage II or III colon cancer.
Key exclusion criteria: prior chemotherapy, immunotherapy, or radiotherapy.
Interventions
N=1123 FOLFOX4 (12 cycles of bolus plus continuous infusion fluorouracil, leucovorin, and oxaliplatin for 6 months).
N=1123 LV5FU2 (12 cycles of bolus plus continuous infusion fluorouracil plus leucovorin for 6 months).
Primary outcome
Disease-free survival at 5 years
73.3%
67.4%
73.3 %
55.0 %
36.6 %
18.3 %
0.0 %
FOLFOX4
LV5FU2
Significant
increase ▲
NNT = 16
Significant increase in disease-free survival at 5 years (73.3% vs. 67.4%; HR 1.25, 95% CI 1.08 to 1.47).
Secondary outcomes
Significant increase in overall survival at 6 years (78.5% vs. 76%; HR 1.19, 95% CI 1 to 1.41).
Significant increase in overall survival at 6 years in patients with stage III disease (72.9% vs. 68.7%; HR 1.25, 95% CI 1.03 to 1.54).
Significant increase in disease-free survival at 5 years in patients with stage III disease (66.4% vs. 58.9%; HR 1.28, 95% CI 1.08 to 1.54).
Safety outcomes
Significant difference in grade 3 peripheral sensory neuropathy during treatment (12.5% vs. 0.2%).
Conclusion
In patients who had undergone resection with curative intent for stage II or III colon cancer, FOLFOX4 was superior to LV5FU2 with respect to a disease-free survival at 5 years.
Reference
Thierry André, Corrado Boni, Matilde Navarro et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16.
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