MOSAIC Safety Update Supports FOLFOX4 Use in Colon Cancer

Allison Gandey

July 27, 2007

July 27, 2007 (Chicago) — New 5-year data confirm earlier 3-year results that FOLFOX4 improves disease-free survival in colon cancer. The safety update was presented at the recent American Society of Clinical Oncology 43rd Annual Meeting. Investigators from the Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) study showed that patients followed beyond the 3-year cutoff for the trial experienced a significant benefit from therapy.

"In addition," lead author and presenter Aimery de Gramont, MD, from the Hôpital Saint Antoine, in Paris, France, said, "at a median follow-up of 6 years, the study demonstrates a significant benefit in overall survival for stage 3 patients."

The MOSAIC trial looked at more than 2200 patients who had undergone resection for stage 2 or 3 colon cancer. Participants were randomly assigned to receive 5-fluorouracil and leucovorin (LV5FU2) alone or with oxaliplatin (FOLFOX4) every 2 weeksfor 12 cycles.

MOSAIC showed that for the overall population, treatment with FOLFOX4 resulted in a significant benefit in disease-free survival — 78.2% vs 72.9% (hazard ratio, 0.77; P = .002). In this latest analysis, patients were followed for longer. "Final disease-free survival at 5-year follow-up is consistent with earlier results — hazard ratio 0.80, P = .003," Dr. de Gramont said.

Probability of Surviving at 6 Years
Patients
LV5FU2 (%)
FOLFOX4 (%)
Hazard Ratio (95% CI)
Overall population
75.8
78.5
0.85 (0.71 – 1.01)
Stage 2
86.8
86.8
1.00 (0.70 – 1.43)
Stage 3
68.3
72.9
0.80 (0.66 – 0.98)
 
Presenting at a second conference in June — the 9th World Congress on Gastrointestinal Cancer in Barcelona, Spain — Dr. de Gramont showed that at a median of 6 years of follow-up, no survival benefit was seen for stage 2 patients. For stage 3 cases, they observed a 4.6% absolute difference in the probability of surviving at 6 years. "It translated in a significant survival advantage," the investigators noted in their abstract, "with a reduction in the risk of death of 20%."

"Longer follow-up confirms the benefit of FOLFOX4, showing that the benefit of prevention of relapse already seen now actually translates into a survival advantage for patients with stage 3 colon cancer," the team reported. Dr. de Gramont pointed out that long-term data show no increase in the rate of secondary cancer (5.0% in both treatment groups). The group concludes, "These results confirm the benefit of the FOLFOX4 regimen in adjuvant colon cancerpatients."

American Society of Clinical Oncology 43rd Annual Meeting: Abstract 4007. Presented June 3, 2007.

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