96.6% of patients randomised were included in the analysis, median follow-up of patients still alive was 42.5 months. At the time of analysis, 385 patients (16%) had died, 198 in the FULV group and 187 in the FLOX group. A formal analysis of survival 5 years after the last patient was entered is expected late 2007.
3 year DFS was the primary end point. Of the 2407 eligible patients with follow-up, 677 experienced treatment failure, defined as the first recurrence, second primary, or death without recurrence. The hazard ratio (FLOX v FULV) is 0.80 (95% CI, 0.69 to 0.93), corresponding to a 20% risk reduction in favour of FLOX (P < .004). The 3 and 4 year disease-free survival (DFS) rates were 71.8% and 67.0% for FULV and 76.1% and 73.2% for FLOX. Grade 3 neurosensory toxicity was noted in 8.2% of patients receiving FLOX and in 0.7% of those receiving FULV (P < .001).
An updated analysis in 2011 showed that the DFS benefit is maintained (HR, 0.82; 95% CI, 0.72 to 0.93; p=0.002).r However, there was no statistically significant difference in OS (HR, 0.88; 95% CI, 0.75 to 1.02; p=0.08).
These results of oxaliplatin plus a bolus 5FU regimen are very similar to the MOSAIC trial which tested the addition of oxaliplatin to an infusional 5FU/LV regimen. Neuropathy was significantly less in the FLOX trial, because of a lower cumulative dose of oxaliplatin. FLOX is therefore considered a reasonable alternative to FOLFOX4 in the adjuvant treatment of Stage III colon cancer, particularly where there is concern about oxaliplatin neurotoxicity.
Kaplan-Meier estimates of (A) Overall survival and (B) Disease-free survivalr
© Journal of Clinical Oncology 2011