FOLFOX4 for all stage III colon cancer patients

Oxaliplatin plus 5-FU and leucovorin should be administered to all patients with stage III colon cancer who have curative resections, but the role of adjuvant therapy for stage II colon cancer patients remains controversial, MOSIAC researchers say. A previously reported phase III study of 2,246 patients who had undergone resection for either stage II or III colon cancer found that bolus plus continuous infusion FU plus leucovorin (LV5FU2) plus oxaliplatin (FOLFOX4) had improved 3 year disease free survival (DFS) compared with LV5FU2 alone. They now report the results for overall survival at 6 years together with the final 5 year disease free results. Published in the Journal of Clinical Oncology this final analysis of the MOSIAC trial showed a statistically significant overall relative risk reduction of 20% for recurrence and 16% for death in favour of oxaliplatin, confirming the benefit in 3 year DFS and demonstrating that the DFS translates into an OS benefit. However, the significant DFS and OS benefits observed with the addition of oxaliplatin to FL in the overall population were driven entirely by the favourable effect in the subgroup of patients with stage III disease, with clinical benefit reaching statistic significance and clinical relevance only in this group of patients. For stage II patients there was no statistically significant improved 5 year DFS and 6 year OS. “Although chemotherapy after surgery is standard for patients with stage III colon cancer, the role of adjuvant therapy for stage II colon cancer patients remains controversial,” the researchers said. “These results suggest that adjuvant oxaliplatin plus FU and leucovorin is useful after surgery for patients undergoing treatment with a curative intent for stage III colon cancer,” they concluded. The researcher say that a similar conclusion cannot be drawn for stage II disease as a whole, although there is some evidence from their results that patients classified as having high-risk stage II disease may also benefit from such treatment. J Clin Oncol 2009; published online before print....