A Phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Survival results of NSABP Protocol C-07
Previous studies have shown a benefit to adding oxaliplatin to the standard 5-FU and leucovorin in adjuvant therapy for stage II or III colon cancer. This report is an update of the results of a phase III study comparing 5-FU/LV (FULV) with 5-FU/LV and oxaliplatin (FLOX) in stage II and III colon tumors.
The study had 2,409 participants randomized to the two regimens. 29% of the participants had stage II disease. At the 3-year update, the difference in disease-free survival was reported as 4.6% (superior in FLOX arm). At this 5-year update, the disease-free survival advantage had increased to a 5.2% advantage in the FLOX arm. However, these differences were not statistically significant. Nonetheless, the authors feel that longer follow up may result in a statistically significant difference. Interestingly, when stage II (node negative) patients were teased out, no benefit was seen for them.
This study could result in a change in the standard of care for adjuvant therapy, but longer follow up is necessary to determine if the benefits seen are significant. The addition of oxaliplatin is not without consequence, as it can cause significant neurotoxicity, affecting quality of life.