Oxaliplatin/5FU/LV in the adjuvant treatment of stage II and stage III colon cancer: Efficacy results with a median follow-up of 4 years.
Reviewer: Christopher Dolinsky, MD
University of Pennsylvania School of Medicine
Last Modified: May 16, 2005
Presenter: A. deGramont
Presenter's Affiliation: Hopital Saint Antoine, Paris, France
Type of Session: Scientific
- Oxaliplatin is a new chemotherapeutic agent with demonstrated activity in colorectal cancer.
- This abstract presents an update to previously published results from a large phase III randomized trial (MOSAIC).
- MOSAIC demonstrated superiority of a regimen containing oxaliplatin/5- fluorouracil/leukovorin (FOLFOX4) to one containing 5-fluorouracil and leukovorin (LV5FU2) as adjuvant therapy for stage II and III colon cancer (Andre et al., NEJM 2004).
Materials and Methods
- A multi-institution phase III prospective trial randomized 2246 patients with stage II/III colon cancer to either FOLFOX4 or LV5FU2 given as adjuvant therapy.
- Both regimens were given every 2 weeks for 6 cycles.
- 40% of patients were stage II and 60% of patients were stage III.
- Primary endpoint was disease free survival.
- Median follow-up was 56.2 months, and all patients had minimum follow-up of 4 years.
- The FOLFOX4 arm had improved disease free survival compared to the LV5FU2 arm at 4 years median follow-up (hazard ratio 0.77, p<0.001).
- This improvement held up for both stage II patients (hazard ratio 0.82) and stage III patients (hazard ratio 0.75)
- Grade 3 or 4 neutropenia was seen in 41% of the FOLFOX4 patients, and 4.7% of the LV5FU2 patients.
- 12.4% of the FOLFOX4 patients developed grade III neurotoxicity, although it resolved completely in 80% of these patients.
- There was no significant difference in overall survival between the two arms (84.9% FOLFOX4 arm vs. 82.8% LV5FU2 arm).
- The disease free survival benefit seen after 4 years of median follow-up was amplified and confirmed with this data.
- Follow-up is ongoing, and a statistically significant difference in overall survival may eventually be realized.
- Late recovery from sensory neuropathy is present and common.