A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08
Carolyn Vachani, RN, MSN, AOCN
Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 8, 2009
Title: A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08
Reviewer: Geoffrey Geiger MD
Presenter: N. Wolmark, G. Yothers, M. J. O'Connell, S. Sharif, J. N. Atkins, T. E. Seay, L. Feherenbacher, S. O'Reilly, C. J. Allegra
Affiliation: NSABP Pittsburg, PA
Bevacizumab is a monoclonal antibody that inhibits tumor angiogenesis (the development of a blood supply to the tumor). It has shown a survival benefit when added to standard chemotherapy for metastatic colorectal cancer. This led investigators to apply bevacizumab to stage III and selected stage II treatments. Early studies determined that the combination of bevacizumab to standard treatments did not increase side effects and was safe. This particular study compared modified FOLFOX6 therapy to modified FOLFOX6 + Bevicizumab.
A total of 2,672 patients with stage II (24.9%) and III (75.1%) colon cancer were enrolled. Patients were randomized to receive either mFF6 (oxaliplatin 85 mg/m2 IV day 1, leucovorin 400 mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, and 5-FU 2400 mg/m2 delivered via continuous infusion (CI) over 46 hrs (days 1 and 2) every 14 days for a total of 12 cycles) or mFF6+B (same mFF6 regimen plus bevacizumab 5 mg/kg IV every 2 wks for 1 year).
There was no statistically significant difference in disease free survival (DFS) between the groups at three years follow up, nor did the stage make a difference in DFS. In this study, bevacizumab was given for 1 year. The authors suggest that longer duration of therapy may produce a benefit, but this agent is extremely costly, and the cumulative effect of this drug is not yet known.
Also see Interpreting a Cancer Research Study