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Adding oxaliplatin to FULV improved survival in colon cancer
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CHICAGO — The addition of oxaliplatin to weekly FULV in patients with stage II or III colon cancer resulted in a trend toward improved survival at 67 months, according to new data presented at the 2008 ASCO Annual Meeting.
“We see that the advantages that we reported at 34 months follow-up relative to disease-free survival are very much apparent, robust and durable,” said Norman Wolmark, MD, chairman and principal investigator of the National Surgical Adjuvant Breast and Bowel Project, during his presentation on May 31.
The NSABP Protocol C-07 trial researchers randomly assigned patients to weekly FULV (n=1,209) or to FULV plus oxaliplatin (Eloxatin, Sanofi Aventis), which they called FLOX (n=1,200). The primary endpoint of the trial was disease-free survival. The median follow-up time for patients was 67 months.
A prior protocol, Protocol C-04, had estimated that there would be about 700 deaths at the five-year interval, but only 560 occurred. At three years, the data indicated an absolute advantage of 4.6% in favor of oxaliplatin, which increased to 5.2% at the five-year mark: a 19% overall risk reduction.
For overall survival, the hazard ratio of FLOX compared with FULV was 0.85 (95% CI, 0.72-1.01).
There were 42 fewer deaths in the oxaliplatin arm compared with the control arm. Five-year point estimates showed a 2% absolute prolongation of survival in favor of oxaliplatin. Survival increased to 4.2% at six years (P=.06).
“It is remarkable how similar the data are relative to survival between C-07 and the MOSIAC trial data,” Wolmark said. “Five-year survival is 80.3% for C-07 and is 81.3% for MOSIAC. Both trials have a hazard ratio of 0.85, both with a P value of .06.”
The oxaliplatin arm had shorter median time between recurrence and death compared with the FULV arm (17.6 months vs. 22.2 months; P=.02). The hazard ratio was 1.24 (P=.02).
The researchers concluded that the benefit of oxaliplatin is independent of the schedule of FULV administration and that the durable consistency between the results of C-07 and MOSAIC validates the benefit of oxaliplatin. Longer follow-up is needed to reliably detect the survival benefit.
Wolmark N. #LBA4005.
FULV and oxaliplatin should be the standard of care for stage III patients. You should consider it for stage II patients with high-risk factures, but not for those who have standard risk stage II.
— Richard M. Goldberg, MD
University of North Carolina