Last Updated: January 19, 2006
NEW YORK (Reuters Health) - Adjuvant chemotherapy regimens involving
fluorouracil in combination with leucovorin, with or without
levamisole, appear to achieve similar survival in patients with high-
risk colon cancer, according to long-term findings from a randomized
trial.
In the December issue of the Journal of Clinical Oncology, Dr. Daniel
G. Haller of the University of Pennsylvania, Philadelphia and
colleagues note that the study, begun in 1988, involves the single
largest population of patients with high-risk colon cancer.
Following surgery, almost 3800 patients were randomized to
fluorouracil in combination with high or low-dose leucovorin or low-
dose leucovorin along with levamisole for up to 32 weeks. Controls
were given fluorouracil with levamisole for 1 year.
After a median follow-up of 10 years, 47% of patients had died. Of
these, 13% died without evidence of recurrence. Some 37% experienced
recurrence and 10% of these patients are still alive. Overall, 48% of
patients were alive and disease free.
The researchers observe that interim analyses suggested survival
advantages with certain regimens. This is no longer the case and
there are no significant differences apparent among treatments. The
researchers also note that hospital volume was not associated with
survival as has been documented in other studies.
Finally, they conclude that although therapy containing leucovorin
and levamisole was significantly more toxic than that containing
leucovorin without levamisole, there were no significant differences
across groups in deaths potentially attributable to treatment.