Study terminated early due to superior results seen with GOLFIG regimen in colorectal cancer patients
Wednesday, April 6, 2011 (Last Updated: 04/08/2011)
WEDNESDAY, April 6 (HealthDay News) -- The addition of gemcitabine to a regimen of FOLFOX followed by granulocyte-macrophage colony stimulating factor and low-dose aldesleukine (GOLFIG) appears to improve progression-free survival in patients with metastatic colorectal cancer, according to research presented at the annual meeting of the American Association for Cancer Research, held April 2 to 6 in Orlando, Fla.
In a multi-center open-label, phase III study, Pierpaolo Correale, M.D., Ph.D., of the Siena University School of Medicine in Italy, and colleagues randomized 130 patients to receive GOLFIG or FOLFOX for a maximum of 12 cycles and then receive maintenance treatment until the disease progressed.
Although the study was originally designed to follow patients until death, the investigators ended it early due to significantly better results associated with the GOLFIG regimen. Progression-free survival was 16.5 months among patients who received GOLFIG compared to 7.5 months among those who received FOLFOX.
"Based on our experience and results to date, we believe that the GOLFIG regimen is superior to FOLFOX chemotherapy in terms of efficacy and comparable in terms of toxicity and cost," Correale said in a statement. "We were very surprised to find such a significant difference in terms of overall survival with this low number of patients."
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