LISBON, Portugal--Although folinic acid and interferon have been shown to heighten the efficacy of 5-fluorouracil (5-FU) in colorectal cancer, the ability of these biochemical modulators to prolong survival is less certain. Now a prospective randomized trial conducted in Germany has revealed that patients with advanced, symptomatic colorectal cancer who are treated with 5-FU and folinic acid live longer and have a better quality of life than do those who receive 5-FU and interferon.
LISBON, Portugal--Although folinic acid and interferon have beenshown to heighten the efficacy of 5-fluorouracil (5-FU) in colorectalcancer, the ability of these biochemical modulators to prolongsurvival is less certain. Now a prospective randomized trial conductedin Germany has revealed that patients with advanced, symptomaticcolorectal cancer who are treated with 5-FU and folinic acid livelonger and have a better quality of life than do those who receive5-FU and interferon.
The 142 patients enrolled in this multicenter study underwentchemotherapy with 5-FU, 600 mg/m², given weekly as a 2-hourIV infusion, plus either folinic acid, 200 mg/m² as a bolus,or interferon alfa-2b (Intron A), 5 million units three timesa week.
In his presentation at the congress of the European Society ofMedical Oncology, Prof. Dr. med. Ernst D. Kreuser, of UniversityMedical Center Benjamin Franklin, Berlin, said that although responserates did not differ significantly between the two treatment arms,patients in the folinic acid group showed a significantly longermedian survival (308 days) than did their interferon-treated counterparts(189 days). "Toxicity of 5-FU was very low, thanks to the2-hour infusion, with 5% to 10% of patients experiencing gastrointestinaltoxicity," Dr. Kreuser noted. "However, flu-like symptomsoccurred in 60% of patients treated with interferon."
The German investigators used the new quality of life instrumentfrom the EORTC, QLQ-C 30, along with a supplementary module featuringquestions specific for colon cancer, to assess physical, role,cognitive, emotional, and social functioning; pain, fatigue, nauseaand vomiting; and global health and global quality of life.
Patients treated with interferon reported progressive increasesin somatic symptoms and a significantly worse quality of lifethan did subjects in the folinic acid group. "Toxicity datado not precisely reflect quality of life," Dr. Kreuser pointedout.
In a multivariate analysis, increased alkaline phosphatase levelsand situation of the tumor in the colon compared to the rectumemerged as the only significant harbingers of a poor prognosisin this study. "These two prognostic factors should be appliedin future clinical trials," he said.