5-fluorouracil and high dose folinic acid in symptomatic advanced colorectal carcinoma: importance of symptomatic relief

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Abstract
Between August 1986 and February 1987, 17 consecutive patients with symptomatic unresectable local or metastatic colorectal carcinoma were admitted to a pilot study designed to evaluate the toxicity and possible benefit, especially in terms of symptomatic relief, of 5-fluorouracil (5-FU) combined with high dose folinic acid (HDF). 5-FU 600mg/m2 IV push and HDF 500mg/m2 by a two-hour infusion were administered ambulatorily. Treatment was given once per week for six consecutive weeks. Cycles were repeated after a two-week rest period. Twelve of the patients (75%) were previously treated with 5-FU. Pain, anorexia and malaise were the most common complaints and 61 % of patients had multiple symptoms. Nine of the 16 patients evaluable for subjective response (60%) achieved marked relief of symptoms of three to ten months' duration. In all these patients improvement in performance status was recorded. Among the 14 patients evaluable for objective response, complete regression of the disease was observed in one patient and minimal regression (less than 50%) in three patients; the duration of response ranged between four and eight months. Side effects were mild and the treatment was well tolerated, with the exception of two patients who developed diarrhoea requiring the discontinuation of treatment. Our results suggest that the 5-FU and HDF regimen used in this study has a significant palliative value in symptomatic patients with advanced colorectal cancer.