ADVANCED COLORECTAL-CANCER IN THE ELDERLY - RESULTS OF CONSECUTIVE TRIALS WITH 5-FLUOROURACIL-BASED CHEMOTHERAPY

To evaluate toxicity and efficacy of chemotherapy in elderly patients (greater than or equal to 65 years of age) with advanced colorectal ca ncer? data from two consecutive trials conducted between 1984 and 1995 at the National Institute for Cancer Research were analysed comparing the results of treatment in those 65 years of age or older and in tho se younger than 65 years. Of 215 patients recruited, 82 elderly patien ts (median age 70 years, median performance status 1) received one of the following regimens based on 5-fluorouracil (5-FU): (1) weekly 5-FU 600 mg/m(2) i.v. bolus (30 patients); (2) weekly 5-FU 600 mg/m(2) bol us plus leucovorin (LV) 500 mg/m(2) 2-h i.v. infusion (28 patients); ( 3) Weekly 5-FU 2600 mg/m(2) 24-h continuous i.v. infusion plus LV 100 mg 4-h i.v. infusion and 50 mg orally every 4 h for five doses (24 pat ients). Overall, 1071 chemotherapy cycles were administered with a med ian number of 12 courses per patient. The main side effects were diarr hoea, observed in 35% of patients, stomatitis in 24% of patients and h and-foot syndrome in 13% of patients, and haematological toxicity affe cted only 15% of patients. No patient suffered grade IV toxicity. In t hree patients chemotherapy was discontinued because of toxicity (two p atients suffered grade III diarrhoea, one patient grade III hand-foot syndrome). No significant difference in toxicity was evident between p atients older than or younger than 65 years. Analysis of median dose i ntensity demonstrated no difference between the two groups. Overall ob jective response was observed in 18% (95% confidence limits 11-29) of elderly patients (15/82) in comparison with 23% (95% CL 17-32) of pati ents < 65 years of age (31/133 pts). In conclusion, chemotherapy in el derly patients with advanced colorectal cancer is a safe and effective treatment with acceptable toxicity and comparable objective response rates.