* Phase I/II Clinical Trials INITIAL RESULTS OF A PHASE II TRIAL OF HIGH DOSE RADIATION THERAPY, 5FLUOROURACIL, AND CISPLATIN FOR PATIENTS WITH ANAL CANCER (E4292): AN EASTERN COOPERATIVE ONCOLOGY GROUP STUDY

Purpose: A prospective clinical trial was performed to assess the response and toxicity associated with the use of h-e radiation therapy, 5fluorouraci1, and cisplatin in patients with anal cancer. Methods and Materials: Patients with anal cancer without distant metastasis were eligible for this study. Radiation therapy consisted of 59.4 Gy in 33 fractions; a 2 week break in treatment was taken after 36 Gy had been given. A treatment of Huorouracil, 1,000 mg/m’ per day intravenously, was given for the first 4 days of radiation therapy, and cisplatin, 75 mg/m’ intravenously, was given on day 1 of radiation therapy. A second course of 5 fluorouracil and cisplatin was given after 36 Gy of radiation, when the radiation therapy was resumed. Results: Nineteen patients entered thii study and received treatment. Thirteen (68%) had a complete response, 5 (26%) had a partial response, and 1 (5%) had stable disease. The patient with stable disease and one of the patients with a partial response had complete disappearance of tumor more than 8 weeks after completion of radiation therapy. Fiien patients had toxicity of Grade 3 or higher: the worst toxicity was Grade 3 in eight patients, Grade 4 in six patients, and Grade 5 in one patient. The most common form of toxicity of Grade 3 or higher was hematologlc. The one lethal toxicity was due to pseudomembranous colitis, which was a complication of antibiotic therapy for a urinary tract infection. Condusion: Radiation therapy, cisplatin, and 5-fluorouracil resulted in an overall response rate of 95%. Signlficant toxicity occurred, an indication that this regimen is near the maximal tolerated dose. A Phase lI1 clinical trial is planned in which radiation therapy, cisplatin, and 5-fluorouracil will be used as an experimental arm. Anal cancer, Cisplatin, 5-Fluorouracil, Radiation therapy, Sphincter preservation.