Fluorouracil, Mitomycin, and Radiotherapy vs Fluorouracil, Cisplatin, and Radiotherapy for Carcinoma of the Anal Canal: A Randomized Controlled Trial

摘要: Context Chemoradiation as definitive therapy is the preferred primary for patients with anal canal carcinoma; however, 5-year disease-free survival rate from concurrent fluorouracil/mitomycin and radiation only approximately 65%. Objective To compare efficacy of cisplatin-based (experimental) vs mitomycin-based (standard) in treatment carcinoma. Design, Setting, Participants US Gastrointestinal Intergroup trial RTOG 98-11, a multicenter, phase 3, randomized controlled comparing fluorouracil plus mitomycin radiotherapy cisplatin 682 carcinoma enrolled between October 31, 1998, June 27, 2005. Stratifications included sex, clinical nodal status, tumor diameter. Intervention were randomly assigned to 1 2 intervention groups: (1) group (n = 341), who received (1000 mg/m on days 1-4 29-32) (10 29) (45-59 Gy) or (2) 1-4, 29-32, 57-60, 85-88) (75 1, 29, 57, 85) Gy; start day = day 57). Main Outcome Measures The end point was survival; secondary points overall time relapse. Results A total 644 assessable. median follow-up all 2.51 years. Median age 55 years, 69% women, 27% had diameter greater than 5 cm, 26% clinically positive nodes. 60% (95% confidence interval [CI], 53%-67%) 54% CI, 46%-60%) (P = .17). 75% 67%-81%) 70% 63%-76%) (P = .10). local-regional recurrence distant metastasis rates 25% 20%-30%) 15% 10%-20%), respectively, 33% 27%-40%) 19% 14%-24%), treatment. cumulative colostomy significantly better (10% 19%; P = .02). Severe hematologic toxicity worse (P  Conclusions In this population carcinoma, failed improve disease-free-survival compared therapy, but resulted rate. These findings do not support use place combination Trial Registration clinicaltrials.gov Identifier: NCT00003596