Long-Term Update of US GI Intergroup RTOG 98-11 Phase III Trial for Anal Carcinoma: Survival, Relapse, and Colostomy Failure With Concurrent Chemoradiation Involving Fluorouracil/Mitomycin Versus Fluorouracil/Cisplatin

• DOI: 10.1200/jco.2012.43.8085
• Publication Date: 2012-11-14T01:59:30Z
• Authors: Leonard L. Gunderson; Kathryn A. Winter; Jaffer A. Ajani; John E. Pedersen; Jennifer Moughan; Al B. Benson; Charles R. Thomas; Robert J. Mayer; Michael G. Haddock; Tyvin A. Rich; Christopher G. Wi...
• Keywords: Log-rank test

Purpose On initial publication of GI Intergroup Radiation Therapy Oncology Group (RTOG) 98-11 [A Phase III Randomized Study 5-Fluorouracil (5-FU), Mitomycin, and Radiotherapy Versus 5-Fluorouracil, Cisplatin in Carcinoma the Anal Canal], concurrent chemoradiation (CCR) with fluorouracil (FU) plus mitomycin (MMC) decreased colostomy failure (CF) when compared induction FU cisplatin (CDDP), but did not significantly impact disease-free survival (DFS) or overall (OS) for anal canal carcinoma. The intent updated analysis was to determine long-term treatment on (DFS, OS, colostomy-free [CFS]), CF, relapse (locoregional [LRF], distant metastasis) this patient group. Patients Methods Stratification factors included sex, clinical node status, primary size. DFS OS were estimated univariately by Kaplan-Meier method, arms log-rank test. Time CF cumulative incidence method using Gray's Multivariate analyses used Cox proportional hazard models test differences after adjusting stratification factors. Results Of 682 patients accrued, 649 analyzable outcomes. statistically better RT + FU/MMC versus FU/CDDP (5-year DFS, 67.8% v 57.8%; P = .006; 5-year 78.3% 70.7%; .026). There a trend toward statistical significance CFS (P .05), LRF .087), .074). significant status both tumor diameter sex OS. Conclusion CCR has significant, clinically meaningful FU/CDDP, it borderline CFS, LRF. Therefore, remains preferred standard care.