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Originally published as JCO Early Release 10.1200/JCO.2008.19.6857 on January 12 2009 © 2009 American Society of Clinical Oncology. US Intergroup Anal Carcinoma Trial: Tumor Diameter Predicts for ColostomyFrom The University of Texas M. D. Anderson Cancer Center, Houston, TX; Radiation Therapy Oncology Group, Philadelphia, PA; Mayo Clinic, Scottsdale, AZ; Northwestern University, Chicago, IL; University of Oregon, Portland, OR; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; University of Virginia, Charlottesville, VA; Duke University, Durham, NC; and Cross Cancer Institute, Edmonton, Alberta, Canada. Corresponding author: Jaffer A. Ajani, MD, Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Mail Stop 426, Houston, TX 77030-4009; e-mail: jajani{at}mdanderson.org. Purpose The US Gastrointestinal Intergroup Radiation Therapy Oncology Group 98-11 anal carcinoma trial showed that cisplatin-based concurrent chemoradiotherapy resulted in a significantly higher rate of colostomy compared with mitomycin-based therapy. Established prognostic variables for patients with anal carcinoma include tumor diameter, clinical nodal status, and sex, but pretreatment variables that would predict the likelihood of colostomy are unknown. Methods A secondary analysis was performed by combining patients in the two treatment arms to evaluate whether new predictive and prognostic variables would emerge. Univariate and multivariate analyses were carried out to correlate overall survival (OS), disease-free survival, and time to colostomy (TTC) with pretreatment and treatment variables.
Results Of 682 patients enrolled, 644 patients were assessable and analyzed. In the multivariate analysis, tumor-related prognosticators for poorer OS included node-positive cancer (P Conclusion The combined analysis of the two arms of RTOG 98-11, representing the largest prospective database, reveals that tumor diameter (irrespective of the nodal status) is the only independent pretreatment variable that predicts TTC and 5-year colostomy rate in patients with anal carcinoma. Supported by Grants No. Radiation Therapy Oncology Group U10 CA21661, Community Clinical Oncology Program U10 CA37422, and Stat U10 CA32115 from the National Cancer Institute, Bethesda, MD. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. Clinical Trials repository link available on JCO.org.
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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.0001), large (> 5 cm) tumor diameter (P = .01), and male sex (P = .016). In the treatment-related categories, cisplatin-based therapy was statistically significantly associated with a higher rate of colostomy (P = .03) than was mitomycin-based therapy. In the pretreatment variables category, only large tumor diameter independently predicted for TTC (P = .008). Similarly, the cumulative 5-year colostomy rate was statistically significantly higher for large tumor diameter than for small tumor diameter (Gray's test; P = .0074). Clinical nodal status and sex were not predictive of TTC. 
