Concurrent Chemotherapy and Intensity-Modulated Radiation Therapy for Anal Canal Cancer Patients: A Multicenter Experience Joseph K. Salama, Loren K. Mell, David A. Schomas, Robert C. Miller, Kiran Devisetty, Ashesh B. Jani, Arno J. Mundt, John C. Roeske, Stanley L. Liauw, and Steven J. Chmura A B S T R A C T Purpose To report a multicenter experience treating anal canal cancer patients with concurrent chemother- apy and intensity-modulated radiation therapy (IMRT). Patients and Methods From October 2000 to June 2006, 53 patients were treated with concurrent chemotherapy and IMRT for anal squamous cell carcinoma at three tertiary-care academic medical centers. Sixty-two percent were T1-2, and 67% were N0; eight patients were HIV positive. Forty-eight patients received fluorouracil (FU)/mitomycin, one received FU/cisplatin, and four received FU alone. All patients underwent computed tomography– based treatment planning with pelvic regions and inguinal nodes receiving a median of 45 Gy. Primary sites and involved nodes were boosted to a median dose of 51.5 Gy. All acute toxicity was scored according to the Common Terminology Criteria for Adverse Events, version 3.0. All late toxicity was scored using Radiation Therapy Oncology Group criteria. Results Median follow-up was 14.5 months (range, 5.2 to 102.8 months). Acute grade 3+ toxicity included 15.1% GI and 37.7% dermatologic toxicity; all acute grade 4 toxicities were hematologic; and acute grade 4 leukopenia and neutropenia occurred in 30.2% and 34.0% of patients, respectively. Treatment breaks occurred in 41.5% of patients, lasting a median of 4 days. Forty-nine patients (92.5%) had a complete response, one patient had a partial response, and three had stable disease. All HIV-positive patients achieved a complete response. Eighteen-month colostomy-free survival, overall survival, freedom from local failure, and freedom from distant failure were 83.7%, 93.4%, 83.9%, and 92.9%, respectively. Conclusion Preliminary outcomes suggest that concurrent chemotherapy and IMRT for anal canal cancers is effective and tolerated favorably compared with historical standards. J Clin Oncol 25:4581-4586. © 2007 by American Society of Clinical Oncology INTRODUCTION Anal cancer affects 4,010 people each year in the US. 1 Traditionally, patients with anal cancer were managed surgically via an abdominoperineal re- section (APR), with an expected 5-year survival of 55% to 71%. 2-4 Alternatively, patients wishing for an organ-preserving approach were managed with radiotherapy (RT), resulting in 5-year over- all survival (OS) of 59% to 65%. 5,6 Nigro et al pioneered the use of neoadjuvant concomitant fluorouracil (FU), mitomycin (MMC), and RT for anal cancer. 7 Pathologic complete responses (CRs) were found in 23 of 28 patients at the time of surgical resection. 8 Based on these positive re- sults, many institutions enacted protocols to treat anal cancer patients with concurrent FU, MMC, and RT as definitive treatment, reserving APR for incomplete response or disease recurrence. 9,10 A series of randomized trials established con- comitant FU, MMC, and RT as the standard of care for all stages of anal cancer. 11-14 This organ- preservation strategy has resulted in 5-year OS and colostomy-free survival (CFS) rates of 50% to 78% and 61% to 76%, respectively. 11-14 However, this sphincter-preserving approach is toxic; 18% of pa- tients experienced acute grade 4 to 5 hematologic toxicity in the US Intergroup trial. 13 In the United Kingdom Coordinating Committee on Cancer Re- search and European Organisation for Research and From the Department of Radiation and Cellular Oncology, University of Chica- go; Department of Radiation Oncology, University of Illinois at Chicago; Univer- sity of Chicago Cancer Research Center, Chicago, IL; Department of Radiation Oncology, Mayo Clinic, Roch- ester, MN; Department of Radiation Oncology, University of California, San Diego, La Jolla, CA; and the Depart- ment of Radiation Oncology, Emory University, Atlanta, GA. Submitted April 12, 2007; accepted July 20, 2007. Supported by the University of Chicago Cancer Research Center. Authors’ disclosures of potential con- flicts of interest and author contribu- tions are found at the end of this article. Address reprint requests to Joseph K. Salama, MD, Department of Radiation and Cellular Oncology, University of Chicago, 5758 S Maryland Ave, MC 9006, Chicago, IL 60637; e-mail: jsalama@radonc.uchicago.edu. © 2007 by American Society of Clinical Oncology 0732-183X/07/2529-4581/$20.00 DOI: 10.1200/JCO.2007.12.0170 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 25  NUMBER 29  OCTOBER 10 2007 4581 Downloaded from jco.ascopubs.org on September 28, 2016. For personal use only. No other uses without permission. Copyright © 2007 American Society of Clinical Oncology. All rights reserved. Downloaded from jco.ascopubs.org on September 28, 2016. For personal use only. No other uses without permission. Copyright © 2007 American Society of Clinical Oncology. All rights reserved. Downloaded from jco.ascopubs.org on September 28, 2016. For personal use only. No other uses without permission. Copyright © 2007 American Society of Clinical Oncology. All rights reserved.