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Adjuvant Therapy in Rectal Cancer: Analysis of Stage, Sex, and Local Control—Final Report of Intergroup 0114

From the Department of Radiation Oncology, University of North Carolina, Chapel Hill, and Cancer and Leukemia Group B Statistical Office, Duke University Medical Center, Durham, NC; Mayo Clinic Cancer Center, Rochester, MN; Division of Hematology Oncology, Northwestern University, Chicago, IL; Department of Radiation Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada; Radiation Oncology, Mayo Clinic, Scottsdale, AZ; Gastrointestinal Oncology Service, St Vincent’s CCC, New York, NY; and Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, MA.

Address reprint requests to Joel E. Tepper, MD, Department of Radiation Oncology, Campus Box #7512, University of North Carolina, Chapel Hill, NC 27599-7512; email: tepper{at}radonc.unc.edu

PURPOSE: The gastrointestinal Intergroup studied postoperative adjuvant chemotherapy and radiation therapy in patients with T3/4 and N+ rectal cancer after potentially curative surgery to try to improve chemotherapy and to determine the risk of systemic and local failure.

PATIENTS AND METHODS: All patients had a potentially curative surgical resection and were treated with two cycles of chemotherapy followed by chemoradiation therapy and two additional cycles of chemotherapy. Chemotherapy regimens were bolus fluorouracil (5-FU), 5-FU and leucovorin, 5-FU and levamisole, and 5-FU, leucovorin, and levamisole. Pelvic irradiation was given to a dose of 45 Gy to the whole pelvis and a boost to 50.4 to 54 Gy.

RESULTS: One thousand six hundred ninety-five patients were entered and fully assessable, with a median follow-up of 7.4 years. There was no difference in overall survival (OS) or disease-free survival (DFS) by drug regimen. DFS and OS decreased between years 5 and 7 (from 54% to 50% and 64% to 56%, respectively), although recurrence-free rates had only a small decrease. The local recurrence rate was 14% (9% in low-risk [T1 to N2+] and 18% in high-risk patients [T3N+, T4N]). Overall, 7-year survival rates were 70% and 45% for the low-risk and high-risk groups, respectively. Males had a poorer overall survival rate than females.

CONCLUSION: There is no advantage to leucovorin- or levamisole-containing regimens over bolus 5-FU alone in the adjuvant treatment of rectal cancer when combined with irradiation. Local and distant recurrence rates are still high, especially in T3N+ and T4 patients, even with full adjuvant chemoradiation therapy.

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