Adjuvant therapy in rectal cancer: Analysis of stage, sex, and local control - Final report of Intergroup 0114

J. E. Tepper*, M. O'Connell, D. Niedzwiecki, D. R. Hollis, A. B. Benson, B. Cummings, L. L. Gunderson, J. S. Macdonald, J. A. Martenson, R. J. Mayer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

279 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1744-1750
Number of pages7
JournalJournal of Clinical Oncology
Issue number7
StatePublished - Apr 1 2002

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


Dive into the research topics of 'Adjuvant therapy in rectal cancer: Analysis of stage, sex, and local control - Final report of Intergroup 0114'. Together they form a unique fingerprint.

Cite this