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JNCI Journal of the National Cancer Institute 2000 92(5):388-396; doi:10.1093/jnci/92.5.388
© 2000 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 92, No. 5, 388-396, March 1, 2000
© 2000 Oxford University Press

Randomized Trial of Postoperative Adjuvant Chemotherapy With or Without Radiotherapy for Carcinoma of the Rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02

Norman Wolmark, H. Samuel Wieand, David M. Hyams, Linda Colangelo, Nikolay V. Dimitrov, Edward H. Romond, Marvin Wexler, David Prager, Anatolio B. Cruz, Jr., Philip H. Gordon, Nicholas J. Petrelli, Melvin Deutsch, Eleftherios Mamounas, D. Lawrence Wickerham, Edwin R. Fisher, Howard Rockette, Bernard Fisher

Affiliations of authors: N. Wolmark, D. L.Wickerham, E. R. Fisher, B. Fisher, National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations Center, Pittsburgh, PA; H. S. Wieand, L. Colangelo, NSABP Biostatistical Center, Pittsburgh; D. M. Hyams, Desert Hospital Comprehensive Cancer Center, Palm Springs, CA; N. V. Dimitrov, Michigan State University, East Lansing; E. H. Romond, University of Kentucky, Lexington; M. Wexler, Royal Victoria Hospital, Montreal, ON, Canada; D. Prager, Lehigh Valley Medical Center, Allentown, PA; A. B. Cruz, Jr., The University of Texas, San Antonio; P. H. Gordon, Sir Mortimer B. Davis Jewish General Hospital, Montreal; N. J. Petrelli, Roswell Park Cancer Institute, Buffalo, NY; M. Deutsch, H. Rockette, University of Pittsburgh; E. Mamounas, Mt. Sinai Center for Breast Health, Cleveland, OH.

Correspondence to: Norman Wolmark, M.D., National Surgical Adjuvant Breast and Bowel Project, East Commons Professional Bldg., 5th Floor, Pittsburgh, PA 15212.

BACKGROUND: The conviction that postoperative radiotherapy and chemotherapy represent an acceptable standard of care for patients with Dukes' B (stage II) and Dukes' C (stage III) carcinoma of the rectum evolved in the absence of data from clinical trials designed to determine whether the addition of radiotherapy results in improved disease-free survival and overall survival. This study was carried out to address this issue. An additional aim was to determine whether leucovorin (LV)-modulated 5-fluorouracil (5-FU) is superior to the combination of 5-FU, semustine, and vincristine (MOF) in men. PATIENTS AND METHODS: Eligible patients (n = 694) with Dukes' B or C carcinoma of the rectum were enrolled in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol R-02 from September 1987 through December 1992 and were followed. They were randomly assigned to receive either postoperative adjuvant chemotherapy alone (n = 348) or chemotherapy with postoperative radiotherapy (n = 346). All female patients (n = 287) received 5-FU plus LV chemotherapy; male patients received either MOF (n = 207) or 5-FU plus LV (n = 200). Primary analyses were carried out by use of a stratified log-rank statistic; P values are two-sided. RESULTS: The average time on study for surviving patients is 93 months as of September 30, 1998. Postoperative radiotherapy resulted in no beneficial effect on disease-free survival (P = .90) or overall survival (P = .89), regardless of which chemotherapy was utilized, although it reduced the cumulative incidence of locoregional relapse from 13% to 8% at 5-year follow-up (P = .02). Male patients who received 5-FU plus LV demonstrated a statistically significant benefit in disease-free survival at 5 years compared with those who received MOF (55% versus 47%; P = .009) but not in 5-year overall survival (65% versus 62%; P = .17). CONCLUSIONS: The addition of postoperative radiation therapy to chemotherapy in Dukes' B and C rectal cancer did not alter the subsequent incidence of distant disease, although there was a reduction in locoregional relapse when compared with chemotherapy alone.


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