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- Title
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.
- Authors
Wolmark, Norman; Wieand, H. Samuel; Wolmark, N; Wieand, H S; Hyams, D M; Colangelo, L; Dimitrov, N V; Romond, E H; Wexler, M; Prager, D; Cruz, A B Jr; Gordon, P H; Petrelli, N J; Deutsch, M; Mamounas, E; Wickerham, D L; Fisher, E R; Rockette, H; Fisher, B
- Abstract
<bold>Background: </bold>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.<bold>Patients and Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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.
- Subjects
RECTAL cancer; DRUG therapy; RADIOTHERAPY; ADJUVANT treatment of cancer; FOLINIC acid; THERAPEUTIC use of antimetabolites; ANTIMETABOLITES; ANTINEOPLASTIC agents; CLINICAL trials; COMBINED modality therapy; COMPARATIVE studies; DRUG administration; FLUOROURACIL; RESEARCH methodology; MEDICAL cooperation; PROGNOSIS; RECTUM tumors; RESEARCH; RESEARCH funding; SEX distribution; SURVIVAL analysis (Biometry); TIME; TUMOR classification; VINCRISTINE; EVALUATION research; RANDOMIZED controlled trials; THERAPEUTICS
- Publication
JNCI: Journal of the National Cancer Institute, 2000, Vol 92, Issue 5, p388
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/92.5.388