Postoperative Adjuvant Chemotherapy or Radiation Therapy for Rectal Cancer: Results From NSABP Protocol R-0112 (original) (raw)

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University of Pittsburgh

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University of Pittsburgh

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University of Pittsburgh

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Received:

03 November 1987

Revision received:

24 December 1987

Accepted:

29 December 1987

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Bernard Fisher, Norman Wolmark, Howard Rockette, Carol Redmond, Melvin Deutsch, D. Lawrence Wickerham, Edwin R. Fisher, Richard Caplan, Judith Jones, Harvey Lerner, Philip Gordon, Merrill Feldman, Anatolio Cruz, Sandra Legault-Poisson, Marvin Wexler, Walter Lawrence, Andre Robidoux, Other NSABP Investigators, Postoperative Adjuvant Chemotherapy or Radiation Therapy for Rectal Cancer: Results From NSABP Protocol R-011, JNCI: Journal of the National Cancer Institute, Volume 80, Issue 1, 2 March 1988, Pages 21–29, https://doi.org/10.1093/jnci/80.1.21
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Abstract

Information is presented from 555 patients with Dukes B and C rectal cancers treated by curative resection who were entered into the National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol R-01 between November 1977 and October 1986. Their average time on study was 64.1 months. The patients were randomized to receive no further treatment (184 patients), postoperative adjuvant chemotherapy with 5-fluorouracil, semustine, and vincristine (MOF) (187 patients), or postoperative radiation therapy (184 patients). The chemotherapy group, when compared with the group treated by surgery alone, demonstrated an overall improvement in disease-free survival (P = .006) and in survival (P = .05). Employing the proportional hazards model, a global test was used to determine the presence of treatment interactions. Investigation of stratification variables employed in this study indicated that sex, and to a lesser extent age and Dukes stage, made individual contributions to the disease-free survival and the survival benefit from chemotherapy. When evaluated according to sex, the benefit for chemotherapy at 5 years, both in disease-free survival (29% vs. 47%; P < .001; relative odds, 2.00) and in survival (37% vs. 60%; P = .001; relative odds, 1.93), was restricted to males. When males were tested for age trend with the use of a logistic regression analysis, chemotherapy was found to be more advantageous in younger patients. When the group receiving postoperative radiation (4,600–4,700 rad in 26–27 fractions; 5, 100–5, 300 rad maximum at the perineum) was compared to the group treated only by surgery, there was an overall reduction in local-regional recurrence from 25% to 16% (P = .06). No significant benefit in overall disease-free survival (P = .4) or survival (P =.7) from the use of radiation has been demonstrated. The global test for interaction to identify heterogeneity of response to radiation within subsets of patients was not significant. In conclusion, this investigation has demonstrated a benefit from adjuvant chemotherapy (MOF) for the management of rectal cancer. The observed advantage was restricted to males. Postoperative radiation therapy reduced the incidence of local-regional recurrence, but it failed to affect overall disease-free survival and survival. [J Natl Cancer Inst 1988; 80: 21–29]

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Topic:

• radiation therapy
• fluorouracil
• cancer
• chemotherapy regimen
• adjuvant chemotherapy
• heterogeneity
• immunologic adjuvants
• pharmaceutical adjuvants
• intestines
• anogenital region
• semustine
• surgical procedures, operative
• vincristine
• breast
• rectal carcinoma
• national surgical adjuvant breast and bowel project
• postoperative radiotherapy
• stratification

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