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Volume 328:1365-1371 May 13, 1993 Number 19 Next

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ABSTRACT

Background Although tests for occult blood in the feces are widely used to screen for colorectal cancers, there is no conclusive evidence that they reduce mortality from this cause. We evaluated a fecal occult-blood test in a randomized trial and documented its effectiveness.

Methods We randomly assigned 46,551 participants 50 to 80 years of age to screening for colorectal cancer once a year, to screening every two years, or to a control group. Participants who were screened submitted six guaiac-impregnated paper slides with two smears from each of three consecutive stools. About 83 percent of the slides were rehydrated. Participants who tested positive underwent a diagnostic evaluation that included colonoscopy. Vital status was ascertained for all participants over 13 years of follow-up. A committee determined causes of death. A single pathologist determined the stage of cancer for each tissue specimen. Differences in mortality from colorectal cancer, the primary study end point, were monitored with the sequential log-rank statistic.

Results The 13-year cumulative mortality per 1000 from colorectal cancer was 5.88 in the annually screened group (95 percent confidence interval, 4.61 to 7.15), 8.33 in the biennially screened group (95 percent confidence interval, 6.82 to 9.84), and 8.83 in the control group (95 percent confidence interval, 7.26 to 10.40). The rate in the annually screened group, but not in the biennially screened group, was significantly lower than that in the control group. Reduced mortality in the annually screened group was accompanied by improved survival in those with colorectal cancer and a shift to detection at an earlier stage of cancer.

Conclusions Annual fecal occult-blood testing with rehydration of the samples decreased the 13-year cumulative mortality from colorectal cancer by 33 percent.

Source Information

From the Divisions of Environmental and Occupational Health (J.S.M., T.R.C.), Epidemiology (L.M.S.), and Biostatistics (F.E.), the School of Public Health; and the Departments of Medicine (J.H.B.) and Laboratory Medicine and Pathology (D.C.S., G.M.B.), the School of Medicine -- all at the University of Minnesota, Minneapolis; and the Emmes Corporation, Potomac, Md. (F.E.). The following persons participated in the study: V. Gilbertsen (deceased), R. McHugh, G. Johnson, G. Watt, M. Geisser, D. Engelhard, S. Williams, and D. Stewart (deceased); Deaths Review Committee -- S. Ewing, D. Plimpton, A. Theologides, and L. Weiland; Policy and Data Monitoring Group -- T. Chalmers, G. Hutchinson, R. Mayer, A.B. Miller, S. Shapiro, W. Taylor, and B. Tilley; National Cancer Institute -- S. Taube, P. Prorok, and I. Masnyk.

Address reprint requests to Dr. Mandel at the Division of Environmental and Occupational Health, School of Public Health, University of Minnesota, Box 807 UMHC, 420 Delaware St., S.E., Minneapolis, MN 55455.

Full Text of this Article

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Allison J. E., Tekawa I. S., Ransom L. J., Adrain A. L., Ransohoff D. F., Lang C. A.
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