Tumor Microsatellite-Instability Status as a Predictor of Benefit from Fluorouracil-Based Adjuvant Chemotherapy for Colon Cancer
Christine M. Ribic, M.Sc., Daniel J. Sargent, Ph.D., Malcolm J. Moore, M.D., Stephen N. Thibodeau, Ph.D., Amy J. French, B.A., Richard M. Goldberg, M.D., Stanley R. Hamilton, M.D., Pierre Laurent-Puig, M.D., Ph.D., Robert Gryfe, M.D., Ph.D., Lois E. Shepherd, M.D., Dongsheng Tu, Ph.D., Mark Redston, M.D., and Steven Gallinger, M.D.
Background Colon cancers with high-frequency microsatelliteinstability have clinical and pathological features that distinguishthem from microsatellite-stable tumors. We investigated theusefulness of microsatellite-instability status as a predictorof the benefit of adjuvant chemotherapy with fluorouracil instage II and stage III colon cancer.
Methods Tumor specimens were collected from patients with coloncancer who were enrolled in randomized trials of fluorouracil-basedadjuvant chemotherapy. Microsatellite instability was assessedwith the use of mononucleotide and dinucleotide markers.
Results Of 570 tissue specimens, 95 (16.7 percent) exhibitedhigh-frequency microsatellite instability. Among 287 patientswho did not receive adjuvant therapy, those with tumors displayinghigh-frequency microsatellite instability had a better five-yearrate of overall survival than patients with tumors exhibitingmicrosatellite stability or low-frequency instability (hazardratio for death, 0.31 [95 percent confidence interval, 0.14to 0.72]; P=0.004). Among patients who received adjuvant chemotherapy,high-frequency microsatellite instability was not correlatedwith increased overall survival (hazard ratio for death, 1.07[95 percent confidence interval, 0.62 to 1.86]; P=0.80). Thebenefit of treatment differed significantly according to themicrosatellite-instability status (P=0.01). Adjuvant chemotherapyimproved overall survival among patients with microsatellite-stabletumors or tumors exhibiting low-frequency microsatellite instability,according to a multivariate analysis adjusted for stage andgrade (hazard ratio for death, 0.72 [95 percent confidence interval,0.53 to 0.99]; P=0.04). By contrast, there was no benefit ofadjuvant chemotherapy in the group with high-frequency microsatelliteinstability.
Conclusions Fluorouracil-based adjuvant chemotherapy benefitedpatients with stage II or stage III colon cancer with microsatellite-stabletumors or tumors exhibiting low-frequency microsatellite instabilitybut not those with tumors exhibiting high-frequency microsatelliteinstability.
Source Information
From the Centre for Cancer Genetics, Samuel Lunenfeld Research Institute (C.M.R., R.G., S.G.), the Department of Medicine and Surgery, Princess Margaret Hospital (M.J.M., S.G.), and the Department of Surgery, Mount Sinai Hospital (R.G., S.G.), University of Toronto, Toronto; the Division of Biostatistics (D.J.S.), the Division of Medical Oncology (R.M.G.), and the Department of Laboratory Medicine and Pathology (S.N.T., A.J.F.), Mayo Foundation, Rochester, Minn.; the Clinical Trials Group, National Cancer Institute of Canada, Queen's University, Kingston, Ont. (M.J.M., L.E.S., D.T., S.G.); the Eastern Cooperative Oncology Group, Brookline, Mass. (S.R.H.); the M.D. Anderson Cancer Center, Houston (S.R.H.); the Fédération Francophone de Cancérologie Digestive, Paris (P.L.-P.); and Brigham and Women's Hospital, Boston (M.R.).
Address reprint requests to Dr. Gallinger at Mount Sinai Hospital, 600 University Ave., Suite 1225, Toronto, ON M5G 1X5, Canada, or at sgallinger{at}mtsinai.on.ca.
Microsatellite Instability in Colon Cancer
Allegra C. J., Kim G., Kirsch I. R., Iacopetta B., Elsaleh H., Zeps N., Jimenez J. J., Blanes A., Diaz-Cano S. J., Gryfe R., Ribic C. M., Sargent D. J.
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N Engl J Med 2003;
349:1774-1776, Oct 30, 2003.
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