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Original Article
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Volume 345:1091-1097 October 11, 2001 Number 15
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A Pooled Analysis of Adjuvant Chemotherapy for Resected Colon Cancer in Elderly Patients
Daniel J. Sargent, Ph.D., Richard M. Goldberg, M.D., Stacy D. Jacobson, M.D., John S. Macdonald, M.D., Roberto Labianca, M.D., Daniel G. Haller, M.D., Lois E. Shepherd, M.D., Jean François Seitz, M.D., and Guido Francini, M.D.

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 by Muss, H. B.

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ABSTRACT

Background Adjuvant chemotherapy is standard treatment for patients with resected colon cancer who are at high risk for recurrence, but the efficacy and toxicity of such treatment in patients more than 70 years of age are controversial.

Methods We performed a pooled analysis, based on the intention to treat, of individual patient data from seven phase 3 randomized trials (involving 3351 patients) in which the effects of postoperative fluorouracil plus leucovorin (five trials) or fluorouracil plus levamisole (two trials) were compared with the effects of surgery alone in patients with stage II or III colon cancer. The patients were grouped into four age categories of equal size, and analyses were repeated with 10-year age ranges (<=50, 51 to 60, 61 to 70, and >70 years), with the same conclusions. The toxic effects measured in all trials were nausea or vomiting, diarrhea, stomatitis, and leukopenia. Patients in the fluorouracil-plus-leucovorin and fluorouracil-plus-levamisole groups were combined for the efficacy analysis but kept separate for toxicity analyses.

Results Adjuvant treatment had a significant positive effect on both overall survival and time to tumor recurrence (P<0.001 for each, with hazard ratios of death and recurrence of 0.76 [95 percent confidence interval, 0.68 to 0.85] and 0.68 [95 percent confidence interval, 0.60 to 0.76], respectively). The five-year overall survival was 71 percent for those who received adjuvant therapy, as compared with 64 percent for those untreated. No significant interaction was observed between age and the efficacy of treatment. The incidence of toxic effects was not increased among the elderly (age >70 years), except for leukopenia in one study.

Conclusions Selected elderly patients with colon cancer can receive the same benefit from fluorouracil-based adjuvant therapy as their younger counterparts, without a significant increase in toxic effects.


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From the Mayo Clinic, Rochester, Minn. (D.J.S., R.M.G., S.D.J.); St. Vincent Comprehensive Cancer Center, New York (J.S.M.); Ospedali Riunit, Bergamo, Italy (R.L.); the University of Pennsylvania Cancer Center, Philadelphia (D.G.H.); the National Cancer Institute of Canada, Queens University, Kingston, Ont. (L.E.S.); the University of the Mediterranean, Marseilles, France (J.F.S.); and the University of Siena, Siena, Italy (G.F.).

Address reprint requests to Dr. Sargent at the Mayo Clinic, 200 First St. SW, Rochester, MN 55905.

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