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Pooled Analysis of Fluorouracil-Based Adjuvant Therapy for Stage II and III Colon Cancer: Who Benefits and by How Much?

Gill, Sharlene, Loprinzi, Charles L., Sargent, Daniel J., Thomé, Stephan D., Alberts, Steven R., Haller, Daniel G., Benedetti, Jacqueline, Francini, Guido, Shepherd, Lois E., Francois Seitz, Jean, Labianca, Roberto, Chen, Wei, Cha, Stephen S., Heldebrant, Michael P., Goldberg, Richard M.·2004·Journal of Clinical Oncology

Abstract

Purpose: Although it is well-established that fluorouracil- (FU-) based adjuvant therapy improves survival for patients with resected high-risk colon cancer, the magnitude of adjuvant therapy benefit across specific subgroups and for individual patients has been uncertain. Patients and Methods: Using a pooled data set of 3,302 patients with stage II and III colon cancer from seven randomized trials comparing FU + leucovorin or FU + levamisole to surgery alone, we performed an analysis based on a Cox proportional hazards regression model. Treatment, age, sex, tumor location, T stage, nodal status, and grade were tested for both prognostic and predictive significance. Model derived estimates of 5-year disease-free survival and overall survival (OS) for surgery alone and surgery plus FU-based therapy were calculated for a range of patient subsets. Results: Nodal status, T stage, and grade were the only prognostic factors independently significant for both disease-free survival and OS. Age was significant only for OS. In a multivariate analysis, adjuvant therapy showed a beneficial treatment effect across all subsets. Treatment benefits were consistent across sex, location, age, T-stage, and grade. A significant stage by treatment interaction was present, with treatment benefiting stage III patients to a greater degree than stage II patients. Conclusion: Patients with high-risk resected colon cancer obtain benefit from FU-based therapy across subsets of age, sex, location, T stage, nodal status, and grade. Model estimates of survival stratified by T stage, nodal status, grade, and age are available at http://www.mayoclinic.com/calcs . This information may improve patients' and physicians' understanding of the potential benefits of adjuvant therapy.

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Metadata

Authors
Gill, S., Loprinzi, C. L., Sargent, D. J., Thomé, S. D., Alberts, S. R., Haller, D. G., Benedetti, J., Francini, G., Shepherd, L. E., Francois Seitz, J., Labianca, R., Chen, W., Cha, S. S., Heldebrant, M. P., & Goldberg, R. M.
Venue
Journal of Clinical Oncology
Published
2004-05-15
Volume
22
Issue
10
Pages
1797-1806
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2121708973
Cited by
1,021
References
45
FWCI
23.36
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Pooled Analysis of Fluorouracil-Based Adjuvant Therapy for Stage II and III Colon Cancer: Who Benefits and by How Much? https://app.cochat.ai/papers/10.1200/jco.2004.09.059
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Gill, S., Loprinzi, C. L., Sargent, D. J., Thomé, S. D., Alberts, S. R., Haller, D. G., Benedetti, J., Francini, G., Shepherd, L. E., Francois Seitz, J., Labianca, R., Chen, W., Cha, S. S., Heldebrant, M. P., & Goldberg, R. M. (2004). Pooled Analysis of Fluorouracil-Based Adjuvant Therapy for Stage II and III Colon Cancer: Who Benefits and by How Much? Journal of Clinical Oncology. https://doi.org/10.1200/jco.2004.09.059

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.