Cited by 713Statistical Methods in Clinical TrialsColorectal Cancer Treatments and StudiesColorectal Cancer Surgical Treatments

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Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: Individual Patient Data From 20,898 Patients on 18 Randomized Trials

Sargent, Daniel J., Wieand, Harry S., Haller, Daniel G., Gray, Richard, Benedetti, Jacqueline K., Buyse, Marc, Labianca, Roberto, Seitz, Jean Francois, O'Callaghan, Christopher J., Francini, Guido, Grothey, Axel, O'Connell, Michael, Catalano, Paul J., Blanke, Charles D., Kerr, David, Green, Erin, Wolmark, Norman, Andre, Thierry, Goldberg, Richard M., De Gramont, Aimery·2005·Journal of Clinical Oncology

DOI 10.1200/jco.2005.01.6071

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Abstract

PURPOSE: A traditional end point for colon adjuvant clinical trials is overall survival (OS), with 5 years demonstrating adequate follow-up. A shorter-term end point providing convincing evidence to allow treatment comparisons could significantly speed the translation of advances into practice. METHODS: Individual patient data were pooled from 18 randomized phase III colon cancer adjuvant clinical trials. Trials included 43 arms, with a pooled sample size of 20,898 patients. The primary hypothesis was that disease-free survival (DFS), with 3 years of follow-up, is an appropriate primary end point to replace OS with 5 years of follow-up. RESULTS: The recurrence rates for years 1 through 5 were 12%, 14%, 8%, 5%, and 3%, respectively. Median time from recurrence to death was 12 months. Eighty percent of recurrences were in the first 3 years; 91% of patients with recurrence by 3 years died before 5 years. Correlation between 3-year DFS and 5-year OS was 0.89. Comparing control versus experimental arms within each trial, the correlation between hazard ratios for DFS and OS was 0.92. Within-trial log-rank testing using both DFS and OS provided the same conclusion in 23 (92%) of 25 cases. Formal measures of surrogacy were satisfied. CONCLUSION: In patients treated on phase III adjuvant colon clinical trials, DFS and OS are highly correlated, both within patients and across trials. These results suggest that DFS after 3 years of median follow-up is an appropriate end point for adjuvant colon cancer clinical trials of fluorouracil-based regimens, although marginally significant DFS improvements may not translate into significant OS benefits.

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“A similar technique was used to demonstrate the validity of 3-year disease-free survival (DFS) as a surrogate marker for 5-year overall survival in the adjuvant colon cancer setting [ 23 ].”
Method
FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data
Schneider, J. A., Eckstein, J., Goldberg, K. B., Ascione, M. C., Bailey, T., Taylor, K., Coffey, A. M., Satchi, D., Philips, H., Sridhara, R., et al. (2023) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-22-3240
Perioperative systemic therapy in renal cell carcinoma
MacPhail, C., Wood, L. A., & Thana, M. (2023) · Current Opinion in Supportive and Palliative Care · doi:10.1097/spc.0000000000000675
“DFS has increasingly been used as a proxy outcome, with a correlation to OS demonstrated in several tumour sites (e.g. breast and colon cancer) [26,27].”
Background
Pilot Study: Prophylatic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Cancers at High Risk of Developing Peritoneal Metastases in a Tertiary Asian Centre
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Evaluation of Time-to-event Surrogate Endpoint Endpoint ─Meta-analytic Approach─
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Colon
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Evaluating surrogates for overall survival in the adjuvant treatment of bladder cancer with chemotherapy
Sternberg, C. N., Squifflet, P., Saad, E. D., Burdett, S., Fisher, D., Kurt, M., Teitsson, S., May, J. R., Patel, M. Y., Stoeckle, M., et al. (2025) · Urologic Oncology Seminars and Original Investigations · doi:10.1016/j.urolonc.2025.07.013
Small Bowel Obstruction Caused by Intraluminal Rectal Cancer Metastasis to the Jejunum: A Case Report and Review of the Literature
Fickenscher, M., Ponsel, O., & Gvozdenovic, N. (2025) · Clinical Case Reports · doi:10.1002/ccr3.71213
“However, after treatment with curative intent, up to 40% of patients develop distant metastasis or local recurrence in 5-year follow-up [5, 6].”
Adjuvant Chemotherapy for Senior Patients After Resection of Colon Cancer
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Maligne Erkrankungen des Gastrointestinaltrakts bei alten Patienten
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Additional file 2 of Targeted panel sequencing of pharmacogenes and oncodrivers in colorectal cancer patients reveals genes with prognostic significance
Heczko, L., Liška, V., Vyčítal, O., Fiala, O., Šůsová, S., Hlaváč, V., & Souček, P. (2024) · Figshare · doi:10.6084/m9.figshare.26751679
Additional file 1 of Targeted panel sequencing of pharmacogenes and oncodrivers in colorectal cancer patients reveals genes with prognostic significance
Heczko, L., Liška, V., Vyčítal, O., Fiala, O., Šůsová, S., Hlaváč, V., & Souček, P. (2024) · Figshare · doi:10.6084/m9.figshare.26751676
Additional file 2 of Integration of RNA-Seq and proteomics data identifies glioblastoma multiforme surfaceome signature
Syafruddin, S. E., Nazarie, W. F. W. M., Moidu, N. A., Soon, B. H., & Mohtar, M. A. (2021) · Figshare · doi:10.6084/m9.figshare.15047812
A commentary on “Robotic versus laparoscopic surgery for middle and low rectal cancer: a retrospective cohort study emulating the target trial”
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“Established methodologies from prior oncology health-economic studies, including those evaluating adjuvant therapies, offer a validated template for this essential step [6] .”
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“26 Moreover, multiple large-scale clinical trials have already adopted 3-year DFS as the primary or co-primary endpoint for evaluating treat-ment efficacy, 7 further supporting its validity as a robust and pragmatic outcome measure.”
Redefining the role of carbon nanoparticles in colorectal cancer surgery: From lymph node yield to diagnostic paradox
Lv, Y., Wang, F., Shen, Y., Yin, S., Jia, X., Tang, W., Xu, J., Huang, X., & Dai, S. (2026) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2026.111782
Development and validation of prognostic models for colon cancer incorporating extramural vascular invasion assessed by contrast-enhanced computed tomography
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Identification et validation des marqueurs protéiques en oncologie
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Authors: Sargent, D. J., Wieand, H. S., Haller, D. G., Gray, R., Benedetti, J. K., Buyse, M., Labianca, R., Seitz, J. F., O'Callaghan, C. J., Francini, G., Grothey, A., O'Connell, M., Catalano, P. J., Blanke, C. D., Kerr, D., Green, E., Wolmark, N., Andre, T., Goldberg, R. M., & De Gramont, A.
Affiliations: University of Siena (IT)
From the North Central Cancer Treatment Group, Mayo Clinic, Rochester, MN; National Surgical Adjuvant Breast and Bowel Project Statistical Center and Operations Office, Pittsburgh; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; QUASAR Collaborative Group, Birmingham and Oxford, United Kingdom; Southwest Oncology Group Statistical Center, Seattle, WA; International Drug Development Institute, Brussels, Belgium; Ospedali Riuniti, Bergamo; University of Siena, Siena, Italy; University...
ORCID: Sargent, Daniel J.
Haller, Daniel G.
Gray, Richard
Buyse, Marc
Labianca, Roberto
Grothey, Axel
Catalano, Paul J.
Blanke, Charles D.
Kerr, David
Green, Erin
Wolmark, Norman
Goldberg, Richard M.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2005-12-01
Volume: 23
Issue: 34
Pages: 8664-8670
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2005.01.6071
OpenAlex: W2172116130
Cited by: 713
References: 34
Citations by year: 2026: 19 · 2025: 14 · 2024: 19 · 2023: 20 · 2022: 34 · 2021: 32 · 2020: 27 · 2019: 20 · 2018: 24 · 2017: 30 · 2016: 26 · 2015: 40 · 2014: 36 · 2013: 40 · 2012: 44
FWCI: 48.43
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Document Server@UHasselt (UHasselt) (submittedVersion)
University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
Use Siena air (University of Siena) (submittedVersion)
Funders: National Cancer Institute ((CA-25224, U10CA025224)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Keywords: colon cancer, adjuvant chemotherapy, disease-free survival, overall survival, primary endpoint, surrogate endpoints, hazard ratio correlation, recurrence, individual patient data pooling
MeSH terms: Aged, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms, Combined Modality Therapy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Regression Analysis, Randomized Controlled Trials as Topic, Treatment Outcome, Chemotherapy, Adjuvant, Disease-Free Survival

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Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: Individual Patient Data From 20,898 Patients on 18 Randomized Trials

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