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

doi:10.1200/jco.2005.01.6071

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

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 +12 more·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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The validity of using DFS, RFS, EFS, distant disease-free survival and TTR as surrogates for survival in curative settings is relatively well supported by data from solid tumour settings including colon, gastric, lung and breast cancers.
“The validity of this approach, though not uncontroversial [13], is relatively well supported by data derived from a wide range of solid tumour settings including in colon [14], gastric [15], lung [16] and breast [17] cancers.”
From A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (2015) · cites this paper as [14]

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Qiu, L., Mao, C., Zhang, J., Zhu, X.-D., Liao, R.-Y., Xue, K., Li, J., & Chen, Q. (2010) · European Journal of Cancer · doi:10.1016/j.ejca.2010.05.022 · Cited by 93 · see citing works

Disease-free survival (DFS) vs. overall survival (OS) as a primary endpoint for adjuvant colon cancer studies: Individual patient data from 12,915 patients on 15 randomized trials
Sargent, D. J., Wieand, S., Benedetti, J., Labianca, R., Haller, D. G., Shepherd, L. E., Seitz, J. F., Francini, G., de Gramont, A., & Goldberg, R. M. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.22.14_suppl.3502 · Cited by 27 · see citing works
Reevaluating Disease-Free Survival as an Endpoint vs Overall Survival in Stage III Adjuvant Colon Cancer Trials
Yin, J., Salem, M. E., Dixon, J. G., Jin, Z., Cohen, R., de Gramont, A., Cutsem, E. V., Taı̈eb, J., Alberts, S. R., Wolmark, N., et al. (2021) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djab187 · Cited by 19 · see citing works
End Points for Colon Cancer Adjuvant Trials: Observations and Recommendations Based on Individual Patient Data From 20,898 Patients Enrolled Onto 18 Randomized Trials From the ACCENT Group
Sargent, D. J., Patiyil, S., Yothers, G., Haller, D. G., Gray, R. G., Benedetti, J., Buyse, M. E., Labianca, R., Seitz, J. F., O'Callaghan, C. J., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.10.4323 · Cited by 240 · see citing works
Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: A Commentary
Abrams, J. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.03.6186 · Cited by 9 · see citing works
Association Between Disease-Free Survival and Overall Survival When Survival Is Prolonged After Recurrence in Patients Receiving Cytotoxic Adjuvant Therapy for Colon Cancer: Simulations Based on the 20,800 Patient ACCENT Data Set
de Gramont, A., Hubbard, J. M., Shi, Q., O’Connell, M. J., Buyse, M. E., Benedetti, J., Bot, B. M., O’Callaghan, C. J., Yothers, G., Goldberg, R. M., et al. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2009.23.1407 · Cited by 80 · see citing works

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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