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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Background
The Colon Health and Life-Long Exercise Change Trial: A Randomized Trial of the National Cancer Institute of Canada Clinical Trials Group
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Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data
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Method
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Molecular Detection of Tumor Cells in Regional Lymph Nodes Is Associated With Disease Recurrence and Poor Survival in Node-Negative Colorectal Cancer: A Systematic Review and Meta-Analysis
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Method
KRAS Codon 12 and 13 Mutations in Relation to Disease-Free Survival in BRAF –Wild-Type Stage III Colon Cancers from an Adjuvant Chemotherapy Trial (N0147 Alliance)
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Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer
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Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer
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Background
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Background
Pharmacoeconomic analysis of adjuvant oral capecitabine vs intravenous 5-FU/LV in Dukes' C colon cancer: the X-ACT trial
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Background
Adjuvant Chemotherapy for Stage III Colon Cancer: Do Physicians Agree About the Importance of Patient Age and Comorbidity?
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Validation of novel imaging methodologies for use as cancer clinical trial end-points
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Polymorphisms inCyclooxygenase-2andEpidermal Growth Factor ReceptorAre Associated with Progression-Free Survival Independent of K-ras in Metastatic Colorectal Cancer Patients Treated with Single-Agent Cetuximab
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Two or three year disease-free survival (DFS) as a primary end-point in stage III adjuvant colon cancer trials with fluoropyrimidines with or without oxaliplatin or irinotecan: Data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07 and C89803
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“Based on a pooled analysis of individual patient data from 18 randomised clinical trials testing 5-FU based treatment, the Adjuvant Colon Cancer End-points (ACCENT) Group previously established that the end-point of disease-free survival (DFS), assessed after 3 years median follow-up, is a valid surrogate end-point fo…”
Influential
Conditional Survival and the Choice of Conditioning Set for Patients With Colon Cancer: An Analysis of NSABP Trials C-03 Through C-07
Zamboni, B. A., Yothers, G., Choi, M., Fuller, C. D., Dignam, J. J., Raich, P. C., Thomas, C. R., O’Connell, M. J., Wolmark, N., & Wang, S. J. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.23.0573 · Cited by 111
Tumor response and progression‐free survival as potential surrogate endpoints for overall survival in extensive stage small‐cell lung cancer
Foster, N. R., Qi, Y., Shi, Q., Krook, J. E., Kugler, J. W., Jett, J. R., Molina, J. R., Schild, S. E., Adjei, A. A., & Mandrekar, S. J. (2010) · Cancer · doi:10.1002/cncr.25526 · Cited by 110
“Trial-level surrogacy was measured in multiple ways, including conventional methods recommended by Sargent et al.23,24 The association between treatment effects on OS and the putative surrogate endpoints of PFS, best response, CR, and confirmed response was evaluated by calculating the Spearman rank correlation coeffi…”
Method
Discrepancy Between Recurrence-Free Survival and Overall Survival in Patients with Resectable Colorectal Liver Metastases: A Potential Surrogate Endpoint for Time to Surgical Failure
Oba, M., Hasegawa, K., Matsuyama, Y., Shindoh, J., Mise, Y., Aoki, T., Sakamoto, Y., Sugawara, Y., Makuuchi, M., & Kokudo, N. (2014) · Annals of Surgical Oncology · doi:10.1245/s10434-014-3504-1 · Cited by 107
“In patients with stage III colorectal cancer, a short-term endpoint assessed after a 3-year median followup period, known as the disease-free survival (DFS) period, has been shown to be a valid surrogate marker for the standard 5-year OS endpoint.(10) This new paradigm has contributed to the development of adjuvant st…”
Background
Pathways, Outcomes, and Costs in Colon Cancer: Retrospective Evaluations in Two Distinct Databases
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What is the clinical benefit of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer in a pooled analysis of EORTC 22921 and FFCD 9203 trials: Surrogacy in question?
Bonnetain, F., Bosset, J. F., Gérard, J., Calais, G., Conroy, T., Mineur, L., Bouché, O., Maingon, P., Chapet, O., Radošević-Jelić, L., et al. (2012) · European Journal of Cancer · doi:10.1016/j.ejca.2012.03.016 · Cited by 106
Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Diffuse Large B-Cell Lymphoma: An Individual Patient–Level Analysis of Multiple Randomized Trials (SEAL)
Shi, Q., Schmitz, N., Ou, F., Dixon, J. G., Cunningham, D., Pfreundschuh, M. G., Seymour, J. F., Jaeger, U., Habermann, T. M., Haïoun, C., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.77.9124 · Cited by 101
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Phase III Randomized Trial Assessing Rofecoxib in the Adjuvant Setting of Colorectal Cancer: Final Results of the VICTOR Trial
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A systematic review and meta-analysis of adjuvant chemotherapy after neoadjuvant treatment and surgery for rectal cancer
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“Further risk (ratio) of death at a predefined time period is a reasonable and sensible choice for quantifying group differences [29].”
Background
Adjuvant Chemotherapy with Uracil–Tegafur for Pathological Stage III Rectal Cancer after Mesorectal Excision with Selective Lateral Pelvic Lymphadenectomy: A Multicenter Randomized Controlled Trial*
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“The median follow-up time of our study was only 3 years, though disease-free survival with 3-year follow-up is suggested to be an appropriate primary endpoint to replace overall survival with 5-year follow-up ( 30 ).”
Background
Disease-Free Survival at 2 or 3 Years Correlates With 5-Year Overall Survival of Patients Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer
Sonpavde, G., Khan, M. M., Lerner, S. P., Svatek, R. S., Novara, G., Karakiewicz, P. I., Skinner, E. C., Derya Tilki, A., Kassouf, W., Fradet, Y., et al. (2010) · The Journal of Urology · doi:10.1016/j.juro.2010.09.110 · Cited by 94
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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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