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

The DOI matches its Crossref record; 33 of the 34 references it cites were found in a registry or an index.

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
Open this paper in CoChat — free account

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.

Overview

Integrity signals

Registry

Crossref · 10.1200/jco.2005.01.6071

Cites

33 of 33 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Flagged first, then by citations

1 of the 34 references couldn’t be matched to a known paper.

Cited by

Sorted by citations

See all 713

Related

See all

Metadata

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
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review