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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“[17] publication, with two additional new trials.”
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Background
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“However, disease-free survival and overall survival have been highly correlated, and the recurrence-free interval may ultimately be a more important statistical parameter than median overall survival due to quality-of-life issues (36).”
Background
Alternative End Points to Evaluate a Therapeutic Strategy in Advanced Colorectal Cancer: Evaluation of Progression-Free Survival, Duration of Disease Control, and Time to Failure of Strategy—An Aide et Recherche en Cancérologie Digestive Group Study
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Time to Progression as a Surrogate Marker for Overall Survival in Patients with Advanced Non-small Cell Lung Cancer
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Dose–response effects of aerobic exercise on body composition among colon cancer survivors: a randomised controlled trial
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“Despite efficacious surgical and chemotherapeutic interventions, 25–40% of patients will experience recurrent and metastatic disease within 3 years of diagnosis (André et al, 2004), and 91% of those who recur within 3 years, die by 5 years (Sargent et al, 2005).”
Background
Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study
Chen, C., Li, X. N., Yuan, S., Antonijevic, Z., Kalamegham, R., & Beckman, R. A. (2016) · Statistics in Biopharmaceutical Research · doi:10.1080/19466315.2016.1193044 · Cited by 57
Adjuvant treatment of colorectal cancer.
Carrato, A. (2008) · PubMed Central · Cited by 57
Geriatric Assessment Predicts Survival and Competing Mortality in Elderly Patients with Early Colorectal Cancer: Can It Help in Adjuvant Therapy Decision-Making?
Antonio, M., Saldaña, J., Carmona‐Bayonas, A., Navarro, V., Tebé, C., Nadal, M., Formiga, F., Salazar, R., & Borràs, J. M. (2017) · The Oncologist · doi:10.1634/theoncologist.2016-0462 · Cited by 57
“In patients with CRC treated with adjuvant therapy, there is a close correlation between 3-year DFS and 5-year OS [36].”
Background
Appropriateness of colonoscopy in Europe (EPAGE II) – Surveillance after polypectomy and after resection of colorectal cancer
Arditi, C., Gonvers, J. J., Burnand, B., Minoli, G., Oertli, D., LACAINE, F., Dubois, R., Vader, J. ‐., Filliettaz, S. S., Peytremann‐Bridevaux, I., et al. (2009) · Endoscopy · doi:10.1055/s-0028-1119646 · Cited by 56
Colon Cancer
Benson, A. B., Arnoletti, J. P., Bekaii‐Saab, T., Chan, E. W., Chen, Y., Choti, M. A., Cooper, H. S., Dilawari, R. A., Engstrom, P. F., Enzinger, P. C., et al. (2011) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2011.0104 · Cited by 56
Statistical Challenges in the Evaluation of Treatments for Small Patient Populations
Korn, E. L., McShane, L. M., & Freidlin, B. (2013) · Science Translational Medicine · doi:10.1126/scitranslmed.3004018 · Cited by 55
Methylation and microsatellite status and recurrence following adjuvant FOLFOX in colorectal cancer
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Local Recurrence in Mismatch Repair–Proficient Colon Cancer Predicted by an Infiltrative Tumor Border and Lack of CD8+ Tumor-Infiltrating Lymphocytes
Zlobec, I., Terracciano, L., & Lugli, A. (2008) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-08-0048 · Cited by 55
Adjuvant Chemotherapy for Stage II Colon Cancer
Rebuzzi, S. E., Pesola, G., Martelli, V., & Sobrero, A. F. (2020) · Cancers · doi:10.3390/cancers12092584 · Cited by 55
“Regarding the role of the DFS surrogacy, a pooled analysis of 18 randomized adjuvant fluorouracil/leucovorin-based chemotherapy trials (ACCENT study) established that 3y DFS is a valid surrogate endpoint for 5y OS in stage III colon cancer [42].”
Method
Clinical trial design: Past, present, and future in the context of big data and precision medicine
Li, A., & Bergan, R. C. (2020) · Cancer · doi:10.1002/cncr.33205 · Cited by 54
“16 This resulted from an analysis of more than 20,000 patients from 18 randomized trials, and it highlights the barriers associated with validation.”
Background
Artificial intelligence-aided clinical annotation of a large multi-cancer genomic dataset
Kehl, K. L., Xu, W. V., Gusev, A., Bakouny, Z., Choueiri, T. K., Riaz, I. B., Elmarakeby, H., Allen, E. M. V., & Schrag, D. (2021) · Nature Communications · doi:10.1038/s41467-021-27358-6 · Cited by 54
Estimating breast cancer‐specific and other‐cause mortality in clinical trial and population‐based cancer registry cohorts
Dignam, J. J., Huang, L. J., Ries, L. A. G., Reichman, M. E., Mariotto, A. B., & Feuer, E. J. (2009) · Cancer · doi:10.1002/cncr.24617 · Cited by 54
“This is unlike the case of colon cancer, in which disease-free survival (time without recurrence, second primary cancer, or death) recently was advocated as a primary endpoint in clinical trials.(25,26) In the current study, we used recurrence not as a surrogate endpoint in the usual sense but, rather, to conclude whe…”
Result
Improving outcomes in colorectal cancer: Where do we go from here?
Cutsem, E. V., Borràs, J. M., Castells, A., Ciardiello, F., Ducreux, M. P., Haq, A., Schmoll, H., & Tabernero, J. M. (2013) · European Journal of Cancer · doi:10.1016/j.ejca.2013.03.026 · Cited by 57
Factors influencing lymph node harvest in colorectal surgery
Gelos, M., Gelhaus, J., Mehnert, P. J., Bonhag, G., Sand, M. S., Philippou, S., & Mann, B. (2007) · International Journal of Colorectal Disease · doi:10.1007/s00384-007-0378-8 · Cited by 53
“In patients receiving adjuvant chemotherapy, overall survival as well as disease-free survival are improved [2, 3]. Recent data demonstrate favourable results in applying the FOLFOX regimen in patients with colon cancer Dukes` stage C [ 3 , 4]. The number of lymph nodes required for accurate staging after surgery has…”
BackgroundResult
Adjuvant Systemic Chemotherapy for Stage II and III Colon Cancer after Complete Resection: An Updated Practice Guideline
Jonker, D. J., Spithoff, K., & Maroun, J. A. (2011) · Clinical Oncology · doi:10.1016/j.clon.2011.02.010 · Cited by 52
“A review of 18 randomised trials of adjuvant chemotherapy in colon cancer showed strong concordance between 2 and 3 year DFS and 5 year overall survival [14,15].”
Method
Progression-free survival as surrogate end point for overall survival in clinical trials of HER2-targeted agents in HER2-positive metastatic breast cancer
Michiels, S., Pugliano, L., Marguet, S., Grun, D., Barinoff, J., Cameron, D., Cobleigh, M., Leo, A. D., Johnston, S. R. D., Gasparini, G. M., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw132 · Cited by 52
Neoadjuvant Chemotherapy for Locally Advanced T4 Colon Cancer: A Nationwide Propensity-Score Matched Cohort Analysis
de Gooyer, J. M., Verstegen, M. G., Lam-Boer, J. ‘., Radema, S. A., Verhoeven, R. H. A., Verhoef, C. K., Schreinemakers, J. M. J., & de Wilt, J. H. W. (2019) · Digestive Surgery · doi:10.1159/000503446 · Cited by 51
Prognostic Models for Predicting Death after Hepatectomy in Individuals with Hepatic Metastases from Colorectal Cancer
Kanemitsu, Y., & Kato, T. (2008) · World Journal of Surgery · doi:10.1007/s00268-007-9348-0 · Cited by 52
Evaluation of Progression-Free Survival as a Surrogate Endpoint for Survival in Chemotherapy and Targeted Agent Metastatic Colorectal Cancer Trials
Sidhu, R., Rong, A., & Dahlberg, S. (2013) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-12-2502 · Cited by 53
“In an extension of the study by Sargent and colleagues (24) and others (6, 7), we conducted a study-level analysis of 24 fluoropyrimidinebased chemotherapy trials in mCRC over the past decade to evaluate the relationships between PFS, response rate, and OS among current treatment regimens that employ targeted agents.”
BackgroundMethod
The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute⊕ Study
Lips, D. J., Koebrugge, B., Liefers, G., van der Linden, J. C., Smit, V. T. H. B. M., Pruijt, H. F. M., Putter, H., van de Velde, C. J., & Bosscha, K. P. (2011) · BMC Surgery · doi:10.1186/1471-2482-11-11 · Cited by 51
“Furthermore, 3-year DFS is recognized as an appropriate surrogate end point for overall 5-year survival in colon cancer trials [32-34].”
Background
Interim futility analysis with intermediate endpoints
Goldman, B. H., LeBlanc, M. L., & Crowley, J. J. (2008) · Clinical Trials · doi:10.1177/1740774507086648 · Cited by 51
“Although promising surrogate endpoints have been identified in colon [11] and prostate cancer [12], these are in very specific disease settings and further validation is required.”
Background
Meta-analyses evaluating surrogate endpoints for overall survival in cancer randomized trials: A critical review
Savina, M., Gourgou, S., Italiano, A., Dinart, D., Rondeau, V., Penel, N., Mathoulin‐Pélissier, S., & Bellera, C. A. (2017) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2017.11.014 · Cited by 54
Overall survival after resection for colon cancer in a national cohort study was adversely affected by TNM stage, lymph node ratio, gender, and old age
Storli, K. E., Søndenaa, K., Bukholm, I., Nesvik, I., Bru, T., Furnes, B., Hjelmeland, B., Iversen, K., & Eide, G. E. (2011) · International Journal of Colorectal Disease · doi:10.1007/s00384-011-1244-2 · Cited by 50
“Three-year disease-free survival has been shown to parallel overall 5year survival [ 30 ].”
Background
Correlation of TNFAIP8 overexpression with the proliferation, metastasis, and disease-free survival in endometrial cancer
Liu, T., Gao, H., Yang, M., Zhao, T., Liu, Y., & Lou, G. (2014) · Tumor Biology · doi:10.1007/s13277-014-1770-y · Cited by 49
“DFS is highly associated with OS and is increasingly received as an acceptable end point [32].”
Background
Is adjuvant therapy with streptozotocin and 5-fluorouracil useful after resection of liver metastases from digestive endocrine tumors?
Maire, F., Hammel, P. R., Kianmanesh, R., Hentic, O., Couvelard, A., Rebours, V., Zappa, M., Raymond, É., Sauvanet, A., Louvet, C., et al. (2008) · Surgery · doi:10.1016/j.surg.2008.08.007 · Cited by 49
Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide
Polley, M.-Y. C., Lamborn, K. R., Chang, S. M., Butowski, N. A., Clarke, J. L., & Prados, M. (2009) · Neuro-Oncology · doi:10.1093/neuonc/nop034 · Cited by 49
Multi Texture Analysis of Colorectal Cancer Continuum Using Multispectral Imagery
Chaddad, A., Desrosiers, C., Bouridane, A., Toews, M., Hassan, L., & Tanougast, C. (2016) · PLoS ONE · doi:10.1371/journal.pone.0149893 · Cited by 49
“Surgical resection of the primary tumor with curative intent is possible in only 70% of patients [2, 3].”
Background
A Systematic Review of Patient Perspectives on Surveillance after Colorectal Cancer Treatment
Berian, J. R., Cuddy, A., Francescatti, A., O'Dwyer, L. C., You, Y., Volk, R., & Chang, G. (2017) · Journal of cancer survivorship · doi:10.1007/s11764-017-0623-2 · Cited by 51
Therapeutic Options in the Management of Colon Cancer: 2005 Update
Wilkes, G. M. (2005) · Clinical journal of oncology nursing · doi:10.1188/05.cjon.31-44 · Cited by 48
Use of Meta-Analysis for the Validation of Surrogate Endpoints and Biomarkers in Cancer Trials
Buyse, M. E. (2009) · The Cancer Journal · doi:10.1097/ppo.0b013e3181b9c602 · Cited by 47
Upregulated Polo-Like Kinase 1 Expression Correlates with Inferior Survival Outcomes in Rectal Cancer
Tut, T. G., Lim, S. H.-S., Dissanayake, I. U., Descallar, J., Chua, W., Ng, W. L., SOUZA, P. D., Shin, J.-S., & Lee, C. S. (2015) · PLoS ONE · doi:10.1371/journal.pone.0129313 · Cited by 47
“1 years, which would be a reflection of longer term survival given that three-year follow up is an appropriate endpoint with a high correlation with overall survival in colorectal cancer [17].”
Background
Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer
Foster, N. R., Renfro, L. A., Schild, S. E., Redman, M. W., Wang, X. F., Dahlberg, S. E., Ding, K., Bradbury, P. A., Ramalingam, S. S., Gandara, D. R., et al. (2015) · Journal of Thoracic Oncology · doi:10.1097/jto.0000000000000548 · Cited by 47
Sentinel Lymph Node Evaluation Does Not Improve Staging Accuracy in Colon Cancer
Lim, S. J., Feig, B. W., Wang, H., Hunt, K. K., Rodrı́guez-Bigas, M. A., Skibber, J. M., Ellis, V., Cleary, K. R., & Chang, G. J. (2007) · Annals of Surgical Oncology · doi:10.1245/s10434-007-9629-8 · Cited by 46
“Patients with positive SLNs, n (%) 29 (24) Patients with positive non-SLNs, n (%) 43 (36) Patients in whom SLN was the only positive LN, n (%) 6 (5)”
Background
Prognostic implication of mucinous histology in colorectal cancer patients treated with adjuvant FOLFOX chemotherapy
Dw, L., Han, S.-W., Lee, H. J., Yy, R., Jm, B., Cho, N.-Y., Lee, K.-H., Ty, K., Oh, D.-Y., Im, S., et al. (2013) · British Journal of Cancer · doi:10.1038/bjc.2013.232 · Cited by 47
“However, the median follow-up duration had passed 3 years, DFS at which point has been shown to have good correlation with 5-year OS in colon cancer (Sargent et al, 2005).”
Background
Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology
Sherrill, B. H., Kaye, J. A., Sandin, Cappelleri, & Chen (2012) · OncoTargets and Therapy · doi:10.2147/ott.s36683 · Cited by 45
“Studies with results falling almost perfectly on a diagonal line to depict the relationship between hazard ratios for disease-free survival and overall survival contributed to the acceptance of this endpoint as a valid surrogate endpoint in the adjuvant treatment setting for colorectal cancer.(13,14) The published met…”
Unmet needs in the first-line treatment of follicular lymphoma
Casulo, C., Nastoupil, L. J., Fowler, N. H., Friedberg, J. W., & Flowers, C. R. (2017) · Annals of Oncology · doi:10.1093/annonc/mdx189 · Cited by 46
“Requirements for surrogate end points have been mathematically defined [75] and precedents exist for their use in other forms of cancer [76, 77], where they have at times served as efficacy end points for FDA approval [78].”
Background
Oxaliplatin-based chemotherapy in the management of colorectal cancer
Capdevila, J., Élez, E., Peralta, S., Macarulla, T. M., Ramos, F. J., & Tabernero, J. M. (2008) · Expert Review of Anticancer Therapy · doi:10.1586/14737140.8.8.1223 · Cited by 45
Adjuvant therapy of colon cancer
Sun, W., & Haller, D. G. (2005) · Seminars in Oncology · doi:10.1053/j.seminoncol.2004.09.037 · Cited by 45
Primary Pulmonary Carcinoid Tumor
Herde, R. F., Kokeny, K. E., Reddy, C. B., Akerley, W., Hu, N., Boltax, J., & Hitchcock, Y. J. (2015) · American Journal of Clinical Oncology · doi:10.1097/coc.0000000000000221 · Cited by 44
“Consistent with prior analyses, all patients who did not achieve complete remission or cure after treatment were censored in disease-free survival calculations.(8,9)”
Prognostic Models for Predicting Death After Hepatectomy in Individuals with Hepatic Metastases from Colorectal Cancer
Smith, M. D., & Parks, R. W. (2008) · World Journal of Surgery · doi:10.1007/s00268-008-9511-2 · Cited by 43
“Recently, the first 3 years after surgery for colorectal cancer are considered a specific time point because a significant correlation between 3-year diseasefree survival (DFS) and 5-year overall survival (OS) in adjuvant colon cancer trials has been proven by Sargent et al. [ 30 ].”
Background
Radiomics of rectal cancer for predicting distant metastasis and overall survival
Li, M., Zhu, Y., Zhang, Y., Yue, Y., Yu, H., & Song, B. (2020) · World Journal of Gastroenterology · doi:10.3748/wjg.v26.i33.5008 · Cited by 43
Chemotherapy and Regional Therapy of Hepatic Colorectal Metastases: Expert Consensus Statement
Bartlett, D. L., Berlin, J. D., Lauwers, G. Y., Messersmith, W. A., Petrelli, N. J., & Venook, A. P. (2006) · Annals of Surgical Oncology · doi:10.1245/s10434-006-9018-8 · Cited by 43
“This pivotal study randomized patients to 6 months of infusional 5-FU/LV with or without oxaliplatin and showed an improvement in the 3-year disease-free survival of the patients in the oxaliplatin arm, which has been widely accepted as a reliable surrogate endpoint for overall survival.(25) Interestingly, in NSABP C-…”
Method

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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