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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
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 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.”
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“9% of recurrences had accumulated within 2 and 3 years (data not shown), respectively, which is comparable with rates reported previously [7, 8].”
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“We used progression-free survival (PFS)—calculated as the time between the date of treatment initiation to that of recurrence, death from any cause, and metastasis or censor at the date of the last follow-up—as a clinical endpoint in this research.(10,20)”
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BackgroundTumor Status at 12 Weeks Predicts Survival in Advanced Colorectal Cancer: Findings from NCCTG N9741
Heun, J. M., Grothey, A. F., Branda, M. E., Goldberg, R. M., & Sargent, D. J. (2011) · The Oncologist · doi:10.1634/theoncologist.2011-0064 · Cited by 15
Kim, S. T., Ahn, T. J., Lee, E., Do, I., Lee, S. J., Park, S. H., Park, J. O., Park, Y. S., Lim, H. Y., Kang, W. K., et al. (2015) · BMC Cancer · doi:10.1186/s12885-015-1759-y · Cited by 16
“Despite progress in cytotoxic chemotherapy during past decade, the five year survival rate for mCRC remains below 10 % [2].”
BackgroundStandard chemotherapy with cetuximab for treatment of colorectal cancer
Li, X.-X., Liang, L., Huang, L.-Y., & Cai, S.-J. (2015) · World Journal of Gastroenterology · doi:10.3748/wjg.v21.i22.7022 · Cited by 15
Sharif‐Askari, N. S., Sharif‐Askari, F. S., Guraya, S. Y., Bendardaf, R., & Hamoudi, R. (2019) · International Journal of Surgery · doi:10.1016/j.ijsu.2019.11.017 · Cited by 16
Immunotherapy for Early Stage Colorectal Cancer: A Glance into the Future
Cohen, R., Shi, Q., & André, T. (2020) · Cancers · doi:10.3390/cancers12071990 · Cited by 18
“At this time, there is no clear consensus concerning the way to screen patients for MSI/dMMR phenotype among agencies responsible of drug labelling (e.g., Food and Drug Administration, the European Medicines Agency).”
BackgroundInfluentialID4 predicts poor prognosis and promotes BDNF-mediated oncogenesis of colorectal cancer
Ha, C.-T., Cheng, C., Zheng, M., Hsu, T.-H., Miao, C., Lee, C.-J., Wang, H., Pan, S., & Chou, Y. (2021) · Carcinogenesis · doi:10.1093/carcin/bgab037 · Cited by 15
Cross-talks in colon cancer between RAGE/AGEs axis and inflammation/immunotherapy
Mollace, A., Coluccio, M. L., Donato, G., Mollace, V., & Malara, N. (2021) · Oncotarget · doi:10.18632/oncotarget.27990 · Cited by 15
“Despite these progresses, 25% of CRC patients are diagnosed at an advanced stage with a 5-year survival < 20%, and only limited targeted therapies are available [1].”
BackgroundRen, H., Bösch, F., Pretzsch, E., Jacob, S., Westphalen, C. B., Holch, J. W., Werner, J., & Angele, M. K. (2022) · Annals of Surgery · doi:10.1097/sla.0000000000005644 · Cited by 15
Sakai, T., Yamashita, Y., Maekawa, T., Mikami, K., Hoshino, S., & Shirakusa, T. (2008) · Cancer Biotherapy and Radiopharmaceuticals · doi:10.1089/cbr.2008.0484 · Cited by 15
Renfro, L. A., Grothey, A. A., Kerr, D. J., Haller, D. G., André, T., Cutsem, E. V., Saltz, L. B., Labianca, R., Loprinzi, C. L., Alberts, S. R., et al. (2015) · Annals of Oncology · doi:10.1093/annonc/mdv073 · Cited by 15
“The Adjuvant Colon Cancer Endpoints (ACCENT) database contains patient-level information on more than 30 000 patients enrolled to 25 phase III adjuvant CC trials since 1977 [13, 14] (supplementary Table S1, available at Annals of Oncology online).”
BackgroundJongeneel, G., Klausch, T. L. T., van Erning, F. N., Vink, G. R., Koopman, M., Punt, C. J. A., Greuter, M. J. E., & Coupé, V. M. H. (2019) · International Journal of Cancer · doi:10.1002/ijc.32629 · Cited by 15
“This is underlined by Sargent et al.(41) who showed that DFS and OS are highly correlated in colon cancer trials evaluating fluorouracil-based regimens in Stage III colon cancer patients.”
BackgroundAn Overview of Approaches to Adjuvant Therapy for Colorectal Cancer in the United States
Hobday, T. J. (2005) · Clinical Colorectal Cancer · doi:10.3816/ccc.2005.s.002 · Cited by 15
Adjuvant Mitotane for Adrenocortical Cancer—Working through Uncertainty
Terzolo, M., Faßnacht, M., Ciccone, G., Allolio, B., & Berruti, A. (2009) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-0120 · Cited by 14
Wilson, K. S., Fitzgerald, C. A., Barnett, J., Pharm, B. S., Gill, S., & Khoo, K. (2007) · Cancer Investigation · doi:10.1080/07357900701518388 · Cited by 14
“The observed plateau in relapse-free survival at 3 years is encouraging and consistent with the current acceptance of 3 year relapse-free proportions as surrogate markers for overall survival in colorectal cancer (25, 26).”
ResultMultidisciplinary Management of Rectal Cancer
Valentini, V., van de Velde, C. J. �., & Schmoll, H. (2012) · Springer eBooks · doi:10.1007/978-3-642-25005-7 · Cited by 14
Community Compliance with Carcinoembryonic Antigen: Follow-up of Patients with Colorectal Cancer
Spratlin, J. L., Hui, D., Hanson, J., Butts, C. A., & Au, H. (2008) · Clinical Colorectal Cancer · doi:10.3816/ccc.2008.n.016 · Cited by 14
(Neo-)adjuvant treatments in colorectal cancer
Arnold, D., & Schmoll, H. (2005) · Annals of Oncology · doi:10.1093/annonc/mdi729 · Cited by 14
Surrogate endpoints: wishful thinking or reality?
Burzykowski, T. (2008) · Statistical Methods in Medical Research · doi:10.1177/0962280207081866 · Cited by 14
Zhu, D., Xia, J., Gu, Y., Lin, J., Ding, K., Zhou, B., Liang, F., Liu, T., Qin, C., Wei, Y., et al. (2020) · Annals of Surgery · doi:10.1097/sla.0000000000004558 · Cited by 13
“Among these factors, the resectability of recurrent diseases was one of the most critical issues.16,17,32 A prolonged survival after recurrence may reduce the association between DFS and OS, and an imbalance between the 2 arms may indicate no advantage in OS.”
BackgroundInfluentialAn Apoptosis-Related Gene Prognostic Index for Colon Cancer
Tang, H., Wang, J., Luo, X., Wang, Q., Chen, J., Zhang, X., Li, Q., Gao, C., Li, Y., & Han, S. (2021) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2021.790878 · Cited by 13
“Approximately 80% of recurrence occurs in the first 3 years after treatment, often causing death (Sargent et al., 2005).”
BackgroundExploring the Evolving Scope of Neoadjuvant Immunotherapy in NSCLC
Roller, J., Veeramachaneni, N. K., & Zhang, J. (2022) · Cancers · doi:10.3390/cancers14030741 · Cited by 14
“Disease free survival (DFS) has been one such surrogate marker that has been utilized for other malignancies, such as breast cancer or colorectal cancer [49,50].”
BackgroundLee, D., Han, S., Cha, Y., Lee, K.-H., Kim, T., Oh, D., Im, S., Bang, Y., Park, J. W., Ryoo, S., et al. (2015) · BMC Cancer · doi:10.1186/s12885-015-1704-0 · Cited by 13
“Lastly, we could not evaluate overall survival due to limited number of death events during the relatively short duration of follow-up, albeit the 3-year DFS has been demonstrated to have a good correlation with 5-year overall survival in colon cancer [31].”
BackgroundCenter-within-trial versus trial-level evaluation of surrogate endpoints
Renfro, L. A., Shi, Q., Xue, Y., Li, J., Shang, H., & Sargent, D. J. (2014) · Computational Statistics & Data Analysis · doi:10.1016/j.csda.2014.03.011 · Cited by 13
Nuhn, P., May, M., Fritsche, H., Büchner, A., Brookman-May, S. D., Bolenz, C., Moritz, R., Herrmann, E. M., Burger, M. M., Höfner, T., et al. (2012) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2012.02.187 · Cited by 13
Vardy, J. L., Tan, S. Y., Turner, J. D., & Dhillon, H. M. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-014803 · Cited by 13
Ortiz‐Ortiz, K. J., Tortolero‐Luna, G., Ríos-Motta, R., Veintidós-Feliú, A., Hunter-Mellado, R., Torres‐Cintrón, C. R., Suárez‐Ramos, T., & Magno, P. (2018) · PLoS ONE · doi:10.1371/journal.pone.0194415 · Cited by 13
Cui, M., Xu, R., & Yan, B. (2020) · Molecular and Clinical Oncology · doi:10.3892/mco.2020.2133 · Cited by 16
“The primary study endpoint was the 3‐year PFS, as used in a previous study (21), and the last follow‐up point occurred in September 2019.”
Method
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
- Published
- 2005-12-01
- Volume
- 23
- Issue
- 34
- Pages
- 8664-8670
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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