Cited by 171Gastric Cancer Management and OutcomesStatistical Methods in Clinical TrialsMeta-analysis and systematic reviews

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Disease-Free Survival as a Surrogate for Overall Survival in Adjuvant Trials of Gastric Cancer: A Meta-Analysis

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Oba, Koji, Paoletti, Xavier, Alberts, Steven, Bang, Yung-Jue, Benedetti, Jacqueline, Bleiberg, Harry, Catalano, Paul, Lordick, Florian, Michiels, Stefan, Morita, Satoshi, Ohashi, Yasuo, Pignon, Jean-pierre, Rougier, Philippe, Sasako, Mitsuru, Sakamoto, Junichi, Sargent, Daniel, Shitara, Kohei, Cutsem, Eric Van, Buyse, Marc, Burzykowski, Tomasz·2013·JNCI Journal of the National Cancer Institute

DOI 10.1093/jnci/djt270PMC PMC4202244

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Abstract

BACKGROUND: In investigations of the effectiveness of surgery and adjuvant chemotherapy for gastric cancers, overall survival (OS) is considered the gold standard endpoint. However, the disadvantage of using OS as the endpoint is that it requires an extended follow-up period. We sought to investigate whether disease-free survival (DFS) is a valid surrogate for OS in trials of adjuvant chemotherapy for gastric cancer. METHODS: The GASTRIC group initiated a meta-analysis of individual patient data collected in randomized clinical trials comparing adjuvant chemotherapy vs surgery alone for patients with curatively resected gastric cancer. Surrogacy of DFS was assessed through the correlation between the endpoints as well as through the correlation between the treatment effects on the endpoints. External validation of the prediction based on DFS was also evaluated. RESULTS: Individual patient data from 14 randomized clinical trials that included a total of 3288 patients were analyzed. The rank correlation coefficient between DFS and OS was 0.974 (95% confidence interval [CI] = 0.971 to 0.976). The coefficient of determination between the treatment effects on DFS and on OS was as high as 0.964 (95% CI = 0.926 to 1.000), and the surrogate threshold effect based on adjusted regression analysis was 0.92. In external validation, the six hazard ratios for OS predicted according to DFS were in very good agreement with those actually observed for OS. CONCLUSIONS: DFS is an acceptable surrogate for OS in trials of cytotoxic agents for gastric cancer in the adjuvant setting.

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Authors: Oba, K., Paoletti, X., Alberts, S., Bang, Y.-J., Benedetti, J., Bleiberg, H., Catalano, P., Lordick, F., Michiels, S., Morita, S., Ohashi, Y., Pignon, J.-P., Rougier, P., Sasako, M., Sakamoto, J., Sargent, D., Shitara, K., Cutsem, E. V., Buyse, M., & Burzykowski, T.
Affiliations: Mayo Clinic (US)
ORCID: Oba, Koji
Bang, Yung-Jue
Catalano, Paul
Lordick, Florian
Michiels, Stefan
Morita, Satoshi
Ohashi, Yasuo
Pignon, Jean-pierre
Sasako, Mitsuru
Sargent, Daniel
Shitara, Kohei
Cutsem, Eric Van
Buyse, Marc
Burzykowski, Tomasz
Venue: JNCI Journal of the National Cancer Institute
Publisher: Oxford University Press (OUP)
Published: 2013-10-09
Volume: 105
Issue: 21
Pages: 1600-1607
ISSN: 0027-8874 (ISSN-L)
1460-2105
DOI: 10.1093/jnci/djt270
PMC: PMC4202244
OpenAlex: W2168202113
Cited by: 168
References: 33
Citations by year: 2026: 5 · 2025: 14 · 2024: 11 · 2023: 15 · 2022: 12 · 2021: 22 · 2020: 12 · 2019: 16 · 2018: 7 · 2017: 19 · 2016: 12 · 2015: 12 · 2014: 8 · 2013: 3
FWCI: 1.86
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JNCI Journal of the National Cancer Institute (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Document Server@UHasselt (UHasselt) (submittedVersion, other-oa)
HighWire Press Open Archive (submittedVersion)
Seoul National University Open Repository (Seoul National University) (submittedVersion)
Funders: GlaxoSmithKline
Institut National Du Cancer
Japan Society for the Promotion of Science (25461577)
National Cancer Institute (U10CA021115, P30CA015083)
Topics: Health Sciences › Medicine › Oncology › Gastric Cancer Management and Outcomes
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: gastric cancer, disease-free survival, overall survival, surrogate endpoints, adjuvant chemotherapy, curative resection, endpoint correlation, external validation, individual patient data, cytotoxic drugs
MeSH terms: Antineoplastic Combined Chemotherapy Protocols, Cost-Benefit Analysis, Drug Administration Schedule, Gastrectomy, Humans, Stomach Neoplasms, Time Factors, Linear Models, Odds Ratio, Randomized Controlled Trials as Topic, Treatment Outcome, Chemotherapy, Adjuvant, Disease-Free Survival, Kaplan-Meier Estimate

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Disease-Free Survival as a Surrogate for Overall Survival in Adjuvant Trials of Gastric Cancer: A Meta-Analysis

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