ArticleEClinicalMedicine2021
A correlation analysis to assess event-free survival as a trial-level surrogate for overall survival in early breast cancer.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Pooled it
- Meta-analysis to Investigate the Correlation Between Event-Free Survival and Overall Survival in Patients with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma.Advances in therapy · 2025Pooled it
- Correlation between pathologic complete response, event-free survival/disease-free survival and overall survival in neoadjuvant and/or adjuvant HR+/HER2-breast cancer.Frontiers in oncology · 2023Pooled it
- Intermediate endpoints as surrogates for long-term outcomes in breast cancer adjuvant chemotherapy trials.The oncologist · 2025Article
- The interplay between the immune response and neoadjuvant therapy in breast cancer.Frontiers in oncology · 2025Review
- Disease-free survival as a surrogate for overall survival in early-stage pancreatic cancer trials: a correlation meta-analysis.BMJ oncology · 2025Article
- Frequently asked questions on surrogate endpoints in oncology-opportunities, pitfalls, and the way forward.EClinicalMedicine · 2024Review
- Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway.Journal of pharmaceutical policy and practice · 2024Article
- A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2024Article
- Randomized Controlled Trials in Lung, Gastrointestinal, and Breast Cancers: An Overview of Global Research Activity.Current oncology (Toronto, Ont.) · 2022Review
- Surrogate endpoints for early-stage breast cancer: a review of the state of the art, controversies, and future prospects.Therapeutic advances in medical oncology · 2021Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEvent-free survival (EFS) has been listed on the FDA Table of Surrogate Endpoints as a surrogate measure that can be considered for accelerated or traditional approval in breast cancer. However, no studies have evaluated the correlation between the treatment effects on EFS and treatment effects on overall survival (OS).
methodsWe performed a systematic search of the literature until May 2020 according to the PRISMA guideline for all published randomized controlled trials (RCTs) in early breast cancer in the neoadjuvant setting. Data on EFS and OS, including the hazard ratio (HR) and 95% confidence intervals (CI), were extracted from each study and the association between the trial-level EFS HR and the trial-level OS HR was estimated using a linear mixed-effects model on the log scale.
findingsOf the 7 RCTs (
interpretationTreatment effects in EFS are moderately correlated with treatment effects in OS in early breast cancer in the neoadjuvant setting, but the association was not significant. Thus, there is currently insufficient evidence to support EFS for use as a surrogate endpoint for traditional approval, although it may be considered for accelerated approval.
fundingArnold Ventures.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.