SynthesisJCO precision oncology2021
Tumor Response End Points as Surrogates for Overall Survival in Immune Checkpoint Inhibitor Trials: A Systematic Review and Meta-Analysis.
Synthesis in JCO precision oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Ivonescimab: The Next United States Food and Drug Administration Project Optimus Flashpoint?JTO clinical and research reports · 2026Article
- Article
- Real-World Effectiveness and Safety of Pembrolizumab-Lenvatinib Versus Axitinib-Based Regimens in Metastatic Clear Cell Renal Cell Carcinoma: A Multicenter Retrospective Study.International journal of urology : official journal of the Japanese Urological Association · 2026Article
- Article
- Frequently asked questions on surrogate endpoints in oncology-opportunities, pitfalls, and the way forward.EClinicalMedicine · 2024Review
- Plasma cell-free RNA PD-L1 or tissue PD-L1 protein expression and outcomes with first-line immunotherapy in metastatic non-small cell lung cancer.The journal of liquid biopsy · 2024Article
- Prediction of Effectiveness and Toxicities of Immune Checkpoint Inhibitors Using Real-World Patient Data.JCO clinical cancer informatics · 2024Article
- Dysthyroidism during immune checkpoint inhibitors is associated with improved overall survival in adult cancers: data mining of 1385 electronic patient records.Journal for immunotherapy of cancer · 2023Article
- Looking ahead in early-phase trial design to improve the drug development process: examples in oncology.BMC medical research methodology · 2023Article
- The predictive and prognostic value of weight loss and body composition prior to and during immune checkpoint inhibition in recurrent or metastatic head and neck cancer patients.Cancer medicine · 2023Article
- The reliability and integrity of overall survival data based on follow-up records only and potential solutions to the challenges.The Lancet regional health. Western Pacific · 2023Review
- Observational study to predict the efficacy and optimal duration of nivolumab treatment in patients with previously treated advanced or recurrent non-small cell lung cancer.Japanese journal of clinical oncology · 2023Observational
- Article
- Evaluation of Surrogate Endpoints Using Information-Theoretic Measure of Association Based on Havrda and Charvat Entropy.Mathematics (Basel, Switzerland) · 2022Article
- Optimal Prognostic Factors for Metastatic and Inoperable Sarcomas Treated With Pazopanib, Eribulin, and Trabectedin.In vivo (Athens, Greece)Article
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeMany immune checkpoint inhibitors (ICIs) have been approved on the basis of tumor response end points in nonrandomized trials, including objective response rate (ORR) and duration and depth of response. We aimed to assess the validity of these end points as surrogate end points for overall survival (OS) in patients with advanced solid tumors treated with ICIs at trial and treatment arm levels.
methodsICI trials in advanced solid cancers published between January 1, 2000, and March 31, 2020, were included. Correlations between ORR, durable response (DR) of ≥ 6 months, complete response (CR), and OS were assessed for treatment comparisons (trial-level) and for patients receiving ICI (arm-level), using weighted linear regression.
resultsSixty-three trials were eligible, including 58 randomized controlled trials and 20 nonrandomized controlled trials (78 ICI arms and 30,815 patients). The majority were phase III (63%), and OS was the most common primary end point (40%). In relative treatment comparisons, correlations between ORR risk ratio and OS hazard ratio (HR), 6-month DR ratio and OS HR, and CR ratio and OS HR were
conclusionRelative measures of tumor response (ORR, 6-month DR, and CR) are poor surrogate end points for OS in ICI studies. However, ORR and 6-month DR are prognostic of 12-month OS in ICI studies supporting their use for screening activity of novel agents in early-phase nonrandomized trials.
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