SynthesisJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012
Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies.
Synthesis in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Twenty Years On: RECIST as a Biomarker of Response in Solid Tumours an EORTC Imaging Group - ESOI Joint Paper.Frontiers in oncology · 2021Pooled it
- Correlations of survival with progression-free survival, response rate, and disease control rate in advanced biliary tract cancer: a meta-analysis of randomised trials of first-line chemotherapy.British journal of cancer · 2016Pooled it
- Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Pooled it
- Correlation of patient survival with clinical tumor measurements in malignant pleural mesothelioma.European radiology · 2019Trial
- Early objective response to avelumab treatment is associated with improved overall survival in patients with metastatic Merkel cell carcinoma.Cancer immunology, immunotherapy : CII · 2019Trial
- Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer.The Journal of clinical endocrinology and metabolism · 2016Trial
- Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2016Trial
- Imaging response assessment in metastatic renal cell carcinoma: a radiologist's guide to contemporary therapeutic strategies.Abdominal radiology (New York) · 2026Review
- Bridging Machine Learning and Clinical Endpoints: A METABRIC-Informed Simulation Study of Missing Data Imputation for RECIST-Based Best Overall Response.Diagnostics (Basel, Switzerland) · 2026Article
- Prognosis and Toxicity Stratified by Best Tumor Burden Change in Japanese Patients With Advanced Melanoma Treated With First-Line Programmed Cell Death Protein 1 Monotherapy.The Journal of dermatology · 2025Article
- A novel Phase II single-arm hybrid design to minimize trial duration and enhance subsequent Phase III trial success rate.Journal of applied statistics · 2025Article
- Multiparametric MRI for characterization of the tumour microenvironment.Nature reviews. Clinical oncology · 2024Review
- Correlation between tumor size change and outcome in a rare cancer immunotherapy basket trial.Journal of the National Cancer Institute · 2024Article
- Article
- Tumor therapeutics in the era of "RECIST": past, current insights, and future prospects.Oncology reviews · 2024Review
- Integration of Next-Generation Sequencing in the Surgical Management of Colorectal Liver Metastasis.Annals of surgical oncology · 2023Review
- Article
- In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part III.International journal of molecular sciences · 2023Article
- Optimized scaling of translational factors in oncology: from xenografts to RECIST.Cancer chemotherapy and pharmacology · 2022Article
- Recruitment, outcomes, and toxicity trends in phase I oncology trials: Six-year experience in a large institution.Cancer reports (Hoboken, N.J.) · 2022Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
purposeRECIST is used to quantify tumor changes during exposure to anticancer agents. Responses are categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Clinical trials dictate a patient's management options based on the category into which his or her response falls. However, the association between response and survival is not well studied in the early trial setting. PATIENTS AND
methodsTo study the correlation between response as quantified by RECIST and overall survival (OS, the gold-standard survival outcome), we analyzed 570 participants of 24 phase I trials conducted between October 2004 and May 2009, of whom 468 had quantifiable changes in tumor size. Analyses of Kaplan-Meier estimates of OS by response and null Martingale residuals of Cox models were the primary outcome measures. All analyses are landmark analyses.
resultsKaplan-Meier analyses revealed strong associations between change in tumor size by RECIST and survival (P = 4.5 × 10(-6) to < 1 × 10(-8)). The relationship was found to be near-linear (R(2) = 0.75 to 0.92) and confirmed by the residual analyses. No clear inflection points were found to exist in the relationship between tumor size changes and survival.
conclusionRECIST quantification of response correlates with survival, validating RECIST's use in phase I trials. However, the lack of apparent boundary values in the relationship between change in tumor size and OS demonstrates the arbitrary nature of the CR/PR/SD/PD categories and questions emphasis placed on this categorization scheme. Describing tumor responses as a continuous variable may be more informative than reporting categoric responses when evaluating novel anticancer therapies.
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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.