Evidence map›Paper›PMID 24516033›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse.

Sumithra J Mandrekar, Ming-Wen An, Jeffrey Meyers, Axel Grothey, Jan Bogaerts, Daniel J Sargent

Abstract readValidation Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
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  6. A call for objectivity: Radiologists' proposed wishlist for response evaluation in solid tumors (RECIST 1.1).Cancer imaging : the official publication of the International Cancer Imaging Society · 2024
    Review
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  17. Enhanced Detection of Treatment Effects on Metastatic Colorectal Cancer with Volumetric CT Measurements for Tumor Burden Growth Rate Evaluation.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Article
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Sumithra J MandrekarSumithra J. Mandrekar, Jeffrey Meyers, Axel Grothey, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Ming-Wen An, Vassar College, Poughkeepsie, NY; and Jan Bogaerts, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Ming-Wen An
Jeffrey Meyers
Axel Grothey
Jan Bogaerts
Daniel J Sargent
Vassar College · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Validation of New Tumor Measurement-based Phase II Clinical Trial EndpointsR21CA167326 · NCI · MAYO CLINIC ROCHESTER · PI AN, MING-WEN, MANDREKAR, SUMITHRA JAY · 2012 to 2013
$373k
NCI NIH HHS P30 CA015083NCI NIH HHS R21 CA167326
6 · The paper itself

Abstract

purposeWe sought to test and validate the predictive utility of trichotomous tumor response (TriTR; complete response [CR] or partial response [PR] v stable disease [SD] v progressive disease [PD]), disease control rate (DCR; CR/PR/SD v PD), and dichotomous tumor response (DiTR; CR/PR v others) metrics using alternate cut points for PR and PD. The data warehouse assembled to guide the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used.

methodsData from 13 trials (5,480 patients with metastatic breast cancer, non-small-cell lung cancer, or colorectal cancer) were randomly split (60:40) into training and validation data sets. In all, 27 pairs of cut points for PR and PD were considered: PR (10% to 50% decrease by 5% increments) and PD (10% to 20% increase by 5% increments), for which 30% and 20% correspond to the RECIST categorization. Cox proportional hazards models with landmark analyses at 12 and 24 weeks stratified by study and number of lesions (fewer than three v three or more) and adjusted for average baseline tumor size were used to assess the impact of each metric on overall survival (OS). Model discrimination was assessed by using the concordance index (c-index).

resultsStandard RECIST cut points demonstrated predictive ability similar to the alternate PR and PD cut points. Regardless of tumor type, the TriTR, DiTR, and DCR metrics had similar predictive performance. The 24-week metrics (albeit with higher c-index point estimate) were not meaningfully better than the 12-week metrics. None of the metrics did particularly well for breast cancer.

conclusionAlternative cut points to RECIST standards provided no meaningful improvement in OS prediction. Metrics assessed at 12 weeks have good predictive performance.

Indexed as

Decision Support Systems, ClinicalDecision Support TechniquesBreast NeoplasmsCarcinoma, Non-Small-Cell LungColorectal NeoplasmsDiscriminant AnalysisDisease-Free SurvivalDisease ProgressionFemaleHumansKaplan-Meier EstimateLung NeoplasmsMalePredictive Value of TestsProportional Hazards ModelsRemission Induction

Identifiers

PMID24516033
PMCPMC3940541
OpenAlexW2028688614

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.