Evidence map›Paper›PMID 26296640›Full record

SynthesisJournal of the National Cancer Institute2015

Evaluating Continuous Tumor Measurement-Based Metrics as Phase II Endpoints for Predicting Overall Survival.

Ming-Wen An, Xinxin Dong, Jeffrey Meyers, Yu Han, Axel Grothey, Jan Bogaerts, Daniel J Sargent, Sumithra J Mandrekar, Response Evaluation Criteria in Solid Tumors Steering Committee

Open access · bronzeAbstract readMeta-Analysis
In one paragraph

Synthesis in Journal of the National Cancer Institute, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  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
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. 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
  13. Article
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  15. Observational
  16. Review
  17. Article
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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

9 authors at 4 institutions in 1 country.

Ming-Wen AnDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB). mian@vassar.edu.
Xinxin DongDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Jeffrey MeyersDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Yu HanDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Axel GrotheyDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Jan BogaertsDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Daniel J SargentDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Sumithra J MandrekarDepartment of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).
Response Evaluation Criteria in Solid Tumors Steering Committee
Mayo Clinic in Florida · USTakeda (United States) · USVassar College · USMayo Clinic in Arizona · 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

backgroundWe sought to develop and validate clinically relevant, early assessment continuous tumor measurement-based metrics for predicting overall survival (OS) using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 data warehouse.

methodsData from 13 trials representing 2096 patients with breast cancer, non-small cell lung cancer (NSCLC), or colorectal cancer were used in a complete case analysis. Tumor measurements from weeks 0-6-12 assessments were used to evaluate the ability of slope (absolute change in tumor size from 0-6 and 6-12 weeks) and percent change (relative change in tumor size from 0-6 and 6-12 weeks) metrics to predict OS using Cox models, adjusted for average baseline tumor size. Metrics were evaluated by discrimination (via concordance or c-index), calibration (goodness-of-fit type statistics), association (hazard ratios), and likelihood (Bayesian Information Criteria), with primary focus on the c-index. All statistical tests were two-sided.

resultsComparison of c-indices suggests slight improvement in predictive ability for the continuous tumor measurement-based metrics vs categorical RECIST response metrics, with slope metrics performing better than percent change metrics for breast cancer and NSCLC. However, these differences were not statistically significant. The goodness-of-fit statistics for the RECIST metrics were as good as or better than those for the continuous metrics. In general, all the metrics performed poorly in breast cancer, compared with NSCLC and colorectal cancer.

conclusionAbsolute and relative change in tumor measurements do not demonstrate convincingly improved overall survival predictive ability over the RECIST model. Continued work is necessary to address issues of missing tumor measurements and model selection in identifying improved tumor measurement-based metrics.

Indexed as

Models, StatisticalBayes TheoremBreast NeoplasmsCarcinoma, Non-Small-Cell LungClinical Trials, Phase II as TopicColorectal NeoplasmsFemaleHumansLung NeoplasmsMaleNeoplasmsOdds RatioPredictive Value of TestsPrognosisProportional Hazards ModelsTumor Burden

Identifiers

PMID26296640
PMCPMC4643633
OpenAlexW1800541283

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.