Evidence map›Paper›PMID 33988475›Full record

ArticleRadiology. Imaging cancer2021

A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials.

Kathleen Ruchalski, Marta Braschi-Amirfarzan, Michael Douek, Victor Sai, Antonio Gutierrez, Rohit Dewan, Jonathan Goldin

Abstract read
In one paragraph

Article in Radiology. Imaging cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Guideline
  2. Guideline
  3. Pooled it
  4. Trial
  5. Article
  6. Same-Patient, Same-Time Point Evidence for Radiomics Benchmarking.Journal of medical Internet research · 2026
    Article
  7. Article
  8. Article
  9. Oncology research · 2026
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Observational
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

7 authors.

Kathleen RuchalskiFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).ORCID 0000-0001-7988-8484
Marta Braschi-AmirfarzanFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).
Michael DouekFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).ORCID 0000-0002-0806-5277
Victor SaiFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).
Antonio GutierrezFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).ORCID 0000-0002-0813-4025
Rohit DewanFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).
Jonathan GoldinFrom the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug discovery and approval in oncology is mediated by the use of imaging to evaluate drug efficacy in clinical trials. Imaging is performed while patients receive therapy to evaluate their response to treatment. Response criteria, specifically Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), are standardized and can be used at different time points to classify response into the categories of complete response, partial response, stable disease, or disease progression. At the trial level, categorical responses for all patients are summated into image-based trial endpoints. These outcome measures, including objective response rate (ORR) and progression-free survival (PFS), are characteristics that can be derived from imaging and can be used as surrogates for overall survival (OS). Similar to OS, ORR and PFS describe the efficacy of a drug. U.S. Food and Drug Administration (FDA) regulatory approval requires therapies to demonstrate direct evidence of clinical benefit, such as improved OS. However, multiple programs have been created to expedite drug approval for life-threatening illnesses, including advanced cancer. ORR and PFS have been accepted by the FDA as adequate predictors of OS on which to base drug approval decisions, thus substantially shortening the time and cost of drug development (1). Use of imaging surrogate markers for drug approval has become increasingly common, accounting for more than 90% of approvals through the Accelerated Approval Program and allowing for use of many therapies which have altered the course of cancer.

Indexed as

Medical OncologyPharmaceutical PreparationsEndpoint DeterminationHumansProgression-Free SurvivalResponse Evaluation Criteria in Solid TumorsPharmaceutical PreparationsOncologyTumor Response

Identifiers

PMID33988475
PMCPMC8183261

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.