Evidence map›Paper›PMID 32528101›Full record

ReviewNature reviews. Clinical oncology2020

Histology-agnostic drug development - considering issues beyond the tissue.

Roberto Carmagnani Pestana, Shiraj Sen, Brian P Hobbs, David S Hong

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature reviews. Clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 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

40 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Article
  4. Article
  5. Agnostic Biomarkers in Molecular Pathology.Journal of clinical practice and research · 2025
    Review
  6. Pyrazolo[1,5-Molecules (Basel, Switzerland) · 2024
    Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Tumor-Agnostic Precision Medicine from the AACR GENIE Database: Clinical Implications.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  15. Combination Early-Phase Trials of Anticancer Agents in Children and Adolescents.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Review
  16. Impact of Biomarker-Matched Therapies on Outcomes in Patients with Sarcoma Enrolled in Early-Phase Clinical Trials (SAMBA 101).Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  17. Review
  18. Article
  19. Examining Stripes on a Herd of Zebras: Impact of Genomic Matching for Ultrarare Sarcomas in Phase 1 Clinical Trials (SAMBA 102).Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  20. Article
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

4 authors.

Roberto Carmagnani PestanaDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shiraj SenSarah Cannon Research Institute, Denver, CO, USA.
Brian P HobbsTaussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.
David S HongDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. dshong@mdanderson.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With advances in tumour biology and immunology that continue to refine our understanding of cancer, therapies are now being developed to treat cancers on the basis of specific molecular alterations and markers of immune phenotypes that transcend specific tumour histologies. With the landmark approvals of pembrolizumab for the treatment of patients whose tumours have high microsatellite instability and larotrectinib and entrectinib for those harbouring NTRK fusions, a regulatory pathway has been created to facilitate the approval of histology-agnostic indications. Negative results presented in the past few years, however, highlight the intrinsic complexities faced by drug developers pursuing histology-agnostic therapeutic agents. When patient selection and statistical analysis involve multiple potentially heterogeneous histologies, guidance is needed to navigate the challenges posed by trial design. Additionally, as new therapeutic agents are tested and post-approval data become available, the regulatory framework for acting on these data requires further optimization. In this Review, we summarize the development and testing of approved histology-agnostic therapeutic agents and present data on other agents currently under development. Finally, we discuss the challenges intrinsic to histology-agnostic drug development in oncology, including biological, regulatory, design and statistical considerations.

Indexed as

Drug DevelopmentMolecular Targeted TherapyAntineoplastic Agents, ImmunologicalBiomarkers, TumorClinical Trials as TopicGene Expression Regulation, NeoplasticHumansNeoplasmsPrecision MedicineAntineoplastic Agents, ImmunologicalBiomarkers, Tumor

Identifiers

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.