Evidence map›Paper›PMID 31477881›Full record

ReviewNature reviews. Clinical oncology2019

Phase I trials as valid therapeutic options for patients with cancer.

Jacob J Adashek, Patricia M LoRusso, David S Hong, Razelle Kurzrock

Abstract readReview
In one paragraph

Review in Nature reviews. Clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing 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

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

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Inequities in enrollment across clinical trial phases and the need for a Spanish perspective.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  5. Article
  6. Article
  7. Considering the caregiver in early-phase clinical trials: a review of trial protocols and consent forms.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  8. Article
  9. Article
  10. Review
  11. Use of supportive care services and advance care planning among early phase oncology clinical trial participants.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Efficacy assessment in phase I clinical trials: endpoints and challenges.Annals of oncology : official journal of the European Society for Medical Oncology · 2025
    Review
  17. Article
  18. Article
  19. Emerging Ethical Challenges in Manufacturing of Cell-Based Medicines.Advances in experimental medicine and biology · 2025
    Review
  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.

Jacob J AdashekDepartment of Internal Medicine, University of South Florida, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.ORCID http://orcid.org/0000-0003-4272-312X
Patricia M LoRussoEarly Therapeutics Program, Yale Cancer Center, New Haven, CT, USA.
David S HongDepartment of Investigational Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Razelle KurzrockCenter for Personalized Cancer Therapy, Department of Medicine, University of California San Diego Moores Cancer Center, La Jolla, CA, USA. rkurzrock@ucsd.edu.ORCID http://orcid.org/0000-0003-4110-1214

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DIANE M SIMEONE · 1985 to 2026
$124.9M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA023100
6 · The paper itself

Abstract

For many years, oncology phase I trials have been referred to as 'toxicity trials' and have been believed to have low clinical utility other than that of establishing the adverse event profile of novel therapeutic agents. The traditional distinction of clinical trials into three phases has been challenged in the past few years by the introduction of targeted therapies and immunotherapies into the routine management of patients with cancer. This transformation has especially affected early phase trials, leading to the current situation in which response rates are increasingly reported from phase I trials. In this Perspectives, we highlight key elements of phase I trials and discuss how each one of them contributes to a new paradigm whereby preliminary measurements of the clinical benefit from a novel treatment can be obtained in current phase I trials, which can therefore be considered to have a therapeutic intent.

Indexed as

Clinical Trials, Phase I as TopicChoice BehaviorDrug-Related Side Effects and Adverse ReactionsDrugs, InvestigationalHumansImmunotherapyMedical OncologyMolecular Targeted TherapyNeoplasmsTherapies, InvestigationalDrugs, Investigational

Identifiers

PMID31477881
PMCPMC6868302

What OpenQuestion holds

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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.