Evidence map›Paper›PMID 24240109›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2014

Tumor growth rate is an early indicator of antitumor drug activity in phase I clinical trials.

Charles Ferté, Marianna Fernandez, Antoine Hollebecque, Serge Koscielny, Antonin Levy, Christophe Massard, Rastislav Balheda, Brian Bot, Carlos Gomez-Roca, Clarisse Dromain and 2 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04722406 (Tumor Growth Rate), which is not on this map. Cited by 98 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 2 pooled it
2.4field-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.

NCT04722406 unknown statusnot on this mapstarted 2019, after this paper: background citation

Tumor Growth Rate (TGR) as an Early Predictor of Clinical Outcomes in Advanced Non-small Cell Lung Cancer Treated With PD-1 Axis Inhibitors.

TypeobservationalSponsorSun Yat-sen UniversityRan2019 to 2021Enrolled350ConditionsNon-Small Cell Lung CancerArmsThis item is not applicable to our observational study.
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 2 syntheses or guidelines pooled it, 173 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  5. Trial
  6. Trial
  7. A Phase II Study of Dovitinib in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Efficacy assessment in phase I clinical trials: endpoints and challenges.Annals of oncology : official journal of the European Society for Medical Oncology · 2025
    Review
  18. Article
  19. Article
  20. Article

38 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Charles FertéAuthors' Affiliations: Departments of Medical Oncology, Biostatistics and Epidemiology, Innovative Therapeutics and Early Drug Development, Radiology, and Radiotherapy; INSERM U981, University Paris Sud, Gustave Roussy, Villejuif, France; and Sage Bionetworks, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Marianna Fernandez
Antoine Hollebecque
Serge Koscielny
Antonin Levy
Christophe Massard
Rastislav Balheda
Brian Bot
Carlos Gomez-Roca
Clarisse Dromain
Samy Ammari
Jean-Charles Soria
Fred Hutch Cancer Center · USCancer Research Center · USSage Bionetworks · USInserm · FRInstitut Gustave Roussy · FR

Funding

Integrating cancer datasets for predictive model development and trainingU54CA149237 · NCI · SAGE BIONETWORKS · PI FRIEND, STEPHEN HENRY · 2010 to 2014
$8.9M
NCI NIH HHS U54 CA149237NCI NIH HHS U54CA149237
6 · The paper itself

Abstract

purposeResponse Evaluation Criteria in Solid Tumors (RECIST) evaluation does not take into account the pretreatment tumor kinetics and may provide incomplete information about experimental drug activity. Tumor growth rate (TGR) allows for a dynamic and quantitative assessment of the tumor kinetics. How TGR varies along the introduction of experimental therapeutics and is associated with outcome in phase I patients remains unknown. EXPERIMENTAL

designMedical records from all patients (N = 253) prospectively treated in 20 phase I trials were analyzed. TGR was computed during the pretreatment period (reference) and the experimental period. Associations between TGR, standard prognostic scores [Royal Marsden Hospital (RMH) score], and outcome [progression-free survival (PFS) and overall survival (OS)] were computed (multivariate analysis).

resultsWe observed a reduction of TGR between the reference versus experimental periods (38% vs. 4.4%; P < 0.00001). Although most patients were classified as stable disease (65%) or progressive disease (25%) by RECIST at the first evaluation, 82% and 65% of them exhibited a decrease in TGR, respectively. In a multivariate analysis, only the decrease of TGR was associated with PFS (P = 0.004), whereas the RMH score was the only variable associated with OS (P = 0.0008). Only the investigated regimens delivered were associated with a decrease of TGR (P < 0.00001, multivariate analysis). Computing TGR profiles across different clinical trials reveals specific patterns of antitumor activity.

conclusionsExploring TGR in phase I patients is simple and provides clinically relevant information: (i) an early and subtle assessment of signs of antitumor activity; (ii) independent association with PFS; and (iii) it reveals drug-specific profiles, suggesting potential utility for guiding the further development of the investigational drugs.

Indexed as

AdultAgedAntineoplastic AgentsCell ProliferationClinical Trials, Phase I as TopicFemaleHumansMaleMiddle AgedMultivariate AnalysisNeoplasmsProportional Hazards ModelsProspective StudiesTreatment OutcomeTumor BurdenYoung AdultAntineoplastic Agents

Identifiers

PMID24240109
PMCPMC3947306
OpenAlexW2102673471

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.