Evidence map›Paper›PMID 30657399›Full record

SynthesisJCO clinical cancer informatics2017

Predicting Successful Phase Advancement and Regulatory Approval in Multiple Myeloma From Phase I Overall Response Rates.

Ehsan Malek, Caner Saygin, Rebecca Ye, Fahrettin Covut, Byung-Gyu Kim, Jeffrey Welge, Neal J Meropol, Marcos De Lima, James J Driscoll

Abstract readMeta-AnalysisReview
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in JCO clinical cancer informatics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

9 authors.

Ehsan MalekEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Caner SayginEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Rebecca YeEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Fahrettin CovutEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Byung-Gyu KimEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Jeffrey WelgeEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Neal J MeropolEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
Marcos De LimaEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.
James J DriscollEhsan Malek, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, University Hospitals Seidman Cancer Center; Ehsan Malek, Byung-Gyu Kim, Fahrettin Covut, Neal J. Meropol, and Marcos De Lima, Case Western Reserve University Case Comprehensive Cancer Center; Caner Saygin, Taussig Cancer Institute; Rebecca Ye, Case Western Reserve University, Cleveland; Jeffrey Welge, University of Cincinnati; and James J. Driscoll, The Vontz Center for Molecular Studies, University of Cincinnati College of Medicine, Cincinnati, OH.

Funding

TRANSLATIONAL RESEARCH ONCOLOGY TRAINING GRANTK12CA076917 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI GERSON, STANTON L. · 1997 to 2022
$14.2M
NCI NIH HHS K12 CA076917
6 · The paper itself

Abstract

purposeDrug development in oncology is resource intensive, time consuming, and frequently unsuccessful. Here, we hypothesized that therapeutic benefit of published phase I studies of antimyeloma investigational agents was associated with advancement to phase II and future regulatory approval. PATIENTS AND

methodsSeventy four phase I trials that treated patients with multiple myeloma (n = 2,408) conducted from 2004 to 2015 were analyzed to assess drug safety, efficacy, phase advancement, and regulatory approval.

resultsThe median overall response rate (ORR) for all single-agent trials evaluated was 13.2%. However, the ORR in trials that advanced to phase II was 19%, whereas it was only 4% in trials that failed to advance. The median ORR was 23% for trials testing agents that were ultimately approved by the US Food and Drug Administration compared with only 8% for trials testing agents that were not approved (hazard ratio, 2.21; 95% CI, 2.01 to 2.61; P = .012). Importantly, the absolute number of phase I trials in multiple myeloma, but not the success rate, significantly increased over the period studied. The proportion of industry-sponsored trials also steadily increased over that same period. The ratio of initial dose to maximum tolerated dose was 0.29, suggesting that many patients were undertreated.

conclusionInvestigational agents with higher ORRs in phase I trials were more likely to advance to phase II trials and achieve US Food and Drug Administration approval. Our results suggest that designing phase I trials to maximize the antimyeloma efficacy of a given compound may lead to more successful and cost-effective drug development.

Indexed as

Antineoplastic AgentsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDrug ApprovalDrugs, InvestigationalFemaleHumansMaleMultiple MyelomaPrognosisTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationAntineoplastic AgentsDrugs, Investigational

Identifiers

PMID30657399
PMCPMC9797233

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.