Evidence map›Paper›PMID 33928209›Full record

Trial reportJCO precision oncology2021

Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT): A Randomized Multicenter Phase II Trial.

Alice P Chen, Shivaani Kummar, Nancy Moore, Lawrence V Rubinstein, Yingdong Zhao, P Mickey Williams, Alida Palmisano, David Sims, Geraldine O'Sullivan Coyne, Christina L Rosenberger and 15 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JCO precision oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06842030 (Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing to Improve Outcomes for Patients With Limited Metastatic Disease That Failed First-Line Systemic Therapy), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 8% 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.

NCT06842030 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing to Improve Outcomes for Patients With Limited Metastatic Disease That Failed First-Line Systemic Therapy

TypeinterventionalSponsorGood Samaritan Hospital Medical Center, New YorkRan2025 to 2027Enrolled20ConditionsPersonalized Medicine, Oligometastatic Disease, FeasibilityArmsDarwin OncoTarget and OncoTreat
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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  20. Making In Vitro Tumor Models Whole Again.Advanced healthcare materials · 2023
    Review
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

25 authors at 7 institutions in 1 country.

Alice P ChenDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Shivaani KummarDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Nancy MooreDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Lawrence V RubinsteinDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Yingdong ZhaoDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
P Mickey WilliamsMolecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
Alida PalmisanoDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
David SimsMolecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
Geraldine O'Sullivan CoyneDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Christina L RosenbergerDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Mel SimpsonApplied/Developmental Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD.
Kanwal P S RaghavDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Funda Meric-BernstamDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Stephen LeongUniversity of Colorado Cancer Center, Aurora, CO.
Saiama WaqarDepartment of Medical Oncology, Washington University School of Medicine, St Louis, MO.
Jared C FosterDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Mariam M KonatéDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Biswajit DasMolecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
Chris KarlovichMolecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
Chih-Jian LihMolecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
Eric PolleyDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.
Richard SimonDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Ming-Chung LiDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Richard PiekarzDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
James H DoroshowDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
National Cancer Institute · USFrederick National Laboratory for Cancer Research · USThe University of Texas MD Anderson Cancer Center · USMayo Clinic · USOregon Health & Science University · USUniversity of Colorado Cancer Center · USWashington University in St. Louis · US

Funding

Phase 01 Clinical TrialsZIABC011078 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI DOROSHOW, JAMES · 2009 to 2025
$9.0M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

This trial assessed the utility of applying tumor DNA sequencing to treatment selection for patients with advanced, refractory cancer and somatic mutations in one of four signaling pathways by comparing the efficacy of four study regimens that were either matched to the patient's aberrant pathway (experimental arm) or not matched to that pathway (control arm). MATERIALS AND

methodsAdult patients with an actionable mutation of interest were randomly assigned 2:1 to receive either (1) a study regimen identified to target the aberrant pathway found in their tumor (veliparib with temozolomide or adavosertib with carboplatin [DNA repair pathway], everolimus [PI3K pathway], or trametinib [RAS/RAF/MEK pathway]), or (2) one of the same four regimens, but chosen from among those not targeting that pathway.

resultsAmong 49 patients treated in the experimental arm, the objective response rate was 2% (95% CI, 0% to 10.9%). One of 20 patients (5%) in the experimental trametinib cohort had a partial response. There were no responses in the other cohorts. Although patients and physicians were blinded to the sequencing and random assignment results, a higher pretreatment dropout rate was observed in the control arm (22%) compared with the experimental arm (6%;

conclusionFurther investigation, better annotation of predictive biomarkers, and the development of more effective agents are necessary to inform treatment decisions in an era of precision cancer medicine. Increasing prevalence of tumor mutation profiling and preference for targeted therapy make it difficult to use a randomized phase II design to evaluate targeted therapy efficacy in an advanced disease setting.

Indexed as

Antineoplastic AgentsNeoplasmsAdultAgedAged, 80 and overBenzimidazolesCarboplatinDNA, NeoplasmDouble-Blind MethodEverolimusFemaleGene Expression ProfilingHumansMaleMiddle AgedMolecular Diagnostic TechniquesadavosertibAntineoplastic AgentsBenzimidazolesCarboplatinDNA, NeoplasmEverolimusPyrazolesPyridonesPyrimidinonesTemozolomidetrametinibveliparib

Identifiers

PMID33928209
PMCPMC8078898
OpenAlexW3119951367

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.