Evidence map›Paper›PMID 32452601›Full record

ArticleThe oncologist2020

Phase I Study of Veliparib on an Intermittent and Continuous Schedule in Combination with Carboplatin in Metastatic Breast Cancer: A Safety and [18F]-Fluorothymidine Positron Emission Tomography Biomarker Study.

Robert Wesolowski, Daniel G Stover, Maryam B Lustberg, Abigail Shoben, Meng Zhao, Ewa Mrozek, Rachel M Layman, Erin Macrae, Wenrui Duan, Jun Zhang and 18 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
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  6. Comparison ofTomography (Ann Arbor, Mich.) · 2022
    Article
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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

28 authors at 10 institutions in 1 country.

Robert Wesolowski *Stefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.
Daniel G Stover *Stefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.ORCID 0000-0001-9003-8165
Maryam B LustbergStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.
Abigail ShobenThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Meng ZhaoStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.
Ewa MrozekMercy Health - St. Rita's Medical Center, Lima, Ohio, USA.
Rachel M LaymanUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Erin MacraeColumbus Oncology, Columbus, Ohio, USA.
Wenrui DuanThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Jun ZhangThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Nathan HallThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Chadwick L WrightThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Susan GillespieStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.
Michael BergerStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.
Jeffrey J ChalmersThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Alahdra CareyThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Priya BalasubramanianThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Brandon L MillerThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Peter AmayaThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Eleni AndreopoulouWeill Cornell Medicine, New York, New York, USA.
Joseph SparanoMontefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Charles L ShapiroTisch Cancer Institute, Mt. Sinai Hospital, New York, New York, USA.
Miguel Angel Villalona-CaleroMiami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.
Susan GeyerUniversity of South Florida, Tampa, Florida, USA.
Alice ChenNational Cancer Institute, Bethesda, Maryland, USA.
Michael R GreverThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Michael V KnoppThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Bhuvaneswari RamaswamyStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, Ohio, USA.
The Ohio State University · USBaptist Health South Florida · USColumbus Oncology and Hematology Associates · USMontefiore Medical Center · USNational Cancer Institute · USSinai Hospital · USSt. Rita's Medical Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of South Florida · USWeill Cornell Medicine · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
Translational Training Grant in Experimental TherapeuticsK12CA133250 · NCI · OHIO STATE UNIVERSITY · PI WILLIAM E. CARSON, Rosa Lapalombella · 2008 to 2026
$15.0M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA076576 · NCI · OHIO STATE UNIVERSITY · PI GREVER, MICHAEL R · 1998 to 2013
$9.1M
NCI NIH HHS K12 CA133250NCI NIH HHS P30 CA016058NCI NIH HHS U01 CA076576NCI NIH HHS UG1 CA189859NCI NIH HHS UM1 CA186712
6 · The paper itself

Abstract

backgroundPoly(ADP-ribose) polymerase inhibitors (PARPis) are U.S. Food and Drug Administration (FDA) approved for treatment of BRCA-mutated metastatic breast cancer. Furthermore, the BROCADE studies demonstrated benefit of adding an oral PARPi, veliparib, to carboplatin and paclitaxel in patients with metastatic breast cancer harboring BRCA mutation. Given multiple possible dosing schedules and the potential benefit of this regimen for patients with defective DNA repair beyond BRCA, we sought to find the recommended phase II dose (RP2D) and schedule of veliparib in combination with carboplatin in patients with advanced breast cancer, either triple-negative (TNBC) or hormone receptor (HR)-positive, human epidermal growth receptor 2 (HER2) negative with defective Fanconi anemia (FA) DNA-repair pathway based on FA triple staining immunofluorescence assay. MATERIALS AND

methodsPatients received escalating doses of veliparib on a 7-, 14-, or 21-day schedule with carboplatin every 3 weeks. Patients underwent [18]fluoro-3'-deoxythymidine (

resultsForty-four patients (39 TNBC, 5 HR positive/HER2 negative with a defective FA pathway) received a median of 5 cycles (range 1-36). Observed dose-limiting toxicities were grade (G) 4 thrombocytopenia (n = 4), G4 neutropenia (n = 1), and G3 akathisia (n = 1). Common grade 3-4 toxicities included thrombocytopenia, lymphopenia, neutropenia, anemia, and fatigue. Of the 43 patients evaluable for response, 18.6% achieved partial response and 48.8% had stable disease. Median progression-free survival was 18.3 weeks. RP2D of veliparib was established at 250 mg twice daily on days 1-21 along with carboplatin at area under the curve 5. Patients with partial response had a significant drop in maximum standard uptake value (SUV

conclusionThe combination of continuous dosing of veliparib and every-3-week carboplatin demonstrated activity and an acceptable toxicity profile. Decrease in SUV IMPLICATIONS FOR PRACTICE: The BROCADE studies suggest that breast cancer patients with BRCA mutation benefit from addition of veliparib to carboplatin plus paclitaxel. This study demonstrates that a higher dose of veliparib is tolerable and active in combination with carboplatin alone. With growing interest in imaging-based early response assessment, the authors demonstrate that decrease in [18]fluoro-3'-deoxythymidine positron emission tomography (FLT-PET) SUV

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBiomarkersCarboplatinFemaleHumansPositron-Emission TomographyBenzimidazolesBiomarkersCarboplatinveliparibFluorothymidine positron emission tomography scanHomologous recombination DNA repairMetastatic breast cancerPhase I clinical trialsPoly(ADP-ribose) polymerase inhibitors

Identifiers

PMID32452601
PMCPMC7418347
OpenAlexW3028787365

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.