Evidence map›Paper›PMID 25594147›Full record

Trial reportInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2015

A phase I-II evaluation of veliparib (NSC #737664), topotecan, and filgrastim or pegfilgrastim in the treatment of persistent or recurrent carcinoma of the uterine cervix: an NRG Oncology/Gynecologic Oncology Group study.

Charles Kunos, Wei Deng, Dawn Dawson, Jayanthi S Lea, Kristine M Zanotti, Heidi J Gray, David P Bender, Perry P Guaglianone, Jori S Carter, Kathleen N Moore

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
9.3field-weighted citation impact, top 2% 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

29 citing papers in PubMed, 63 citations in OpenAlex.

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  6. PARP inhibitors in non-ovarian gynecologic cancers.Therapeutic advances in medical oncology · 2024
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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

10 authors at 9 institutions in 1 country.

Charles Kunos*Summa Cancer Institute, Summa Health System, Akron, OH; †NRG Oncology/Gynecologic Oncology Group Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY; ‡Case Western Reserve University, Cleveland, OH; §UT Southwestern Medical Center, Dallas, TX; ∥University Hospitals Case Medical Center, Cleveland, OH; ¶University of Washington, Seattle, WA; #University of Iowa, Iowa City, IA; **Decatur Memorial Hospital, Cancer Care Specialists of Central Illinois, Decatur, IL; ††Virginia Commonwealth University, Richmond, VA; and ‡‡Oklahoma University Health Science Center, Oklahoma City, OK.
Wei Deng
Dawn Dawson
Jayanthi S Lea
Kristine M Zanotti
Heidi J Gray
David P Bender
Perry P Guaglianone
Jori S Carter
Kathleen N Moore
Cancer Care Specialists of Illinois · USCase Western Reserve University · USGynecologic Oncology Group · USOU HealthThe University of Texas Southwestern Medical Center · USUniversity Hospitals Case Medical Center · USUniversity of Iowa · USUniversity of Washington · USVirginia Commonwealth University · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
Lead Academic Participating Site for the Development and Conduct of NCTN TrialsU10CA180798 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI MANNEL, ROBERT S., MOORE, KATHLEEN N. · 2014 to 2018
$6.7M
NCI NIH HHS 1 U10 CA180822NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS L30 CA130084NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeThe aim of this study was to evaluate the tolerability and efficacy of poly(ADP-ribose) polymerase (PARP) inhibition by veliparib during cytotoxic topotecan administration with filgrastim or pegfilgrastim neutrophil support in women with persistent or recurrent uterine cervix cancer. EXPERIMENTAL

designThis phase I-II trial examined twice-daily oral veliparib (10 mg) given during once-daily intravenous topotecan (0.6 mg/m²) on days 1 to 5 of each treatment cycle. Cycles were repeated every 21 days until disease progression or until toxicity prohibited further therapy. Toxicity and objective response rate were primary endpoints.

resultsTwenty-seven women were enrolled. Frequently reported grade 3 or higher treatment-related toxicities were anemia (59%), thrombocytopenia (44%), leukopenia (22%), and neutropenia (19%). There were 2 partial responses (7% [90% confidence interval, 1%-22%]). Four patients had a disease progression date more than 6 months after the start of veliparib-topotecan therapy. Patients with low immunohistochemical expression (0-1+) of PARP-1 in their primary uterine cervix cancer were more likely to have a longer progression-free interval (hazard ratio, 0.25; P = 0.02) and survival (hazard ratio, 0.12; P = 0.005) after veliparib-topotecan therapy.

conclusionsClinical activity of a veliparib-topotecan combination was minimal in women with persistent or recurrent uterine cervix cancer. Women whose uterine cervix cancers express PARP-1 at low levels may benefit preferentially from PARP inhibitors combined with cytotoxic therapies, suggesting further study of PARP expression as an integral triage biomarker.

Indexed as

AdultAgedAnemiaAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarcinomaCell Cycle ProteinsDisease ProgressionFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedNeoplasm Recurrence, LocalNeutropeniaPoly (ADP-Ribose) Polymerase-1BenzimidazolesCell Cycle ProteinsFilgrastimGranulocyte Colony-Stimulating FactorPARP1 protein, humanPARP2 protein, humanpegfilgrastimPoly (ADP-Ribose) Polymerase-1Poly(ADP-ribose) PolymerasesPolyethylene GlycolsRecombinant ProteinsRibonucleotide ReductasesRRM2B protein, humanTopotecanveliparib

Identifiers

PMID25594147
PMCPMC4336206
OpenAlexW2329531543

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.