Evidence map›Paper›PMID 33610319›Full record

ArticleGynecologic oncology2021

Post hoc analyses of GOG 9923: Does BRCA status affect toxicities?: An NRG oncology study.

Jessica Gillen, Austin Miller, Katherine M Bell-McGuinn, Russell J Schilder, Joan L Walker, Cara A Mathews, Linda R Duska, Saketh R Guntupalli, Roisin O'Cearbhaill, John Hays and 8 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Gynecologic 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 NCT00989651 (A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

NCT00989651 phase1completednot on this map

A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2009 to 2020Enrolled431ConditionsFallopian Tube Carcinoma, Fallopian Tube Carcinosarcoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid AdenocarcinomaArmsBevacizumab, Carboplatin, Cisplatin, Laboratory Biomarker Analysis, Paclitaxel
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

18 authors at 14 institutions in 1 country.

Jessica GillenStephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, United States of America. Electronic address: Jessica-Gillen@ouhsc.edu.
Austin MillerNRG Oncology SDMC, CTD Division, Roswell Park Cancer Institute, Buffalo, NY, United States of America. Electronic address: millerA@nrgoncology.org.
Katherine M Bell-McGuinnMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, United States of America. Electronic address: Katherine.bellmcguinn@abbvie.com.
Russell J SchilderSidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America. Electronic address: russell.schilder@jefferson.edu.
Joan L WalkerStephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, United States of America. Electronic address: joan-walker@ouhsc.edu.
Cara A MathewsWomen and Infants Hospital of Rhode Island, Providence, RI, United States of America. Electronic address: cmathews@wihri.org.
Linda R DuskaUniversity of Virginia School of Medicine, Charlottesville, VA, United States of America. Electronic address: lduska@virginia.edu.
Saketh R GuntupalliUniversity of Colorado, Denver, CO, United States of America. Electronic address: saketh.guntupalli@UCDENVER.edu.
Roisin O'CearbhaillMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, United States of America. Electronic address: ocearbhr@mskcc.org.
John HaysThe Ohio State University, Columbus, OH, United States of America. Electronic address: john.hays@osumc.edu.
Andrea R HagemannWashington University, St. Louis, MO, United States of America. Electronic address: hagemanna@wustl.edu.
Heidi J GrayUniversity of Washington, Seattle, WA, United States of America. Electronic address: hgray@u.washington.edu.
Sarah W GordonVirginia Commonwealth University, Richmond, VA, United States of America. Electronic address: sarah.gordon@vcuhealth.org.
Deborah K ArmstrongJohns Hopkins University, Baltimore, MD, United States of America. Electronic address: armstde@jhmi.edu.
Alice ChenDivision of Cancer Treatment and Diagnosis, NCI, NIH, Bethesda, MD, United States of America. Electronic address: chenali@mail.nih.gov.
Paula M FracassoUniversity of Virginia School of Medicine, Charlottesville, VA, United States of America. Electronic address: fracasso@virginia.edu.
Carol AghajanianMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, United States of America. Electronic address: aghajanc@mskcc.org.
Kathleen N MooreStephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, United States of America. Electronic address: Kathleen-Moore@ouhsc.edu.
Memorial Sloan Kettering Cancer Center · USUniversity of Oklahoma · USUniversity of Virginia · USCenter for Cancer Research · USJohns Hopkins University · USNRG Oncology · USOklahoma State University Oklahoma City · USSidney Kimmel Cancer Center · USThe Ohio State University · USUniversity of Colorado Denver · USUniversity of Washington · USVirginia Commonwealth University · USWashington University in St. Louis · USWomen & Infants Hospital of Rhode Island · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
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, GREG YOTHERS · 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
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical TrialsUG1CA233193 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Muhammad Furqan · 2019 to 2026
$13.7M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233193NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233324NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

objectiveTo evaluate how women with epithelial ovarian cancer (EOC), dichotomized by BRCA status, tolerate intravenous (IV) or intraperitoneal (IP) chemotherapy given with veliparib and bevacizumab (bev) on a GOG phase I study (GOG 9923, NCT00989651).

methodsThis is an unplanned, post hoc analysis of an IRB approved, multi-institutional, prospective study (GOG 9923). Clinical characteristics and toxicity data based on BRCA status were evaluated and descriptive statistics were used to summarize baseline patient characteristics and toxicities. The Kaplan Meier method was used to generate survival estimates.

resultsFour hundred twenty-four patients were evaluable. Patients were treated with IV carboplatin, paclitaxel, and bev every 21 days (regimen 1), weekly IV paclitaxel with carboplatin and bev (regimen 2) or IV paclitaxel and bev with IP cisplatin (regimen 3). Bev was continued as maintenance in all arms. Within each of these regimens, veliparib was given either twice daily for the entirety of each cycle (continuous) or on days -2 to 5 (intermittent). Ten percent of patients treated on regimen 1, 12% on regimen 2, and 19.8% on regimen 3 had BRCA-associated tumors. Patients with BRCA-associated tumors, when compared to wild type, experienced similar rates of anemia, febrile neutropenia (, abdominal pain, colonic perforation, nausea, vomiting, and peripheral sensory neuropathy. Median progression free survival (PFS) was not significantly different between BRCA-associated and wild type cancers (HR 0.96, CI 0.65-1.42), though this study's primary aim was not to evaluate outcomes.

conclusionsGermline BRCA mutations positively affect chemosensitivity in EOC, but whether differences in toxicities among BRCA-associated and BRCA wild type tumors existed was previously not reported. In this population with newly diagnosed ovarian cancer no differences in reported toxicity between the two groups was observed.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBevacizumabBRCA1 ProteinBRCA2 ProteinCarboplatinCarcinoma, Ovarian EpithelialClinical Trials, Phase I as TopicFemaleGenes, BRCA1Genes, BRCA2Hematologic DiseasesHumansBenzimidazolesBevacizumabBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCarboplatinPaclitaxelveliparibBRCAEpithelial ovarian cancerPost hoc analysesToxicities

Identifiers

PMID33610319
PMCPMC8084973
OpenAlexW3133289667

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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.