Evidence map›Paper›PMID 34930617›Full record

Trial reportGynecologic oncology2022

Impact of veliparib, paclitaxel dosing regimen, and germline BRCA status on the primary treatment of serous ovarian cancer - an ancillary data analysis of the VELIA trial.

Carol Aghajanian, Elizabeth M Swisher, Aikou Okamoto, Karina Dahl Steffensen, Michael A Bookman, Gini F Fleming, Michael Friedlander, Kathleen N Moore, Krishnansu S Tewari, David M O'Malley and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gynecologic oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02470585 (A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 21% 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.

NCT02470585 phase3terminatednot on this map

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

TypeinterventionalSponsorAbbVieRan2015 to 2023Enrolled1,140ConditionsOvarian Cancer, Ovarian NeoplasmArmsVeliparib, Paclitaxel, Carboplatin, Placebo to Veliparib
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Observational
  7. Review
  8. Review
  9. Review
  10. Mechanisms of PARP Inhibitor Resistance.Cancer treatment and research · 2023
    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

16 authors at 14 institutions in 4 countries.

Carol AghajanianMemorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: aghajanc@MSKCC.ORG.
Elizabeth M SwisherDepartment of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.
Aikou OkamotoDepartment of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
Karina Dahl SteffensenDepartment of Oncology, Lillebaelt University Hospital of Southern Denmark, Vejle, Denmark.
Michael A BookmanKaiser Permanente Northern California, San Francisco, CA, USA.
Gini F FlemingThe University of Chicago Medicine, Chicago, IL, USA.
Michael FriedlanderPrince of Wales Clinical School UNSW, Prince of Wales Hospital and ANZGOG, Sydney, Australia.
Kathleen N MooreStephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Krishnansu S TewariUniversity of California, Irvine Medical Center, Orange, CA, USA.
David M O'MalleyThe Ohio State University Comprehensive Cancer Center - James, Columbus, OH, USA.
John K ChanPalo Alto Medical Foundation, California Pacific Medical Center, Sutter Health, San Francisco, CA, USA.
Christine RatajczakAbbVie Inc., North Chicago, IL, USA.
Hideyuki HashibaAbbVie GK, Tokyo, Japan.
Meijing WuAbbVie Inc., North Chicago, IL, USA.
Minh H DinhAbbVie Inc., North Chicago, IL, USA.
Robert L ColemanUS Oncology Research, The Woodlands, TX, USA.
AbbVie (United States) · USAbbVie (Japan)Australia New Zealand Gynaecological Oncology Group · AUJikei University School of Medicine · JPKaiser Permanente · USLillebaelt Hospital · DKMemorial Sloan Kettering Cancer Center · USSutter Health · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe US Oncology Network · USUniversity of California, Irvine Medical Center · USUniversity of Chicago · USUniversity of Oklahoma Health Sciences Center · USUniversity of Washington · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectiveIn the Phase 3 VELIA trial (NCT02470585), veliparib added to carboplatin plus paclitaxel concomitantly and as maintenance for women with newly-diagnosed advanced ovarian cancer significantly improved progression-free survival (PFS) versus chemotherapy alone. Here we present exploratory analyses by paclitaxel dosing schedule and germline BRCA (gBRCA) status.

methodsWomen with untreated ovarian carcinoma were randomized (1:1:1) to: veliparib during chemotherapy and maintenance (veliparib-throughout), veliparib during chemotherapy followed by placebo maintenance (veliparib-combination only), or placebo during chemotherapy and maintenance (control). Chemotherapy included carboplatin plus dose-dense (DD; weekly) or every-3-week (Q3W) paclitaxel (a stratification factor at randomization), selected at the investigator's discretion pre-randomization. PFS was assessed by paclitaxel dosing schedule using a Cox proportional hazard model adjusted by treatment arm and stratification factors; safety was analyzed based on paclitaxel dosing schedule and gBRCA status.

results1132 patients were analyzed by paclitaxel schedule. Pooled treatment arms demonstrated longer median PFS with DD (n = 586) versus Q3W (n = 546) paclitaxel (ITT: 20.5 vs 15.7 months, hazard ratio [HR] 0.77; homologous recombination proficient cancer: 15.1 vs 11.8 months, HR 0.64; BRCAwt: 18.0 vs 12.9 months, HR 0.70). Comparison between arms favored veliparib-throughout versus control in both DD (PFS, 24.2 vs 18.3 months, hazard ratio 0.67) and Q3W (19.3 vs 14.6, hazard ratio 0.69) subgroups. DD paclitaxel was associated with higher incidence of Grade 3/4 neutropenia, fatigue, and anemia versus Q3W. There were no differences in toxicity between gBRCAm (n = 211) and gBRCAwt (n = 902) subgroups.

conclusionsDD paclitaxel was tolerable and associated with longer PFS in the HR proficient and gBRCAwt groups, versus Q3W. gBRCA status did not impact safety.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarboplatinCarcinoma, Ovarian EpithelialDrug Administration ScheduleFemaleGenes, BRCA1Genes, BRCA2Germ-Line MutationHereditary Breast and Ovarian Cancer SyndromeHumansInduction ChemotherapyMaintenance ChemotherapyBenzimidazolesCarboplatinPaclitaxelPoly(ADP-ribose) Polymerase InhibitorsveliparibDose-dense paclitaxelgBRCAHomologous recombination deficiencyOvarian cancerPARP inhibitorVeliparib

Identifiers

PMID34930617
PMCPMC9399938
OpenAlexW4200037850

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.