Evidence map›Paper›PMID 35550709›Full record

Trial reportGynecologic oncology2022

Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study.

Roisin E O'Cearbhaill, Jose-Alejandro Pérez-Fidalgo, Bradley J Monk, Ignacio Tusquets, Colleen McCormick, Jose Fuentes, Richard G Moore, Christof Vulsteke, Mark S Shahin, Frédéric Forget and 15 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
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 NCT02655016 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy), which is not on this map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
6.5field-weighted citation impact, top 3% 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.

NCT02655016 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

TypeinterventionalSponsorTesaro, Inc.Ran2016 to 2026Enrolled733ConditionsOvarian NeoplasmsArmsNiraparib, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  5. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 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

25 authors at 20 institutions in 10 countries.

Roisin E O'CearbhaillGOG Foundation and the Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: ocearbhr@mskcc.org.
Jose-Alejandro Pérez-FidalgoDepartment of Medical Oncology, INCLIVA University Hospital of Valencia, CIBERONC, Valencia, Spain.
Bradley J MonkArizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA.
Ignacio TusquetsMedical Oncology Department, Hospital del Mar, Barcelona, Spain.
Colleen McCormickGOG and Legacy Medical Group Gynecologic Oncology, Portland, OR, USA.
Jose FuentesServicio de Oncologia, Hospital de Valme, Sevilla, Spain.
Richard G MooreDivision of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester, NY, USA.
Christof VulstekeBGOG and the Department of Medical Oncology and Hematology, AZ Maria Middelares, Ghent, Belgium, and the Department of Molecular Imaging, Pathology, Radiotherapy, and Oncology, Center for Oncological Research, Antwerp University, Antwerp, Belgium.
Mark S ShahinAbington Hospital-Jefferson Health, Sidney Kimmel Cancer Center of Thomas Jefferson University, Willow Grove, PA, USA.
Frédéric ForgetDepartment of Medical Oncology, Libramont Hospital, Libramont, Belgium.
William H BradleyGOG and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, USA.
Sakari HietanenDepartment of Obstetrics and Gynecology, Turku University Hospital and FICAN West, Turku, Finland.
David M O'MalleyOhio State University, James Comprehensive Cancer Center, Columbus, OH, USA.
Anne DørumGynecologic Oncology, Oslo University Hospital, The Norwegian Radiumhospital, Oslo, Norway.
Brian M SlomovitzBroward Health, Mount Sinai Medical Center, Florida International University Wertheim College of Medicine, Miami Beach, FL, USA.
Klaus BaumannArbeitsgemeinschaft Gynäkologische Onkologie and the Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
Frédéric SelleGINECO and Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris, France.
Paula M CalvertCancer Trials Ireland, Dublin, Ireland.
Grazia ArtioliUlss2 Oncologia Medica Marca Trevigiana, Treviso, Italy.
Tally LevyDepartment of Obstetrics and Gynecology, Wolfson Medical Center, Sackler School of Medicine, Tel Aviv University, Holon, Israel.
Aalok KumarDepartment of Medical Oncology, BC Cancer, Fraser Valley Cancer Centre, Surrey, BC, Canada.
Izabela A MalinowskaGlaxoSmithKline, Waltham, MA, USA.
Yong LiGlaxoSmithKline, Waltham, MA, USA.
Divya GuptaGlaxoSmithKline, Waltham, MA, USA.
Antonio González-MartínGrupo Español de Investigación en Cáncer de Ovario (GEICO), the Medical Oncology Department, Clínica Universidad de Navarra, and Program in Solid Tumors, Center for Applied Medical Research (CIMA), Madrid, Spain.
GlaxoSmithKline (United States) · USAzienda ULSS 9 TREVISO · ITAZ Maria Middelares · BECancer Trials Ireland · IECentro de Investigación Biomédica en Red de Cáncer · ESGroupe Hospitalier Diaconesses Croix Saint-Simon · FRGynecologic Oncology Group · USHospital Del Mar · ESHospital Universitario de Valme · ESJefferson Hospital · USKlinikum Ludwigshafen · DEMedical College of Wisconsin · USMount Sinai Medical Center · USOslo University Hospital · NOSpanish Ovarian Cancer Research Group · ESThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USTurku University Hospital · FIUniversity of Arizona · USUniversity of Rochester · USWolfson Medical Center · IL

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

objectiveTo evaluate the association between surgical timing and postoperative residual disease status on the efficacy of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer at high risk of recurrence.

methodsPost hoc analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) study of niraparib in patients with newly diagnosed primary advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete/partial response to first-line platinum-based chemotherapy. Progression-free survival (PFS) was assessed by surgical status (primary debulking surgery [PDS] vs neoadjuvant chemotherapy/interval debulking surgery [NACT/IDS]) and postoperative residual disease status (no visible residual disease [NVRD] vs visible residual disease [VRD]) in the intent-to-treat population.

resultsIn PRIMA (N = 733), 236 (32.2%) patients underwent PDS, and 481 (65.6%) received NACT/IDS before enrollment. Median PFS (niraparib vs placebo) and hazard ratios (95% CI) for progression were similar in PDS (13.7 vs 8.2 months; HR, 0.67 [0.47-0.96]) and NACT/IDS (14.2 vs 8.2 months; HR, 0.57 [0.44-0.73]) subgroups. In patients who received NACT/IDS and had NVRD (n = 304), the hazard ratio (95% CI) for progression was 0.65 (0.46-0.91). In patients with VRD following PDS (n = 183) or NACT/IDS (n = 149), the hazard ratios (95% CI) for progression were 0.58 (0.39-0.86) and 0.41 (0.27-0.62), respectively. PFS was not evaluable for patients with PDS and NVRD because of sample size (n = 37).

conclusionsIn this post hoc analysis, niraparib efficacy was similar across PDS and NACT/IDS subgroups. Patients who had NACT/IDS and VRD had the highest reduction in the risk of progression with niraparib maintenance.

Indexed as

Ovarian NeoplasmsCarcinoma, Ovarian EpithelialChemotherapy, AdjuvantCytoreduction Surgical ProceduresFemaleHumansIndazolesNeoadjuvant TherapyNeoplasm, ResidualNeoplasm StagingPiperidinesIndazolesniraparibPiperidinesMaintenance therapyNiraparibOvarian cancerPARP inhibitorSurgery

Identifiers

PMID35550709
PMCPMC10025898
OpenAlexW4229450749

What OpenQuestion holds

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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.