Evidence map›Paper›PMID 38000795›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2023

Real-world data on niraparib maintenance treatment in patients with non-gBRCA mutated platinum-sensitive recurrent ovarian cancer.

Bente Vilming, Jørgen Fallås Dahl, Anne Gry Bentzen, Vibeke Anett Ingebrigtsen, Elisabeth Berge Nilsen, Ingvild Vistad, Anne Dørum, Olesya Solheim, Line Bjørge, Manuela Zucknick and 2 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 15% 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

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. Review
  6. Safety and management of niraparib monotherapy in ovarian cancer clinical trials.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Review
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

12 authors at 6 institutions in 1 country.

Bente VilmingDepartment of Gynecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway Bente.Vilming@ous-hf.no.ORCID 0000-0001-7873-415X
Jørgen Fallås DahlDepartment of Clinical and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Anne Gry BentzenDepartment of Gynecological Oncology, University Hospital of North Norway, Tromsø, Norway.
Vibeke Anett IngebrigtsenDepartment of Gynecological Oncology, University Hospital of North Norway, Tromsø, Norway.
Elisabeth Berge NilsenDepartment of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway.
Ingvild VistadDepartment of Gynaecology and Obstetrics, Hospital of Southern Norway, Kristiansand, Norway.
Anne DørumDepartment of Gynecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
Olesya SolheimDepartment of Gynecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.ORCID 0000-0003-1936-3453
Line BjørgeDepartment of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway.ORCID 0000-0002-0240-2770
Manuela ZucknickDepartment of Biostatistics, University of Oslo, Oslo, Norway.
Guro AuneDepartment of Clinical and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Kristina LindemannDepartment of Gynecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
Oslo University Hospital · NONorwegian University of Science and Technology · NOUniversity Hospital of North Norway · NOUniversity of Oslo · NOHaukeland University Hospital · NOStavanger University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to provide real-world efficacy and safety data on niraparib maintenance treatment in patients with non-germline (gBRCA)1/2 mutated platinum-sensitive recurrent ovarian cancer.

methodsThis retrospective multi-center cohort study included 94 platinum-sensitive recurrent ovarian cancer patients without known gBRCA1/2 mutation treated in an individual patient access program in Norway. The primary outcome was time from start of niraparib treatment to first subsequent treatment. Secondary endpoints included progression-free survival, safety, and tolerability.

resultsAfter median follow-up of 13.4 months (95% confidence interval (CI) 10.0 to 16.8), 68.1% had progressed and 22.3% had died. Of the entire cohort, 61.7% had commenced a new line of treatment, and 24.5% were still receiving niraparib. The median duration of niraparib treatment was 5.0 months (range 0.4 to 27.3), and the median time to first subsequent treatment was 10.7 months (95% CI 8.4 to 13.0). Patients with elevated CA125 prior to start of niraparib had shorter time to first subsequent treatment (7.3 months, 95% CI 4.2 to 10.3) than patients with normalized CA125 (12.2 months, 95% CI 10.9 to 13.7 (p=0.002). Patients who started on individual dose based on weight and platelet counts had fewer dose reductions (p<0.001) and interruptions (p=0.02).

conclusionIn a real-world setting, niraparib maintenance treatment in patients with non-gBRCA1/2 mutated recurrent platinum-sensitive ovarian cancer showed effectiveness comparable with published phase III studies and acceptable safety. Individualized dosing is essential to minimize adverse events. CA125 levels at start of niraparib treatment may help to estimate the individual prognosis.

Indexed as

Ovarian NeoplasmsCarcinoma, Ovarian EpithelialCohort StudiesFemaleHumansIndazolesNeoplasm Recurrence, LocalPiperidinesPoly(ADP-ribose) Polymerase InhibitorsRetrospective StudiesIndazolesniraparibPiperidinesPoly(ADP-ribose) Polymerase InhibitorsOvarian Cancer

Identifiers

PMID38000795
PMCPMC10803952
OpenAlexW4388977897

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.