Evidence map›Paper›PMID 39244209›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2024

Characteristics and real-world outcomes of patients with epithelial ovarian cancer who received niraparib plus bevacizumab first-line maintenance therapy in the COMB1NE study.

Premal H Thaker, Tirza Areli Calderón Boyle, Sara Burns, Jonathan Lim, John Hartman, Linda V Kalilani, Jeanne M Schilder, Jean A Hurteau, Amanda K Golembesky

Registry-linked trialAbstract read
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In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03326193 (A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03326193 phase2completednot on this map

A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab

TypeinterventionalSponsorTesaro, Inc.Ran2017 to 2024Enrolled105ConditionsOvarian NeoplasmsArmsNiraparib, Bevacizumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. 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

9 authors.

Premal H ThakerWashington University School of Medicine, St Louis, Missouri, USA thakerp@wustl.edu.ORCID 0000-0002-0568-6959
Tirza Areli Calderón BoyleGSK, Upper Providence, Pennsylvania, USA.
Sara BurnsGSK, Waltham, Massachusetts, USA.
Jonathan LimGSK, Upper Providence, Pennsylvania, USA.
John HartmanGSK, Philadelphia, Pennsylvania, USA.
Linda V KalilaniGSK, Durham, North Carolina, USA.
Jeanne M SchilderGSK, Philadelphia, Pennsylvania, USA.
Jean A HurteauGSK, Waltham, Massachusetts, USA.
Amanda K GolembeskyGSK, Durham, North Carolina, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn the phase 2 OVARIO trial (NCT03326193) investigating niraparib-bevacizumab first-line maintenance, median progression-free survival was 14.2 months (95% confidence interval (CI) 8.6 to 16.8) for patients with homologous recombination (HR)-proficient (HRp) epithelial ovarian cancer, and 12.1 months (95% CI8.0-not evaluated) for patients with undefined HR status. However, real-world data are limited for patients who receive niraparib-bevacizumab first-line maintenance therapy. The COMB1NE study describes real-world clinical outcomes (time to treatment discontinuation; time to next treatment) in patients with epithelial ovarian cancer who received niraparib-bevacizumab first-line maintenance, regardless of first-line bevacizumab use.

methodsThis real-world, retrospective study used a US nationwide electronic health record-derived deidentified database. Eligible patients were 18 years or older at initial epithelial ovarian cancer diagnosis and initiated niraparib-bevacizumab first-line maintenance (January 1, 2017-September 2, 2022) following first-line treatment. The index date was the start of first-line maintenance. Patients were followed until death, last clinical activity, or end of study, whichever occurred first. Time to treatment discontinuation and time to next treatment, a proxy for real-world progression-free survival, were estimated using the Kaplan-Meier method.

resultsAmong 59 included patients, the median age was 67 years (interquartile range (IQR) 61-76), and 81.4% had stage III/IV epithelial ovarian cancer at diagnosis. Overall, 83.1% of patients had

conclusionIn this real-world study of patients receiving niraparib-bevacizumab first-line maintenance, the majority of whom had HRp/HR status unknown, the median time to next treatment was consistent with observed progression-free survival in patients with similar HR status in the OVARIO study.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Ovarian EpithelialIndazolesOvarian NeoplasmsPiperidinesAdultAgedFemaleHumansMaintenance ChemotherapyMiddle AgedProgression-Free SurvivalRetrospective StudiesBevacizumabIndazolesniraparibPiperidinesCarcinoma, Ovarian EpithelialOvarian Cancer

Identifiers

PMID39244209
PMCPMC11672017

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Registered trials

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