Evidence map›Paper›PMID 40097725›Full record

Trial reportBritish journal of cancer2025

Overall survival with maintenance olaparib in platinum-sensitive relapsed ovarian cancer by somatic or germline BRCA and homologous recombination repair mutation status.

Sandro Pignata, Amit Oza, Geoff Hall, Beatriz Pardo, Radoslaw Madry, David Cibula, Jaroslav Klat, Ana Montes, Rosalind Glasspool, Nicoletta Colombo and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02476968 (An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza), 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.

NCT02476968 phase4completednot on this map

An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed Somatic or Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy (ORZORA).

TypeinterventionalSponsorAstraZenecaRan2015 to 2021Enrolled181ConditionsBRCA or HRR+ Mutated Ovarian Cancer PatientsArmsOlaparib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

20 authors.

Sandro PignataDepartment of Urology and Gynecology, Istituto Nazionale Tumori 'Fondazione G Pascale', IRCCS, Napoli, Italy. s.pignata@istitutotumori.na.it.ORCID http://orcid.org/0000-0002-8836-2633
Amit OzaDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Geoff HallLeeds Institute of Medical Research, St James's University Hospital, Leeds, UK.
Beatriz PardoDepartment of Medical Oncology, ICO l'Hospitalet - Hospital Duran i Reynals, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Radoslaw MadryDepartment of Gynecologic Oncology, Medical University Karol Marcinkowski, Poznań, Poland.
David CibulaDepartment of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.ORCID http://orcid.org/0000-0001-6387-9356
Jaroslav KlatDepartment of Obstetrics and Gynecology, University Hospital Ostrava, and University of Ostrava, Ostrava Poruba, Czech Republic.
Ana MontesDepartment of Oncology, Cancer Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Rosalind GlasspoolMedical Oncology Department, Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-5000-1680
Nicoletta ColomboDepartment of Medicine and Surgery, University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy.
Imre PeteDepartment of Gynecology, National Institute of Cancer, Budapest, Hungary.
Ana Herrero IbáñezServico de Oncología Médica, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Margarita RomeoMedical Oncology Department, ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Rumyana IlievaMedical Oncology Clinic, MHAT "Central Onco Hospital", OOD, Plovdiv, Bulgaria.
Constanta TimchevaMedical Oncology Clinic, MHAT for Women's Health - Nadezhda, OOD, Sofia, Bulgaria.
Massimo Di MaioDepartment of Oncology, University of Turin, at Mauriziano Hospital, Turin, Italy.
Zahid BashirGlobal Medical Affairs, AstraZeneca, Cambridge, UK.
Rosie TaylorGMA Payer Biometrics, Oncology R&D, AstraZeneca, Cambridge, UK.
Alan BarnicleTranslational Medicine, Oncology R&D, AstraZeneca, Cambridge, UK.
Andrew ClampDepartment of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe open-label, single-arm, multicentre ORZORA trial (NCT02476968) evaluated maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) with a germline (g) or somatic (s) BRCA1 and/or BRCA2 mutation (BRCAm) or a non-BRCA homologous recombination repair mutation (non-BRCA HRRm).

methodsPatients were in response to platinum-based chemotherapy after ≥2 prior lines of treatment and underwent prospective central screening for tumour BRCA status, then central gBRCAm testing to determine sBRCAm or gBRCAm status. An exploratory cohort evaluated non-BRCA HRRm in 13 predefined genes. Patients received olaparib 400 mg (capsules) twice daily until investigator-assessed disease progression. Secondary endpoints included overall survival (OS) and safety.

results177 patients received olaparib. At the final data cutoff (25 June 2021), median OS from study enrolment was 46.8 (95% confidence interval [CI] 37.9-54.4), 43.2 (31.7-NC [not calculated]), 47.4 (37.9-NC) and 44.9 (28.9-NC) months in the BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts, respectively. No new safety signals were identified.

conclusionMaintenance olaparib showed consistent clinical activity in the BRCAm and sBRCAm cohorts; exploratory analysis suggested similar activity in the non-BRCA HRRm cohort. These findings highlight that patients with PSR OC, beyond those with gBRCAm, may benefit from maintenance olaparib.

Indexed as

BRCA1 ProteinBRCA2 ProteinNeoplasm Recurrence, LocalOvarian NeoplasmsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsAdultAgedFemaleGerm-Line MutationHumansMiddle AgedRecombinational DNA RepairBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase Inhibitors

Identifiers

PMID40097725
PMCPMC11997082

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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.