Evidence map›Paper›PMID 30353045›Full record

Trial reportBritish journal of cancer2018

Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy.

Michael Friedlander, Ursula Matulonis, Charlie Gourley, Andreas du Bois, Ignace Vergote, Gordon Rustin, Clare Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra and 11 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 12 pooled it
8.2field-weighted citation impact, top 1% 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

94 citing papers in PubMed, 12 syntheses or guidelines pooled it, 178 citations in OpenAlex.

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34 more citing papers are in PubMed but not listed here.

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

21 authors at 16 institutions in 8 countries.

Michael FriedlanderUniversity of New South Wales Clinical School, Prince of Wales Hospital, Randwick, NSW, Australia. Michael.friedlander@health.nsw.go.au.
Ursula MatulonisDana-Farber Cancer Institute, Boston, MA, USA.
Charlie GourleyCancer Research UK Edinburgh Centre, Western General Hospital, Edinburgh, UK.
Andreas du BoisKliniken Essen Mitte, Essen, Germany.
Ignace VergoteUniversity of Leuven, Leuven Cancer Institute, Leuven, Belgium.
Gordon RustinMount Vernon Hospital, Northwood, UK.
Clare ScottRoyal Melbourne Hospital, Parkville, VIC, Australia.
Werner MeierUniversity of Düsseldorf, Düsseldorf, Germany.
Ronnie Shapira-FrommerChaim Sheba Medical Center, Tel Hashomer, Israel.
Tamar SafraTel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Daniela MateiNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Vadim ShirinkinOrenburg Regional Clinical Oncological Dispensary, Orenburg, Russia.
Frédéric SelleGroupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.
Anitra FieldingAstraZeneca, Cambridge, UK.
Elizabeth S LoweAstraZeneca, Gaithersburg, MD, USA.
Emma L McMurtryAstraZeneca, Cambridge, UK.
Stuart SpencerAstraZeneca, Cambridge, UK.
Philip RoweAstraZeneca, Cambridge, UK.
Helen MannAstraZeneca, Cambridge, UK.
David ParryAstraZeneca, Cambridge, UK.
Jonathan LedermannUniversity College London Cancer Institute, London, UK.
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USDana-Farber Cancer Institute · USGroupe Hospitalier Diaconesses Croix Saint-Simon · FRHeinrich Heine University Düsseldorf · DEKliniken Essen-Mitte · DEKU Leuven · BEMount Vernon Hospital · GBNorthwestern University · USOrenburg Regional Clinical Oncology Center · RUPrince of Wales Hospital · AUSheba Medical Center · ILTel Aviv University · ILThe Royal Melbourne Hospital · AUUniversity College London · GBWestern General Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Study 19, maintenance monotherapy with olaparib significantly prolonged progression-free survival vs placebo in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer.

methodsStudy 19 was a randomised, placebo-controlled, Phase II trial enrolling 265 patients who had received at least two platinum-based chemotherapy regimens and were in complete or partial response to their most recent regimen. Patients were randomised to olaparib (capsules; 400 mg bid) or placebo. We present long-term safety and final mature overall survival (OS; 79% maturity) data, from the last data cut-off (9 May 2016).

resultsThirty-two patients (24%) received maintenance olaparib for over 2 years; 15 (11%) did so for over 6 years. No new tolerability signals were identified with long-term treatment and adverse events were generally low grade. The incidence of discontinuations due to adverse events was low (6%). An apparent OS advantage was observed with olaparib vs placebo (hazard ratio 0.73, 95% confidence interval 0.55‒0.95, P = 0.02138) irrespective of BRCA1/2 mutation status, although the predefined threshold for statistical significance was not met.

conclusionsStudy 19 showed a favourable final OS result irrespective of BRCA1/2 mutation status and unprecedented long-term benefit with maintenance olaparib for a subset of platinum-sensitive, recurrent ovarian cancer patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBRCA1 ProteinBRCA2 ProteinCapsulesCystadenocarcinoma, SerousDisease-Free SurvivalDouble-Blind MethodFemaleHumansMaintenance ChemotherapyMiddle AgedMutationNeoplasm Recurrence, LocalAntineoplastic AgentsBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCapsulesolaparibPhthalazinesPiperazinesPlatinum

Identifiers

PMID30353045
PMCPMC6219499
OpenAlexW2896628407

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.