Evidence map›Paper›PMID 27824811›Full record

Trial reportBritish journal of cancer2016

Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer.

Jonathan A Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra and 7 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00753545 (Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 4% 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.

NCT00753545 phase2completednot on this map

Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

TypeinterventionalSponsorAstraZenecaRan2008 to 2023Enrolled265ConditionsOvarian CancerArmsAZD2281, matching placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Olaparib for ovarian cancer: a single-institution, multi-site qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
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  8. Review
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  13. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
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  15. Review
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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

17 authors at 13 institutions in 6 countries.

Jonathan A LedermannUniversity College London, Cancer Research UK and UCL Cancer Trials Centre, 90 Tottenham Court Road, London W1T 4TJ, UK.
Philipp HarterKliniken Essen Mitte, Henricistraße 95, D-45136 Essen, Germany.
Charlie GourleyUniversity of Edinburgh Cancer Research UK Centre, MRC IGMM, Western General Hospital, Crewe Road South, Edinburgh EH4 2XR, UK.
Michael FriedlanderUNSW Clinical School, Prince of Wales Hospital, High Street, Randwick, NSW 2031, Australia.
Ignace VergoteUniversity of Leuven, Herestraat 49, 3000 Leuven, Belgium.
Gordon RustinMount Vernon Hospital, Rickmansworth Road, Northwood HA6 2RN, UK.
Clare ScottRoyal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.
Werner MeierEvangelisches Krankenhaus, Kirchfeldstraße 40, 40217 Düsseldorf, Germany.
Ronnie Shapira-FrommerChaim Sheba Medical Center, Derech Sheba 2, Tel Hashomer 52621, Israel.
Tamar SafraTel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv 64239, Israel.
Daniela MateiIndiana University School of Medicine, 980 West Walnut Street, Indianapolis, IN 46202, USA.
Anitra FieldingAstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Bryan BennettAstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
David ParryAstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Stuart SpencerAstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Helen MannAstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Ursula MatulonisDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.
AstraZeneca (United Kingdom) · GBDana-Farber Cancer Institute · USEdinburgh Cancer Research · GBEvangelisches Krankenhaus Düsseldorf · DEIndiana University School of MedicineKliniken Essen-Mitte · DEKU Leuven · BELondon Cancer · GBMount Vernon Hospital · GBPrince of Wales Hospital · AUSheba Medical Center · ILTel Aviv Sourasky Medical Center · ILThe Royal Melbourne Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaintenance monotherapy with the poly(ADP-ribose) polymerase inhibitor olaparib significantly prolongs progression-free survival over placebo in patients with platinum-sensitive relapsed serous ovarian cancer, with greatest benefit seen in patients with a BRCA1/2 mutation (BRCAm). Preservation of health-related quality of life (HRQoL) is important during maintenance therapy; we evaluated the effect of olaparib on HRQoL in this Phase II trial (NCT00753545, Study 19).

methodsPatients received olaparib 400 mg b.i.d. (capsules) or placebo until progression. Patient-reported HRQoL and disease-related symptoms were evaluated using the FACT-Ovarian (FACT-O) questionnaire (completed at baseline and every 28 days until progression), the FACT/NCCN Ovarian Symptom Index (FOSI) and the Trial Outcome Index (TOI). TOI of the FACT-O was the primary measure.

resultsOverall, 265 women were randomised to maintenance olaparib (n=136) or placebo (n=129). Compliance for HRQoL assessment was high (∼80% over time). Most patients in both arms reported a best response of 'no change' on TOI (81%) and other HRQoL measures. There were no statistically significant differences in time to worsening or improvement rates of TOI, FOSI and FACT-O scores in the overall, BRCAm and germline BRCAm populations.

conclusionsMaintenance treatment with olaparib was well tolerated and had no adverse impact on HRQoL in this study of patients with platinum-sensitive relapsed serous ovarian cancer who had responded to their most recent platinum-based therapy (partial or complete response). Interpretation of the HRQoL results in this population may differ from patients who have not responded to their most recent platinum-based therapy.

Indexed as

Quality of LifeAdultAgedAged, 80 and overAntineoplastic AgentsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPhthalazinesPiperazinesPlacebosYoung AdultAntineoplastic AgentsolaparibPhthalazinesPiperazinesPlacebos

Identifiers

PMID27824811
PMCPMC5129820
OpenAlexW2550229146

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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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.