Evidence map›Paper›PMID 31562758›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib.

P Hammel, H L Kindler, M Reni, E Van Cutsem, T Macarulla, M J Hall, J O Park, D Hochhauser, D Arnold, D-Y Oh and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02184195 (A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–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.

NCT02184195 phase3completednot on this map

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled154ConditionsGermline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the PancreasArmsOlaparib, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Homologous Recombination Deficiency in Pancreatic Cancer: A Systematic Review and Prevalence Meta-Analysis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Pooled it
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  13. Which test for crossing survival curves? A user's guideline.BMC medical research methodology · 2022
    Review
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  18. World journal of gastroenterology · 2021
    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

21 authors.

P HammelDepartment of Digestive Oncology, Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France. Electronic address: pascal.hammel@aphp.fr.
H L KindlerDepartment of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, USA.
M ReniDepartment of Oncology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy.
E Van CutsemDivision of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium.
T MacarullaDepartment of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.
M J HallDepartment of Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA.
J O ParkDivision of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
D HochhauserDepartment of Oncology, University College London Cancer Institute, London, UK.
D ArnoldDepartment of Oncology, Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg, Germany.
D-Y OhDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
A Reinacher-SchickDepartment of Hematology, Oncology and Palliative Care, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.
G TortoraDepartment of Medicine, Section of Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona, Verona and Fondazione Policlinico Universitario Gemelli IRCCS, Rome, Italy.
H AlgülSecond Department of Internal Medicine, Klinikum rechts der Isar, Comprehensive Cancer Center Munich-TUM and Department of Internal Medicine II, Technische Universität München, Munich, Germany.
E M O'ReillyGastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, USA.
D McGuinnessAstraZeneca, Cambridge, UK.
K Y CuiAstraZeneca, Gaithersburg, USA.
S JooMerck & Co., Inc., Kenilworth, USA.
H K YooAstraZeneca, Cambridge, UK.
N PatelAstraZeneca, Gaithersburg, USA.
T GolanThe Oncology Institute, Sheba Medical Center, Tel Aviv, Israel.
POLO Investigators

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatients with metastatic pancreatic cancer often have a detriment in health-related quality of life (HRQoL). In the randomized, double-blind, phase III POLO trial progression-free survival was significantly longer with maintenance olaparib, a poly(ADP-ribose) polymerase inhibitor, than placebo in patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and metastatic pancreatic cancer whose disease had not progressed during first-line platinum-based chemotherapy. The prespecified HRQoL evaluation is reported here. PATIENTS AND

methodsPatients were randomized to receive maintenance olaparib (300 mg b.i.d.; tablets) or placebo. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module at baseline, every 4 weeks until disease progression, at discontinuation, and 30 days after last dose. Scores ranged from 0 to 100; a ≥10-point change or difference between arms was considered clinically meaningful. Adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TSCMD) was analysed using a log-rank test.

resultsOf 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses. The adjusted mean change in Global Health Status (GHS) score from baseline was <10 points in both arms and there was no significant between-group difference [-2.47; 95% confidence interval (CI) -7.27, 2.33; P = 0.31]. Analysis of physical functioning scores showed a significant between-group difference (-4.45 points; 95% CI -8.75, -0.16; P = 0.04). There was no difference in TSCMD for olaparib versus placebo for GHS [P = 0.25; hazard ratio (HR) 0.72; 95% CI 0.41, 1.27] or physical functioning (P = 0.32; HR 1.38; 95% CI 0.73, 2.63).

conclusionsHRQoL was preserved with maintenance olaparib treatment with no clinically meaningful difference compared with placebo. These results support the observed efficacy benefit of maintenance olaparib in patients with a gBRCAm and metastatic pancreatic cancer. CLINCALTRIALS.GOV NUMBER: NCT02184195.

Indexed as

AdultAgedBRCA1 ProteinBRCA2 ProteinDouble-Blind MethodFemaleGerm-Line MutationHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPancreatic NeoplasmsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsBRCAhealth-related quality of lifemetastaticolaparibpancreatic cancer

Identifiers

PMID31562758
PMCPMC6938600

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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.