Evidence map›Paper›PMID 30689707›Full record

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

OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer.

M E Robson, N Tung, P Conte, S-A Im, E Senkus, B Xu, N Masuda, S Delaloge, W Li, A Armstrong and 4 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyRandomized 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 2 registered trials, which are not on this map. Cited by 442 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
442citing papers in PubMed, 6 pooled it
37.6field-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.

NCT02000622 phase3completednot on this map

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

TypeinterventionalSponsorAstraZenecaRan2014 to 2025Enrolled302ConditionsBreast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene MutationArmsOlaparib, Physician's choice chemotherapy
NCT05035745 phase1 / phase2recruitingnot on this mapstarted 2021, after this paper: background citation

Phase I Dose Finding Study of Selinexor and Talazoparib in Patients With Advanced Refractory Solid Tumors, Followed by Phase II Expansion Cohort Study in Patients With Advanced/ Metastatic Triple Negative Breast Cancers. (START)

TypeinterventionalSponsorNational University Hospital, SingaporeRan2021 to 2027Enrolled63ConditionsAdvanced Refractory Solid Tumors, Advanced Triple Negative Breast Cancers, Metastatic Triple Negative Breast CancersArmsTalazoparib, Selinexor
3 · Its place in the literature

Who cites it

442 citing papers in PubMed, 6 syntheses or guidelines pooled it, 736 citations in OpenAlex.

  1. Pooled it
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  4. The impact of PET imaging on triple negative breast cancer: an updated evidence-based perspective.European journal of nuclear medicine and molecular imaging · 2024
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  20. TALAVE in Breast Cancer:bioRxiv : the preprint server for biology · 2026
    Article

382 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

14 authors at 13 institutions in 8 countries.

M E RobsonBreast Medicine Service, Memorial Sloan Kettering Cancer Center, New York. Electronic address: robsonm@mskcc.org.
N TungCancer Risk and Prevention Program, Beth Israel Deaconess Medical Center, Department of Medicine, Dana-Farber Harvard Cancer Center, Boston, USA.
P ConteDivision of Oncology, University of Padova, Istituto Oncologico Veneto IRCCS, Padova, Italy.
S-A ImDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
E SenkusCenter of Breast Diseases, Medical University of Gdańsk, Gdańsk, Poland.
B XuDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
N MasudaDepartment of Surgery, Osaka National Hospital, National Hospital Organization, Osaka, Japan.
S DelalogeBreast Oncology, Institut Gustave Roussy, Villejuif, France.
W LiDepartment of Emergency, The First Hospital of Jilin University, Changchun, China.
A ArmstrongMedical Oncology, Christie Hospital NHS Foundation Trust, Manchester, UK.
W WuGlobal Medicines Development, AstraZeneca, Gaithersburg, USA.
C GoesslGlobal Medicines Development, AstraZeneca, Gaithersburg, USA.
S RunswickGlobal Medicines Development, AstraZeneca, Macclesfield, UK.
S M DomchekDepartment of Medicine, Basser Center, University of Pennsylvania, Philadelphia, USA.
AstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBBeth Israel Deaconess Medical Center · USChinese Academy of Medical Sciences & Peking Union Medical College · CNGdańsk Medical University · PLInstitut Gustave Roussy · FRIstituto Oncologico Veneto · ITJilin University · CNMemorial Sloan Kettering Cancer Center · USOsaka National Hospital · JPSeoul National University Hospital · KRThe Christie NHS Foundation Trust · GBUniversity of Pennsylvania · US

Funding

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

Abstract

backgroundIn the OlympiAD study, olaparib was shown to improve progression-free survival compared with chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA1 and/or BRCA2 mutation (BRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC). We now report the planned final overall survival (OS) results, and describe the most common adverse events (AEs) to better understand olaparib tolerability in this population. PATIENTS AND

methodsOlympiAD, a Phase III, randomized, controlled, open-label study (NCT02000622), enrolled patients with a germline BRCAm and HER2-negative mBC who had received ≤2 lines of chemotherapy for mBC. Patients were randomized to olaparib tablets (300 mg bid) or predeclared TPC (capecitabine, vinorelbine, or eribulin). OS and safety were secondary end points.

resultsA total of 205 patients were randomized to olaparib and 97 to TPC. At 64% data maturity, median OS was 19.3 months with olaparib versus 17.1 months with TPC (HR 0.90, 95% CI 0.66-1.23; P = 0.513); median follow-up was 25.3 and 26.3 months, respectively. HR for OS with olaparib versus TPC in prespecified subgroups were: prior chemotherapy for mBC [no (first-line setting): 0.51, 95% CI 0.29-0.90; yes (second/third-line): 1.13, 0.79-1.64]; receptor status (triple negative: 0.93, 0.62-1.43; hormone receptor positive: 0.86, 0.55-1.36); prior platinum (yes: 0.83, 0.49-1.45; no: 0.91, 0.64-1.33). Adverse events during olaparib treatment were generally low grade and manageable by supportive treatment or dose modification. There was a low rate of treatment discontinuation (4.9%), and the risk of developing anemia did not increase with extended olaparib exposure.

conclusionsWhile there was no statistically significant improvement in OS with olaparib compared to TPC, there was the possibility of meaningful OS benefit among patients who had not received chemotherapy for metastatic disease. Olaparib was generally well-tolerated, with no evidence of cumulative toxicity during extended exposure. Please see the article online for additional video content.

Indexed as

Administration, OralAdultAgedAnemiaAntineoplastic Combined Chemotherapy ProtocolsBRCA1 ProteinBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesGerm-Line MutationHumansMiddle AgedPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsBRCA1 ProteinBRCA1 protein, humanERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsTabletsbreast cancergermline BRCA mutationolapariboverall survivalPARP inhibitortolerability

Identifiers

PMID30689707
PMCPMC6503629
OpenAlexW2913584903

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.