Evidence map›Paper›PMID 37005966›Full record

Trial reportBreast cancer (Tokyo, Japan)2023

Adjuvant olaparib in the subset of patients from Japan with BRCA1- or BRCA2-mutated high-risk early breast cancer from the phase 3 OlympiA trial.

Hideko Yamauchi, Masakazu Toi, Shin Takayama, Seigo Nakamura, Toshimi Takano, Karen Cui, Christine Campbell, Liesbet De Vos, Charles Geyer, Andrew Tutt

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02032823 (A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 15% 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.

NCT02032823 phase3active not recruitingnot on this map

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2014 to 2029Enrolled1,837ConditionsBreast CancerArmsOlaparib, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 4 countries.

Hideko YamauchiJapan Breast Cancer Research Group (JBCRG), Tokyo, Japan. hidekoyamauchi@gmail.com.ORCID http://orcid.org/0000-0002-1450-7211
Masakazu ToiJapan Breast Cancer Research Group (JBCRG), Tokyo, Japan.
Shin TakayamaJapan Breast Cancer Research Group (JBCRG), Tokyo, Japan.
Seigo NakamuraJapan Breast Cancer Research Group (JBCRG), Tokyo, Japan.
Toshimi TakanoJapan Breast Cancer Research Group (JBCRG), Tokyo, Japan.
Karen CuiAstraZeneca, Gaithersburg, MD, USA.
Christine CampbellFrontier Science (Scotland) Ltd, Kingussie, UK.
Liesbet De VosBreast International Group (BIG), Brussels, Belgium.
Charles GeyerNSABP Foundation/NRG Oncology, Pittsburgh, PA, USA.
Andrew TuttBreast International Group (BIG), Brussels, Belgium.
Japan Breast Cancer Research Group · JPAstraZeneca (United States) · USBreast Cancer Now · GBBreast International Group · BEFrontier Agriculture (United Kingdom) · GBSt. Luke's International Hospital · JPThe Cancer Institute Hospital · JPUPMC Hillman Cancer Center · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
NCI NIH HHS U10 CA180822NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

backgroundThe efficacy and safety of olaparib compared with placebo in the subset of patients from Japan in the phase 3 OlympiA trial (NCT02032823) are reported here and contextualized with reference to the global OlympiA population.

methodsPatients with germline BRCA1 and/or BRCA2 pathogenic variants and HER2-negative, high-risk early breast cancer who had received neoadjuvant or adjuvant chemotherapy and completed local treatment were eligible. Patients were randomized 1:1 to receive olaparib or placebo for 1 year. PRIMARY ENDPOINT: invasive disease-free survival (IDFS). Secondary endpoints: distant disease-free survival (DDFS), overall survival (OS), and safety. Data are reported from the first pre-specified interim analysis (data cut-off [DCO] March 27, 2020) and the second, event driven, pre-specified interim analysis of OS (DCO July 12, 2021) in patients from Japan.

results140 patients were randomized in Japan (olaparib, n = 64; placebo, n = 76). At the first pre-specified interim analysis (median follow-up: 2.9 years), hazard ratios (HRs) for adjuvant olaparib compared with placebo were 0.5 for IDFS (95% confidence interval [CI] 0.18-1.24) and 0.41 for DDFS (95% CI 0.11-1.16). At the second pre-specified interim analysis of OS, three deaths occurred in the olaparib group versus six deaths in the placebo group (HR, 0.62 [95% CI 0.13-2.36]). Findings were consistent with those for the global population. No new safety signals were observed.

conclusionsWhile this analysis in a Japanese subset of patients was not powered to detect population-related treatment differences, efficacy and safety analysis results were consistent with the global OlympiA population, suggesting the findings from the global study are generalizable to clinical practice in Japan.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBRCA1 ProteinBRCA2 ProteinFemaleGold AlloysHumansJapanPhthalazinesPiperazinesBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanGold AlloysolaparibolympiaPhthalazinesPiperazinesAdjuvantBRCAEarly breast cancerOlaparibPARP inhibitor

Identifiers

PMID37005966
PMCPMC10284949
OpenAlexW4362505810

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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.