Evidence map›Paper›PMID 33781053›Full record

Trial reportCancer research and treatment2021

Talazoparib Versus Chemotherapy in Patients with HER2-negative Advanced Breast Cancer and a Germline BRCA1/2 Mutation Enrolled in Asian Countries: Exploratory Subgroup Analysis of the Phase III EMBRACA Trial.

Kyung-Hun Lee, Joohyuk Sohn, Annabel Goodwin, Tiziana Usari, Silvana Lanzalone, Seock-Ah Im, Sung-Bae Kim

Open access · diamondAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 27% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
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

7 authors at 5 institutions in 3 countries.

Kyung-Hun LeeSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Joohyuk SohnYonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Annabel GoodwinConcord Repatriation General Hospital, Concord, NSW, Australia.
Tiziana UsariPfizer, Milan, Italy.
Silvana LanzalonePfizer, Milan, Italy.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Sung-Bae KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Pfizer (Italy) · ITSeoul National University Hospital · KRConcord Repatriation General Hospital · AUUniversity of Ulsan · KRYonsei University · KR

Funding

MedivationPfizer
6 · The paper itself

Abstract

purposeWe evaluated study outcomes in patients enrolled in Asian regions in the phase III EMBRACA trial of talazoparib vs. chemotherapy. MATERIALS AND

methodsPatients with human epidermal growth factor receptor 2-negative germline BRCA1/2-mutated advanced breast cancer who received prior chemotherapy were randomized 2:1 to talazoparib 1 mg/day or chemotherapy (physician's choice). Primary endpoint was progression-free survival (PFS) per independent central review in the intent-to-treat (ITT) population. This post-hoc analysis evaluated efficacy/safety endpoints in the ITT population of patients enrolled in Asian regions.

resultsThirty-three patients were enrolled at Asian sites (talazoparib, n=23; chemotherapy, n=10). Baseline characteristics were generally comparable with the overall EMBRACA population. In Asian patients, median PFS was 9.0 months (95% confidence interval [CI], 3.0 to 15.2) for talazoparib and 7.1 months (95% CI, 1.2 to not reached) for chemotherapy (hazard ratio [HR], 0.74 [95% CI, 0.22 to 2.44]). Objective response rate was numerically higher for talazoparib vs. chemotherapy (62.5% [95% CI, 35.4 to 84.8] vs. 25.0% [95% CI, 3.2 to 65.1]). Median overall survival was 20.7 months (95% CI, 9.4 to 40.1) versus 21.2 months (95% CI, 2.7 to 35.0) (HR, 1.41 [95% CI, 0.49 to 4.05]). In Asian patients, fewer grade 3/4 adverse events (AEs), serious AEs (SAEs), grade 3/4 SAEs, and AEs resulting in dose reduction/discontinuation occurred with talazoparib than chemotherapy; for talazoparib, the frequency of these events was lower in Asian patients versus overall EMBRACA population.

conclusionIn this subgroup analysis, talazoparib numerically improved efficacy versus chemotherapy and was generally well tolerated in Asian patients, with fewer grade 3/4 treatment-emergent AE (TEAEs), SAEs, and TEAEs leading to dose modification vs. the overall EMBRACA population.

Indexed as

Germ-Line MutationAdultAntineoplastic Combined Chemotherapy ProtocolsAsiaBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsCapecitabineDeoxycytidineErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesFuransGemcitabineHumansKetonesBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCapecitabineDeoxycytidineERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransGemcitabineKetonesPhthalazinesPolyether PolyketidestalazoparibVinorelbineAsianBRCA1/2 mutationBreast neoplasmsHER2-negativePARP inhibitorPhase IIITalazoparib

Identifiers

PMID33781053
PMCPMC8524025
OpenAlexW3136171303

What OpenQuestion holds

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LicenceCC BY-NC
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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.