Evidence map›Paper›PMID 36168844›Full record

Trial reportCancer science2023

Abemaciclib plus fulvestrant in East Asian women with HR+, HER2- advanced breast cancer: Overall survival from MONARCH 2.

Masakazu Toi, Chiun-Sheng Huang, Young-Hyuck Im, Joohyuk Sohn, Wei Zhang, Sachi Sakaguchi, Nadine Haddad, Gertjan van Hal, George W Sledge

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Cancer science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Article
  6. Review
  7. Article
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

9 authors at 8 institutions in 5 countries.

Masakazu ToiBreast Cancer Unit, Graduate School of Medicine, Kyoto University Hospital, Kyoto University, Kyoto, Japan.ORCID https://orcid.org/0000-0003-1488-9958
Chiun-Sheng HuangNational Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Young-Hyuck ImDepartment of Medicine, Sungkyunkwan University, Seoul, South Korea.
Joohyuk SohnYonsei Cancer Center, Seoul, South Korea.
Wei ZhangEli Lilly and Company, Indianapolis, Indiana, USA.
Sachi SakaguchiEli Lilly and Company, Tokyo, Japan.
Nadine HaddadEli Lilly and Company, Indianapolis, Indiana, USA.
Gertjan van HalEli Lilly and Company, Utrecht, The Netherlands.
George W SledgeStanford University, Stanford, California, USA.
Eli Lilly (United States) · USEli Lilly (Japan) · JPEli Lilly (Netherlands) · NLKyoto University Hospital · JPNational Taiwan University Hospital · TWStanford University · USSungkyunkwan University · KRYonsei University · KR

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

MONARCH 2 is a global, randomized, double-blind, phase 3 study of abemaciclib/placebo + fulvestrant in patients with hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer. The East Asian population comprised 212 (31.7%) of the 669 intent-to-treat population in the MONARCH 2 trial. Consistent with the primary analysis, this subpopulation analysis of East Asian patients indicated progression-free survival benefit in the abemaciclib arm. The median overall survival was not reached in the abemaciclib arm and was 48.9 months in the placebo arm (hazard ratio 0.80; 95% confidence interval 0.52-1.24; p = 0.377). In addition, other efficacy endpoints, including time to chemotherapy, chemotherapy free survival, and time to second disease progression, indicated benefit in the abemaciclib arm. This analysis found no new safety concerns with longer follow-up. These findings support the positive benefit-risk balance of the MONARCH 2 regimen in East Asian patients with hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer.

Indexed as

Breast NeoplasmsAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesEast Asian PeopleErb-b2 Receptor Tyrosine KinasesFemaleFulvestrantHumansabemaciclibAminopyridinesBenzimidazolesErb-b2 Receptor Tyrosine KinasesFulvestrantabemaciclibbreast cancercyclin-dependent kinase inhibitorEast Asiametastatic

Identifiers

PMID36168844
PMCPMC9807498
OpenAlexW4297459504

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.