Evidence map›Paper›PMID 32012411›Full record

Trial reportCancer science2020

Pembrolizumab monotherapy in Japanese patients with advanced ovarian cancer: Subgroup analysis from the KEYNOTE-100.

Shin Nishio, Koji Matsumoto, Kazuhiro Takehara, Naoki Kawamura, Kosei Hasegawa, Nobuhiro Takeshima, Daisuke Aoki, Shoji Kamiura, Atsushi Arakawa, Eiji Kondo and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02674061 (A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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.

NCT02674061 phase2completednot on this map

A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2016 to 2021Enrolled376ConditionsOvarian NeoplasmsArmsPembrolizumab
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Observational
  9. Article
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  11. Article
  12. Article
  13. Review
  14. Chemotherapy-free treatment of recurrent advanced ovarian cancer: myth or reality?International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Review
  15. Article
  16. Review
  17. Article
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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

17 authors at 13 institutions in 2 countries.

Shin NishioKurume University School of Medicine, Kurume, Japan.ORCID https://orcid.org/0000-0003-2526-630X
Koji MatsumotoHyogo Cancer Center, Akashi, Japan.
Kazuhiro TakeharaNational Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Naoki KawamuraOsaka City General Hospital, Osaka, Japan.
Kosei HasegawaSaitama Medical University International Medical Center, Hidaka, Japan.
Nobuhiro TakeshimaCancer Institute Hospital of JFCR, Tokyo, Japan.
Daisuke AokiKeio University Hospital, Tokyo, Japan.
Shoji KamiuraOsaka International Cancer Institute, Osaka, Japan.
Atsushi ArakawaNagoya City University Hospital, Nagoya, Japan.
Eiji KondoMie University Hospital, Tsu, Japan.
Tomoko HirakawaOita University Hospital, Yufu, Japan.
Keiko YamamotoMSD K.K., Tokyo, Japan.
Masayuki AokiMSD K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0001-5746-332X
Karen SteinMerck & Co., Inc., Kenilworth, NJ, USA.
Stephen KeefeMerck & Co., Inc., Kenilworth, NJ, USA.
Keiichi FujiwaraSaitama Medical University International Medical Center, Hidaka, Japan.
Kimio UshijimaKurume University School of Medicine, Kurume, Japan.
Kurume University · JPMerck & Co., Inc., Rahway, NJ, USA (United States) · USMSD K.K. (Japan) · JPSaitama Medical University · JPHyogo Prefectural Cancer Center · JPKeio University Hospital · JPMie University Hospital · JPNagoya City University Hospital · JPOita University Hospital · JPOsaka City General Hospital · JPOsaka International Cancer Institute · JPShikoku Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

Merck Sharp & Dohme
6 · The paper itself

Abstract

Interim results from the two-cohort, phase 2 KEYNOTE-100 study (NCT02674061) of 376 patients with previously treated advanced recurrent ovarian cancer (ROC) showed that pembrolizumab monotherapy was associated with an objective response rate (ORR) of 8.0% (95% CI, 5.4-11.2). We present outcomes for the Japanese patients (n = 21) enrolled in KEYNOTE-100. Patients with epithelial ROC had received either 1-3 prior chemotherapy lines and had platinum-free interval or treatment-free interval (PFI; TFI) of 3-12 months (cohort A) or 4-6 prior chemotherapy lines and had PFI/TFI of ≥3 months (cohort B). All patients received pembrolizumab 200 mg every 3 weeks as monotherapy for 2 years or until progression, death, unacceptable toxicity or consent withdrawal. Primary objectives were ORR per RECIST v1.1 for each cohort and higher programmed death ligand-1 (PD-L1) tumor expression. The relationship between PD-L1 expression (measured as combined positive score [CPS]) and ORR was assessed. Twenty-one Japanese patients (cohort A, n = 19; cohort B, n = 2) were treated. The median (range) age was 57 (37-78) years; 19 (90.5%) patients had ECOG status of 0 and 16 (76.2%) patients had stage III-IV disease. ORR was 19.0% (95% CI, 5.4-41.9) and seemed to increase with increasing PD-L1 expression. A total of 13 (61.9%) patients had treatment-related adverse events (TRAE), and 5 (23.8%) had grade 3-4 TRAE. There were no treatment-related deaths in this subpopulation. Pembrolizumab monotherapy was associated with antitumor activity in Japanese patients with ROC, with no new safety signals identified in this subpopulation. The data suggested a trend toward higher PD-L1 expression among some patients with higher ORR.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedB7-H1 AntigenCohort StudiesDrug-Related Side Effects and Adverse ReactionsFemaleGene Expression Regulation, NeoplasticHumansJapanMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingOvarian NeoplasmsAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanpembrolizumabcombined positive scoreobjective response rateovarian cancerPD-L1pembrolizumab

Identifiers

PMID32012411
PMCPMC7156846
OpenAlexW3004428272

What OpenQuestion holds

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LicenceCC BY-NC
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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.