Evidence map›Paper›PMID 29284202›Full record

Trial reportCancer science2018

Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012.

Makoto Tahara, Kei Muro, Yasuhisa Hasegawa, Hyun Cheol Chung, Chia-Chi Lin, Bhumsuk Keam, Kenichi Takahashi, Jonathan D Cheng, Yung-Jue Bang

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

Trial report in Cancer science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01848834 (A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 6% 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.

NCT01848834 phase1completednot on this map

A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2020Enrolled297ConditionsCancer, Solid TumorArmsPembrolizumab
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. FeInternational journal of nanomedicine · 2024
    Article
  11. [Tislelizumab monotherapy for the treatment of recurrent/metastatic head and neck squamous cell carcinoma].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2023
    Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Immune Cells in Head-and-Neck Tumor Microenvironments.Journal of personalized medicine · 2022
    Review
  17. Review
  18. Review
  19. Article
  20. Reshaping the Immune Microenvironment by Oncolytic Herpes Simplex Virus in Murine Pancreatic Ductal Adenocarcinoma.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 4 countries.

Makoto TaharaNational Cancer Center Hospital East, Kashiwa, Japan.ORCID http://orcid.org/0000-0001-9035-3106
Kei MuroAichi Cancer Center Hospital, Nagoya, Japan.
Yasuhisa HasegawaAichi Cancer Center Hospital, Nagoya, Japan.
Hyun Cheol ChungYonsei Cancer Center, Seoul, Korea.
Chia-Chi LinNational Taiwan University Hospital, Taipei, Taiwan.
Bhumsuk KeamSeoul National University College of Medicine, Seoul, Korea.
Kenichi TakahashiMSD K.K, Tokyo, Japan.
Jonathan D ChengMerck & Co., Inc., Kenilworth, NJ, USA.
Yung-Jue BangSeoul National University College of Medicine, Seoul, Korea.
Aichi Cancer Center · JPSeoul National University · KRMerck & Co., Inc., Rahway, NJ, USA (United States) · USMSD K.K. (Japan) · JPNational Cancer Center Hospital East · JPNational Taiwan University Hospital · TWYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted ≥6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAsiaCarcinoma, Squamous CellCohort StudiesDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansMaleSquamous Cell Carcinoma of Head and NeckSurvival AnalysisTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalpembrolizumabAsia-Pacifichead and neck squamous cell carcinomaPD-1PD-L1Pembrolizumab

Identifiers

PMID29284202
PMCPMC5834807
OpenAlexW2778965629

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.