Evidence map›Paper›PMID 34878659›Full record

Trial reportCancer2022

Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients.

Hyun Cheol Chung, Yoon-Koo Kang, Zhendong Chen, Yuxian Bai, Wan Zamaniah Wan Ishak, Byoung Yong Shim, Young Lee Park, Dong-Hoe Koo, Jianwei Lu, Jianming Xu and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03019588 (A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab), which is not on this map. Cited by 41 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 12 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT03019588 phase3terminatednot on this map

A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2021Enrolled94ConditionsGastric Neoplasms, Gastroesophageal Junction AdenocarcinomaArmsPembrolizumab, Paclitaxel
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 12 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  6. Guideline
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  13. Tackling similarities and differences in global practice guidelines for gastric cancer: a review on the latest Taiwan guidelines with Asia-Pacific, European and US guidelines.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Review
  14. Review
  15. Article
  16. Review
  17. Progress of immune checkpoint inhibitors in gastric cancer.World journal of gastrointestinal oncology · 2025
    Review
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  20. 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

20 authors at 17 institutions in 5 countries.

Hyun Cheol ChungYonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.ORCID 0000-0002-0920-9471
Yoon-Koo KangAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Zhendong ChenHospital of Anhui Medical University, Hefei, China.
Yuxian BaiHarbin Medical University Cancer Hospital, Harbin, China.
Wan Zamaniah Wan IshakClinical Oncology Unit, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia.
Byoung Yong ShimSt. Vincent's Hospital, The Catholic University of Korea, Gyeonggi-Do, South Korea.
Young Lee ParkNational Cancer Center, Goyang-si, South Korea.
Dong-Hoe KooKangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Jianwei LuJiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Jianming XuThe People's Liberation Army General Hospital, Beijing, China.
Hong Jae ChonCHA Bundang Medical Center, Seongnam, South Korea.
Li-Yuan BaiChina Medical University Hospital and China Medical University, Taichung, Taiwan.
Shan ZengXiangya Hospital, Central South University, Changsha, China.
Ying YuanDepartment of Medical Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Yen-Yang ChenKaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Kangsheng GuHospital of Anhui Medical University, Hefei, China.
Wen Yan ZhongMSD China, Shanghai, China.
Shu KuangMSD China, Beijing, China.
Chie-Schin ShihMerck & Co., Inc., Kenilworth, New Jersey.
Shu-Kui QinPeople's Liberation Army Cancer Centre of Nanjing Bayi Hospital, Nanjing, China.
Anhui Medical University · CN81th Hospital of PLA · CNCentral South University · CNChang Gung University · TWCHA University Bundang Medical Center · KRChina Medical University · TWHarbin Medical University · CNJiangsu Cancer Hospital · CNKangbuk Samsung Hospital · KRMerck & Co., Inc., Rahway, NJ, USA (United States) · USNational Cancer Center · KRPeople's Liberation Army No. 150 Hospital · CNThe Catholic University of Korea St. Vincent's Hospital · KRUlsan College · KRUniversity Malaya Medical Centre · MYYonsei University · KRZhejiang Cancer Hospital · CN

Funding

Merck & Co., Inc.Merck Sharp and Dohme Corp
6 · The paper itself

Abstract

backgroundKEYNOTE-063 (NCT03019588) investigated pembrolizumab versus paclitaxel as second-line therapy in Asian patients with advanced programmed death ligand 1 (PD-L1)-positive (combined positive score ≥1) gastric/gastroesophageal junction (GEJ) cancer.

methodsThis randomized, open-label, phase 3 study was conducted at 36 medical centers in China (mainland), Malaysia, South Korea, and Taiwan. Patients were randomly assigned 1:1 to 200 mg of pembrolizumab intravenously every 3 weeks for ≤2 years or 80 mg/m

resultsBetween February 16, 2017, and March 12, 2018, 94 patients were randomly assigned (47 pembrolizumab/47 paclitaxel) after screening; enrollment was stopped on March 12, 2018, based on the results of the global KEYNOTE-061 study, and patients were followed until the last patient's last visit. Median OS was 8 months (95% confidence interval [CI], 4-10 months) with pembrolizumab versus 8 months (95% CI, 5-11 months) with paclitaxel (hazard ratio [HR], 0.99; 95% CI, 0.63-1.54). Median PFS was 2 months (95% CI, 1-3 months) with pembrolizumab versus 4 months (95% CI, 3-6 months) with paclitaxel (HR, 1.62; 95% CI, 1.04-2.52). ORR was 13% for pembrolizumab versus 19% for paclitaxel. Any-grade treatment-related adverse events occurred in 28 pembrolizumab-treated patients (60%) and 42 paclitaxel-treated patients (96%); grades 3 to 5 events occurred in 5 patients (11%) and 28 patients (64%), respectively.

conclusionsDefinitive conclusions about the efficacy of second-line pembrolizumab in Asian patients with advanced PD-L1-positive gastric/GEJ cancer are limited because of insufficient power, but pembrolizumab was well tolerated in this patient population. Efficacy followed a trend similar to that observed in the phase 3 KEYNOTE-061 trial.

Indexed as

Antibodies, Monoclonal, HumanizedEsophageal NeoplasmsPaclitaxelStomach NeoplasmsChinaEsophagogastric JunctionHumansAntibodies, Monoclonal, HumanizedPaclitaxelpembrolizumabAsiachemotherapygastric cancergastroesophageal junction cancerpembrolizumabprogrammed death 1

Identifiers

PMID34878659
PMCPMC9299889
OpenAlexW4200006936

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.