Evidence map›Paper›PMID 41259897›Full record

Trial reportESMO open2025

Pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer: 5-year extended follow-up for the randomized phase III KEYNOTE-590 study.

J-P Metges, K Kato, J-M Sun, L Shen, P C Enzinger, A Adenis, T Doi, T Kojima, Z Li, S-B Kim and 12 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

14 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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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

22 authors.

J-P MetgesCHU Brest-Institut de Cancerologie et d'Hematologie ARPEGO Network, Brest, France. Electronic address: jean-philippe.metges@chu-brest.fr.
K KatoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
J-M SunDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
L ShenDepartment of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
P C EnzingerDepartment of Medicine, Dana-Farber Cancer Institute, Boston, USA.
A AdenisDepartment of Medical Oncology, IRCM, Université Montpellier, ICM, Montpellier, France.
T DoiDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
T KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Z LiDepartment of Thoracic Surgery, Section of Esophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
S-B KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
B C ChoDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
W MansoorDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
S-H LiDivision of Hematology and Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
P SunpaweravongDivision of Medical Oncology, Department of Internal Medicine, Prince of Songkla University Hospital, Songkhla, Thailand.
M AlsinaDepartment of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona; Medical Oncology Department, Hospital Universitario de Navarra, Pamplona, Spain.
G L BuchschacherDepartment of Oncology, Kaiser Permanente Southern California, Los Angeles Medical Center, Los Angeles, USA.
H HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama.
A TsujiDepartment of Medical Oncology, Kagawa University Hospital, Kagawa, Japan.
J WuMerck & Co., Inc., Rahway.
S ShahMerck & Co., Inc., Rahway.
P BhagiaMerck & Co., Inc., Rahway.
M A ShahGastrointestinal Oncology Program, Weill Cornell Medical College, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe global KEYNOTE-590 trial was the first to show a significant improvement in survival with immunotherapy plus chemotherapy in the first-line treatment of esophageal cancer (EC) and supported the approval of pembrolizumab plus chemotherapy in this setting. After a median follow-up of 22.6 months, pembrolizumab plus chemotherapy compared with placebo plus chemotherapy had a manageable safety profile and significantly improved survival of participants with previously untreated advanced EC. Results of a median follow-up of 58.8 months (range 49.2-70.6 months) are reported. PATIENTS AND

methodsAdults with previously untreated advanced EC or Siewert type 1 gastroesophageal junction cancer were randomly assigned 1 : 1 to receive chemotherapy with or without pembrolizumab. Study outcomes were efficacy and safety.

resultsOverall, 749 participants received pembrolizumab plus chemotherapy (n = 373) or placebo plus chemotherapy (n = 376). Median overall survival was 12.3 months versus 9.8 months [hazard ratio (HR) 0.72, 95% confidence interval (CI) 0.62-0.84] with pembrolizumab plus chemotherapy versus placebo plus chemotherapy; 5-year survival rates were 10.6% and 3.0%. Median progression-free survival (PFS) was 6.3 months versus 5.8 months (HR 0.64, 95% CI 0.54-0.75); 5-year PFS rates were 5.5% and not reached. Grade ≥3 treatment-related adverse events occurred in 71.9% and 67.6% of participants in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups, respectively.

conclusionData from KEYNOTE-590 continue to show durable efficacy after 5 years, and pembrolizumab plus chemotherapy more than tripled the 5-year overall survival rate compared with placebo plus chemotherapy, with no new safety signals. These results support first-line therapy with pembrolizumab plus chemotherapy as standard for previously untreated patients with advanced EC with programmed death-ligand 1 combined positive score ≥1.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabchemotherapyesophageal cancerpembrolizumabpreviously untreated

Identifiers

PMID41259897
PMCPMC12670541

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Registered trials

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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.