Evidence map›Paper›PMID 38815152›Full record

Trial reportThe oncologist2024

Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer.

Wasat Mansoor, Seongjung Joo, Josephine M Norquist, Ken Kato, Jong-Mu Sun, Manish A Shah, Peter Enzinger, Antoine Adenis, Toshihiko Doi, Takashi Kojima and 10 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03189719 (A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 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.

NCT03189719 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2023Enrolled749ConditionsEsophageal NeoplasmsArmsPembrolizumab, Placebo, Cisplatin, 5-FU
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Health-related quality-of-life outcomes with regorafenib in advanced gastric and esophagogastric junction cancer: results from the INTEGRATE trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Trial
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Wasat MansoorDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom.ORCID 0000-0002-1477-4934
Seongjung JooMerck & Co., Inc., Rahway, NJ, United States.
Josephine M NorquistMerck & Co., Inc., Rahway, NJ, United States.
Ken KatoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-1733-5072
Jong-Mu SunDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Manish A ShahGastrointestinal Oncology Program, Weill Cornell Medical College, New York, NY, United States.
Peter EnzingerDepartment of Medicine, Dana-Farber Cancer Institute, Boston, MA, United States.
Antoine AdenisDepartment of Medical Oncology, Institut du Cancer de Montpellier (ICM), Montpellier, France.
Toshihiko DoiDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takashi KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Jean-Philippe MetgesCentre Hospitalier Regional Universitaire (CHRU) Brest, Institut de Cancerologie et d'Hematologie ARPEGO Network, Brest, France.
Zhigang LiDepartment of Thoracic Surgery, Section of Esophageal Surgery, Shanghai Chest Hospital, Esophageal Disease Center, Shanghai, People's Republic of China.
Sung-Bae KimDepartment of Oncology, Asan Medical Center, Seoul, South Korea.
Byoung Chol ChoDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Patrapim SunpaweravongDivision of Medical Oncology, Department of Internal Medicine, Prince of Songkla University Hospital, Songkhla, Thailand.
Maria AlsinaDepartment of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Eray GoekkurtHematology Oncology Practice Eppendorf, University Cancer Center Hamburg, Hamburg, Germany.
Shailaja SuryawanshiMerck & Co., Inc., Rahway, NJ, United States.
Sukrut ShahMerck & Co., Inc., Rahway, NJ, United States.
Lin ShenDepartment of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.

Funding

Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
6 · The paper itself

Abstract

backgroundIn the KEYNOTE-590 study, first-line pembrolizumab plus chemotherapy provided statistically significant improvement in overall survival, progression-free survival, and objective response rate compared with chemotherapy, with a manageable safety profile in patients with advanced esophageal cancer. Prespecified health-related quality-of-life (HRQoL) outcomes are reported. MATERIALS AND

methodsChange from baseline to week 18 in the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/QoL (GHS/QoL) and QLQ-Esophageal cancer module (OES18) dysphagia, pain, and reflux scales were evaluated.

resultsThe HRQoL analysis included 730 patients who received treatment and completed ≥1 HRQoL assessment. Least squares mean (LSM) change from baseline to week 18 was similar between treatment groups for QLQ-C30 GHS/QoL and physical functioning and QLQ-OES18 reflux scales. The QLQ-OES18 dysphagia (LSM difference, -5.54; 95% CI, -10.93 to -0.16) and pain (LSM difference, -2.94; 95% CI, -5.86 to -0.02) scales favored pembrolizumab plus chemotherapy over placebo plus chemotherapy. Median time to confirmed deterioration (TTD) was similar between treatment groups for QLQ-C30 GHS/QoL and physical functioning and QLQ-OES18 dysphagia and reflux scales. Compared with chemotherapy, pembrolizumab plus chemotherapy prolonged median TTD, as seen on the QLQ-OES18 pain scale (HR, 0.69; 95% CI, 0.51 to 0.95).

conclusionThe use of pembrolizumab plus chemotherapy maintained HRQoL at week 18 relative to baseline and was comparable with placebo plus chemotherapy. These HRQoL results together with published reports of efficacy, support the use of pembrolizumab plus chemotherapy as first-line therapy for advanced/metastatic esophageal cancer. CLINICALTRIALS.GOV ID: NCT03189719.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsQuality of LifeAdultAgedFemaleHumansMaleMiddle AgedSurveys and QuestionnairesAntibodies, Monoclonal, Humanizedpembrolizumabchemotherapyesophageal canceresophagogastric junction cancerhealth-related quality of lifepembrolizumab

Identifiers

PMID38815152
PMCPMC11449114

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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.