YUHSpace

BROWSE

Export
0 13

Cited 0 times in

Cited 0 times in

Patient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in participants with high-risk locally advanced cervical cancer

DC Field Value Language
dc.contributor.author이정윤-
dc.date.accessioned2026-01-29T06:26:37Z-
dc.date.available2026-01-29T06:26:37Z-
dc.date.issued2025-08-
dc.identifier.issn0090-8258-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/210335-
dc.description.abstract10.1016/j.ygyno.2025.06.003-
dc.description.statementOfResponsibilityAdult ; Aged ; Antibodies, Monoclonal, Humanized* / administration & dosage ; Antibodies, Monoclonal, Humanized* / adverse effects ; Antibodies, Monoclonal, Humanized* / therapeutic use ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Chemoradiotherapy* / methods ; Cisplatin / administration & dosage ; Double-Blind Method ; Female ; Humans ; Middle Aged ; Neoplasm Staging ; Patient Reported Outcome Measures ; Progression-Free Survival ; Quality of Life ; Uterine Cervical Neoplasms* / drug therapy ; Uterine Cervical Neoplasms* / pathology ; Uterine Cervical Neoplasms* / therapy-
dc.languageEnglish-
dc.publisherAcademic Press-
dc.relation.isPartOfGYNECOLOGIC ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHChemotherapy-
dc.subject.MESHHealth-related quality of life-
dc.subject.MESHLocally advanced cervical cancer-
dc.subject.MESHPatient-reported outcomes-
dc.subject.MESHpembrolizumab-
dc.titlePatient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in participants with high-risk locally advanced cervical cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Obstetrics and Gynecology (산부인과학교실)-
dc.contributor.googleauthorLeslie Randall-
dc.contributor.googleauthorYang Xiang-
dc.contributor.googleauthorTakashi Matsumoto-
dc.contributor.googleauthorDiana Giannarelli-
dc.contributor.googleauthorDency Pilar Milla-
dc.contributor.googleauthorKarla Alejandra Lopez-
dc.contributor.googleauthorAlejandro Acevedo-
dc.contributor.googleauthorJulia Vizkeleti-
dc.contributor.googleauthorRitu Salani-
dc.contributor.googleauthorAngelica Nogueira-Rodrigues-
dc.contributor.googleauthorFernando Contreras Mejia-
dc.contributor.googleauthorJacob Korach-
dc.contributor.googleauthorHüseyin Akilli-
dc.contributor.googleauthorJung-Yun Lee-
dc.contributor.googleauthorValeriya Vladimirovna Saevets-
dc.contributor.googleauthorVanessa Samouelian-
dc.contributor.googleauthorJalid Sehouli-
dc.contributor.googleauthorEkkasit Tharavichikul-
dc.contributor.googleauthorVladyslav Sukhin-
dc.contributor.googleauthorNicoletta Colombo-
dc.contributor.googleauthorChih-Long Chang-
dc.contributor.googleauthorJuan F Cueva-
dc.contributor.googleauthorSusan Lalondrelle-
dc.contributor.googleauthorEdgar Petru-
dc.contributor.googleauthorElizabeth Szamreta-
dc.contributor.googleauthorAllison Martin Nguyen-
dc.contributor.googleauthorKarin Yamada-
dc.contributor.googleauthorKan Li-
dc.contributor.googleauthorSandro Pignata-
dc.contributor.googleauthorDomenica Lorusso-
dc.identifier.doi40592026-
dc.contributor.localIdA04638-
dc.relation.journalcodeJ00956-
dc.identifier.eissn1095-6859-
dc.subject.keywordObjective: In ENGOT-cx11/GOG-3047/KEYNOTE-A18 (NCT04221945), pembrolizumab (vs placebo) + concurrent chemoradiotherapy (CCRT) followed by pembrolizumab (vs placebo) significantly improved progression-free survival and overall survival in participants with newly diagnosed, high-risk locally advanced cervical cancer (LACC). We report patient-reported outcomes (PROs) from the study. Methods: Participants (≥18 years) with high-risk LACC (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA) were randomized 1:1 to 5 cycles of pembrolizumab 200 mg or placebo Q3W plus CCRT, followed by 15 cycles of pembrolizumab 400 mg or placebo Q6W. CCRT was 5 cycles (optional 6th dose) of cisplatin 40 mg/m2 Q1W plus external beam radiotherapy followed by brachytherapy. Secondary PRO endpoints included EORTC QLQ-C30 GHS/QoL and physical functioning subscales and EORTC QLQ-CX24 symptom experience scale-
dc.subject.keywordEQ-5D-5L visual analogue scale (VAS) was an exploratory endpoint. No alpha was assigned to the PRO analyses. Results: 1008 (95.1 %) of 1060 randomized participants were included in the PRO full analysis set population. No meaningful between-group differences were observed for any of the prespecified PRO instruments. Between-group differences (95 % CIs) in least-squares mean score changes from baseline to week 36 (primary time point) were 0.57 (-2.34 to 3.49) for QLQ-C30 GHS/QoL, 0.64 (-1.54 to 2.82) for QLQ-C30 physical functioning, 0.54 (-1.02 to 2.09) for QLQ-CX24 symptom experience, and -0.55 (-2.97 to 1.86) for EQ-5D-5L VAS. Empirical mean score changes over time and the proportions of participants whose scores improved, remained stable, or deteriorated over time were similar between treatment arms. Conclusions: Pembrolizumab+CCRT did not negatively impact participants' health-related quality of life.-
dc.contributor.alternativeNameLee, Jung-Yun-
dc.contributor.affiliatedAuthor이정윤-
dc.citation.volume199-
dc.citation.startPage88-
dc.citation.endPage95-
dc.identifier.bibliographicCitationGYNECOLOGIC ONCOLOGY, Vol.199 : 88-95, 2025-08-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Show simple item record Find it @ YMLIB

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

  • License
    sherpa_romeo
    sherpa_juliet

OAK

DSpace Software Copyright © 2002-2017 Duraspace Yonsei University Medical Library All right Reserves. / TEL:02-2228-2915 /
YUHSpace는 국립중앙도서관 OAK 보급사업으로 구축되었습니다.

Browse

Links