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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
- Authors
- Leslie Randall ; Yang Xiang ; Takashi Matsumoto ; Diana Giannarelli ; Dency Pilar Milla ; Karla Alejandra Lopez ; Alejandro Acevedo ; Julia Vizkeleti ; Ritu Salani ; Angelica Nogueira-Rodrigues ; Fernando Contreras Mejia ; Jacob Korach ; Hüseyin Akilli ; Jung-Yun Lee ; Valeriya Vladimirovna Saevets ; Vanessa Samouelian ; Jalid Sehouli ; Ekkasit Tharavichikul ; Vladyslav Sukhin ; Nicoletta Colombo ; Chih-Long Chang ; Juan F Cueva ; Susan Lalondrelle ; Edgar Petru ; Elizabeth Szamreta ; Allison Martin Nguyen ; Karin Yamada ; Kan Li ; Sandro Pignata ; Domenica Lorusso
- Citation
- GYNECOLOGIC ONCOLOGY, Vol.199 : 88-95, 2025-08
- Journal Title
- GYNECOLOGIC ONCOLOGY
- ISSN
- 0090-8258
- Issue Date
- 2025-08
- MeSH
- Chemotherapy ; Health-related quality of life ; Locally advanced cervical cancer ; Patient-reported outcomes ; pembrolizumab
- Keywords
- Objective: 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 ; EQ-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.
- Abstract
- 10.1016/j.ygyno.2025.06.003
- DOI
- 40592026
- Appears in Collections:
- 1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
- Yonsei Authors
-
Lee, Jung-Yun(이정윤)
https://orcid.org/0000-0001-7948-1350
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