Gynecologic oncology · 2025
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.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Randall Leslie, Xiang Yang, Matsumoto Takashi, Giannarelli Diana, Milla Dency Pilar, Lopez Karla Alejandra, Acevedo Alejandro, Vizkeleti Julia, Salani Ritu, Nogueira-Rodrigues Angelica, Mejia Fernando Contreras, Korach Jacob, Akilli Hüseyin, Lee Jung-Yun, Saevets Valeriya Vladimirovna, Samouelian Vanessa, Sehouli Jalid, Tharavichikul Ekkasit, Sukhin Vladyslav, Colombo Nicoletta, Chang Chih-Long, Cueva Juan F, Lalondrelle Susan, Petru Edgar, Szamreta Elizabeth, Nguyen Allison Martin, Yamada Karin, Li Kan, Pignata Sandro, Lorusso Domenica
Аннотация
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.
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.