Browsing by Author "Ivanescu, Cristina"

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    Patient-Reported Outcomes with Cemiplimab Monotherapy for First-Line Treatment of Advanced Non-Small Cell Lung Cancer with PD-L1 Of >= 50%: The EMPOWER-Lung 1 Study
    (2023) Gumus, Mahmut; Chen, Chieh-, I; Ivanescu, Cristina; Kilickap, Saadettin; Bondarenko, Igor; Ozguroglu, Mustafa; Gogishvili, Miranda; Turk, Haci M.; Cicin, Irfan; Harnett, James; Mastey, Vera; Naumann, Ulrike; Reaney, Matthew; Konidaris, Gerasimos; Sasane, Medha; Brady, Keri J. S.; Li, Siyu; Gullo, Giuseppe; Rietschel, Petra; Sezer, Ahmet; 36308296
    Background In the EMPOWER-Lung 1 trial (, NCT03088540), cemiplimab conferred longer survival than platinum-doublet chemotherapy for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) >= 50%. Patient-reported outcomes were evaluated among trial participants. Methods Adults with NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. At baseline and day 1 of each treatment cycle, patients were administered the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Mixed-model repeated measures analysis estimated overall change from baseline for PD-L1 >= 50% and intention-to-treat populations. Kaplan-Meier analysis estimated time to definitive deterioration. Results In PD-L1 >= 50% patients (cemiplimab, n = 283; chemotherapy, n = 280), baseline QLQ-C30 and QLQ-LC13 scores showed moderate-to-high functioning and low symptom burden. Change from baseline favored cemiplimab on global health status/quality of life (GHS/QOL), functioning, and most symptom scales. Risk of definitive deterioration across functioning scales was reduced versus chemotherapy; hazard ratios were 0.48 (95% CI, 0.32-0.71) to 0.63 (95% CI, 0.41-0.96). Cemiplimab showed lower risk of definitive deterioration for disease-related (dyspnea, cough, pain in chest, pain in other body parts, fatigue) and treatment-related symptoms (peripheral neuropathy, alopecia, nausea/vomiting, appetite loss, constipation, diarrhea) (nominal p < .05). Results were similar in the intention-to-treat population. Conclusions Results support cemiplimab for first-line therapy of advanced NSCLC from the patient's perspective. Improved survival is accompanied by improvements versus platinum-doublet chemotherapy in GHS/QOL and functioning and reduction in symptom burden.