TTD was similar between groups for EORTC QLQ-C30 GHS/QoL (pembrolizumab vs cetuximab-chemotherapy: HR, 1.38 95% CI, 0.95-2.00 pembrolizumab-chemotherapy vs cetuximab-chemotherapy: HR, 1.37 95% CI, 0.94-2.00), as was TTD in EORTC QLQ-H&N35 pain and swallowing scores. Median TTD in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing scores was not reached over 51 weeks across groups, showing stable HRQoL. At week 15, EORTC QLQ-C30 GHS/QoL scores remained stable no clinically meaningful between-group differences were observed (least squares mean difference, pembrolizumab vs cetuximab-chemotherapy, 0.24 95% CI, -3.34 to 3.82 pembrolizumab-chemotherapy vs cetuximab-chemotherapy, 0.40 95% CI, -3.46 to 4.26). 4092 - Primary results of ALESIA: A randomised, phase III, open-label study of alectinib vs crizotinib in Asian patients with treatment-naïve ALK+ advanced NSCLC. Results: Of 882 enrolled participants, 844 received ≥ 1 dose of study treatment and completed ≥ 1 HRQoL assessment adherence was ≥ 79% at week 15 across treatment groups. KEYNOTE-048 was an open-label, randomized phase 3 study of P or P + chemotherapy (C) vs EXTREME (E) as first-line systemic therapy for R/M HNSCC (NCT02358031).
Secondary endpoints included mean change from baseline in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) at week 15 and time to deterioration (TTD) in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing. Materials and methods: HRQoL was measured using the European Organisation for Research and Treatment of Cancer 30-question quality-of-life (EORTC QLQ-C30), the EORTC 35-question quality-of-life head and neck cancer-specific module (EORTC QLQ-H&N35), and the EuroQol 5-dimension 3-level instruments (EQ-5D-3L). The KEYNOTE-040 and -048 studies investigating pembrolizumab in advanced HNSCC both used the combined positive score (CPS), which is the number of PD-L1. Immunotherapy Trials in Metastatic Head and Neck Squamous Cell Carcinoma.
#KEYNOTE 048 RESULTS TRIAL#
Objectives: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the phase 3 KEYNOTE-048 trial (NCT02358031). The results were similar to those of KEYNOTE-012, with pembrolizumab having an ORR of 16, a duration of response of 8 months, and no new safety concerns. First-line pembrolizumab monotherapy resulted in a statistically significant and clinically meaningful improvement in OS over cetuximab-chemotherapy in the PD-L1 CPS 20 and CPS 1 populations in the primary analysis of KEYNOTE-048, as did pembrolizumab-chemotherapy in the overall, CPS 20, and CPS 1 populations. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048 Please use this identifier to cite or link to this item:
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