Τίτλος:
Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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). 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). 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. 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. 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). 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. 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. Conclusions: Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC. © 2022 Merck Sharp & Dohme Corp, The Author(s)
Συγγραφείς:
Rischin, D.
Harrington, K.J.
Greil, R.
Soulières, D.
Tahara, M.
de Castro Jr, G.
Psyrri, A.
Braña, I.
Neupane, P.
Bratland, Å.
Fuereder, T.
Hughes, B.G.M.
Mesía, R.
Ngamphaiboon, N.
Rordorf, T.
Ishak, W.Z.W.
Hong, R.-L.
Mendoza, R.G.
Jia, L.
Chirovsky, D.
Norquist, J.
Jin, F.
Burtness, B.
Εκδότης:
Elsevier Ireland Ltd
Λέξεις-κλειδιά:
antineoplastic agent; cetuximab; monoclonal antibody; pembrolizumab, chronic disease; head and neck tumor; human; pain; quality of life; questionnaire; tumor recurrence, Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Cetuximab; Chronic Disease; Head and Neck Neoplasms; Humans; Neoplasm Recurrence, Local; Pain; Quality of Life; Squamous Cell Carcinoma of Head and Neck; Surveys and Questionnaires
DOI:
10.1016/j.oraloncology.2022.105815
