Rischin, Danny and Harrington, Kevin J. and Greil, Richard and Soulieres, Denis and Tahara, Makoto and de Castro Jr, Gilberto and Psyrri, Amanda and Brana, Irene and Neupane, Prakash and Bratland, Ase and Fuereder, Thorsten and Hughes, Brett G. M. and Mesia, Ricard and Ngamphaiboon, Nuttapong and Rordorf, Tamara and Ishak, Wan Zamaniah Wan and Hong, Ruey-Long and Mendoza, Rene Gonzalez and Jia, Liyi and Chirovsky, Diana and Norquist, Josephine and Jin, Fan and Burtness, Barbara (2022) Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048. Oral Oncology, 128. ISSN 1368-8375, DOI https://doi.org/10.1016/j.oraloncology.2022.105815.
Full text not available from this repository.Abstract
Objectives: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumabchemotherapy, 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; pembrolizumabchemotherapy 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 cetuximabchemotherapy: 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.
| Item Type: | Article |
|---|---|
| Funders: | Ananya Roy, Merck, Merck Sharp and Dohme |
| Uncontrolled Keywords: | Phase III clinical trial; Chemotherapy head and neck neoplasms; Immunotherapy; Patient reported outcome measures; Pembrolizumab |
| Subjects: | R Medicine > R Medicine (General) R Medicine > R Medicine (General) > Medical technology |
| Divisions: | Faculty of Medicine > Clinical Oncology Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 05 Oct 2023 08:49 |
| Last Modified: | 05 Oct 2023 08:49 |
| URI: | http://eprints.um.edu.my/id/eprint/42907 |
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