• Login
    View Item 
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of ChristieCommunitiesTitleAuthorsIssue DateSubmit DateSubjectsThis CollectionTitleAuthorsIssue DateSubmit DateSubjectsProfilesView

    My Account

    LoginRegister

    Local Links

    The Christie WebsiteChristie Library and Knowledge Service

    Statistics

    Display statistics

    Health-related quality of life for pembrolizumab (pembro) plus ipilimumab (ipi) versus pembro plus placebo in patients with metastatic NSCLC with PD-L1 tumor proportion score >= 50%: KEYNOTE-598

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Authors
    Sendur, M. N.
    Reck, M.
    Rodriguez-Abreu, D.
    Park, K.
    Lee, D. H.
    Cicin, I.
    Yumuk, P. F.
    Orlandi, F. J.
    Leal, T. A.
    Molinier, O.
    Soparattanapaisarn, N.
    Langleben, A.
    Califano, Raffaele
    Medgyasszay, B.
    Hsia, T. C.
    Otterson, G. A.
    Xu, L.
    Burke, T. A.
    Samkari, A.
    Boyer, M. J.
    Show allShow less
    Affiliation
    Ankara Yıldırım Beyazıt University, Faculty of Medicine and Ankara City Hospital, Ankara, Turkey
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Background: In the phase 3 KEYNOTE-598 study (NCT03302234), OS (HR, 1.08; 95% CI, 0.85–1.37; P = 0.74) and PFS (1.06; 95% CI, 0.86–1.30; P = 0.72) were not improved for pembro + ipi vs pembro + placebo in patients (pts) with previously untreated metastatic NSCLC with PD-L1 tumor proportion score (TPS) ≥50% and without EGFR/ALK genomic alterations. Incidence of treatment-related grade 3–5 AEs, fatal AEs, and AEs leading to discontinuation was higher with pembro + ipi vs pembro + placebo. We present prespecified patient-reported outcome (PRO) analyses from KEYNOTE-598. Methods: Pts (n = 568) with previously untreated stage IV NSCLC with PD-L1 TPS ≥50% were randomized 1:1 to pembro 200 mg Q3W for up to 35 cycles + ipi 1 mg/kg or placebo Q6W for up to 18 cycles. The EORTC QLQ-C30, QLQ-LC13, EQ-5D-5L, and NSCLC-SAQ were administered at cycles 1‒7, then every 3 cycles through cycle 19, and every 4 cycles until PD or a maximum of 35 cycles. Change from baseline in global health status (GHS)/quality of life (QoL) score from the QLQ-C30 and the time to true deterioration (TTD) in the composite endpoint of cough (LC13), chest pain (LC13), or dyspnea (C30) were secondary objectives in KEYNOTE-598. Change from baseline in GHS/QoL was analyzed using a constrained longitudinal data analysis model with missing at random assumption. Difference in TTD was evaluated using a Cox proportional hazards model and stratified log-rank test. PROs were analyzed in all pts who completed ≥1 PRO assessment and received ≥1 dose of study treatment. P values are two-sided and nominal. Results: As of data cutoff (Sept 1, 2020), PRO analyses included 280 pts in the pembro + ipi group and 280 pts in the pembro + placebo group. QLQ-C30 completion rates were 95.7% in the pembro + ipi group vs 96.1% in the pembro + placebo group at baseline and 63.6% vs 70.0% at week 18. QLQ-LC13 completion rates were 95.4% vs 96.4% at baseline and 63.6% vs 69.6% at week 18. Mean QLQ-C30 GHS/QoL scores at baseline were 62.8 in the pembro + ipi group and 64.2 in the pembro + placebo group and were similar between the groups across the follow-up period. Least squares (LS) mean (95% CI) change from baseline to week 18 in GHS/QoL scores was improved in both groups (pembro + ipi: 3.7 [0.9‒6.5]; pembro + placebo: 4.1 [1.4‒6.9]), with no significant difference between groups (LS mean difference −0.4 [−4.0 to 3.1], P = 0.82). Median TTD in composite of cough, chest pain, or dyspnea was not reached (NR; 95% CI, 13.0 mo–NR) in the pembro + ipi group vs 20.0 (95% CI, 12.7–NR) mo in the pembro + placebo group (hazard ratio, 0.98 [95% CI, 0.74‒1.30]; P = 0.91). Conclusions: There was no difference in health-related QoL or TTD in lung cancer symptoms between pembro + ipi and pembro + placebo in pts with previously untreated metastatic NSCLC with PD-L1 TPS ≥50%.
    Citation
    Sendur MN, Reck M, Rodriguez-Abreu D, Park K, Lee DH, Cicin I, et al. Health-related quality of life for pembrolizumab (pembro) plus ipilimumab (ipi) versus pembro plus placebo in patients with metastatic NSCLC with PD-L1 tumor proportion score ≥ 50%: KEYNOTE-598. Vol. 39, Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2021. p. 9038–9038.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/624868
    DOI
    10.1200/JCO.2021.39.15_suppl.9038
    Additional Links
    https://dx.doi.org/10.1200/JCO.2021.39.15_suppl.9038
    Type
    Meetings and Proceedings
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2021.39.15_suppl.9038
    Scopus Count
    Collections
    All Christie Publications

    entitlement

     
    DSpace software (copyright © 2002 - 2025)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.