Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629

Åse Bratland*, Eva Munoz-Couselo, Laurent Mortier, Osama Roshdy, Rene González, Jacob Schachter, Ana M. Arance, Florent Grange, Nicolas Meyer, Abhishek Jagdish Joshi, Salem Billan, Brett G.M. Hughes, Jean Jacques Grob, Karthik Ramakrishnan, Joy Ge, Burak Gumuscu, Ramona F. Swaby, Ralf Gutzmer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Introduction: At first interim analysis of KEYNOTE-629, health-related quality of life (HRQoL) with pembrolizumab was stable or improved over 48 weeks in recurrent or metastatic (R/M) cutaneous squamous cell carcinoma (cSCC). HRQoL results from the second interim analysis in R/M or locally advanced (LA) cSCC are presented. Methods: Patients received pembrolizumab 200 mg every 3 weeks for ≤ 2 years. Change in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EQ-5D-5L scores were exploratory end points. Primary analysis was performed at week 12 to ensure adequate completion/compliance. Descriptive analyses were also conducted through weeks 48 and 75 for the LA and R/M cohorts, respectively. Results: At data cutoff (29 July 2020), mean scores in the LA cohort (n = 47) were stable from baseline to week 12 for EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) (−0.27 points [95% confidence interval (CI) −10.93 to 10.39]), physical functioning (−1.29 points [95% CI −8.77 to 6.19]), and EQ-5D-5L visual analog scale (2.06 [95% CI −7.70 to 11.82]). HRQoL remained stable through week 48 in the LA cohort; 76.6% and 74.5% of patients had improved or stable GHS/QoL and physical functioning scores, respectively. HRQoL continued to show stability or improvement through week 75 in the R/M cohort (n = 99); 71.7% and 64.6% of patients had improved or stable GHS/QoL and physical functioning scores, respectively. Conclusions: Pembrolizumab has demonstrated antitumor activity and manageable safety. The current analysis shows pembrolizumab treatment preserved HRQoL. Collectively, these results support pembrolizumab as standard of care for LA or R/M cSCC. Trial Registration: ClinicalTrials.gov, NCT03284424—September 15, 2017.

Original languageEnglish
Pages (from-to)3165-3180
Number of pages16
JournalDermatology and Therapy
Volume13
Issue number12
DOIs
StatePublished - Dec 2023
Externally publishedYes

Funding

FundersFunder number
Merck Sharp & Dohme LLC
Merck Sharp & Dohme LLC.

    Keywords

    • Advanced squamous cell carcinoma
    • Immunotherapy
    • Pembrolizumab
    • Quality of life

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