Health-related quality of life in patients treated with pembrolizumab for microsatellite instability–high/mismatch repair–deficient advanced solid tumours: Results from the KEYNOTE-158 study

• Published in: European journal of cancer (1990) Vol. 169; pp. 188 - 197
• Main Authors: Maio, Michele, Amonkar, Mayur M., Norquist, Josephine M., Ascierto, Paolo A., Manzyuk, Ludmila, Motola-Kuba, Daniel, Penel, Nicolas, Cassier, Philippe A., Bariani, Giovanni M., De Jesus Acosta, Ana, Doi, Toshihiko, Longo, Federico, Miller, Wilson H., Oh, Do-Youn, Gottfried, Maya, Wang, Ruixue, Norwood, Kevin, Marabelle, Aurelien
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.07.2022; Elsevier Science Ltd; Elsevier
• Series: European Journal of Cancer
• Subjects: Cognitive ability; Global health; Health services; Health-related quality of life; Immunotherapy; Life Sciences; Metastases; Microsatellite instability; Microsatellites; Mismatch repair; Monoclonal antibodies; Patients; Pembrolizumab; Public health; Quality of life; Questionnaires; Repair; Solid tumors; Targeted cancer therapy; Tumors; Health-related quality of life; Pembrolizumab; Microsatellite instability
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2022.03.040

In the KEYNOTE-158 study (NCT02628067), pembrolizumab showed a high objective response rate and durable clinical benefit for patients with previously treated, unresectable/metastatic microsatellite instability−high (MSI-H)/mismatch repair‒deficient (dMMR) non-colorectal solid tumours. We present health-related quality of life (HRQoL) results from the MSI-H/dMMR population (cohort K). Eligible patients had previously treated MSI-H/dMMR advanced non-colorectal solid tumours, measurable disease per RECIST v1.1, and ECOG performance status ≤1. Patients received pembrolizumab 200 mg Q3W for 35 cycles (2 years). The EORTC Quality of Life Questionnaire (QLQ-C30) and EQ-5D-3L were administered at baseline, at regular intervals throughout treatment, and 30 days after treatment discontinuation. Prespecified analyses (exploratory endpoints) included the magnitude of change from baseline to post-baseline timepoints in all patients and by the best overall response for QLQ-C30 global health status (GHS)/QoL, QLQ-C30 functional/symptom scales/items, and EQ-5D-3L visual analogue scale (VAS) score. At data cutoff (October 5, 2020), 351 patients were enrolled, of whom 311 and 315 completed baseline QLQ-C30 and EQ-5D-3L questionnaires, respectively. QLQ-C30 GHS/QoL scores improved from baseline to week 9 (mean [95% CI] change, 3.07 [0.19–5.94]), then remained stable or improved by week 111, with greater improvements observed in patients with a best response of complete response (CR) or partial response (PR) (10.85 [6.36–15.35]). Patients with CR/PR showed improvements in physical (5.58 [1.91–9.25]), role (9.88 [3.80–15.97]), emotional (5.62 [1.56–9.68]), and social (8.33 [2.70–13.97]) functioning, and stable cognitive functioning (1.74 [−1.45 to 4.94]). Pembrolizumab generally improved or preserved HRQoL in patients with previously treated MSI-H/dMMR advanced non-colorectal solid tumours. •Patients with previously treated MSI-H/dMMR cancer received pembrolizumab treatment.•Treatment was associated with improved QLQ-C30 GHS/QoL from baseline to week 9.•Improvements were greatest among patients with a complete or partial response.•Pembrolizumab improved or preserved QoL in previously treated MSI-H/dMMR cancer.