TY - JOUR
T1 - Health-related quality of life in patients treated with pembrolizumab for microsatellite instability–high/mismatch repair–deficient advanced solid tumours
T2 - Results from the KEYNOTE-158 study
AU - Maio, Michele
AU - Amonkar, Mayur M.
AU - Norquist, Josephine M.
AU - Ascierto, Paolo A.
AU - Manzyuk, Ludmila
AU - Motola-Kuba, Daniel
AU - Penel, Nicolas
AU - Cassier, Philippe A.
AU - Bariani, Giovanni M.
AU - De Jesus Acosta, Ana
AU - Doi, Toshihiko
AU - Longo, Federico
AU - Miller, Wilson H.
AU - Oh, Do Youn
AU - Gottfried, Maya
AU - Wang, Ruixue
AU - Norwood, Kevin
AU - Marabelle, Aurelien
N1 - Publisher Copyright:
© 2022 Merck Sharp & Dohme Corp., The Author(s)
PY - 2022/7
Y1 - 2022/7
N2 - Background: 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). Patients and methods: 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. Results: 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]). Conclusions: Pembrolizumab generally improved or preserved HRQoL in patients with previously treated MSI-H/dMMR advanced non-colorectal solid tumours.
AB - Background: 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). Patients and methods: 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. Results: 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]). Conclusions: Pembrolizumab generally improved or preserved HRQoL in patients with previously treated MSI-H/dMMR advanced non-colorectal solid tumours.
KW - Health-related quality of life
KW - Microsatellite instability
KW - Pembrolizumab
UR - http://www.scopus.com/inward/record.url?scp=85130333977&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130333977&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2022.03.040
DO - 10.1016/j.ejca.2022.03.040
M3 - Article
C2 - 35588692
AN - SCOPUS:85130333977
SN - 0959-8049
VL - 169
SP - 188
EP - 197
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -