RT Journal Article
T1 Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study.
A1 Khattak, Muhammad A
A1 Luke, Jason J
A1 Long, Georgina V
A1 Ascierto, Paolo A
A1 Rutkowski, Piotr
A1 Schadendorf, Dirk
A1 Robert, Caroline
A1 Grob, Jean-Jacques
A1 de la Cruz Merino, Luis
A1 Del Vecchio, Michele
A1 Spagnolo, Francesco
A1 Mackiewicz, Jacek
A1 Chiarion-Sileni, Vanna
A1 Carlino, Matteo S
A1 Mohr, Peter
A1 De Galitiis, Federica
A1 Ross, Merrick I
A1 Eroglu, Zeynep
A1 Chen, Ke
A1 Jiang, Ruixuan
A1 Fukunaga-Kalabis, Mizuho
A1 Krepler, Clemens
A1 Eggermont, Alexander M M
A1 Kirkwood, John M
K1 Adjuvant
K1 Immunotherapy
K1 Melanoma
K1 Patient-reported outcomes
K1 Pembrolizumab
AB Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) versus placebo in resected stage IIB and IIC melanoma in the phase 3 KEYNOTE-716 study. Health-related quality of life (HRQoL) results are reported. Patients were randomly assigned 1:1 to pembrolizumab 200 mg (2 mg/kg, patients ≥12 to  The HRQoL population included 969 patients (pembrolizumab, n = 483; placebo, n = 486). Compliance at week 48 was ≥80% for both instruments. EORTC QLQ-C30 GHS/QoL, physical functioning, role functioning, and EQ-5D-5L VAS scores were stable from baseline to week 48 in both arms, with no clinically meaningful decline observed. Scores did not differ significantly between pembrolizumab and placebo. EORTC QLQ-C30 GHS/QoL, physical functioning, role functioning, and EQ-5D-5L VAS scores remained stable through week 96 in both arms. HRQoL was stable with adjuvant pembrolizumab, with no clinically meaningful decline observed. Change from baseline in HRQoL was similar between arms. These results, in conjunction with the improved RFS and manageable safety previously reported, support the use of adjuvant pembrolizumab for high-risk stage II melanoma.
YR 2022
FD 2022-10-03
LK http://hdl.handle.net/10668/22180
UL http://hdl.handle.net/10668/22180
LA en
DS RISalud
RD Apr 18, 2025