dc.creator | Khattak, Muhammad A. | es |
dc.creator | Luke, Jason J. | es |
dc.creator | Long, Georgina V. | es |
dc.creator | Ascierto, Paolo A. | es |
dc.creator | Rutkowski, Piotr | es |
dc.creator | Schadendorf, Dirk | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Kirkwood, John M. | es |
dc.date.accessioned | 2024-03-05T16:50:01Z | |
dc.date.available | 2024-03-05T16:50:01Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Khattak, M.A., Luke, J.J., Long, G.V., Ascierto, P.A., Rutkowski, P., Schadendorf, D.,...,Kirkwood, J.M. (2022). Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study. European Journal of Cancer, 176, 207-217. https://doi.org/10.1016/j.ejca.2022.08.004. | |
dc.identifier.issn | 0959-8049 | es |
dc.identifier.issn | 1879-0852 | es |
dc.identifier.uri | https://hdl.handle.net/11441/155852 | |
dc.description.abstract | Abstract Background: 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.
Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg (2 mg/kg, patients
12 to <18 years) Q3W or placebo for 17 cycles or until disease recurrence, unacceptable
toxicity, or withdrawal. Change from baseline in EORTC QLQ-C30 global health status
(GHS)/quality of life (QoL) was a prespecified exploratory end point. Change in EORTC
QLQ-C30 functioning, symptom, and single-item scales, and EQ-5D-5L visual analog scale
(VAS) were also summarized. Primary analyses were performed at week 48 to ensure adequate
completion/compliance. The HRQoL population comprised patients who received 1 dose of
treatment and completed 1 assessment.
Results: The HRQoL population included 969 patients (pembrolizumab, n Z 483; placebo,
n Z 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.
Conclusions: 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. | es |
dc.format | application/pdf | es |
dc.format.extent | 11 p. | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier Science Ltd | es |
dc.relation.ispartof | European Journal of Cancer, 176, 207-217. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Melanoma | es |
dc.subject | Adjuvant | es |
dc.subject | Immunotherapy | es |
dc.subject | Pembrolizumab | es |
dc.subject | Patient-reported outcomes | es |
dc.title | Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S0959804922004774?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.ejca.2022.08.004 | es |
dc.contributor.group | Universidad de Sevilla. CTS151: Bioquímica médica. | es |
dc.journaltitle | European Journal of Cancer | es |
dc.publication.volumen | 176 | es |
dc.publication.initialPage | 207 | es |
dc.publication.endPage | 217 | es |