Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study

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 pembr...

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Autores: Khattak, Muhammad A., Luke, Jason J., Long, Georgina V., Ascierto, Paolo A., Rutkowski, Piotr, Schadendorf, Dirk, Cruz Merino, Luis de la, Kirkwood, John M.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/155852
Acceso en línea:https://hdl.handle.net/11441/155852
https://doi.org/10.1016/j.ejca.2022.08.004
Access Level:acceso abierto
Palabra clave:Melanoma
Adjuvant
Immunotherapy
Pembrolizumab
Patient-reported outcomes
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spelling Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 studyKhattak, Muhammad A.Luke, Jason J.Long, Georgina V.Ascierto, Paolo A.Rutkowski, PiotrSchadendorf, DirkCruz Merino, Luis de laKirkwood, John M.MelanomaAdjuvantImmunotherapyPembrolizumabPatient-reported outcomesAbstract 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.Elsevier Science LtdMedicinaCTS151: Bioquímica médica2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/155852https://doi.org/10.1016/j.ejca.2022.08.004reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésEuropean Journal of Cancer, 176, 207-217.https://www.sciencedirect.com/science/article/pii/S0959804922004774?via%3Dihubinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1558522026-06-17T12:51:07Z
dc.title.none.fl_str_mv Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
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
spellingShingle Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
Khattak, Muhammad A.
Melanoma
Adjuvant
Immunotherapy
Pembrolizumab
Patient-reported outcomes
title_short Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
title_full Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
title_fullStr Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
title_full_unstemmed Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
title_sort Adjuvant pembrolizumab versus placebo in resected high risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
dc.creator.none.fl_str_mv Khattak, Muhammad A.
Luke, Jason J.
Long, Georgina V.
Ascierto, Paolo A.
Rutkowski, Piotr
Schadendorf, Dirk
Cruz Merino, Luis de la
Kirkwood, John M.
author Khattak, Muhammad A.
author_facet Khattak, Muhammad A.
Luke, Jason J.
Long, Georgina V.
Ascierto, Paolo A.
Rutkowski, Piotr
Schadendorf, Dirk
Cruz Merino, Luis de la
Kirkwood, John M.
author_role author
author2 Luke, Jason J.
Long, Georgina V.
Ascierto, Paolo A.
Rutkowski, Piotr
Schadendorf, Dirk
Cruz Merino, Luis de la
Kirkwood, John M.
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
CTS151: Bioquímica médica
dc.subject.none.fl_str_mv Melanoma
Adjuvant
Immunotherapy
Pembrolizumab
Patient-reported outcomes
topic Melanoma
Adjuvant
Immunotherapy
Pembrolizumab
Patient-reported outcomes
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/155852
https://doi.org/10.1016/j.ejca.2022.08.004
url https://hdl.handle.net/11441/155852
https://doi.org/10.1016/j.ejca.2022.08.004
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv European Journal of Cancer, 176, 207-217.
https://www.sciencedirect.com/science/article/pii/S0959804922004774?via%3Dihub
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier Science Ltd
publisher.none.fl_str_mv Elsevier Science Ltd
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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