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Article: Health-Related Quality-of-Life Impact of Pembrolizumab Versus Best Supportive Care in Previously Systemically Treated Patients With Advanced Hepatocellular Carcinoma: KEYNOTE-240

TitleHealth-Related Quality-of-Life Impact of Pembrolizumab Versus Best Supportive Care in Previously Systemically Treated Patients With Advanced Hepatocellular Carcinoma: KEYNOTE-240
Authors
Keywordshepatocellular carcinoma
immunotherapy
patient-reported outcome measures
pembrolizumab
quality of life
Issue Date2021
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1097-0142
Citation
Cancer, 2021, v. 127 n. 6, p. 865-874 How to Cite?
AbstractBackground: Health-related quality of life (HRQoL) is an important outcome measure and prognostic indicator in hepatocellular carcinoma (HCC). KEYNOTE-240 (NCT02702401) assessed the efficacy and safety of pembrolizumab plus best supportive care (BSC) versus placebo plus BSC in patients with HCC who previously received sorafenib. This study presents the results of a prespecified exploratory analysis of patient-reported outcomes. Methods: Patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its HCC supplement (EORTC QLQ-HCC18) electronically at baseline; at weeks 2, 3, 4, 6, 9, 12, and 18; and then every 9 weeks until 1 year or end of treatment, and at the 30-day safety follow-up visit. Results: The HRQoL population included 271 and 127 patients randomly assigned to pembrolizumab and placebo, respectively. From baseline to week 12, changes in both scores were similar between pembrolizumab and placebo; global health status/QoL scores were stable. The proportions of patients who improved, remained stable, or deteriorated across all functional domain and symptom scores were generally similar between pembrolizumab and placebo. Time to deterioration was similar between the 2 arms based on the prespecified analysis of EORTC QLQ-HCC18 domains of abdominal swelling, fatigue, and pain. Conclusion: Pembrolizumab preserved HRQoL during treatment for advanced HCC. Combined with efficacy and safety results from KEYNOTE-240, these findings support a positive benefit/risk profile for pembrolizumab in a second-line treatment setting for patients with HCC who previously received sorafenib.
DescriptionThis study was presented as a poster at the European Society for Medical Oncology's ESMO Congress 2019, Barcelona, Spain, 27 September - 1 October 2019.
Persistent Identifierhttp://hdl.handle.net/10722/289772
ISSN
2020 Impact Factor: 6.86
2020 SCImago Journal Rankings: 3.052
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorRyoo, BY-
dc.contributor.authorMerle, P-
dc.contributor.authorKulkarni, AS-
dc.contributor.authorCheng, AL-
dc.contributor.authorBouattour, M-
dc.contributor.authorLim, HY-
dc.contributor.authorBreder, V-
dc.contributor.authorEdeline, J-
dc.contributor.authorChao, Y-
dc.contributor.authorOgasawara, S-
dc.contributor.authorYau, T-
dc.contributor.authorGarrido, M-
dc.contributor.authorChan, SL-
dc.contributor.authorDaniele, B-
dc.contributor.authorNorquist, JM-
dc.contributor.authorChen, E-
dc.contributor.authorSiegel, AB-
dc.contributor.authorZhu, AX-
dc.contributor.authorFinn, RS-
dc.contributor.authorKudo, M-
dc.date.accessioned2020-10-22T08:17:15Z-
dc.date.available2020-10-22T08:17:15Z-
dc.date.issued2021-
dc.identifier.citationCancer, 2021, v. 127 n. 6, p. 865-874-
dc.identifier.issn0008-543X-
dc.identifier.urihttp://hdl.handle.net/10722/289772-
dc.descriptionThis study was presented as a poster at the European Society for Medical Oncology's ESMO Congress 2019, Barcelona, Spain, 27 September - 1 October 2019.-
dc.description.abstractBackground: Health-related quality of life (HRQoL) is an important outcome measure and prognostic indicator in hepatocellular carcinoma (HCC). KEYNOTE-240 (NCT02702401) assessed the efficacy and safety of pembrolizumab plus best supportive care (BSC) versus placebo plus BSC in patients with HCC who previously received sorafenib. This study presents the results of a prespecified exploratory analysis of patient-reported outcomes. Methods: Patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its HCC supplement (EORTC QLQ-HCC18) electronically at baseline; at weeks 2, 3, 4, 6, 9, 12, and 18; and then every 9 weeks until 1 year or end of treatment, and at the 30-day safety follow-up visit. Results: The HRQoL population included 271 and 127 patients randomly assigned to pembrolizumab and placebo, respectively. From baseline to week 12, changes in both scores were similar between pembrolizumab and placebo; global health status/QoL scores were stable. The proportions of patients who improved, remained stable, or deteriorated across all functional domain and symptom scores were generally similar between pembrolizumab and placebo. Time to deterioration was similar between the 2 arms based on the prespecified analysis of EORTC QLQ-HCC18 domains of abdominal swelling, fatigue, and pain. Conclusion: Pembrolizumab preserved HRQoL during treatment for advanced HCC. Combined with efficacy and safety results from KEYNOTE-240, these findings support a positive benefit/risk profile for pembrolizumab in a second-line treatment setting for patients with HCC who previously received sorafenib.-
dc.languageeng-
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1097-0142-
dc.relation.ispartofCancer-
dc.rightsSubmitted (preprint) Version This is the pre-peer reviewed version of the following article: [FULL CITE], which has been published in final form at [Link to final article using the DOI]. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. Accepted (peer-reviewed) Version This is the peer reviewed version of the following article: [FULL CITE], which has been published in final form at [Link to final article using the DOI]. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions.-
dc.subjecthepatocellular carcinoma-
dc.subjectimmunotherapy-
dc.subjectpatient-reported outcome measures-
dc.subjectpembrolizumab-
dc.subjectquality of life-
dc.titleHealth-Related Quality-of-Life Impact of Pembrolizumab Versus Best Supportive Care in Previously Systemically Treated Patients With Advanced Hepatocellular Carcinoma: KEYNOTE-240-
dc.typeArticle-
dc.identifier.emailYau, T: tyaucc@hku.hk-
dc.identifier.authorityYau, T=rp01466-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1002/cncr.33317-
dc.identifier.pmid33231873-
dc.identifier.scopuseid_2-s2.0-85096702993-
dc.identifier.hkuros316119-
dc.identifier.volume127-
dc.identifier.issue6-
dc.identifier.spage865-
dc.identifier.epage874-
dc.identifier.isiWOS:000591767000001-
dc.publisher.placeUnited States-
dc.identifier.issnl0008-543X-

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