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Health-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355

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dc.contributor.authorCescon, David W.-
dc.contributor.authorSchmid, Peter-
dc.contributor.authorRugo, Hope S.-
dc.contributor.authorIm, Seock-Ah-
dc.contributor.authorYusof, Mastura Md-
dc.contributor.authorGallardo, Carlos-
dc.contributor.authorLipatov, Oleg-
dc.contributor.authorBarrios, Carlos H.-
dc.contributor.authorPerez-Garcia, Jose-
dc.contributor.authorIwata, Hiroji-
dc.contributor.authorMasuda, Norikazu-
dc.contributor.authorOtero, Marco Torregroza-
dc.contributor.authorGokmen, Erhan-
dc.contributor.authorLoi, Sherene-
dc.contributor.authorHaiderali, Amin-
dc.contributor.authorZhou, Xuan-
dc.contributor.authorGuo, Zifang-
dc.contributor.authorNguyen, Allison Martin-
dc.contributor.authorCortes, Javier-
dc.date.accessioned2024-01-04T08:00:13Z-
dc.date.available2024-01-04T08:00:13Z-
dc.date.created2024-01-04-
dc.date.created2024-01-04-
dc.date.created2024-01-04-
dc.date.issued2024-05-
dc.identifier.citationJournal of the National Cancer Institute, Vol.116 No.5, pp.717-727-
dc.identifier.issn0027-8874-
dc.identifier.urihttps://hdl.handle.net/10371/198773-
dc.description.abstractBackground In KEYNOTE-355 (NCT02819518), the addition of pembrolizumab to chemotherapy led to statistically significant improvements in progression-free survival and overall survival in patients with advanced triple-negative breast cancer with tumor programmed cell death ligand 1 (PD-L1) combined positive score of at least 10. We report patient-reported outcomes from KEYNOTE-355.Methods Patients were randomly assigned 2:1 to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus investigator's choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Breast Cancer-Specific Quality of Life Questionnaire, and EuroQol 5-Dimension questionnaire visual analog scale were prespecified. Patient-reported outcomes were analyzed for patients who received at least 1 dose of study treatment and completed at least 1 patient-reported outcome assessment. Changes in patient-reported outcome scores from baseline were assessed at week 15 (latest time point at which completion and compliance rates were at least 60% and at least 80%, respectively). Time to deterioration in patient-reported outcomes was defined as time to first onset of at least a 10-point worsening in score from baseline.Results Patient-reported outcome analyses included 317 patients with tumor PD-L1 combined positive score of at least 10 (pembrolizumab plus chemotherapy: n = 217; placebo plus chemotherapy: n = 100). There were no between-group differences in change from baseline to week 15 in QLQ-C30 global health status/quality of life (QOL; least-squares mean difference = -1.81, 95% confidence interval [CI] = -6.92 to 3.30), emotional functioning (least-squares mean difference = -1.43, 95% CI = -7.03 to 4.16), physical functioning (least-squares mean difference = -1.05, 95% CI = -6.59 to 4.50), or EuroQol 5-Dimension questionnaire visual analog scale (least-squares mean difference = 0.18, 95% CI = -5.04 to 5.39) and no between-group difference in time to deterioration in QLQ-C30 global health status/QOL, emotional functioning, or physical functioning.Conclusions Together with the efficacy and safety findings, patient-reported outcome results from KEYNOTE-355 support pembrolizumab plus chemotherapy as a standard of care for patients with advanced triple-negative breast cancer with tumor PD-L1 expression (combined positive score >= 10).-
dc.language영어-
dc.publisherOxford University Press-
dc.titleHealth-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355-
dc.typeArticle-
dc.identifier.doi10.1093/jnci/djad240-
dc.citation.journaltitleJournal of the National Cancer Institute-
dc.identifier.wosid001128335100001-
dc.identifier.scopusid2-s2.0-85192679548-
dc.citation.endpage727-
dc.citation.number5-
dc.citation.startpage717-
dc.citation.volume116-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorIm, Seock-Ah-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusEUROPEAN-ORGANIZATION-
dc.subject.keywordPlusDOUBLE-BLIND-
dc.subject.keywordPlusPACLITAXEL-
dc.subject.keywordPlusATEZOLIZUMAB-
dc.subject.keywordPlusCARBOPLATIN-
dc.subject.keywordPlusSOCIETY-
dc.subject.keywordPlusIMPACT-
dc.subject.keywordPlusTRIAL-
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  • Department of Medicine
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