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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
DC Field | Value | Language |
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dc.contributor.author | Cescon, David W. | - |
dc.contributor.author | Schmid, Peter | - |
dc.contributor.author | Rugo, Hope S. | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Yusof, Mastura Md | - |
dc.contributor.author | Gallardo, Carlos | - |
dc.contributor.author | Lipatov, Oleg | - |
dc.contributor.author | Barrios, Carlos H. | - |
dc.contributor.author | Perez-Garcia, Jose | - |
dc.contributor.author | Iwata, Hiroji | - |
dc.contributor.author | Masuda, Norikazu | - |
dc.contributor.author | Otero, Marco Torregroza | - |
dc.contributor.author | Gokmen, Erhan | - |
dc.contributor.author | Loi, Sherene | - |
dc.contributor.author | Haiderali, Amin | - |
dc.contributor.author | Zhou, Xuan | - |
dc.contributor.author | Guo, Zifang | - |
dc.contributor.author | Nguyen, Allison Martin | - |
dc.contributor.author | Cortes, Javier | - |
dc.date.accessioned | 2024-01-04T08:00:13Z | - |
dc.date.available | 2024-01-04T08:00:13Z | - |
dc.date.created | 2024-01-04 | - |
dc.date.created | 2024-01-04 | - |
dc.date.created | 2024-01-04 | - |
dc.date.issued | 2024-05 | - |
dc.identifier.citation | Journal of the National Cancer Institute, Vol.116 No.5, pp.717-727 | - |
dc.identifier.issn | 0027-8874 | - |
dc.identifier.uri | https://hdl.handle.net/10371/198773 | - |
dc.description.abstract | Background 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.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Health-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355 | - |
dc.type | Article | - |
dc.identifier.doi | 10.1093/jnci/djad240 | - |
dc.citation.journaltitle | Journal of the National Cancer Institute | - |
dc.identifier.wosid | 001128335100001 | - |
dc.identifier.scopusid | 2-s2.0-85192679548 | - |
dc.citation.endpage | 727 | - |
dc.citation.number | 5 | - |
dc.citation.startpage | 717 | - |
dc.citation.volume | 116 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | EUROPEAN-ORGANIZATION | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | PACLITAXEL | - |
dc.subject.keywordPlus | ATEZOLIZUMAB | - |
dc.subject.keywordPlus | CARBOPLATIN | - |
dc.subject.keywordPlus | SOCIETY | - |
dc.subject.keywordPlus | IMPACT | - |
dc.subject.keywordPlus | TRIAL | - |
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