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Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study
DC Field | Value | Language |
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dc.contributor.author | Schmid, Peter | - |
dc.contributor.author | Lipatov, Oleg | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Goncalves, Anthony | - |
dc.contributor.author | Muñoz-Couselo, Eva | - |
dc.contributor.author | Lee, Keun Seok | - |
dc.contributor.author | Tamura, Kenji | - |
dc.contributor.author | Testa, Laura | - |
dc.contributor.author | Witzel, Isabell | - |
dc.contributor.author | Ohtani, Shoichiro | - |
dc.contributor.author | Turner, Nicholas | - |
dc.contributor.author | Zambelli, Stefania | - |
dc.contributor.author | Harbeck, Nadia | - |
dc.contributor.author | Andre, Fabrice | - |
dc.contributor.author | Dent, Rebecca | - |
dc.contributor.author | Mejia, Jaime A. | - |
dc.contributor.author | Zhou, Xuan | - |
dc.contributor.author | Haiderali, Amin | - |
dc.contributor.author | Nguyen, Allison Martin | - |
dc.contributor.author | Cortes, Javier | - |
dc.contributor.author | Winer, Eric P. | - |
dc.date.accessioned | 2024-01-04T08:00:55Z | - |
dc.date.available | 2024-01-04T08:00:55Z | - |
dc.date.created | 2023-12-14 | - |
dc.date.created | 2023-12-14 | - |
dc.date.issued | 2023-12 | - |
dc.identifier.citation | European Journal of Cancer, Vol.195, p. 113393 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.uri | https://hdl.handle.net/10371/198786 | - |
dc.description.abstract | Background: In KEYNOTE-119 (ClinicalTrials.gov, NCT02555657), overall survival (primary end-point) was similar between pembrolizumab and chemotherapy in patients with previously treated metastatic triple-negative breast cancer (TNBC), although the pembrolizumab treatment effect increased with tumour PD-L1 expression. We report results of prespecified health-related quality of life (HRQoL) analyses from KEYNOTE-119. Methods: Eligible patients were randomised 1:1 to pembrolizumab 200 mg Q3W intravenously for up to 35 cycles or treatment of physician's choice per local/country guidelines. Prespecified exploratory end-points were the change from baseline in HRQoL (EORTC QLQ-C30, QLQ-BR23) and to characterise utilities (EQ-5D-3L). Time to deterioration (TTD) was the time from start of treatment to first onset of a ≥10-point worsening from baseline. Results: HRQoL analyses included 187 patients with tumour PD-L1 combined positive score (CPS) ≥10. Changes from baseline at 6 weeks (primary analysis time point) were directionally better with pembrolizumab versus chemotherapy for QLQ-C30 GHS/QoL (between-group difference in least-squares mean scores of 4.21 [95% CI, −1.38 to 9.80]), QLQ-C30 functional scales (physical, role, cognitive, social), QLQ-C30 symptom scales/items (fatigue, nausea/vomiting, dyspnoea, appetite loss), and QLQ-BR23 symptom scales/items (systemic therapy side-effects, upset by hair loss). Median TTD was directionally longer for pembrolizumab versus chemotherapy for QLQ-C30 QHS/QoL (4.3 versus 1.7 months), QLQ-C30 nausea/vomiting (7.7 versus 4.8 months), and QLQ-BR23 systemic therapy side-effects (6.1 versus 3.4 months). Minimal treatment differences were observed for other HRQoL end-points. Conclusions: HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumour PD-L1 CPS ≥10. | - |
dc.language | 영어 | - |
dc.publisher | Elsevier Ltd | - |
dc.title | Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.ejca.2023.113393 | - |
dc.citation.journaltitle | European Journal of Cancer | - |
dc.identifier.wosid | 001149036300001 | - |
dc.identifier.scopusid | 2-s2.0-85177984131 | - |
dc.citation.startpage | 113393 | - |
dc.citation.volume | 195 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordAuthor | Chemotherapy | - |
dc.subject.keywordAuthor | Health-related quality of life | - |
dc.subject.keywordAuthor | Patient-reported outcomes | - |
dc.subject.keywordAuthor | Pembrolizumab | - |
dc.subject.keywordAuthor | Triple-negative breast cancer | - |
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