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
Copyright © 2023 Elsevier Ltd. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:195 |
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| Enthalten in: |
European journal of cancer (Oxford, England : 1990) - 195(2023) vom: 15. Dez., Seite 113393 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Schmid, Peter [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 01.12.2023 Date Revised 05.12.2023 published: Print-Electronic ClinicalTrials.gov: NCT02555657 Citation Status MEDLINE |
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| doi: |
10.1016/j.ejca.2023.113393 |
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| 100 | 1 | |a Schmid, Peter |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer |b results from the phase 3 randomised KEYNOTE-119 study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 01.12.2023 | ||
| 500 | |a Date Revised 05.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02555657 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Ltd. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSIONS: HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumour PD-L1 CPS ≥10 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Chemotherapy | |
| 650 | 4 | |a Health-related quality of life | |
| 650 | 4 | |a Patient-reported outcomes | |
| 650 | 4 | |a Pembrolizumab | |
| 650 | 4 | |a Triple-negative breast cancer | |
| 650 | 7 | |a B7-H1 Antigen |2 NLM | |
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| 700 | 1 | |a Im, Seock-Ah |e verfasserin |4 aut | |
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| 700 | 1 | |a Turner, Nicholas |e verfasserin |4 aut | |
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| 700 | 1 | |a Harbeck, Nadia |e verfasserin |4 aut | |
| 700 | 1 | |a Andre, Fabrice |e verfasserin |4 aut | |
| 700 | 1 | |a Dent, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Mejia, Jaime A |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Xuan |e verfasserin |4 aut | |
| 700 | 1 | |a Haiderali, Amin |e verfasserin |4 aut | |
| 700 | 1 | |a Nguyen, Allison Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Cortes, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Winer, Eric P |e verfasserin |4 aut | |
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