Health-related quality-of-life analysis from KEYNOTE-045: a phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer

David J. Vaughn, Joaquim Bellmunt, Yves Fradet, Jae Lyun Lee, Lawrence Fong, Nicholas J. Vogelzang, Miguel A. Climent, Daniel P. Petrylak, Toni K. Choueiri, Andrea Necchi, Winald Gerritsen, Howard Gurney, David I. Quinn, Stephane Culine, Cora N. Sternberg, Yabing Mai, Haojie Li, Rodolfo F. Perini, Dean F. Bajorin, Ronald de Wit

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Purpose: In the phase III KEYNOTE-045 study (ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. 

Patients and Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. 

Results: Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004).Mean (95%CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (22.40 to 3.77)with pembrolizumab and 28.36 (211.84 to 24.89)  with chemotherapy (mean difference, 9.05 points; 95% CI, 4.61 to 13.50; nominal two-sided P <.001). 

Conclusion: Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator's choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.

LanguageEnglish
Pages1579-1587
Number of pages12
JournalJournal of Clinical Oncology
Volume36
Issue number16
DOIs
Publication statusPublished - 1 Jun 2018

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Quality of Life
Drug Therapy
Neoplasms
Health Status
Research Personnel
docetaxel
pembrolizumab
Standard of Care
Paclitaxel
Platinum
Compliance
Global Health
Safety
Survival

Cite this

Vaughn, David J. ; Bellmunt, Joaquim ; Fradet, Yves ; Lee, Jae Lyun ; Fong, Lawrence ; Vogelzang, Nicholas J. ; Climent, Miguel A. ; Petrylak, Daniel P. ; Choueiri, Toni K. ; Necchi, Andrea ; Gerritsen, Winald ; Gurney, Howard ; Quinn, David I. ; Culine, Stephane ; Sternberg, Cora N. ; Mai, Yabing ; Li, Haojie ; Perini, Rodolfo F. ; Bajorin, Dean F. ; de Wit, Ronald. / Health-related quality-of-life analysis from KEYNOTE-045 : a phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 16. pp. 1579-1587.
@article{9dfa654e3e9a4f8f83d93349883afd54,
title = "Health-related quality-of-life analysis from KEYNOTE-045: a phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer",
abstract = "Purpose: In the phase III KEYNOTE-045 study (ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. Patients and Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. Results: Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95{\%} at baseline and approximately 88{\%} at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004).Mean (95{\%}CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (22.40 to 3.77)with pembrolizumab and 28.36 (211.84 to 24.89)  with chemotherapy (mean difference, 9.05 points; 95{\%} CI, 4.61 to 13.50; nominal two-sided P <.001). Conclusion: Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator's choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.",
author = "Vaughn, {David J.} and Joaquim Bellmunt and Yves Fradet and Lee, {Jae Lyun} and Lawrence Fong and Vogelzang, {Nicholas J.} and Climent, {Miguel A.} and Petrylak, {Daniel P.} and Choueiri, {Toni K.} and Andrea Necchi and Winald Gerritsen and Howard Gurney and Quinn, {David I.} and Stephane Culine and Sternberg, {Cora N.} and Yabing Mai and Haojie Li and Perini, {Rodolfo F.} and Bajorin, {Dean F.} and {de Wit}, Ronald",
year = "2018",
month = "6",
day = "1",
doi = "10.1200/JCO.2017.76.9562",
language = "English",
volume = "36",
pages = "1579--1587",
journal = "Journal of Clinical Oncology",
issn = "1527-7755",
publisher = "American Society of Clinical Oncology",
number = "16",

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Vaughn, DJ, Bellmunt, J, Fradet, Y, Lee, JL, Fong, L, Vogelzang, NJ, Climent, MA, Petrylak, DP, Choueiri, TK, Necchi, A, Gerritsen, W, Gurney, H, Quinn, DI, Culine, S, Sternberg, CN, Mai, Y, Li, H, Perini, RF, Bajorin, DF & de Wit, R 2018, 'Health-related quality-of-life analysis from KEYNOTE-045: a phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer', Journal of Clinical Oncology, vol. 36, no. 16, pp. 1579-1587. https://doi.org/10.1200/JCO.2017.76.9562

Health-related quality-of-life analysis from KEYNOTE-045 : a phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. / Vaughn, David J.; Bellmunt, Joaquim; Fradet, Yves; Lee, Jae Lyun; Fong, Lawrence; Vogelzang, Nicholas J.; Climent, Miguel A.; Petrylak, Daniel P.; Choueiri, Toni K.; Necchi, Andrea; Gerritsen, Winald; Gurney, Howard; Quinn, David I.; Culine, Stephane; Sternberg, Cora N.; Mai, Yabing; Li, Haojie; Perini, Rodolfo F.; Bajorin, Dean F.; de Wit, Ronald.

In: Journal of Clinical Oncology, Vol. 36, No. 16, 01.06.2018, p. 1579-1587.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Health-related quality-of-life analysis from KEYNOTE-045

T2 - Journal of Clinical Oncology

AU - Vaughn, David J.

AU - Bellmunt, Joaquim

AU - Fradet, Yves

AU - Lee, Jae Lyun

AU - Fong, Lawrence

AU - Vogelzang, Nicholas J.

AU - Climent, Miguel A.

AU - Petrylak, Daniel P.

AU - Choueiri, Toni K.

AU - Necchi, Andrea

AU - Gerritsen, Winald

AU - Gurney, Howard

AU - Quinn, David I.

AU - Culine, Stephane

AU - Sternberg, Cora N.

AU - Mai, Yabing

AU - Li, Haojie

AU - Perini, Rodolfo F.

AU - Bajorin, Dean F.

AU - de Wit, Ronald

PY - 2018/6/1

Y1 - 2018/6/1

N2 - Purpose: In the phase III KEYNOTE-045 study (ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. Patients and Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. Results: Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004).Mean (95%CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (22.40 to 3.77)with pembrolizumab and 28.36 (211.84 to 24.89)  with chemotherapy (mean difference, 9.05 points; 95% CI, 4.61 to 13.50; nominal two-sided P <.001). Conclusion: Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator's choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.

AB - Purpose: In the phase III KEYNOTE-045 study (ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. Patients and Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. Results: Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004).Mean (95%CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (22.40 to 3.77)with pembrolizumab and 28.36 (211.84 to 24.89)  with chemotherapy (mean difference, 9.05 points; 95% CI, 4.61 to 13.50; nominal two-sided P <.001). Conclusion: Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator's choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.

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U2 - 10.1200/JCO.2017.76.9562

DO - 10.1200/JCO.2017.76.9562

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SP - 1579

EP - 1587

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 1527-7755

IS - 16

ER -