Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma

Dirk Schadendorf, Reinhard Dummer, Axel Hauschild, Caroline Robert, Omid Hamid, Adil Daud, Alfons van den Eertwegh, Lee Cranmer, Steven O'Day, Igor Puzanov, Jacob Schachter, Christian Blank, April Salama, Carmen Loquai, Janice M Mehnert, Darcy Hille, Scot Ebbinghaus, S Peter Kang, Wei Zhou, Antoni Ribas

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND: In KEYNOTE-002, pembrolizumab significantly prolonged progression-free survival and was associated with a better safety profile compared with chemotherapy in patients with advanced melanoma that progressed after ipilimumab. We present health-related quality of life (HRQoL) outcomes from KEYNOTE-002.

METHODS: Patients were randomly assigned 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or investigator-choice chemotherapy. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 instrument. A constrained longitudinal data analysis model was implemented to assess between-arm differences in HRQoL scores. The study is registered with ClinicalTrials.gov, number NCT01704287.

RESULTS: Of the 540 patients enrolled, 520 were included in the HRQoL analysis. Baseline global health status (GHS) was similar across treatment arms. Compliance rates at week 12 were 76.6% (n = 108), 82.3% (n = 121), and 86.4% (n = 133) for the control, pembrolizumab 2 mg/kg Q3W, and pembrolizumab 10 mg/kg Q3W arms, respectively. From baseline to week 12, GHS/HRQoL scores were maintained to a higher degree in the pembrolizumab arms compared with the chemotherapy arm (decrease of -2.6 for each pembrolizumab arm versus -9.1 for chemotherapy; P = 0.01 for each pembrolizumab arm versus chemotherapy). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31.8% for pembrolizumab 2 mg/kg, 26.6% for 10 mg/kg, and 38.3% for chemotherapy), with similar trends observed for the individual functioning and symptoms scales.

CONCLUSIONS: HRQoL was better maintained with pembrolizumab than with chemotherapy in KEYNOTE-002, supporting the use of pembrolizumab in patients with ipilimumab-refractory melanoma.

Original languageEnglish
Pages (from-to)46-54
Number of pages9
JournalEuropean Journal of Cancer
Volume67
DOIs
Publication statusPublished - Nov 2016

Cite this

Schadendorf, Dirk ; Dummer, Reinhard ; Hauschild, Axel ; Robert, Caroline ; Hamid, Omid ; Daud, Adil ; van den Eertwegh, Alfons ; Cranmer, Lee ; O'Day, Steven ; Puzanov, Igor ; Schachter, Jacob ; Blank, Christian ; Salama, April ; Loquai, Carmen ; Mehnert, Janice M ; Hille, Darcy ; Ebbinghaus, Scot ; Kang, S Peter ; Zhou, Wei ; Ribas, Antoni. / Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. In: European Journal of Cancer. 2016 ; Vol. 67. pp. 46-54.
@article{bf7f87fcd0e14245986fa6f8ab65b4da,
title = "Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma",
abstract = "BACKGROUND: In KEYNOTE-002, pembrolizumab significantly prolonged progression-free survival and was associated with a better safety profile compared with chemotherapy in patients with advanced melanoma that progressed after ipilimumab. We present health-related quality of life (HRQoL) outcomes from KEYNOTE-002.METHODS: Patients were randomly assigned 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or investigator-choice chemotherapy. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 instrument. A constrained longitudinal data analysis model was implemented to assess between-arm differences in HRQoL scores. The study is registered with ClinicalTrials.gov, number NCT01704287.RESULTS: Of the 540 patients enrolled, 520 were included in the HRQoL analysis. Baseline global health status (GHS) was similar across treatment arms. Compliance rates at week 12 were 76.6{\%} (n = 108), 82.3{\%} (n = 121), and 86.4{\%} (n = 133) for the control, pembrolizumab 2 mg/kg Q3W, and pembrolizumab 10 mg/kg Q3W arms, respectively. From baseline to week 12, GHS/HRQoL scores were maintained to a higher degree in the pembrolizumab arms compared with the chemotherapy arm (decrease of -2.6 for each pembrolizumab arm versus -9.1 for chemotherapy; P = 0.01 for each pembrolizumab arm versus chemotherapy). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31.8{\%} for pembrolizumab 2 mg/kg, 26.6{\%} for 10 mg/kg, and 38.3{\%} for chemotherapy), with similar trends observed for the individual functioning and symptoms scales.CONCLUSIONS: HRQoL was better maintained with pembrolizumab than with chemotherapy in KEYNOTE-002, supporting the use of pembrolizumab in patients with ipilimumab-refractory melanoma.",
author = "Dirk Schadendorf and Reinhard Dummer and Axel Hauschild and Caroline Robert and Omid Hamid and Adil Daud and {van den Eertwegh}, Alfons and Lee Cranmer and Steven O'Day and Igor Puzanov and Jacob Schachter and Christian Blank and April Salama and Carmen Loquai and Mehnert, {Janice M} and Darcy Hille and Scot Ebbinghaus and Kang, {S Peter} and Wei Zhou and Antoni Ribas",
note = "Copyright {\circledC} 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.",
year = "2016",
month = "11",
doi = "10.1016/j.ejca.2016.07.018",
language = "English",
volume = "67",
pages = "46--54",
journal = "European Journal of Cancer",
issn = "0959-8049",
publisher = "Pergamon",

}

Schadendorf, D, Dummer, R, Hauschild, A, Robert, C, Hamid, O, Daud, A, van den Eertwegh, A, Cranmer, L, O'Day, S, Puzanov, I, Schachter, J, Blank, C, Salama, A, Loquai, C, Mehnert, JM, Hille, D, Ebbinghaus, S, Kang, SP, Zhou, W & Ribas, A 2016, 'Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma' European Journal of Cancer, vol. 67, pp. 46-54. https://doi.org/10.1016/j.ejca.2016.07.018

Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. / Schadendorf, Dirk; Dummer, Reinhard; Hauschild, Axel; Robert, Caroline; Hamid, Omid; Daud, Adil; van den Eertwegh, Alfons; Cranmer, Lee; O'Day, Steven; Puzanov, Igor; Schachter, Jacob; Blank, Christian; Salama, April; Loquai, Carmen; Mehnert, Janice M; Hille, Darcy; Ebbinghaus, Scot; Kang, S Peter; Zhou, Wei; Ribas, Antoni.

In: European Journal of Cancer, Vol. 67, 11.2016, p. 46-54.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma

AU - Schadendorf, Dirk

AU - Dummer, Reinhard

AU - Hauschild, Axel

AU - Robert, Caroline

AU - Hamid, Omid

AU - Daud, Adil

AU - van den Eertwegh, Alfons

AU - Cranmer, Lee

AU - O'Day, Steven

AU - Puzanov, Igor

AU - Schachter, Jacob

AU - Blank, Christian

AU - Salama, April

AU - Loquai, Carmen

AU - Mehnert, Janice M

AU - Hille, Darcy

AU - Ebbinghaus, Scot

AU - Kang, S Peter

AU - Zhou, Wei

AU - Ribas, Antoni

N1 - Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

PY - 2016/11

Y1 - 2016/11

N2 - BACKGROUND: In KEYNOTE-002, pembrolizumab significantly prolonged progression-free survival and was associated with a better safety profile compared with chemotherapy in patients with advanced melanoma that progressed after ipilimumab. We present health-related quality of life (HRQoL) outcomes from KEYNOTE-002.METHODS: Patients were randomly assigned 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or investigator-choice chemotherapy. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 instrument. A constrained longitudinal data analysis model was implemented to assess between-arm differences in HRQoL scores. The study is registered with ClinicalTrials.gov, number NCT01704287.RESULTS: Of the 540 patients enrolled, 520 were included in the HRQoL analysis. Baseline global health status (GHS) was similar across treatment arms. Compliance rates at week 12 were 76.6% (n = 108), 82.3% (n = 121), and 86.4% (n = 133) for the control, pembrolizumab 2 mg/kg Q3W, and pembrolizumab 10 mg/kg Q3W arms, respectively. From baseline to week 12, GHS/HRQoL scores were maintained to a higher degree in the pembrolizumab arms compared with the chemotherapy arm (decrease of -2.6 for each pembrolizumab arm versus -9.1 for chemotherapy; P = 0.01 for each pembrolizumab arm versus chemotherapy). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31.8% for pembrolizumab 2 mg/kg, 26.6% for 10 mg/kg, and 38.3% for chemotherapy), with similar trends observed for the individual functioning and symptoms scales.CONCLUSIONS: HRQoL was better maintained with pembrolizumab than with chemotherapy in KEYNOTE-002, supporting the use of pembrolizumab in patients with ipilimumab-refractory melanoma.

AB - BACKGROUND: In KEYNOTE-002, pembrolizumab significantly prolonged progression-free survival and was associated with a better safety profile compared with chemotherapy in patients with advanced melanoma that progressed after ipilimumab. We present health-related quality of life (HRQoL) outcomes from KEYNOTE-002.METHODS: Patients were randomly assigned 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or investigator-choice chemotherapy. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 instrument. A constrained longitudinal data analysis model was implemented to assess between-arm differences in HRQoL scores. The study is registered with ClinicalTrials.gov, number NCT01704287.RESULTS: Of the 540 patients enrolled, 520 were included in the HRQoL analysis. Baseline global health status (GHS) was similar across treatment arms. Compliance rates at week 12 were 76.6% (n = 108), 82.3% (n = 121), and 86.4% (n = 133) for the control, pembrolizumab 2 mg/kg Q3W, and pembrolizumab 10 mg/kg Q3W arms, respectively. From baseline to week 12, GHS/HRQoL scores were maintained to a higher degree in the pembrolizumab arms compared with the chemotherapy arm (decrease of -2.6 for each pembrolizumab arm versus -9.1 for chemotherapy; P = 0.01 for each pembrolizumab arm versus chemotherapy). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31.8% for pembrolizumab 2 mg/kg, 26.6% for 10 mg/kg, and 38.3% for chemotherapy), with similar trends observed for the individual functioning and symptoms scales.CONCLUSIONS: HRQoL was better maintained with pembrolizumab than with chemotherapy in KEYNOTE-002, supporting the use of pembrolizumab in patients with ipilimumab-refractory melanoma.

U2 - 10.1016/j.ejca.2016.07.018

DO - 10.1016/j.ejca.2016.07.018

M3 - Article

VL - 67

SP - 46

EP - 54

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -