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

Publication ,  Journal Article
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 ...
Published in: Eur J Cancer
November 2016

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.

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Published In

Eur J Cancer

DOI

EISSN

1879-0852

Publication Date

November 2016

Volume

67

Start / End Page

46 / 54

Location

England

Related Subject Headings

  • Young Adult
  • Temozolomide
  • Skin Neoplasms
  • Quality of Life
  • Patient Reported Outcome Measures
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Middle Aged
  • Melanoma
  • Male
 

Citation

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Schadendorf, D., Dummer, R., Hauschild, A., Robert, C., Hamid, O., Daud, A., … Ribas, A. (2016). Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. Eur J Cancer, 67, 46–54. https://doi.org/10.1016/j.ejca.2016.07.018
Schadendorf, Dirk, Reinhard Dummer, Axel Hauschild, Caroline Robert, Omid Hamid, Adil Daud, Alfons van den Eertwegh, et al. “Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma.Eur J Cancer 67 (November 2016): 46–54. https://doi.org/10.1016/j.ejca.2016.07.018.
Schadendorf D, Dummer R, Hauschild A, Robert C, Hamid O, Daud A, et al. Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. Eur J Cancer. 2016 Nov;67:46–54.
Schadendorf, Dirk, et al. “Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma.Eur J Cancer, vol. 67, Nov. 2016, pp. 46–54. Pubmed, doi:10.1016/j.ejca.2016.07.018.
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. Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. Eur J Cancer. 2016 Nov;67:46–54.
Journal cover image

Published In

Eur J Cancer

DOI

EISSN

1879-0852

Publication Date

November 2016

Volume

67

Start / End Page

46 / 54

Location

England

Related Subject Headings

  • Young Adult
  • Temozolomide
  • Skin Neoplasms
  • Quality of Life
  • Patient Reported Outcome Measures
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Middle Aged
  • Melanoma
  • Male