Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study

Authors

Muhammad A. KhattakFollow
Jason J. Luke
Georgina V. Long
Paolo A. Ascierto
Piotr Rutkowski
Dirk Schadendorf
Caroline Robert
Jean-Jacques Grob
Luis de la Cruz Merino
Michele Del Vecchio
Francesco Spagnolo
Jacek Mackiewicz
Vanna Chiarion-Sileni
Matteo S. Carlino
Peter Mohr
Federica De Galitiis
Merrick I. Ross
Zeynep Eroglu
Ke Chen
Ruixuan Jiang
Mizuho Fukunaga-Kalabis
Clemens Krepler
Alexander M. M. Eggermont
John M. Kirkwood

Document Type

Journal Article

Publication Title

European Journal of Cancer

Volume

176

First Page

207

Last Page

217

PubMed ID

36202690

Publisher

Elsevier

School

School of Medical and Health Sciences

RAS ID

51784

Funders

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Comments

Khattak, M. A., Luke, J. J., Long, G. V., Ascierto, P. A., Rutkowski, P., Schadendorf, D., ... & Kirkwood, J. M. (2022). Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study. European Journal of Cancer, 176, 207-217. https://doi.org/10.1016/j.ejca.2022.08.004

Abstract

Background: Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) versus placebo in resected stage IIB and IIC melanoma in the phase 3 KEYNOTE-716 study. Health-related quality of life (HRQoL) results are reported. Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg (2 mg/kg, patients ≥ 12 to < 18 years) Q3W or placebo for ≤ 17 cycles or until disease recurrence, unacceptable toxicity, or withdrawal. Change from baseline in EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) was a prespecified exploratory end point. Change in EORTC QLQ-C30 functioning, symptom, and single-item scales, and EQ-5D-5L visual analog scale (VAS) were also summarized. Primary analyses were performed at week 48 to ensure adequate completion/compliance. The HRQoL population comprised patients who received ≥ 1 dose of treatment and completed ≥ 1 assessment. Results: The HRQoL population included 969 patients (pembrolizumab, n = 483; placebo, n = 486). Compliance at week 48 was ≥ 80 % for both instruments. EORTC QLQ-C30 GHS/QoL, physical functioning, role functioning, and EQ-5D-5L VAS scores were stable from baseline to week 48 in both arms, with no clinically meaningful decline observed. Scores did not differ significantly between pembrolizumab and placebo. EORTC QLQ-C30 GHS/QoL, physical functioning, role functioning, and EQ-5D-5L VAS scores remained stable through week 96 in both arms. Conclusions: HRQoL was stable with adjuvant pembrolizumab, with no clinically meaningful decline observed. Change from baseline in HRQoL was similar between arms. These results, in conjunction with the improved RFS and manageable safety previously reported, support the use of adjuvant pembrolizumab for high-risk stage II melanoma.

DOI

10.1016/j.ejca.2022.08.004

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