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J Thorac Oncol. 2019 May;14(5):793-801. doi: 10.1016/j.jtho.2019.01.016. Epub 2019 Jan 31.

Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC.

Author information

1
Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France. Electronic address: Fabrice.Barlesi@ap-hm.fr.
2
David Geffen School of Medicine at University of California, Los Angeles, Santa Monica, California.
3
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
4
Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.
5
Division of Translational & Clinical Research, National Cancer Center (Korea), Goyang-si, Republic of Korea.
6
Department of Medical Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Republic of Korea.
7
Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Seoul, Republic of Korea.
8
Division of Hematology Oncology, Rush University Medical Center, Chicago, Ilinois.
9
University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California.
10
Clinical Oncology, Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil.
11
Department of Respiratory Medicine/Thoracic Oncology, Universitar Ziekenhuis Ghent, Ghent, Belgium.
12
Biostatistics, Merck & Co., Inc., Kenilworth, New Jersey.
13
Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, New Jersey.
14
Department of Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey.
15
Department of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.

Erratum in

Abstract

INTRODUCTION:

In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1-expressing (tumor proportion score ≥ 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here.

METHODS:

Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m2 every 3 weeks. HRQoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30 (C30), EORTC QLQ-Lung Cancer 13 (LC13), and EuroQoL-5D. Key analyses included mean baseline-to-week-12 change in global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ-LC13 composite endpoint of cough, dyspnea, and chest pain.

RESULTS:

Patient reported outcomes compliance was high across all three instruments. Pembrolizumab was associated with better QLQ-C30 GHS/QoL scores from baseline to 12 weeks than docetaxel, regardless of pembrolizumab dose or tumor proportion score status (not significant). Compared with docetaxel, fewer pembrolizumab-treated patients had "deteriorated" status and more had "improved" status in GHS/QoL. Nominally significant improvement was reported in many EORTC symptom domains with pembrolizumab, and nominally significant worsening was reported with docetaxel. Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose.

CONCLUSIONS:

These findings suggest that HRQoL and symptoms are maintained or improved to a greater degree with pembrolizumab than with docetaxel in this NSCLC patient population.

KEYWORDS:

EORTC QLQ-C30; EORTC QLQ-LC13; NSCLC; PD-L1; Pembrolizumab

PMID:
30711649
DOI:
10.1016/j.jtho.2019.01.016

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