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Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057.

Author information

1
Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Wöhrendamm 80, 22927, Grosshansdorf, Germany. Electronic address: dr.martin.reck@web.de.
2
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, CRB 440, Baltimore, MD, 21231, USA.
3
Adelphi Values, Adelphi Mill, Grimshaw Ln, Bollington, Cheshire, SK10 5JB, UK.
4
Adelphi Values, 290 Congress Street 7th Floor, Boston, MA, 02210, USA.
5
Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
6
Sarah Cannon Research Institute/Tennessee Oncology, PLLC, 250 25th Ave North, Suite 100, Nashville, TN, 37203, USA.
7
Albert Einstein College of Medicine, 1400 Pelham Parkway South Building 1, Room 3N20, Bronx, NY, 10461, USA.

Abstract

BACKGROUND:

Nivolumab, a programmed death-1 inhibitor, prolonged overall survival and had a favourable safety profile versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) in the phase III CheckMate 057 trial.

AIM:

To evaluate health-related quality of life (HRQoL) using patient-reported outcomes.

METHODS:

Disease-related symptoms and general health status were assessed using two validated patient-reported instruments, the Lung Cancer Symptom Scale (LCSS) and the European Quality of Life Five Dimensions (EQ-5D), respectively. The proportion of patients with disease-related symptom improvement at 12 weeks on the LCSS average symptom burden index (ASBI) was a secondary end-point. LCSS 3-item global index (3-IGI), EQ-5D utility index and EQ-5D visual analogue scale (VAS) scores were also determined. Mixed-effects model repeated measures (MMRM) and time to first deterioration analyses assessed longitudinal changes.

RESULTS:

Mean baseline LCSS ASBI scores were similar in both arms. By week 12, rates of disease-related improvement (95% confidence interval) were similar between nivolumab (17.8% [13.6-22.7]) and docetaxel (19.7% [15.2-24.7]); however, numerical differences in LCSS ASBI mean change from baseline favoured nivolumab. Subsequently, LCSS ASBI scores improved with nivolumab and worsened with docetaxel, with statistically significant between-arm differences at weeks 12, 24, 30 and 42. HRQoL improvements with nivolumab versus docetaxel were also supported by the LCSS 3-IGI, EQ-5D VAS and MMRM analysis. Time to first HRQoL deterioration was longer with nivolumab than with docetaxel.

CONCLUSION:

Nivolumab improved disease-related symptoms and overall health status versus docetaxel for second-line treatment of advanced non-squamous NSCLC.

CLINICAL TRIAL REGISTRATION:

NCT01673867.

KEYWORDS:

Antineoplastic agents; Carcinoma; Docetaxel; Lung neoplasms; Nivolumab; Non-small cell lung; Quality of life; Surveys and questionnaires

PMID:
30103096
DOI:
10.1016/j.ejca.2018.05.005

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