Martin Reck1, Julie Brahmer2, Bryan Bennett3, Fiona Taylor4, John R Penrod5, Michael DeRosa4, Homa Dastani5, David R Spigel6, Richard J Gralla7. 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.
RCT Entities:
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.
Authors: Fillipe Dantas Pinheiro; Adriano Fernandes Teixeira; Breno Bittencourt de Brito; Filipe Antônio França da Silva; Maria Luísa Cordeiro Santos; Fabrício Freire de Melo Journal: World J Clin Oncol Date: 2020-05-24