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

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

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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Carcinoma, Non-Small-Cell Lung / psychology
  • Cost of Illness
  • Docetaxel / adverse effects
  • Docetaxel / therapeutic use*
  • Health Status
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Lung Neoplasms / psychology
  • Nivolumab / adverse effects
  • Nivolumab / therapeutic use*
  • Patient Reported Outcome Measures*
  • Predictive Value of Tests
  • Quality of Life*
  • Time Factors
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Immunological
  • Docetaxel
  • Nivolumab

Associated data

  • ClinicalTrials.gov/NCT01673867