The Importance of Health-Related QOL Measures Used in Early-Stage NSCLC Trials

Clinical trial investigators should use a mindful approach when planning to assess health-related quality of life (HRQOL) in patients with early-stage NSCLC, said Margarita Majem, MD, PhD.

In evaluating HRQOL instruments across recent early-stage NSCLC studies, Majem et al learned that there has not been a consistent approach in the types of HRQOL tools used for reporting HRQOL data. Furthermore, there are limited HRQOL data available in the neoadjuvant and unresectable settings.

Key challenges were also observed in HRQOL assessment related to factors such as timing of assessment and whether the data are published in a primary or secondary publication. For instance, a cross-sectional analysis of 75 studies showed that 51% assessed HRQOL during treatment, 47% assessed HRQOL at the end of treatment, and 65% assessed HRQOL during end-of-treatment follow-up. HRQOL was assessed at progression and until death in only 8% and 5% of the studies, respectively.

“Frequent assessments during and after treatment are warranted to capture the true impact of treatment and disease progression on HRQOL, and changes in the relative importance of these factors over time,” the researchers said.

Although the researchers did not determine one best HRQOL instrument for use in early-stage disease, they shared important considerations for trial design that include instrument-, disease-, and patient-related factors.