Suboptimal HRQoL Evaluation in Early-Stage NSCLC Trials
HEALTH-RELATED quality of life (HRQoL) remains significantly underreported in trials evaluating tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) for early-stage non-small cell lung cancer (NSCLC). This is according to a new systematic review. The findings highlight a critical evidence gap in assessing patient-centered outcomes during curative treatment phases.
Researchers identified 25 randomized controlled trials (RCTs) of resectable NSCLC testing these targeted and immunotherapeutic agents. Despite increasing focus on survival and recurrence endpoints, nearly half (48%) of the trials did not include HRQoL as an outcome measure. Among those that did, most designated it only as a secondary or exploratory endpoint.
Limited Use of Validated HRQoL Tools
Among studies incorporating HRQoL measures, the most common instruments were the Functional Assessment of Cancer Therapy–Lung (FACT-L), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30/LC13), and the Short Form-36 (SF-36). Reporting varied widely by study phase and treatment setting, with phase III and perioperative trials more likely to evaluate HRQoL than phase II or adjuvant studies.
Only three of 22 full-text RCTs published primary HRQoL findings within the main results. A small number reported data separately in follow-up publications or conference abstracts, leaving nearly 70% of eligible studies without any accessible HRQoL data.
Call for Standardized and Transparent Reporting
The authors emphasize that HRQoL should be considered an essential measure in early-stage NSCLC trials, where the goal extends beyond survival to achieving cure with preserved well-being. Consistent integration of validated HRQoL tools and transparent reporting frameworks would enhance the interpretability of trial outcomes and support treatment decisions that align with patients’ lived experiences.
Reference: Salomone F et al. Health-related Quality of Life assessment in trials testing Tyrosine Kinase Inhibitors or Immune Checkpoints Inhibitors in early-stage NSCLC. Oncologist. 2025:oyaf339.
