Patient-centered perspectives: Examining quality-of-life integration in recent phase III lung cancer trials (2019–2023)

Abstract

Background

In the dynamic landscape of lung cancer treatment, marked by precision medicine advancements, addressing the persistent global health challenge of lung cancer requires nuanced evaluations beyond traditional endpoints like Overall Survival (OS). Both the US FDA and ASCO advocate for consistent integration of Quality of Life (QoL) and Patient-Reported Outcomes (PRO). This study evaluates the extent to which recent Phase III lung cancer trials incorporate QoL, highlighting implications for global cancer policy and research priorities.

Methods

This systematic review analyzed PubMed for Phase III lung cancer clinical trials involving anticancer drugs conducted between 2019 and 2023. The study assessed if QoL was included as an endpoint. Subgroup analyses categorized trials by cancer subtype (e.g., non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC]). Analyses were also stratified by publication year to explore potential temporal trends. Subanalyses included impact factor categories (≥10 and <10) and differentiation between superiority and noninferiority trials.

Results

191 Phase III lung cancer clinical trials published between 2019 and 2023, meeting the criteria were included in this study. QoL was included in 31.93 % of trials across all subtypes, 33.72 % of NSCLC trials incorporated QoL vs 19.04 % of SCLC trials included QoL. Our analysis reveals a significant shortfall in incorporating quality of life (QoL) as an endpoint, highlighting a crucial gap in evaluating the comprehensive impact of interventions.

Conclusions

The limited integration of QoL assessments in lung cancer trials underscores a missed opportunity to inform patient-centered care and highlights disparities across cancer subtypes. To address these gaps, global cancer policy should prioritize standardized QoL measures in clinical trial design. This shift is essential for aligning research with patient needs, ensuring equitable evaluation of treatment impacts, and advancing value-based care in oncology.