Less focus on quality of life in recent phase 3 trials

A high proportion of phase 3 trials which evaluate lung cancer patients in various settings do not assess quality of life (QoL). This is not only the case in studies initiated by the pharmaceutical industry or investigator-initiated trials, but also in non-profit trials and the metastatic setting, despite symptom burden and limited life expectancy. Also, timely inclusion of QoL results in primary publications has been significantly worsening in recent years, which is particularly frequent in papers published in high impact factor journals.

Reale et al. described the prevalence and heterogeneity of QoL reporting in lung cancer phase 3 trials. This was done using a selection of all primary publications of lung cancer phase 3 trials evaluating anticancer drugs published between 2012-2018 by 11 major journals. This resulted in 122 publications which could be assessed.

It was found that QoL was not listed among endpoints in 32.0% of publications. The proportion of trials not including QoL was similar over time; this concerned 32.9% of publications in 2012-2015 vs 30.6% of publications in 2016-2018. Of 83 trials which did include QoL among endpoints, QoL results were not reported in 43.4%. The proportion of trials not reporting QoL results in a primary publication significantly increased over time from 30.6% between 2012-2015 vs. 61.8% between 2016-2018 (p = 0.005). Overall, QoL data were not available in 61.5% of primary publications, due to the absence as endpoint or unpublished results.

It was also mentioned that the type of QoL questionnaires, modality of analysis, and presentation in trials with QoL results are not homogeneous which complicates any comparisons. The most frequently used QoL questionnaires in trials which included QoL as an endpoint were EORTC QLQ C30 (50.6%), EORTC QLQ LC13 (47.0%), and EQ5D (44.6%).

Researchers branded the results of this study rather disappointing, especially in the era of precision medicine which is fast becoming increasingly important. Patient-reported outcomes and QoL analyses play a crucial role in the shared-decision making process, representing a tool to guide physicians in the selection of the most tailored therapy for every single patient and for the full understanding of treatment value [1].

1. Reale L, et al. OA07.07. WCLC 2019.

Posted on 8 November, 20195 March, 2021