Background
NSCLC, dyspnea, cancer, pain, cough, hemoptysis, shortness of breath
CANCER, DISEASE, METASTATIC NON-SMALL CELL LUNG CANCER, NSCLC
Overall survival (OS) and progression-free survival (PFS) are the primary study endpoints in randomized controlled trials (RCTs) testing novel treatments in oncology [In addition to increasing OS, the aim of new treatments should be to improve the quality of life (QoL) of patients with cancer [In patients with cancer, QoL is certainly influenced by symptoms caused by disease burden, side effects of therapies, and daily life domains, such as emotional, physical, and social functions. However, although the development of new anticancer treatments aims to prolong the survival of patients, such progresses are not always associated with improvements in QoL. Previous studies analyzed data from RCTs in oncology and revealed that, for systemic anticancer treatments, improvements in PFS did not correlate with QoL benefits [Assessment of QoL is particularly relevant in patients with metastatic non-small cell lung cancer (NSCLC), due to symptoms that have a strong negative impact on QoL, such as dyspnea, cough, hemoptysis, shortness of breath, pain, and possible neurological symptoms [Despite the well-known relevance of QoL assessment in patients undergoing treatments for cancer, we and other groups have previously revealed that QoL results are poorly reported in publications of RCTs in oncology, hindering a complete evaluation of the effects of new anticancer drugs [Herein, we report the results from our study aiming to investigate QoL outcomes in publications of phase III RCTs testing novel systemic treatments in patients with metastatic NSCLC, published between 2012 and December 2021. We selected phase III RCTs because they explore new therapies that may receive approval from regulatory agencies. In addition, RCTs should include QoL assessment among study endpoints. We evaluated whether QoL results correlate with PFS and OS outcomes, exploring such correlation in different drug classes. Finally, we analyzed how QoL results were described in these manuscripts and if favorable framing was enriched in profit studies, compared to non-profit trials.