Discussion
NSCLC, tumors, oncogene-addicted NSCLC
TUMORS, NSCLC, EMA
In the last years, the prognosis of patients with metastatic NSCLC has certainly improved. Indeed, target therapies for oncogene-addicted NSCLC, as well as immunotherapy in non-oncogene-addicted tumors, have produced a remarkable extension of survival, in comparison with the previously available standard treatments. However, despite this considerable improvement in survival outcomes, less information is available about the effect of novel treatments on QoL. Previous publications revealed that new oncology therapies approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) often lack published QoL data [First, we observed a high rate (We found a positive correlation between QoL results and PFS outcomes (Table Interestingly, we found that the correlation between QoL improvement and PFS was statistically significant only for target therapies, particularly for EGFR and ALK inhibitors (Table In our study, we evaluated the experimental treatments as “superior” in terms of QoL only when they were directly compared to the control arm. Indeed, assuming that novel treatments should guarantee an improved QoL compared to the standard of care, an “intra-arm” comparison between “before” and “after” treatment is not acceptable [We observed that several publications reported QoL results in a favorable manner. As also previously reported, there is a correlation between sponsorship by pharma companies and favorable interpretation of QoL results (Table Assessment of survival outcomes, such as PFS and OS, relies on well-established methods. Instead, several different tools are used to assess QoL in trials and clinical practice. The absence of a uniformly accepted methodology impedes a homologous and systematic assessment of QoL in clinical trials, as well as a comprehensive evaluation of the effects of novel treatments in NSCLC. We found that EORTC, EuroQoL, LCSS, and FACT were the most used tools among the 81 selected RCTs (Table We acknowledge that our work has some limitations. First, the data regarding the correlation between QoL results and PFS/OS outcomes are influenced by the fact that a large fraction of RCTs (