Abstract 59P
Background
In addition to improvements of survival outcomes, new oncology treatments should lead to amelioration of patients’ quality of life (QoL). In patients with non-small lung cancer (NSCLC), a potential correlation between QoL results with progression-free survival (PFS) and overall survival (OS) outcomes is unknown.
Methods
We examined whether QoL results correlated with PFS and OS outcomes in phase III randomized controlled trials (RCTs) investigating new systemic treatments in metastatic non-small cell lung cancer (NSCLC), published between 2012 and 2021. Our systematic review identified 81 RCTs for further analysis.
Results
Compared to control arms, experimental treatments led to superior QoL in 30 (37.0%) RCTs and inferior QoL in 3 (3.7%) RCTs. In the remaining 48 (59.3%) RCTs, a statistically significant difference between experimental and control arms was not found. QoL results did not positively correlate with OS outcomes (X2 = 0.81, p = 0.368). Instead, we found a statistically significant correlation between QoL and PFS improvements (X2 = 3.93, p = 0.0473). More in detail, this correlation was not significant in trials testing immunotherapy or chemotherapy. On the contrary, in RCTs testing target therapies QoL results positively correlated with PFS outcomes (p = 0.0196). This correlation was stronger in the 32 trials testing EGFR or ALK inhibitors (p = 0.0077). Furthermore, we found that experimental treatments led to superior QoL in 27/57 (47.4%) trials with positive results and in 3/24 (12.5%) RCTs with negative results (p = 0.0028). Next, we analyzed how QoL data were described in publications of RCTs in which QoL outcomes were not improved (n = 51). We found that a favorable description of QoL results was associated with sponsorship by industries (p = 0.0232).
Conclusions
Our study reveals a positive correlation of QoL results with PFS outcomes, but not with OS, in RCTs testing novel treatments in advanced NSCLC, particularly for target therapies. Moreover, inappropriate description of QoL data was more frequent in RCTs funded by pharma companies.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Servetto: Non-Financial Interests, Personal, Other, Travel Support: Bristol-Myers Squibb, AstraZeneca; Financial Interests, Personal and Institutional, Research Grant, Research funding: Associazione Italiana per la Ricerca sul Cancro. L. Formisano: Financial Interests, Personal and Institutional, Research Grant: Associazione Italiana per la Ricerca sul Cancro. R. Bianco: Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb, MSD, AstraZeneca, Eli Lilly, Roche, Novartis; Financial Interests, Personal and Institutional, Research Grant, Funding for research: Associazione Italiana per la Ricerca sul Cancro. All other authors have declared no conflicts of interest.