Real-World Data on EGFR and ALK Testing and TKI Usage in Norway-A Nation-Wide Population Study

Simple Summary Drugs acting against specific molecular alterations in cancer cells are tested in clinical studies and found to be highly efficacious in some patients with lung cancer. However, the true benefit in patients treated outside of clinical trials is, to some extent, unknown. It is also not well-described how many of the patients that could benefit from such treatment are offered these drugs. One could imagine that the molecular alterations are not tested for, or that not all relevant patients are treated. Based on national registries in Norway, we have here analysed these issues, and found that a high fraction of patients are tested according to guidelines. Additionally, at high ages, most patients are provided therapy, and the benefit seems to replicate what is seen in the clinical trials. Thus, we may trust the study results and have confidence that the new drugs do prolong the lives of the relevant patients. Clinical studies have shown the efficacy of EGFR- and ALK-directed therapies in non-small cell lung cancer (NSCLC). Real-world data on, e.g., testing patterns, uptake, and duration of treatment are scarce. Reflex EGFR and ALK testing of non-squamous NSCLCs were implemented in Norwegian guidelines in 2010 and 2013, respectively. We present a complete national registry data on incidence, pathology procedures, and drug prescription in the period of 2013 to 2020. Test rates for both EGFR and ALK increased over time and were 85% and 89%, respectively, at the end of the study period, independent of age up to 85 years. The positivity rate for EGFR was higher among females and young patients, whereas no sex difference was observed for ALK. EGFR-treated patients were older than ALK-treated patients (71 vs. 63 years at start, p < 0.001). Male ALK-treated patients were significantly younger than females at the start of treatment (58 vs. 65 years, p = 0.019). The time from the first dispensation to the last dispensation of TKI (as a surrogate for progression-free survival) was shorter for EGFR- than for ALK-TKI, and survival for both EGFR- and ALK-positive patients was substantially longer than for non-mutated patients. We found a high adherence to molecular testing guidelines, good concordance of mutation positivity and treatment, and the real-world replication of findings in clinical trials, indicating that the relevant patients are provided substantially life-prolonging therapy.