Non-small cell lung cancer (NSCLC) diagnosed in late stages carries high mortality. Targeted therapy and immunotherapy may increase survival and symptom relief although high drug prices limit their use. Promising results from small clinical studies need corroboration from ordinary clinical practice. This study aims to describe clinical, socioeconomic and geographical factors for recipients of these new treatments, to estimate their survival, to describe related outcomes such as hospitalizations and symptomatic treatment, and to evaluate the cost of patient care.
Design and data
The study population comprises all advanced NSCLC patients diagnosed in 2010-2018 in Norway and registered in the Cancer Registry of Norway. We will retrieve individual information about hospitalizations, treatments and socioeconomy from the Norwegian Patient Registry, the INSPIRE database, the Norwegian Prescription registry, the KUHR database, the Cause of Death Registry and Statistics Norway. Prognostic factors for receiving the new treatments will be evaluated using multivariable logistic regression models. Differences in survival and health outcomes will be assessed by applying multivariable Cox and flexible parametric models. Being the first of its kind, the study will provide a necessary reevaluation of the new therapies when used in ordinary clinical practice. Identification of possible undertreatment of groups of patients may increase the clinicians’ awareness.
Impact to patients and society
Being first to study immunotherapy and targeted therapies for advanced non-small cell lung carcinoma (NSCLC) in a large unselected real-life patient population in Norway, we will provide new knowledge about patient characteristics: age, comorbidities, tumor histology, and socioeconomic and geographical factors. Using the INSPIRE database, the Lung cancer quality registry and Causes of death registry, we can evaluate effectiveness of the new treatment modalities with respect to cause-specific and overall survival stratified according to relevant prognostic factors and histological subtypes.
Furthermore, we will be able to provide an overview of other health outcomes such as number and duration of hospitalizations and other drug use in NSCLC patients who received these treatments versus patients who received traditional treatment modalities. Having access to the individual costs of patient care at the hospitals and costs of all prescribed treatment, we will present an estimate of the direct medical costs for NSCLC patients within the different treatment regimens.
All in all, results of the study will enable us to provide a comprehensive re-evaluation of the benefits of the new treatments in ordinary clinical practice. Possible undertreatment with new drugs due to institutional, geographical or socioeconomic factors may be identified, which in turn will contribute to clinicians’ awareness of groups of patients that may be missing out on treatment that they are entitled to receive. Moreover, one can speculate that the use of the new drugs may contribute to a decrease in other treatment expenses for these patients due to fewer and shorter hospital stays and less use of other supportive care and drugs for symptomatic relief. If the study demonstrates that costs have been overestimated in the authorization evaluations, new estimates may contribute to the justification of more liberal use of these new treatments, which would be directly relevant for the future treatment of advanced NSCLC patients in Norway.