Lung cancer is the most common cause for cancer-related death. It can roughly be divided into two major groups: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). In the UK the majority of lung cancer patients experience a form of NSCLC.
In early stages, surgery is the primary treatment option. However, if the tumour has spread, surgery is often no longer possible. In that case systemic treatment, a drug given orally or intravenously that spreads through the whole body, becomes the primary treatment option. Previously, chemotherapy was the only systemic treatment available for those patients. In the last decade, several new treatment options have become available, such as targeted therapies (for example alectinib or osimertinib) and immune checkpoint inhibitors (ifor example nivolumab or pembrolizumab). In patients with more developed NSCLC (higher stages) those therapies have become first-line treatment options and are extensively used in the clinical practice.
New drugs are evaluated in clinical trials. Before inclusion, patients are screened based on their characteristics and their comorbidities (inclusion- and exclusion-criteria). Comorbidities are other conditions that occur simultaneously with the condition of interest. Those criteria used for screening of the patients could lead to differences between the patients included in the study and NSCLC-patients in clinical practice.
The aim of this study is to describe characteristics and comorbidities of British lung cancer patients and to evaluate the representativeness of recently performed, clinical trials evaluating targeted therapies and immune checkpoint inhibitors in lung cancer patients.
Primary objective is to compare the characteristics of patients included in phase III randomized clinical trials that evaluated targeted therapies or immunotherapy for treatment of lung cancer with the characteristics of patients with lung cancer in CPRD from 2014 through 2018.
Secondary objective is to compare overall survival among patients with lung cancer in CPRD (2014-2018) who were eligible for inclusion in phase III RCTs that evaluated targeted therapies or immunotherapy for treatment of lung cancer with those in CPRD who did not meet those eligibility criteria.
First, we will create a base study population including all patients with any diagnosis of lung cancer between 01-01-2014 and 31-12-2018. The comorbidities of the included patients will be described, and subsequently the included patients will be compared based on their characteristics, with the study population of different clinical trials. This will enable us to evaluate which proportion of UK lung cancer patients would be eligible to participate in one of the clinical trials, thereby defining the representativeness of the included study population in the clinical trials. In addition to representativeness, for all lung cancer patients in CPRD, Kaplan-Meier analyses will compare overall survival between those who met eligibility criteria for each individual RCT versus those did not meet eligibility criteria. Corresponding Kaplan-Meier curves will compare overall survival in CPRD patients whose characteristics made them eligible or ineligible for inclusion in published RCTs. In addition, Cox proportional hazards analyses will estimate crude and age-sex adjusted hazard ratios (HRs) of overall survival of patients with lung cancer, comparing patients who were eligible for participation in RCTs to those who were not.
Overall survival
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Anne-Marie Dingemans - Collaborator - Maastricht University Medical Centre
Ard van Veelen - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Robin van Geel - Collaborator - Maastricht University Medical Centre
Sander Croes - Collaborator - Maastricht University Medical Centre
Shahab Abtahi - Collaborator - Utrecht University