First-line anticancer drugs in patients with advanced, primary Non-Small Cell Lung Cancer: drug-utilization and effectiveness studies from Tuscany Region healthcare database

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  All patients with a NSCLC record in PR registry of Tuscany Region between January 1, 2009 and June 30, 2019 will be identified. Patients with a diagnosis of NSCLC will be selected using a specific algorithm for the PR.; The date of the first NSCLC diagnosis recorded in PR will be considered as the index date. Thereafter, the PR will be linked to regional AHD, in order to select patients with ≥18 years old and with at least two years of look back. In order to select only patients with a primary NSCLC, only patients without a cancer diagnosis other than lung cancer recorded in HDR in the 5 years before index date will be included in the study cohort.; Moreover, in order to avoid patients with a cancer recurrence, only patients with a lung cancer diagnosis (162* ICD-9CM) recorded between 3 months and 5 years before index date will be excluded.; In order to select only lung cancer patients with an advanced stage of the disease, patients without a lung surgery (ICD9-CM codes: 32*) in the six months before or after index date will be included.; we aim to exclude those patients receiving neoadjuvant therapy (generally less than six months), and those patients receiving adjuvant therapy (generally no more than six months after PR record).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  4500

Study design details

• Main study objective:
  The aim of the project is evaluate drug utilization and the effectiveness of first-line anticancer therapies approved for the treatment of advanced, non-resectable, NSCLC patients between 2009 and 2019 in the Tuscany population.
• Outcomes:
  Drug utilization and survival
• Data analysis plan:
  Descriptive analyses will be conducted to assess demographic and clinical characteristics of selected NSCLC patients in relation to the histology of NSCLC. Characteristics of patients according to first-line therapy registered will be compared using chi-square tests or Fisher exact test for categorical variables and ANOVA tests for continuous variables. In order to evaluate if squamous and non-squamous patients have a different profile on the basis of first-line treatment, a logistic regression model will be used (odds ratio and CI95%). Trend, seasonality and cyclical irregularity about the percentage of not treated patients and chemotherapy patients will be evaluated using a time series model. As for survival analysis, a COX proportional hazards model will be used to analyze predictors of survival. Results of the Cox model will be reported as HR with 95%CI. Finally, Kaplan Maier method will be used to describe OS.