Real-world treatment patterns and outcomes of patients with advanced renal cell carcinoma (aRCC) treated with first-line (1L) axitinib + pembrolizumab therapy

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  INLYTA
• Study drug International non-proprietary name (INN) or common name:
  AXITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EK01) axitinib

  axitinib
• Medical condition to be studied:
  Renal cell carcinoma stage IV

Population studied

• Short description of the study population:
  Providers from Cardinal Health Oncology Provider Extended Network (OPEN) in the United States (US) will be eligible to participate in the study if they have treated at least 5 aRCC patients in the past year, are able to participate in research monitored/approved by a centralized independent institutional review board (IRB), and agree to participate in data quality assurance (QA)/quality control (QC) procedures. For the retrospective chart; abstraction, patients meeting the eligibility criteria will be identified by oncologists in OPEN. These patients will be adults diagnosed with aRCC who initiated axitinib + pembrolizumab as 1L treatment and have at least six months of follow-up data after initiation of index therapy.
• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 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:
  Patients with advanced renal cell carcinoma (aRCC)
• Estimated number of subjects:
  300

Study design details

• Study design:
  This is a cohort study that includes a cross-sectional physician survey and a retrospective, multi-site, oncology community-based, medical chart abstraction of patients with clear cell aRCC treated with 1L axitinib + pembrolizumab therapy.
• Main study objective:
  The primary objective of the study is to describe patient-level treatment patterns and sequences of therapy after initiation of 1L axitinib + pembrolizumab therapy among patients with advanced renal cell carcinoma (aRCC).
• Setting:
  Patients meeting the eligibility criteria will be identified by oncologists from the Cardinal Health Oncology Provider Extended Network (OPEN) in the US who are the patients’ treating providers or work in the patient’s treating practice.
• Outcomes:
  Primary outcomes: Treatment patterns (duration of treatment, rationale for treatment discontinuation, treatments received beyond 1L axi+pembro); treatment management (dose holds, dose modifications, etc.); Secondary outcomes: Demographic and clinical characteristics; physicians’ perceptions of treatment management approaches for aRCC; Exploratory outcomes: Real-world overall response rate, real-world progression-free survival, real-world overall survival;
• Data analysis plan:
  This is a descriptive analysis of physician survey data a patient-level data, and no formal hypotheses are specified a priori. Counts and frequencies will be used to describe dichotomous and categorical variables and measures of central tendency (mean, median) and spread (minimum, maximum, standard deviation [SD], interquartile range [IQR], as appropriate) for continuous variables. The Kaplan-Meier method will be used for time-to-event estimates, accounting for right-censoring. All statistical analyses will be conducted using Statistical Analysis Software (SAS v. 9.4).