Assessment of Disease Feature and Treatment Pattern of Locally Advanced, Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma in China (ADAPT-H&N)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, non-interventional study

Study drug and medical condition

• Medical condition to be studied:
  Squamous cell carcinoma of head and neck
• Additional medical condition(s):
  Locally Advanced, Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Population studied

• 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)
• Estimated number of subjects:
  840

Study design details

• Main study objective:
  (1) To describe patient demographics, clinical characteristics in R/M disease (2) To describe the first line systemic treatment distribution in R/M disease (3) To describe patient demographics, clinical characteristics in LA disease (4) To describe the primary treatment approach in LA disease • Overall, and according to tumor location and tumor stage
• Outcomes:
  Demographic variables and disease related variables will be reported using descriptive statistics. Treatment regimens and treatment exposure (if available) will be reported using descriptive statistics for R/M disease Treatment approaches will be analyzed overall and according to tumor locations (lip/oral cavity, oropharynx, hypopharynx, larynx) and tumor stage (III and IVA-B) for LA disease. Description of subsequent systemic treatment in R/M disease Estimation of Time to Next Treatment from initiation of first line systemic treatment in R/M disease usage of pembrolizumab in the first line in R/M disease PD-L1 testing rate in R/M disease Description of the primary treatment approach in LA disease according to HPV status
• Data analysis plan:
  Descriptive analysis of patient demographic, clinical characteristics and treatment patterns: minimum, maximum, median, standard deviation values for continuous variables and frequencies and percentages for categorical variables. Time to event analyses: Kaplan Meier product limit method for Time to next treatment