Real-world Comparative Effectiveness of Anti-EGFRs with Doublet Chemotherapy Versus Doublet Chemotherapy with or without Bevacizumab in Firstline Among RAS/RAF Wild-type, non-dMMR/MSI High mCRC Patients with Left-sided Primary Tumors in the Flatiron Health CRC Enhanced Datamart (20240215)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VECTIBIX
• Study drug International non-proprietary name (INN) or common name:
  PANITUMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FE02) panitumumab

  panitumumab
• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  Adults with diagnosis of metastatic (Stage IV) mCRC
• Age groups:
  Adults (18 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  22000

Study design details

• Study design:
  Retrospective, active comparator, new user cohort study.
• Main study objective:
  The main study objectives are: ; - To compare overall survival in Rat sarcoma (RAS)/ Rapidly accelerated fibrosarcoma (RAF) Wild-type (WT), non-Mismatch repair deficient (dMMR)/ Microsatellite instability (MSI) high mCRC patients with left-sided primary tumors initiating treatment with panitumumab in combination with FOLFOX versus bevacizumab in combination with FOLFOX in the front-line (1L) setting, within the US Flatiron Health Enhanced Datamart (FH EDM).; - To compare overall survival in RAS/RAF WT, non-dMMR/MSI high mCRC patients with left-sided primary tumors initiating treatment with panitumumab in combination with FOLFOX versus FOLFOX alone in the front-line setting, within the US FH EDM.
• Comparators:
  FOLFOX (Leucovorin, fluorouracil, oxaliplatin); Bevacizumab; FOLFIRI (Leucovorin, fluorouracil, irinotecan); CAPEOX (Capecitabine and oxaliplatin)
• Outcomes:
  Overall Survival (OS)
• Data analysis plan:
  The study will use propensity score weighting (inverse probability of treatment weights – IPTW) to create treatment cohorts for evaluation of the comparative effectiveness (i.e. OS) of: ; 1) panitumumab plus FOLFOX versus FOLFOX with or without bevacizumab in the 1L setting (primary objective); and ; 2) anti-epidermal growth factor receptor (EGFR) agent (panitumumab/cetuximab) versus doublet chemotherapy (FOLFOX/FOLFIRI/CAPEOX) with or without bevacizumab in the 1L setting (secondary objective).