Prospective international observational cohort non-comparative study describing the safety and effectiveness of ZALTRAP® administered in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer in current clinical practice: A Post-Authorisation Safety Study (PASS) (OZONE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Zaltrap
• Study drug International non-proprietary name (INN) or common name:
  AFLIBERCEPT
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX44) aflibercept
• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  Patients treated with ZALTRAP® in the clinical setting (not as part of an interventional clinical trial) and followed for 24 months after initiation of ZALTRAP®.; Patients with following criteria were included:; 1. Patient planned to be treated with ZALTRAP® in combination with a 5FU plus irinotecan regimen (FOLFIRI) for mCRC after failure of an oxaliplatin based regimen (including bevacizumab pretreated patients). Patient for which the Physician has decided to prescribe ZALTRAP® independently from entry in study; 2. Age ≥18 years old; 3. Availability of a written informed consent
• 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:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  750

Study design details

• Main study objective:
  To describe the long term safety & clinical outcomes of ZALTRAP® in combination with FOLFIRI in patients treated in daily practice for a mCRC after failure of an oxaliplatin-based regimen.; To assess safety of ZALTRAP® in the following cohorts: Elderly patients (?65 years old); Patients with renal or hepatic impairment; Non Caucasian; Number and type of prior anti cancer-therapy.
• Outcomes:
  Safety: TEAEs; ; Efficacy: OS, physician assessed PFS and RR, Effectiveness in the following cohorts:; • Elderly (≥65 years),; • Hepatic or renal impairment patients,; • Non Caucasian,; • Number and type of prior anti-cancer therapy (e.g. prior bevacizumab); ; Health Resource Utilization
• Data analysis plan:
  All statistical analyses will be descriptive. Safety endpoints will be summarized as count and frequencies with 95% confidence interval. Best Overall Response will be summarized as count of patients and frequencies with 95% CI. For the PFS and OS outcomes, the Kaplan-Meier estimates will be computed and the 95% confidence interval for the median survival times / survival rates at given time points will be provided. Subgroups analyses will be performed in following patients cohorts: elderly, hepatic or renal impairment, non-Caucasian and number & type of prior anti-cancer therapy.

Documents

Study results

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