Modalities of G-CSF Zarzio® use in clinical practice in patients receiving cytotoxic chemotherapy regimens in which the rest period does not exceed 14 days for breast, lung, gastrointestinal cancers and lymphoma. (TOPAZE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Febrile neutropenia

  Breast cancer

  Lung neoplasm malignant

  Gastrointestinal carcinoma

  Lymphoma

  Neutropenia

  Chemotherapy

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:
  1431

Study design details

• Main study objective:
  Describe modalities of Zarzio® use in routine clinical practice, for the prevention of febrile neutropenia, in patients receiving cytotoxic chemotherapy in which the rest period* does not exceed 14 days, for the treatment of a breast, lung, gastrointestinal cancer, or a lymphoma.*Rest period= duration between two cytotoxic administrations, with the same cycle or between 2 different cycles.
• Outcomes:
  Description of modalities of Zarzio® use in patients receiving a cytotoxic chemotherapy in which the rest period does not exceed 14 days:Date of Zarzio® onset,Zarzio® Treatment duration/Frequency/daily dose administered/Type of administration,Date and reason of Zarzio® discontinuation (if applicable),Comparison of Zarzio® administration versus initial prescription,Ongoing chemotherapy. Proportion of patients with a chemotherapy dose-intensity maintained with the use of Zarzio®, Characteristics of patients treated by Zarzio®, Factors related to a primary prophylaxis versus secondary prophylaxis, Characteristics of the patients’ subgroup aged of 65 years and above receiving Zarzio®.
• Data analysis plan:
  The sample size calculation relies on the alpha risk and on the precision level desired for presenting observed frequencies.The primary objective is to describe the conditions of Zarzio® use in patients receiving a chemotherapy in which the rest period does not exceed 14 days.In order to have a sufficient precision for each tumor type, the number of patients has been calculated independently for each type of tumor. The recruitment will be competitive.For each solid tumor (breast, lung, gastrointestinal cancer), a 5% precision is expected. For lymphoma, a 8% precision is expected.Descriptive analysis:Qualitative variables: effective and frequency, CI 95%,Quantitative variables: mean, standard deviation, CI 95%, median, quartiles and extreme valuesUnivarious analysis:Qualitative variables: association measured by Pearson’s chi-squared test,Quantitative variables: Student test if normal distribution /non parametric test if application conditions are not met.