Prophylactic pegfilgrastim to prevent febrile neutropenia among patients receiving Q2W chemotherapy regimen: A systematic review of efficacy, effectiveness, and safety (20190355) (Pegfilgrastim in Q2W regimen: A systematic review)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PEGFILGRASTIM
• Medical condition to be studied:
  Febrile neutropenia

Population studied

• Short description of the study population:
  Patients diagnosed with non-myeloid malignancy and treated with a Q2W chemotherapy regimen with high (>20%) or intermediate (10-20%) risk for Febrile neutropenia (FN) and receiving prophylactic pegfilgrastim.
• 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:
  Other
• Special population of interest, other:
  Non-myeloid malignancy patients
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  Among patients with Q2W regimens with high or intermediate risk for FN, systematically review the evidence regarding risk of1) FN2) grade 1-4 neutropenia 3) all-cause hospitalization4) dose delays or dose reductions5) adverse events, and6) mortalityfor patients receiving prophylactic pegfilgrastim versus no prophylactic pegfilgrastim
• Outcomes:
  FN: defined as an ANC of < 0.5 × 109/L, or a count of < 1.0 × 109/L that is predicted to fall to < 0.5 109/L within 48 hours, with fever or clinical signs of sepsis. OR defined as an in-patient stay with a diagnosis claim for neutropenia or fever or infection,We will not exclude studies if the FN definition is a variant of the commonly used definitions presented above.
• Data analysis plan:
  This review will include randomized trials and observational studies of patients diagnosed with non-myeloid malignancies receiving Q2W myelosuppressive chemotherapy regimen and a primary prophylactic pegfilgrastim. Comparators will include “no primary prophylactic pegfilgrastim”, “primary prophylaxis with other G-CSF”, or “placebo”. We will also include studies where comparator is patients receiving Q3W chemotherapy regimens with primary prophylactic pegfilgrastim. Only publications that address relevant outcomes such as FN, grade 3 or 4 neutropenia, all-cause hospitalization, dose delays or dose reductions, adverse events, or mortality will be included. Systematic reviews that include studies of patients receiving Q2W chemotherapy regimens with primary prophylactic pegfilgrastim will also be reviewed for additional data that include the relevant outcomes.

Documents

Study results

20190355_Observational Research Study Report Published Report_Redacted