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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/38452
• EU PAS number:
  EUPAS31967
• Study ID:
  38452
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  Febrile neutropenia (FN) following myelosuppressive chemotherapy is a potentially life-threatening complication and is associated with loss of treatment efficacy because of dose delays, and dose reductions. To prevent FN, the National Comprehensive Care Network (NCCN) guidelines recommends prophylactic use of granulocyte colony stimulating factor (G-CSF) for patients receiving a chemotherapy regimen associated with high risk of developing FN (≥ 20%) or those receiving regimens with intermediate-risk of FN (10-20%) and have at least one patient-level risk factor. Pegfilgrastim is a long-acting G-CSF that is administered once per cycle and is the most commonly used G-CSF in the US. The US prescribing information for pegfilgrastim specifies that Neulasta should not be administered in the period between 14 days before and 24 hours after administration of myelosuppressive chemotherapy. This restriction was placed because of the potential for an increase in sensitivity of rapidly dividing myeloid cells stimulated by pegfilgrastim to myelosuppressive chemotherapy. However, this restriction precludes the prophylactic use of pegfilgrastim among several Q2W chemotherapy regimens associated with high or intermediate risk for FN. The European label for pegfilgrastim does not include the 14-day exclusion period for Neulasta prior to chemotherapy, only exclusion in the 24 hours after cytotoxic chemotherapy is administered. The latest NCCN guidelines recommend that there should be at least 12 days between the dose of pegfilgrastim and the next cycle of chemotherapy supporting the use of prophylactic pegfilgrastim in patients receiving Q2W regimens. This is consistent with the guidelines of the European Organisation for Research and Treatment of Cancer (EORTC). The objective of this review is to provide a single-source information for oncologists and payers to make evidence-based decisions.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 13/08/2019

Actual: 13/08/2019

Study start date

Planned: 15/12/2019

Actual: 27/11/2019

Data analysis start date

Planned: 01/01/2020

Actual: 10/12/2019

Date of final study report

Planned: 31/10/2020

Actual: 07/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 2019-10-08 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable