Various G-CSF Regimens to Prevent Infection During Chemotherapy
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis
with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious
[1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines
conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to
patients at a more than 20% risk of febrile neutropenia.
Based on many positive and few negative trials, one can consider the use of taxanes as
standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or
without anthracyclines) have an increased risk for febrile neutropenia.
The updated guidelines and changes in daily clinical practice will have a significant impact
on the investigators health care resources. There is a higher risk of febrile neutropenia for
the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer
patients. Also in advanced breast cancer the majority of first observed episodes of febrile
neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or
chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles
of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely
seems to disappear.
So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is
justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy
cycles as compared to the current practice of continuous G-CSF prophylaxis.
Phase:
Phase 3
Details
Lead Sponsor:
Academisch Ziekenhuis Maastricht
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development