Back to Search
Start Over
A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer
- Source :
- Annals of Oncology
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Background The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days. Patients and methods In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome was a composite of either FN or treatment-related hospitalisations. Secondary outcomes included chemotherapy dose reductions, delays and discontinuations. Analyses were carried out by per protocol (primary) and intention-to-treat, and the non-inferiority margin was set at 3% for the risk of having FN and/or hospitalisation per cycle of chemotherapy. Results Patients (N = 466) were randomised to receive 5 (184, 39.5%), or 7/10 (282, 60.5%) days of filgrastim. In our primary analysis, the difference in risk of either FN or treatment-related hospitalisation per cycle was −1.52% [95% confidence interval (CI): −3.22% to 0.19%] suggesting non-inferiority of a 5-day filgrastim schedule compared with 7/10-days. The difference in events per cycle for FN was 0.11% (95% CI: −1.05 to 1.27) while for treatment-related hospitalisations it was −1.68% (95% CI: −2.73% to −0.63%). The overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalisation were 11.8% and 14.96% for the 5- and 7/10-day groups, respectively (risk difference: −3.17%, 95% CI: −9.51% to 3.18%). Conclusion Five days of filgrastim was non-inferior to 7/10 days. Given the cost and toxicity of this agent, 5 days should be considered standard of care. ClinicalTrials.gov registration NCT02428114 and NCT02816164.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Filgrastim
medicine.medical_treatment
Breast Neoplasms
Article
Polyethylene Glycols
03 medical and health sciences
0302 clinical medicine
Breast cancer
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
medicine
Humans
Chemotherapy-Induced Febrile Neutropenia
Stage (cooking)
Febrile Neutropenia
Chemotherapy
business.industry
Absolute risk reduction
Hematology
medicine.disease
Recombinant Proteins
Confidence interval
3. Good health
030104 developmental biology
Oncology
030220 oncology & carcinogenesis
Toxicity
business
Febrile neutropenia
medicine.drug
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 31
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....dca646365c81b5eedde70aeecc5fb69b