REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.
The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
233
Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy
Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Bone pain
Bone pain over the first 5 days after the administration of G-CSF. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) based on a patient's daily pain score, starting after the first dose of G-CSF injection.
Time frame: 5 days after first G-CSF injection
Incidence of Febrile Neutropenia
Number of times participants have Febrile neutropenia during chemotherapy treatment
Time frame: 2.5 years after study initiation
Incidence of treatment-related hospitalizations
Number of times participants have a treatment-related hospitalization
Time frame: 2.5 years after study initiation
Incidence of chemotherapy alteration
Number of times participants have a chemotherapy alteration including: dose delay, reduction and/or discontinuation
Time frame: 2.5 years after study initiation
Incidence of chemotherapy-related mortality
Number of times there is a chemotherapy-related mortality
Time frame: 2.5 years after study initiation
Rate of G-CSF compliance as prescribed
Number of times there is a G-CSF compliance
Time frame: 2.5 years after study initiation
Differences in healthcare resource utilization
Differences in healthcare resource utilization: number of emergency room visits, number of planned/unplanned provider clinic visits (including stretcher bay), patient-reported phone calls or email to patient support line or provider, and additional medication use or management strategies related to G-CSF side effects or efficacy
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Time frame: 2.5 years after study initiation
HR-QoL
HR-QoL based on EQ-5D-5L
Time frame: 2.5 years after study initiation
Cost-effectiveness
Cost differences associated with prescribing Filgrastim and Pegfilgrastim
Time frame: 2.5 years after study initiation
Patient G-CSF preference
To survey patient preference in selection of G-CSF treatment before and after undergoing chemotherapy and G-CSF treatment
Time frame: 2.5 years after study initiation
Study feasibility
Interim analysis/feasibility. After the first year of study initiation, if study recruitment is less than 30% at one year (70 patients), or if there are unanticipated safety issues, a review of study conduct will be performed to consider stopping the study unless there are unexpected or exceptional reasons, or in the case of low recruitment, there is a plan to boost recruitment efforts
Time frame: 1 year after study initiation