REaCT-5G: a randomized trial of bone pain with 5-day-filgrastim vs. pegfilgrastim for neutropenia in breast cancer
Mené sur 233 patientes atteintes d'un cancer du sein de stade précoce, cet essai randomisé compare l'efficacité, du point de vue de la réduction de la douleur osseuse, d'un traitement de 5 jours par filgrastim et d'un traitement par dose unique de pegfilgrastim dans le cadre d'une neutropénie induite par la chimiothérapie
Introduction: Granulocyte colony stimulating factors (G-CSF), including filgrastim and pegfilgrastim, are associated with bone pain, potentially impacting treatment adherence. This study hypothesized that a 5-day regimen of filgrastim (5-day-FIL) would result in less bone pain than single-dose pegfilgrastim (PEG) in patients receiving chemotherapy for early breast cancer.
Methods: In this multicenter, open-label, randomized controlled trial, patients requiring prophylactic G-CSF during chemotherapy were randomized 1:1 to receive either 5-day FIL or PEG. The primary outcome was patient-reported bone pain, assessed as area under the curve (AUC) of daily pain scores (0 = no pain to 10 = worst pain) over the first 5 days following G-CSF in cycle 1. Secondary outcomes included bone pain in cycles 2-4, febrile neutropenia (FN), hospitalizations, chemotherapy delays, dose reductions, early discontinuations, chemotherapy-related deaths, health-related quality-of-life, and healthcare resource utilization.
Results: From June 2021 to March 2023, 233 patients were randomized, with 219 analyzed (110 FIL/109 PEG) after excluding those who withdrew before receiving treatment. Adjusting for stratification factors and prespecified baseline co-variates using repeated measures linear regression, the mean AUC (0 to 40) for cycle 1 bone pain was 10.2 (SD 11.2) for 5-Day-FIL and 10.2 (SD 9.81) for PEG, with an adjusted mean difference of 0.70 (95% CI: -1.62, 3.02; p = .556). While no significant differences were observed in most secondary outcomes, the 5-day-FIL group exhibited a numerically higher incidence of FN (6.4% vs 0.9%, p = .065) and hospitalization (10.0% vs 3.7%, p = .106).
Conclusions: There was no significant difference in bone pain between 5-day-FIL and PEG.
JNCI Cancer Spectrum , résumé, 2025