Preliminary efficacy and safety profile of dual histamine blockade on preventing filgrastim‐associated bone pain in breast cancer patients: Randomized controlled trial

AIMS: Granulocyte colony-stimulating factors (G-CSF) are often associated with severe medullary bone pain. Combining loratadine and famotidine represents a novel strategy to alleviate the G-CSF-induced bone pain due to the dual histamine blockade. This study aims to clinically investigate the efficacy of this strategy. METHODS: Patients were randomly assigned either to the control group, who received only filgrastim administered after each paclitaxel cycle, or the intervention group, who received filgrastim plus a combination of famotidine and loratadine daily. The primary outcome was the difference in the incidence of grade ≥ 2 bone pain after the first dose of filgrastim. The secondary outcomes included: assessment of the patient's quality of life (QoL) by the Functional Assessment of Cancer Therapy- Bone pain (FACT-BP). RESULTS: After the first dose of filgrastim, the incidence of grade ≥ 2 bone pain was significantly lower in the intervention group compared to the control group: 60.71% vs. 93.10%, respectively (P = 0.004). The intervention group demonstrated significantly improved FACT-BP scores as compared to those recorded in the control group following both the first dose (P = 0.009), and the second dose of filgrastim (P = 0.043). CONCLUSIONS: The prophylactic dual histamine blockade strategy, when administered alongside filgrastim, could significantly ameliorate the incidence and severity of G-CSF-associated bone pain, and therefore improve patient's QoL. Further larger clinical studies are warranted to validate the clinical utility of this novel approach.