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Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial - PubMed

6 hours ago
  • #Pegfilgrastim
  • #Chemotherapy
  • #Bone Pain
  • Pegfilgrastim-induced bone pain (PIBP) is common and lacks effective treatment.
  • A randomized controlled trial was conducted to determine the association between the timing of pegfilgrastim administration and PIBP.
  • Patients with stage I to III breast cancer naive to chemotherapy were allocated to 24-hour, 48-hour, or 72-hour pegfilgrastim administration postchemotherapy.
  • The primary endpoint was the area under the curve (AUC) of daily worst bone pain scores over 5 days in the first chemotherapy cycle.
  • The 72-hour group showed a significant reduction in mean AUC (6.05) compared to the 24-hour (12.74) and 48-hour (14.20) groups (P < 0.001).
  • Incidence of severe bone pain (>5 on NRS) declined from 58.5% (24-hour) and 66.0% (48-hour) to 22.6% (72-hour) (P < 0.001).
  • No significant difference in neutropenia incidence among groups, and no cases of febrile neutropenia (FN) were reported.
  • Limitations include open-label design, single-center study, and relatively small sample size.
  • Conclusion: Pegfilgrastim administration at 72 hours postchemotherapy reduces PIBP without increasing neutropenia or FN rates.