Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial
Abstract
Background: Pegfilgrastim-induced bone pain (PIBP) is common and lacks effective treatment.
Objective: To determine whether there is an association between the timing of pegfilgrastim administration and PIBP.
Design: Three-arm randomized controlled trial. (ClinicalTrials.gov: NCT05841186).
Setting: A tertiary A-level hospital.
Patients: Patients with I to III stage breast cancer who were naive to chemotherapy.
Intervention: Patients were randomly allocated in a 1:1:1 ratio to the 24-hour, 48-hour, or 72-hour group based on the timing of pegfilgrastim administration postchemotherapy.
Measurements: The primary end point was the area under the curve (AUC) of the daily worst bone pain score (assessed using the "worst pain" question from the Brief Pain Inventory, a 0 to 10 numerical rating scale [NRS]) for 5 consecutive days in the first chemotherapy cycle. Secondary end points included the incidence of severe bone pain (>5 on the NRS), neutropenia, and febrile neutropenia (FN).
Results: The intention-to-treat analyses included 159 patients, with 53 in each group. For the first cycle, in the 72-hour group, the mean AUC exhibited a statistically significant reduction from 12.74 in the 24-hour group and 14.20 in the 48-hour group to 6.05 (all P 0.001). Furthermore, the incidence of severe bone pain also declined significantly from 58.5% in the 24-hour group and 66.0% in the 48-hour group to 22.6% in the 72-hour group (all P 0.001). There was no substantial difference in the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 159 participants or records.
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