Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial
Peiyong Li1, Yitian Chen2, Yingyi Lin3
1Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China; and Guangdong Medical University, Zhanjiang, China (P.L.).
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 incidence of neutropenia among groups, and no patients developed FN.
Limitation:
Open label, single center, and relatively small sample size.
Conclusion:
Administration of pegfilgrastim 72 hours postchemotherapy reduced PIBP compared with 24- and 48-hour administration and did not seem to be associated with higher rates of neutropenia or FN.
Primary Funding Source:
National Natural Science Foundation of China.
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