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

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.