(ChemotherapyAdvisor) – Twice daily naproxen 500mg reduced incidence and severity of pegfilgrastim-induced bone pain, a trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base concluded in the Journal of Clinical Oncology online April 16.
The Phase 3 trial randomly assigned 510 patients at 17 sites to receive naproxen 500mg two times per day or placebo on the day of pegfilgrastim administration, continuing for five to eight days following pegfilgrastim. Using daily diaries, patients recorded pain severity (scale of 0–10) and duration. Mean age was 55.6 years; 86% were female. A total of 68% of patients had breast cancer and 10%, lung cancer.
For both groups, pain reached its peak at three days. Mean AUC for pain was 7.71 for the placebo group and 6.04 for the naproxen group (P=0.037). Naproxen reduced maximum pain from 3.40 to 2.59 (P=0.005); reduced overall pain incidence from 71.3% to 61.1% (P=0.02) and reduced pain duration from 2.40 to 1.92 days (P=0.009).
Naproxen also significantly reduced severe pain, defined as >5 on a scale of 1–10, from 27.0% to 19.2% (P=0.048). The investigators could not identify risk factors that might predict incidence, severity, or ability to prevent pegfilgrastim-induced bone pain.
“In summary, our study confirms the relatively high incidence of pegfilgrastim-induced bone pain in the clinical oncology setting,” they wrote. “Naproxen decreased the incidence, duration, and severity of pegfilgrastim-induced bone pain. Even with this preventive treatment, more than 60% of patients still experienced some pain. For 19% of patients the pain was severe, indicating a need to develop better strategies to prevent and/or treat pegfilgrastim-induced bone pain. Future trials of naproxen or other agents to prevent pegfilgrastim-induced bone pain are needed.”