Naproxen reduced the percentage of patients who experienced any pain, the authors note. “Of even greater impact was the significant decrease in severe pain (score, >5 on a scale of 1-10), which is often debilitating and can lead to discontinuation of pegfilgrastim,” they add.
Dr. Jeffrey J. Kirshner, with Hematology/Oncology Associates of Central New York, in East Syracuse, and colleagues point out that the development of pegfilgrastim has facilitated administration of full-dose myelosuppressive chemotherapy, but it can cause bone pain. They previously observed that NSAIDs appeared to provide the most relief.
To test this, they randomly assigned 510 cancer patients to receive either 500 mg naproxen BID or placebo on the day of pegfilgrastim administration and for up to 8 days after. Patients recorded pain levels daily using a 10-point scale.
The primary outcome of pain severity during days 1 through 5, as indicated by the area under the curve (AUC), averaged 7.71 for the placebo group compared to 6.04 for the naproxen group (p=0.037), the investigators report.
Mean maximum pain scores in the two groups were 3.40 vs 2.50 (p=0.005), respectively, and corresponding pain durations were 2.40 versus 1.92 days (p=0.009), according to the report.
Some degree of pain occurred in 71.3% of the placebo group compared with 61.1% of the naproxen group (p=0.020), while the corresponding incidence of pain rated as >5 was 27.0% versus 19.2% (p=0.048) in the two arms, respectively.
Dr. Kirshner and colleagues were unable to identify any factors that predicted the occurrence of pain or response to naproxen.
Summing up, they conclude, “Naproxen was able to significantly reduce the incidence, severity, and duration of pegfilgrastim-induced bone pain.” However, they add, “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.”
Prevention of Pegfilgrastim-Induced Bone Pain: A Phase III Double-Blind Placebo-Controlled Randomized Clinical Trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base