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

SUMMARY:Bone pain related to NEULASTA® (Pegfilgrastim) has been reported to 25%-60% of patients in various clinical trials. In this randomized placebo controlled clinical trial, 510 patients were randomly assigned to receive either Naproxen 500 mg PO BID or placebo, for 5-8 days following NEULASTA®. Naproxen reduced the proportion of pain, patients reported, by 10% (71% vs 61%, P=0.02) and severe pain was reduced by 8% (27% vs 19%, P=0.05). Naproxen also reduced the overall pain incidence (P=0.02) and duration of pain (P=0.009). The authors concluded that Naproxen 500mg PO BID is effective in modestly reducing the incidence and severity of NEULASTA® induced bone pain. The adverse effects of Naproxen, has to be taken into consideration before prescribing this agent for bone pain. Kirshner JJ, Heckler CE, Janelsins MC, et al. J Clin Oncol 2012;30:1974-1979.