Dexamethasone reduced radiation-induced pain flare after palliative radiotherapy for painful bone metastases, a new study published online ahead of print in the journal The Lancet Oncology has shown.1
Because dexamethasone has demonstrated potential as a prophylactic agent for pain flare occurring after palliative radiotherapy, researchers sought to compare the efficacy of dexamethasone with that of placebo in reducing the incidence of pain flare.
For the multicenter, double-blind, placebo-controlled, phase III trial, researchers enrolled 298 patients with a non-hematologic malignancy and pain in the area or areas of bone metastases.
Participants were randomly assigned 1:1 to receive either dexamethasone 8 mg orally or placebo at least 1 hour prior to the start of radiation, which was given as a single 8-Gy dose to bone metastases on day 0, and then each day for 4 days after radiation.
Results showed that 26% of patients in the dexamethasone group and 35% of those in the placebo group experienced a pain flare, defined as at least a 2-point increase on a 0 to 10 worst pain scale with no reduction in analgesic intake or a 25% or greater increase in analgesic intake with no reduction in worst pain score from days 0 to 10.
In regard to safety, the most common adverse events were bone pain, fatigue, constipation, and nausea. Researchers found that three grade 3 or 4 hyperglycemic events occurred in the dexamethasone group.
- Chow E, Meyer RM, Ding K, et al. Dexamethasone in the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases: a double-blind, randomised placebo-controlled, phase 3 trial [published online ahead of print October 18, 2015]. Lancet Oncol. doi:10.1016/S1470-2045(15)00199-0.