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ASTRO 2015: Patients With Bone Metastases Undergoing Radiation Therapy for Symptom Control Have Lower Pain Flare Rates With Steroid Use

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Key Points

  • In the intention-to-treat analysis, 39 patients (26.4%) in the dexamethasone group had a pain flare, compared to 53 patients (35.3%) in the placebo group.
  • In a sensitivity analysis treating those with missing data as inevaluable, pain flare occurred in 26 patients (17.6%) who received dexamethasone, compared to 44 patients (29.3%) who received the placebo.
  • At 10 days post-treatment, patients in the dexamethasone arm showed statistically significant improvement (vs the placebo group) with regard to nausea, functional interference, and appetite when compared to baseline levels.

The steroid dexamethasone reduces radiation-induced pain flare in cancer patients with painful bone metastases, according to research presented by Chow et al (Abstract LBA1) October 18, 2015 at the American Society for Radiation Oncology’s (ASTRO’s) 57th Annual Meeting in San Antonio, Texas.

Patients with cancer that metastasized to their bones can experience debilitating pain. While radiation therapy is commonly used to treat patients with bone metastases to lessen this pain, it can also temporarily cause pain flare in some patients. According to the U.S. National Cancer Database, between 2005 and 2011, nearly 25,000 patients with breast, lung, or prostate cancer were treated with radiation for bone metastases.

Study Details

This multi-institutional trial, led and conducted by the NCIC Clinical Trials Group, was a double-blind study that compared the effectiveness of dexamethasone, a steroid that aids in controlling inflammation, to a placebo in reducing the incidence of pain flare. The study also looked at toxicity and the impact on the patients’ quality of life.

A total of 298 patients with bone metastases were enrolled in the study from 23 centers throughout Canada. The patients were to be treated with a single 8-Gy fraction of radiation therapy to one or two bone metastases, and using a Web-based system, were randomly assigned into two groups. One group (n = 148) received 8 mg of oral dexamethasone daily for 5 days beginning on the first day of radiation, and the other group (n = 150) received an oral placebo.

Patients reported their worst pain scores before radiation therapy and daily for 10 days after radiation therapy. They completed the EORTC QLQ-C15-PAL and the EORTC-QLQ BM22 (both European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires), and the Dexamethasone Symptom Questionnaire at baseline, and again at 10 and 42 days after radiation therapy.

The questionnaire completion rate was high: 99% at baseline and 82% at days 10 and 42. Pain flare was defined as at least a 2-point increase in patient-rated worst pain on a scale of 0 to 10, with no decrease in analgesic intake; or a 25% or greater increase in analgesic intake with no decrease in the worst pain score from days 0 to 10.

Survey Findings

The results showed that patients in the dexamethasone group experienced fewer episodes of pain flare than the placebo group. Additionally, when the dexamethasone group did have pain flare, they reported that their pain was less severe than that of the placebo group.

In the intention-to-treat analysis, 39 patients (26.4%) in the dexamethasone group had a pain flare, compared to 53 patients (35.3%) in the placebo group. In a sensitivity analysis treating those with missing data as inevaluable, pain flare occurred in 26 patients (17.6%) who received dexamethasone, compared to 44 patients (29.3%) who received the placebo.

The results also showed that at 10 days post-treatment, patients in the dexamethasone arm had statistically significant improvement (vs the placebo group) with regard to nausea, functional interference, and appetite when compared to baseline levels.

“The potential side effects of radiation treatment for bone metastases can be well managed in the majority of people, and therefore pain flare should not be viewed as a barrier to receiving this highly effective therapy for symptom control,” said Alysa Fairchild, MD, a radiation oncologist at the Cross Cancer Institute and University of Alberta. “Based on our results, we recommend that patients who are scheduled to receive radiation therapy to control painful bone metastases also receive a short course of dexamethasone to reduce the risk of experiencing an acute pain flare.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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