Hypofractionated radiotherapy for complicated bone metastases in patients with poor performance

Purpose or Objective: To evaluate the efficacy of hypofractionated radiotherapy (16 Gy in 2 fractions one week apart) in pain relief in patients with complicated bone metastases and poor performance status. Material and Methods: This was a phase 2 multicenter study of patients with complicated bone metastases and Karnofsky performance status from 30 to 60 who underwent 2 fractions of radiotherapy with 8 Gy each one week apart. Pain response and quality of life (QOL) were measured using the International Consensus on Palliative Radiotherapy Endpoints and EORTC QOL Pal 15 and BM 22 questionnaires. Complete response was defined as a pain score of 0 at treated site with no concomitant increase in daily oral morphine equivalent (OMED). Partial response was defined as pain reduction of 2 or more on a scale of 0 to 10 scales without analgesic increase, or analgesic reduction of 25% or more from baseline without an increase in pain. Pain progression as an increase in pain score of 2 or more above baseline with stable OMED, or an increase of 25% or more in OMED compared with baseline with the pain score stable or 1 point above baseline, and others were indeterminate. The study was registered on clinicaltrial.gov (NCT02376322) Results: Thirty patients were enrolled from 4 centres in Brazil, Italy and Canada during July 2014 to September 2015. There were 14 male and 16 female patients. The median age was 58 years old (range 26 - 79). Twenty-two (73%) had extraosseous soft tissue component, 4 neuropathic pain, 2 post-surgical intervention, and 2 impending fracture in weight bearing bone. The most common primary cancer sites were breast (n = 7) and lung/prostate (n = 4 each). The most commonly irradiated areas were lumbosacral spine (n = 10), pelvis/hips (n = 8), thoracic spine (n = 7), cervical spine (n = 3), and superficial bones (n = 2). The median pre-treatment worst pain score was 8 (range 1 to 10) and the median daily OMED was 40 mg (range 0 to 360). The median follow up was 3.7 months (range 0.3 to 9.6). At 2 months, 20 patients were alive (66%). Eleven (55%) had complete or partial response, 4 (20%) progressive disease and 5 (25%) indeterminate response. A statistically significant improvement (p < 0.0001) was seen in the painful sites and physical functioning for the BM22 while the other items in BM 22 and C15-PAL remained stable. No patient suffered from spinal cord compression or pathologic fracture, and re-irradiation was not required. Conclusion: The 2 fractions of radiotherapy with 8 Gy each one week apart appears to be well tolerated without serious side effects in patients with complicated bone metastases and poor performance status. QOL remained stable. The efficacy was similar in patients with uncomplicated bone metastases treated with hypofractionated radiotherapy.