Some bone metastases appear to be at higher risk for such complications as pathologic fracture, spinal cord compression, pain or surgery to bone, even if they’re asymptomatic. While evidence has shown that radiation therapy may help prevent those complications, further evidence is needed. A phase 3 clinical trial underway at Roswell Park Comprehensive Cancer Center will help determine whether adding radiation to standard-of-care treatment can provide that protection.
Led by site Principal Investigator Simon Fung-Kee-Fung, MD, Assistant Professor of Oncology and Director of the Breast Radiation Service at Roswell Park, the PREEMPT Trial (NCT06745024) will assign patients to one of two arms: standard of care alone — including systemic cancer therapy or observation and bone-modifying agents as ordered by the treating physician — or standard of care plus conventional radiation therapy or stereotactic body radiation therapy, given once daily for up to five days.
“Complications from bone metastases occur in approximately 29% of high-risk lesions under the current standard of care,” says Dr. Fung-Kee-Fung. “Phase 2 data indicate that prophylactic radiotherapy can reduce that incidence to just 1%. Preventing those events — such as fractures, hospitalizations and spinal cord compression — with as few as five fractions or less of radiotherapy could significantly improve patient quality of life, minimize interruptions in systemic therapy and potentially enhance survival outcomes.”
To be considered for the study, patients must have been diagnosed with any type of solid tumor. Those with multiple myeloma are not eligible. Participants must have:
- More than five sites of radiographically evident systemic metastatic disease (other than intracranial disease)
- High-risk, asymptomatic bone metastases scoring below five for maximum pain on the Brief Pain Inventory, with at least one of the following high-risk criteria:
- Bulky site of disease in bone (2 cm or above)
- Disease involving the hip, shoulder or sacroiliac joints
- Disease in long bones occupying up to 2/3 of the cortical thickness
- Disease in junctional spine and/or disease involving posterolateral element
Follow-up will take place at three, six, 12 and 24 months to compare the incidence of skeletal-related events, overall survival, hospitalization rates and pain-related quality of life between the two groups.
Says Dr. Fung-Kee-Fung, “The results of this trial have the potential to deliver immediate and meaningful benefits to our patients.”
BROADCASTMED