Balloon kyphoplasty*, a quick and minimally invasive spinal repair procedure, provides rapid pain relief, increases mobility, and reduces the need for painkillers compared with standard non-surgical care of vertebral compression fractures (VCFs) that often occur in cancer patients. These findings from the first randomised trial of kyphoplasty in cancer patients with VCFs, published Online First in The Lancet Oncology, suggest that the procedure is a safe alternative treatment that should be offered to all cancer patients with painful VCFs.
Painful and debilitating VCFs are a common complication of cancers that have spread (metastasised). Although normally treated non-surgically with painkillers, bed rest, and physiotherapy, these methods have limited effectiveness and can cause serious side-effects. Because poor bone quality is common among patients with cancer, open surgery is usually reserved for those with neurological impairment. A few non-randomised studies in cancer patients with VCFs have reported reduced pain and improved function and quality of life after kyphoplasty treatment.
The Cancer Patient Fracture Evaluation (CARE) randomised trial was designed to compare the safety and efficacy of balloon kyphoplasty with standard non-surgical care of cancer patients with VCFs, at 22 sites across Europe, the USA, Canada, and Australia.
Between 2005 and 2008, 134 patients were randomly assigned to balloon kyphoplasty (70) or non-surgical management (64) and their back function assessed one month after surgery or start of treatment using a questionnaire to measure disability**. Additionally, quality of life, back pain and function, and use of pain killers were assessed at regular intervals up to 12 months.
At 1 month, patients in the kyphoplasty group reported a marked improvement in their back disability score whereas there was no change in the non-surgical treated patients.
Patients given immediate kyphoplasty also had significant improvements in quality of life and more rapid pain relief (one week after surgery) than those receiving non-surgical care. Additionally, fewer patients in the kyphoplasty group were using painkillers, walking aids, back bracing, or were on bed rest at 1 month.
During the first month, adverse events were similar between the two groups. The most common side-effects were back pain and symptomatic vertebral fractures. Importantly, a low incidence of new fractures in the kyphoplasty group at 1 year, suggests that the procedure does not increase the risk of new fractures.
Patients given kyphoplasty treatment showed improvements in spinal function, quality of life, and pain during the entire study (12 months).
The authors point out: "Kyphoplasty for patients with cancer can be done and patients discharged from the treatment facility within 24 h…[it] typically requires minimal recovery time, and does not delay chemotherapy or radiation therapy."
They conclude: "The improved survival times of patients with cancer in general, especially those with metastatic bone disease, accentuate the importance of managing their comorbidities…The results of this study indicate that balloon kyphoplasty should be considered as an early treatment option for patients with cancer with symptomatic VCFs."
See also linked Comment.
Dr James Berenson, Institute for Myeloma and Bone Cancer Research, Los Angeles, USA. T) +1 310 623 1214 or +1 310 420 9649 (mobile) E) jberenson@imbcr.org
Comment: Dr James Schiff, University of Virginia Health Science Center, Charlottesville, VA, USA. E) davidschiff@virginia.edu
For full Article and Comment, see: http://press.thelancet.com/tlokypho.pdf
Notes to Editors:
*During the procedure a balloon is inserted through a small incision in the fractured vertebra, inflated (increasing the space inside the collapsed bone) and removed. The resulting intravertebral cavity is then filled with a cement-like substance restoring the shape and function of the vertebrae.
**Patients in the non-surgical care were allowed to have kyphoplasty after the 1 month assessment time point.
Journal
The Lancet Oncology