Cancer patients who suffer painful vertebral compression fractures (VCFs) may find relief through balloon kyphoplasty, a technique that appears to relieve pain and improve function quickly.
The Cancer Patient Fracture Evaluation (CAFE) study enrolled 134 cancer patients in the United States, Canada, Europe, and Australia. All subjects were aged 21 years and older and had 1 to 3 painful VCFs. Participants were randomized to nonsurgical management (n=64) or to kyphoplasty (n=70), a technique in which an inflatable balloon-like device is inserted into the damaged vertebra through a trocar. The inflated balloon opens a space for bone cement to be added.
The primary end point was back-specific functional status as reflected by scores on the Roland-Morris disability questionnaire (RDQ). At the 1-month mark, data on 65 kyphoplasty patients and 52 controls were available: Mean RDQ score improved from 17.6 at baseline to 9.1 in the kyphoplasty group, compared with a mean improvement of 18.2 to 18.0 in the control group. The most common adverse events at that point were back pain (experienced by 4 of the original 70 kyphoplasty patients and 5 of the original 64 controls) and symptomatic vertebral fracture (in two members of the kyphoplasty group and three controls). In addition, one kyphoplasty patient suffered a myocardial infarction (MI), which resolved and was attributed to anesthesia, whereas another had a new VCF.
In their study, published online ahead of print by The Lancet Oncology, James Berenson, MD, of the Institute for Myeloma and Bone Cancer Research in West Hollywood, California, and colleagues deemed kyphoplasty “an effective and safe treatment that rapidly reduces pain and improves function.”
The study was funded by Medtronic Spine LLC.