In a randomized trial of patients with cancer and vertebral compression fractures (VCFs), balloon kyphoplasty was associated with greater pain relief and better of quality of life than nonsurgical care. According to the authors, patients who received kyphoplasty relied significantly less on pain medication, bed rest, and walking assistance 1 month after the procedure.
James Berenson, MD, founder and president of the Institute for Myeloma and Bone Cancer Research in West Hollywood, California, led the multinational CAFE (Cancer Patient Fracture Evaluation) study, and results were published online in Lancet Oncology. In an interview with The Oncology Pharmacist, Berenson said, “Any cancer patient with a vertebral compression, whether the cancer involves the vertebral body or not, would be a candidate for this procedure.” He said balloon kyphoplasty should be performed “without delay” as soon as a symptomatic VCF is diagnosed but added that it might be contraindicated in patients who are not expected to survive long or are poor surgical risks.
The study enrolled 134 adults with cancer, each of whom had 1 to 3 VCFs. More than half of the patients (60%) had multiple myeloma or breast cancer. Investigators randomized 70 patients to undergo balloon kyphoplasty with the option to use nonsurgical care as needed. The remaining 64 patients made up the control group and received only nonsurgical care. All patients were allowed to continue their cancer treatments as prescribed.
To measure improvement in back-specific functionality, the research team administered the Roland-Disability Questionnaire (RDQ) at baseline and again at 1-month follow-up. On the RDQ scale, 0 indicates no disability and 24 represents the maximum level of disability. At baseline, mean RDQ score for the kyphoplasty group was 17.6 compared with 18.2 for the control group. At 1-month follow-up, RDQ scores for the kyphoplasty group declined by a mean of 8.3 points to 9.1 (P <.0001). In contrast, RDQ scores declined a mean of 0.1 points for the control arm, to 18.0 (P <.0001).
Other standardized tests were used to measure pain, physical and mental health, and performance status. The 10-point pain scale reflected a significant drop of 3.8 points in pain levels for the kyphoplasty group at 7 days postprocedure compared with a 0.3 point drop for the control arm (P <.0001). At 1-month, results continued to favor balloon kyphoplasty.
At 1 year, pain assessments for the groups began to converge, and no significant difference in pain levels was observed between the two arms. Berenson said data at the end of the trial were biased because “only a small minority of patients made it to that time point.” He noted that those patients in the study who were alive at 1 year follow-up likely had better quality of life in general, particularly regarding pain levels, compared with the study population as a whole.
Berenson and colleagues noted that 94% of patients treated with kyphoplasty were taking pain medications before the procedure and this had dropped to 52% at 1 month. Medication use remained consistent in the control arm.
After 1 month, patients in the control group were permitted to cross over into the kyphoplasty group, which 38 patients did. This subgroup of patients experienced improvement in pain and function at similar rates and levels to the patients in the original kyphoplasty group. Both kyphoplasty groups maintained their improvement according to 1-year assessments.
The authors hypothesized that the improved function afforded by balloon kyphoplasty might reduce the risk of events such as decubitus ulcers and pneumonia, which are not uncommon in patients with cancer. "A procedure that effectively treats VC Fs for patients with cancer might confer clinical and quality of life benefits beyond treatment of the fracture itself," they wrote.
Balloon kyphoplasty is associated with few adverse effects. Berenson said, “Very rarely, there can be significant extravasation of the cement outside of the cavity in which it is intended.”
The study was limited by its short duration and its open-label design. In an accompanying editorial, David Schiff, MD, and Mary E. Jensen, MD, University of Virginia, Charlottesville, said because of the study design, a placebo effect could not be ruled out. They suggested additional trials were warranted before making the costly surgical procedure standard practice.
Medtronic, which makes the Kyphon balloon kyphoplasty device used in the study, provided funding. Berenson and other authors have received consulting fees, honoraria, and research funding from Medtronic. Several authors were Medtronic employees, and one disclosed relationships with Synthes, Orthofix, and Alphtec. Schiff has received consulting fees from Genentech, and Jensen acknowledged consulting fees from Kuros Biosurgery.