In a randomized trial of patients with cancer who were suffering from vertebral compression fractures (VCFs), balloon kyphoplasty was associated with greater pain relief and better 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 undergoing the procedure.
James Berenson, MD, founder and president of the Institute for Myeloma and Bone Cancer Research in West Hollywood, California, led the multinational Cancer Patient Fracture Evaluation (CAFE) study, and results were published online in Lancet Oncology. In an interview with The Oncology Nurse-APN/PA, 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. Balloon kyphoplasty might be contraindicated, however, in patients with advanced disease who are not expected to survive long or those who are considered poor surgical risks.
The study enrolled 134 adults with cancer, each of whom had suffered 1 to 3 VCFs. More than half the patients (60%) had a diagnosis of multiple myeloma or breast cancer, both of which are associated with bone complications. Investigators randomized 70 patients to undergo the balloon kyphoplasty procedure, along with the option to use nonsurgical care for pain as needed. The remaining 64 patients made up the control group, and these patients could only use nonsurgical methods of relieving pain. All patients were allowed to continue their cancer treatments as prescribed.
To measure improvement in backspecific functionality, the research team administered the Roland- Disability Questionnaire (RDQ) at baseline and repeated it at a 1-month follow-up appointment. Using the RDQ scale, 0 indicates no disability and 24 indicates a maximum level of disability. At baseline, the mean RDQ score for patients in the kyphoplasty group was 17.6 compared with 18.2 for the control scores for the kyphoplasty group declined by a mean of 8.3 points to 9.1 (P <.0001). In contrast, RDQ scores only declined a mean of 0.1 points for the control arm, falling 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; this compared with a 0.3-point drop in pain levels for the control arm (P <.0001). At 1 month, end points 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 2 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 followup 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 had been taking pain medications prior to the procedure. At a follow-up assessment 1 month after undergoing the procedure, in - vestigators found the proportion of patients using pain medication had declined to 52%. In the control arm, however, the use of pain medication remained consistent.
After 1 month, patients initially randomized to the control group were permitted to cross over into the kyphoplasty group, and 38 patients decided to do so. This subgroup of 38 patients experienced improvement in pain and function at similar rates and levels to the patients assigned to the original kyphoplasty group. One-year assessments of patients in the initial kyphoplasty group and patients in the kyphoplasty crossover group showed that they had maintained their 1-month improvements in pain and function.
The authors hypothesized that the improved function afforded by balloon kyphoplasty might contribute to a reduction in the risk of events such as decubitus ulcers and pneumonia, which are not uncommon in patients who have cancer. “A procedure that effectively treats VCFs 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 said additional trials should be conducted before adopting the costly surgical procedure as 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
To sign up for our newsletter or print publications, please enter your contact information below.
