New study results suggest that balloon kyphoplasty produces more rapid pain relief and a better functional outcome than conventional nonsurgical management for painful vertebral compression fractures (VCFs) in cancer patients. The data are from the Cancer Patient Fracture Evaluation (CAFE) study, in which 134 patients were randomized to minimally invasive balloon kyphoplasty or nonsurgical care over a 3-year period at 22 sites worldwide. Patients in the control group were offered kyphoplasty after their 1-month assessment.
“Given the limited improvement in the control group, the results of this study indicate that balloon kyphoplasty should be considered as an early treatment option for patients with cancer with symptomatic VCFs,” reported James Berenson, MD, the lead author of the study from the Institute for Myeloma & Bone Cancer Research in West Hollywood, California.
The incidence of VCF is estimated at 24% in patients with multiple myeloma and 14%, 6%, and 8% in patients with breast, prostate, and lung cancer, respectively. This type of fracture, which is typically painful and debilitating, is treated by nonsurgical and surgical methods. Nonsurgical methods use analgesics, bed rest, and radiotherapy to decrease pain. Orthotic devices are used to boost functional status, and antiresorptive therapy prevents future fractures. Nonsurgical methods have limited efficacy with potentially serious side effects.
Open surgery can stabilize VCFs. However, poor bone quality is common in cancer patients, and open techniques are thus generally used only in individuals with a neurological deficit. Until this trial, all of the clinical studies on kyphoplasty in cancer patients had been nonrandomized.
Participants in the CAFE study had 1 to 3 painful VCFs (T5-L5) that had been clinically diagnosed in conjunction with either plain x-rays or magnetic resonance imaging. The primary endpoint was the change in Roland-Morris disability questionnaire (RDQ) score at 1 month. The RDQ is a 0- to 24-point questionnaire that has been validated for the evaluation of back-specific physical functioning.
"Given the limited improvement in the control group, the results of this study indicate that balloon kyphoplasty should be considered as an early treatment option for patients with cancer with symptomatic VCFs."
–James Berenson, MD
Data in 117 evaluable patients showed that the mean RDQ score in the kyphoplasty group decreased from a baseline score of 17.6 to a 1-month score of 9.1, for a mean change of 8.3 points (P <.0001), while the mean score in the control group remained virtually unchanged (a baseline score of 18.2 and a 1-month score of 18.0, for a mean change of 0.1 points, P = .83). At 1 month, the kyphoplasty treatment effect for RDQ was–8.4 points, P <.0001.
Patients assigned to immediate kyphoplasty also had significant improvements in quality of life and faster pain relief than control patients 1 week after surgery and also were less likely to use analgesics, walking aids, or back braces or require bed rest at 1 month.
Adverse events were similar between the kyphoplasty and control groups during the first month. The most common side effects were back pain and symptomatic vertebral fractures. The kyphoplasty group had a low incidence of new fractures at 12 months, which suggests that the intervention does not increase the risk of new fractures.
Berenson and colleagues said that while prior reports have suggested a benefit of kyphoplasty for cancer patients with painful VCFs, the present trial is the first to document a clear-cut benefit for the new repair procedure for a range of different endpoints using a randomized design.
They emphasized, however, that treatment randomization lasted only 1 month, after which control patients could cross over to the kyphoplasty arm, thereby establishing a nonrandomized population for the long-term analysis. They noted that the intervention was not masked, and thus the possibility that knowledge of the treatment assignment may have affected results cannot be categorically excluded.
Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus nonsurgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011;12(3):225-235. doi:10.1016/S1470-2045(11)70008-0. [Epub ahead of print]