Kyphoplasty appears effective in treatment of vertebral compression fractures in patients with cancer

Berenson J. Lancet Oncol. 2011;doi:10.1016/S1470-2045(11)70008-0.

Issue: March 10, 2011

Kyphoplasty reduced pain and improved function among cancer patients with vertebral compression fractures, according to results from a randomized controlled trial.

“The results of this landmark study should be welcomed news to cancer patients across the world suffering from the debilitating effects of painful vertebral compression fractures,” James Berenson, MD, medical and scientific director of the Institute for Myeloma and Bone Cancer Research, said in a press release.

Berenson and colleagues conducted the Cancer Patient Fracture Evaluation (CAFE) study at 22 sites in Europe, the US, Canada and Australia. Patients aged 21 years or older who had cancer and one to three painful vertebral compression fractures were enrolled and randomly assigned to kyphoplasty (n=70) or nonsurgical management (n=64) between May 16, 2005, and March 11, 2008. The researchers used the Roland-Morris Disability Questionnaire (RDQ) to determine back-specific functional status at 1 month; this was the primary endpoint. All patients with available data at baseline and 1-month follow-up were included in the modified intention-to-treat analysis. Crossover to the kyphoplasty group was possible after 1 month.

At 1-month, follow-up data were available for 65 patients in the kyphoplasty group and 52 patients in the control group. In the kyphoplasty group, the mean change in RDQ score was –8.3 points from baseline to 1 month (95% CI, –6.4 to –10.2) compared with a mean change of 0.1 points in the control group (95% CI, –0.8 to 1.0). The kyphoplasty treatment effect for RDQ at 1 month was –8.4 points (95% CI, –7.6 to –9.2).

Back pain and symptomatic vertebral fracture were the most common adverse events at 1 month. In the treatment arm, one patient had an intraoperative non-Q-wave myocardial infarction attributed to anesthesia, and one patient had a new vertebral compression fracture that was likely device-related, according to the researchers.

In an accompanying editorial, David Schiff, MD, of the neuro-oncology center, and Mary E. Jensen, MD, of the department of radiology, both at the University of Virginia Health Science Center, said the current study raises questions about vertebral augmentation in patients with cancer.

“Perhaps the time is ripe for a randomized controlled trial of kyphoplasty vs. vertebroplasty in patients with cancer and painful [vertebral compression fractures] of clearly defined cause and morphology,” they wrote. “However, before we compare these two vertebral augmentation techniques, to first assess whether the benefit of kyphoplasty is also primarily a placebo effect would not be unreasonable before patients are subjected to a costly and potentially dangerous procedure.”

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