MILAN – Balloon kyphoplasty significantly relieved the pain of vertebral compression fractures in the first randomized clinical trial looking at the safety and efficacy of the technique specifically in patients with cancer.
Leonard Bastian
One month after surgery, a significant (P = .0001) 8.5-point decrease in Roland-Morris Disability Questionnaire (RMDQ) scores from baseline was seen, while a nonsignificant decrease of 0.2 occurred in the patients who used conventional methods of pain relief (P = .82).
Compression fractures can be very painful for patients and may be the result of a variety of causes, such as osteoporosis and trauma, as well as certain cancer treatments. Balloon kyphoplasty is a minimally invasive procedure during which a cannula is inserted into the compressed area. This allows a balloon to be inserted through it and inflated, which restores the height of the vertebra. After deflating and removing the balloon, the gap is filled with cement to ensure that the vertebral space cannot collapse again.
“The most important message for patients is that it is a safe procedure and there is improved quality of life, especially in terms of pain,” Dr. Leonard Bastian explained in an interview at the annual congress of the European Society for Medical Oncology.
Dr. Bastian, director of the department for orthopedics, trauma, hand, and reconstructive surgery at the Klinikum Leverkusen (Germany), said that the one-off intervention is usually performed at his clinic under general anesthesia but may be performed under local anesthesia to allow for outpatient treatment. Another unique feature of the method his clinic uses is that two balloons (rather than one) are inserted on either side of the fracture during the 30-minute procedure, enabling more cement to be used to fill the gap.
The international, multicenter, randomized Cancer Patient Fracture Evaluation (CAFE) study involved 134 patients with a mean age of 63-64 years. Seventy were treated with balloon kyphoplasty and 64 with nonsurgical management. The latter included the use of analgesics, bed rest, physical therapy, and, in some cases, a brace, but was dependent on the study center.
For inclusion, patients with cancer had to have one to three acute vertebral compression fractures (T5-L5), painful compression fractures, and a pain score of at four or higher on a scale of 0-10. Patients’ life expectancy had to be more than 3 months and they had to have no planned changes to their current chemotherapy regimen, except dosing, in the month prior to or after enrollment.
Crossover to the balloon kyphoplasty arm was allowed after 1 month, and Dr. Bastian reported that 38 patients from the nonsurgical arm decided to undergoing the technique at that time, with a further 28 patients deciding to have surgery at 12 months.
The primary end point was change in functional status from baseline to 1 month as assessed by the RMDQ, which rates patients’ back pain on a scale of 0-24. Respective scores in the balloon kyphoplasty group and the nonsurgical group were 17.6 and 18.2 at baseline and 9.10 and 18.00 at the 1-month follow-up. The difference in score between groups was statistically significant (P = .0001) and maintained during 12-month follow up.
Secondary measures, including the Short Form 36v2 physical and mental components, the Karnofsky Performance Scale (KPS), a 10-point back pain score, use of analgesics for back pain, and change in ambulation status and activities of daily living, all showed significant improvement in favor of surgery over nonsurgical management.
Although Dr. Bastian noted that the incidence of device-related adverse events was low, one patient who underwent kyphoplasty had an intra-operative myocardial infarction with intermittent atrial fibrillation and another with cement leakage to the disc had an adjacent fracture. One patient who crossed over to have surgery had a new fracture approximately 2 weeks later, although there was not any difference between the number of patients with clinical or radiographic new fractures at 1 month.
Balloon kyphoplasty is not without risk, said the official discussant, Dr. Fausto Roila, a medical oncologist from the Ospedale Santa Maria, Terni, Italy, who was not involved in the study. “Reported complications, such as soft-tissue damage and nerve-root pain and compression, are related to the leakage of bone cement,” he said.
Dr. Roila noted that the CAFE study lacked true blinding and a placebo effect could not be excluded. “More studies, especially double-blind studies, are necessary to identify the real role of balloon kyphoplasty,” he observed.
“When investigating the treatment effect on subjective symptoms, the only way to distinguish the effect of expectations by the patients from the intervention itself is to conceal the treatment from the patients,” he added.