Becky McCall

October 9, 2010 (Milan, Italy) — Patients with cancer who have vertebral compression fractures (VCF) treated with balloon kyphoplasty (BKP) show greater improvement than patients receiving nonsurgical management in terms of disability score, back pain, quality of life, and limitation of daily activities, according to results of the first randomized controlled study comparing BKP with nonsurgical management, specifically in patients with metastatic cancer.

The evidence base for BKP is growing, but these are the first results in metastatic cancer, said lead author Leonard Bastian, MD, director of Klinikum Leverkusen, Germany. He reported the findings of the Cancer Patient Fracture Evaluation study here at the 35th European Society for Medical Oncology Congress.

"Most importantly, we saw pain relief, improvement of quality of life, and improvement in the limitation of daily activities," Dr. Bastian told Medscape Medical News. "Patients who received BKP showed significant improvement compared to the nonsurgical management group. At baseline, back pain score in both groups was just over 7, but this dropped to 3 one month after surgery."

Patients were followed-up for 12 months. "In a cancer patient, 12 months is a long time, and if you see improvement in quality of life of 1 year, then this is a big advantage for the patient," he said. "We cannot treat the disease, but we can try to improve the quality of life. This is a minimally invasive procedure, which can improve the quality of life immediately. "

BKP is recognized as a minimally invasive surgical procedure for patients with painful VCFs, which often occur as a result of cancer progression beyond the initial tumor site. During surgery, a small orthopaedic balloon is inserted into the fractured vertebra. Inflation of the balloon restores the shape and height of the damaged vertebrae, after which the balloon is removed and quick-setting cement is injected into the vertebral body, restoring the shape and strength of the vertebrae.

In this study, Dr. Bastian and colleagues randomly assigned adult patients diagnosed with cancer and fewer than 3 painful VCFs to receive either BKP (n = 70) or nonsurgical management (n = 64) and followed them for 12 months.

Patients in the BKP group showed an improvement of −8.3 points in the Roland-Morris Disability questionnaire score, whereas the nonsurgical management group showed no significant change (0.1; P < .0001 for difference between groups) at 1 month.

With respect to back pain, BKP-treated patients also showed a significant improvement of −3.8 points, whereas patients treated with nonsurgical management showed no significant change (&mnus;0.3 points; P < .0001 for difference between groups) at 1 week.

Back pain was also assessed in terms of the number of days during which activity was limited by back pain. Patients receiving BKP were found to have 6.3 fewer days per 2 weeks of limited activity resulting from back pain (treatment effect P < .001). Quality of life, as measured by SF-36 physical health component score, showed an improvement of 8.4 points (P < .001).

Improvements were sustained across the 12-month follow-up period in all BKP patients. The Karnofsky Performance Scale for quality of life started at a baseline value of 57.1 and then increased to 73.2 at 1 month, before reaching 82.3 at 12 months (P < .0001).

In contrast, change in the nonsurgical management group was minimal. The Roland-Morris Disability questionnaire decreased from a baseline value of 17.6 to 9.1 at 1 month, and at the 12-month follow-up, this improvement was sustained at 7.0 (P < .0001).

After 1 month, 38 of the 61 nonsurgical management patients were permitted to cross over to BKP treatment, and they were similarly assessed for safety and efficacy through the 12-month study period. These patients showed similar benefits with regard to back pain relief, analgesic use, activity level, and quality of life as those patients originally assigned to BKP.

Dr. Bastian commented that nonsurgical management provided a small improvement over time but added that results were limited by low patient numbers in the long term. "You can wait and manage patients nonsurgically, but time is important, and often the patient will have progressed too far," he pointed out. "A few weeks or months is a long time for these patients."

Adverse events were similar between groups. One serious adverse event in the form of an intraoperative non-Q-wave myocardial infarction was resolved and was attributed to anesthesia. One patient with a cement leakage to the disc had an adjacent fracture 1 day after the BKP procedure.

"Cement leakage is often a problem with this procedure. If cement leaks into the disc, then this can cause a subsequent fracture above or below the original fracture site. We know this can be a problem, but we also know that the incidence rate is less with BKP than vertebroplasty," added Dr. Bastian.

Commenting on the study, Fausto Roila, MD, from the Medical Oncology Division, Silvestrini Hospital, Perugia, Italy, said that BKP was an important procedure. "Spinal fractures are a hot topic now, considering quality of life for our patients," he noted. "Dr. Bastian presented an important study showing that this procedure can ameliorate quality of life and symptoms.

"Unfortunately this study was not double-blinded, so we need further studies, especially double-blind studies, which evaluate this procedure with respect to nonsurgical management and to investigate the placebo effect," Dr. Roila added.

35th European Society for Medical Oncology Congress: Abstract 1181O. Presented October 9, 2010.