Fast track — ArticlesBalloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial
Introduction
Bone metastases are a common complication associated with many types of solid tumours, occurring in 30–95% of patients with breast, prostate, lung, bladder, and thyroid cancers.1 Most patients with multiple myeloma also have osteolytic lesions or generalised osteoporosis during the course of their disease.1 Some cancer treatments (eg, aromatase inhibitors for breast cancer and antiandrogens for prostate cancer) and the cancers themselves can lead to generalised bone loss or weakening of bone at specific sites. Radiation therapy, especially radiosurgery, can contribute to osteonecrosis.2 As a result, disease or treatments often cause bone loss among patients with multiple myeloma, and many different types of common solid tumours cause fractures, especially painful vertebral compression fracture (VCF). Incidences of VCF are estimated to be 24%, 14%, 6%, and 8% among patients with multiple myeloma and cancers of the breast, prostate, and lung, respectively.3
Surgical and non-surgical methods are used to treat VCFs. The goals of non-surgical management are to reduce pain (with analgesics, bed rest, and radiation therapy), improve functional status (with orthotic devices), and prevent future fractures (with antiresorptive therapy).3 However, non-surgical management of VCFs has limited effectiveness and many of these non-surgical treatments cause serious side-effects.4 Open surgical techniques with instrumentation can stabilise VCFs, but because patients typically have poor bone quality, these techniques are often reserved for patients with neurological deficit. Compared with open surgery, balloon kyphoplasty is a minimally invasive technique in which inflatable bone tamps are inserted, inflated, and removed; the resulting intravertebral cavity is filled with viscous polymethylmethacrylate cement. Kyphoplasty reduces pain caused by osteoporosis VCFs, restores lost vertebral body height, and improves function and quality of life.4, 5 Only non-randomised clinical trials on kyphoplasty for patients with cancer and VCFs have been done, which suggest similar benefits as have been achieved for patients with osteoporosis.6, 7, 8
We aimed to compare the safety and efficacy of kyphoplasty treatment with standard non-surgical management in a randomised trial of patients with cancer who have painful VCFs.
Section snippets
Patients
The Cancer Patient Fracture Evaluation (CAFE) study was a randomised controlled trial at 22 sites in Australia, Canada, Europe, and the USA. Patients aged at least 21 years who had cancer and one to three painful VCFs (T5–L5) clinically diagnosed in conjunction with either plain radiographs9 or MRI were included. Other inclusion criteria were a pain numeric rating score (NRS) of at least 4 and a Roland-Morris disability questionnaire (RDQ) score of at least 10.
Patients were excluded if they had
Results
Between May 16, 2005, and March 11, 2008, 134 patients were enrolled and randomly assigned to kyphoplasty (n=70) or non-surgical management (n=64; figure 1). 95 of 477 screened patients refused to participate and 248 were not eligible for inclusion. Two patients in the kyphoplasty group and three in the control group withdrew early without baseline or 1-month data. An additional three patients in the kyphoplasty group and nine in the control group discontinued before 1 month; thus, 65 patients
Discussion
Patients with cancer who had VCFs and were treated with kyphoplasty had a superior functional (RDQ) outcome at 1 month than patients who received non-surgical management. At 1 month, patients in the kyphoplasty group also showed a marked reduction in back pain and improvement in quality of life, with fewer kyphoplasty patients using pain medications. At 1 month, results for RDQ, SF-36 PCS, KPS, and back pain were statistically and clinically significant. Improvement in functional status,
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Investigators listed in webappendix p 1