Elsevier

The Lancet Oncology

Volume 12, Issue 3, March 2011, Pages 225-235
The Lancet Oncology

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Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial

https://doi.org/10.1016/S1470-2045(11)70008-0Get rights and content

Summary

Background

Non-randomised trials have reported benefits of kyphoplasty in patients with cancer and vertebral compression fractures (VCFs). We aimed to assess the efficacy and safety of balloon kyphoplasty compared with non-surgical management for patients with cancer who have painful VCFs.

Methods

The Cancer Patient Fracture Evaluation (CAFE) study was a randomised controlled trial at 22 sites in Europe, the USA, Canada, and Australia. We enrolled patients aged at least 21 years who had cancer and one to three painful VCFs. Patients were randomly assigned by a computer-generated minimisation randomisation algorithm to kyphoplasty or non-surgical management (control group). Investigators and patients were not masked to treatment allocation. The primary endpoint was back-specific functional status measured by the Roland-Morris disability questionnaire (RDQ) score at 1 month. Outcomes at 1 month were analysed by modified intention to treat, including all patients with data available at baseline and at 1 month follow-up. Patients in the control group were allowed to crossover to receive kyphoplasty after 1 month. This study is registered with ClinicalTrials.gov, NCT00211237.

Findings

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). 65 patients in the kyphoplasty group and 52 in the control group had data available at 1 month. The mean RDQ score in the kyphoplasty group changed from 17·6 at baseline to 9·1 at 1 month (mean change −8·3 points, 95% CI −6·4 to −10·2; p<0·0001). The mean score in the control group changed from 18·2 to 18·0 (mean change 0·1 points; 95% CI −0·8 to 1·0; p=0·83). At 1 month, the kyphoplasty treatment effect for RDQ was −8·4 points (95% CI −7·6 to −9·2; p<0·0001). The most common adverse events within the first month were back pain (four of 70 in the kyphoplasty group and five of 64 in the control group) and symptomatic vertebral fracture (two and three, respectively). One patient in the kyphoplasty group had an intraoperative non-Q-wave myocardial infarction, which resolved and was attributed to anaesthesia. Another patient in this group had a new VCF, which was thought to be device related.

Interpretation

For painful VCFs in patients with cancer, kyphoplasty is an effective and safe treatment that rapidly reduces pain and improves function.

Funding

Medtronic Spine LLC.

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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