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Supportive Oncology Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures in Cancer Patients Leonard Bastian Director, Department Of Orthopaedics, Klinikum Leverkusen GmbH, Leverkusen, Germany Abstract Patients with cancer are at increased risk of painful vertebral compression fractures (VCFs). The Cancer Patient Fracture Evaluation (CAFE) trial was the first randomised controlled study to compare the safety and effectiveness of balloon kyphoplasty (BKP – a minimally invasive procedure) with non-surgical fracture management in the treatment of VCFs in patients with cancer. Data from the CAFE trial demonstrated that BKP is a safe and effective treatment option that quickly reduces pain and improves physical function and vertebral body height in patients with cancer and painful VCFs. Data from peer-reviewed published studies support the CAFE trial findings. Keywords Balloon kyphoplasty, vertebral compression fracture, cancer, safety, effectiveness, pain, risk Disclosure: Leonard Bastian has received honoraria for consulting for Medtronic Spine LLC. Acknowledgement: Medical writing support was provided by Dr Richard Barry (Quintiles Medical Communications) and was funded by Medtronic Inc. Received: 19 April 2012 Accepted: 8 May 2012 Citation: European Oncology & Haematology, 2012;8(3):144–7 Correspondence: Leonard Bastian, Direktor, Klinik für Orthopädie, Unfall-, Hand- und Wiederherstellungschirurgie, Klinikum Leverkusen GmbH, Am Gesundheitspark 11, 51375 Leverkusen, Germany. E: leonard.bastian@klinikum-lev.de Support: The publication of this article was funded by Medtronic Inc. The views and opinions expressed are those of the author and not necessarily those of Medtronic Inc. Patients with cancer are at increased risk of painful vertebral compression fractures (VCFs), loss of mobility, neurological deficits and reduced quality of life (QoL). 1,2 VCFs can occur as a direct consequence of cancer or as an indirect consequence of the cancer therapy and are prevalent in patients with multiple myeloma or secondary metastases (in particular from breast and prostate carcinoma). 3 Indeed, the risk of developing a VCF is five times higher in women with breast cancer than in women without breast cancer. 4 Furthermore, the presence of one VCF is frequently associated with an increased risk of future vertebral fractures 5 that can lead to further deteriorations in health and wellbeing. Thus, the long-term consequences of VCFs include progressive spinal deformity and pain as well as substantial impairments in physical, psychological and social functioning. 6 Painful VCFs are usually treated using either non-surgical management or surgical methods. The aims of non-surgical management, which uses analgesics, bed rest, radiation therapy and antiresorptive therapy, are to reduce pain, improve functional status and prevent future fractures. 7 However, non-surgical management often proves to be of limited effectiveness. Furthermore, as patients with VCFs often have poor bone quality, conventional open surgery may not always be the optimum treatment choice and is normally reserved for individuals with neurological impairment. 8 Balloon kyphoplasty (BKP) represents a minimally invasive surgical treatment option. About Balloon Kyphoplasty BKP involves percutaneous augmentation of the fractured vertebra by orthopaedic balloon dilation and injection of bone cement under low 144 manual pressure. It is a minimally invasive procedure that has been used worldwide to treat over one million patients with VCFs in all indications. It aims to restore the anatomic shape of the vertebral body, decrease spinal deformity, reduce pain and improve physical function. The procedure usually takes less than one hour per fracture level and requires little or no post-operative rehabilitation. The different steps of a BKP procedure are shown in Figure 1. More information about BKP can be found on the Medtronic website. 9 The Cancer Patient Fracture Evaluation (CAFE) Trial The Cancer Patient Fracture Evaluation (CAFE) trial was the first study designed to compare the safety and efficacy of BKP with non-surgical management for the treatment of painful VCFs in patients with cancer. Data from this trial were published by Berenson and colleagues in The Lancet Oncology 7 and were also presented at several oncology congresses by Professor Leonard Bastian, CAFE trial Investigator and author of this article. Study Design and Included Patients In total, 22 sites across Europe, the US, Canada and Australia participated in the CAFE trial. The study was a randomised controlled trial in patients ≥21 years of age with cancer and painful VCFs. Each patient had between one and three VCFs and reported considerable pain (10-point numerical rating scale score ≥4) and disability (Roland–Morris disability questionnaire [RMDQ] score ≥10) at baseline. The primary endpoint was back-specific functional status measured by the RMDQ score at one month. Enrolled patients were randomised © TOUCH BRIEFINGS 2012