Medtronic announced the results of the CAFE (Cancer patient fracture evaluation) study. This is the first randomised, controlled trial comparing Kyphon Balloon Kyphoplasty with non-surgical care in treating spinal fractures in cancer patients.The study found that Kyphon Balloon Kyphoplasty provided cancer patients better back-specific function, more rapid back pain relief and improved quality of life compared with non-surgical care one month after treatment.
The study took place at 22 sites in the USA, Europe, Australia and Canada and was published in the online edition of The Lancet Oncology on 16 of February 2011. It involved 134 patients with vertebral compression fractures who also had various types of cancer such as breast, lung, and prostate or had multiple myeloma.
“The results of this landmark study should be welcomed news to cancer patients across the world suffering from the debilitating effects of painful vertebral compression fractures,” said James Berenson, principal author of the study and medical and scientific director of the Institute for Myeloma and Bone Cancer Research in California, USA.
“It is documented that nearly 24% of patients with multiple myeloma, 14% with breast cancer, 8% with lung cancer and 6% with prostate cancer suffer painful vertebral compression fractures. With the results of this new randomised study, there is now clinical evidence of a treatment option for spinal fractures in cancer patients that can provide excellent relief of pain and improved quality of life,” Berenson added.
Patients in the CAFE study were randomised to either a Kyphon Balloon Kyphoplasty group (n=70) or a non-surgical control group (n=64). Members of both groups were able to receive non-surgical care, such as pain medications, best rest, bracing, walking aids and radiation therapy, as medically appropriate.
Multiple outcomes relating to quality of life, physical function and back pain were evaluated in 129 patients (68 kyphoplasty and 61 non-surgical patients).The primary outcome was the change in back-specific function from baseline to one month between the groups as measured by the validated Roland-Morris Disability Questionnaire (RDQ) score, with 0 equal to no disability and 24 equal to maximum disability.
“In the CAFE study, most balloon kyphoplasty patients experienced early pain reduction and improved activity, mobility and ability to take part in daily activities,” said Professor Leonard Bastian, director of the department for Orthopaedics, Trauma, Hand, and Reconstructive Surgery at the Klinikum Leverkusen, Germany and one of the study’s authors. “For patients treated conservatively, pain relief was delayed. This rapid effect on pain from balloon kyphoplasty is important for cancer patients today as many need to complete their scheduled cancer treatment.”
Medtronic said that this procedure is not for everyone, there are risks associated such as cement leakage and includes serious complications, some of which may be fatal. Patients should consult their physicians for a complete list of indications, contraindications, benefits, and risks. Only patients and their physicians can determine whether this procedure is right for a particular patient.
