ALBERT

Description: Abstract 2873 Poster Board II-849 Destructive vertebral lesions are a common source of morbidity for patients with cancer. Balloon kyphoplasty (BKP) is a minimally invasive surgical procedure for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability. We report the final results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of BKP. Twenty-two multinational sites enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with cancer and ' 3 painful VCFs were randomly assigned to BKP or nonsurgical management (NSM) and followed for 12 months. Patients were excluded with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site, or spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire (RMDQ), a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Following this assessment, cross-over to BKP was allowed in the NSM arm. Patients were randomized to BKP (N=70) or NSM (N=64). Five patients withdrew early from the study without significant baseline data; the 3 patients assigned to BKP did not undergo the procedure. Thus, 68 BKP and 61 control patients were evaluable. Mean patient age was 64 years, 58% were female, and tumor types included multiple myeloma (38%), cancers of the breast (22%), lung (8.5%), prostate (6.2%) and other sites (26%). At baseline, 35% of patients were currently on daily corticosteroids, 50% had received bisphosphonates within 12 months of study entry, 49% had received prior radiation (52 % to the spine), and 67% of patients were previously treated with chemo/hormonal therapies. VCFs were identified in a single (34%), two (26%) or three (40%) sites. Mean baseline RMDQ scores were similar between the groups; 17.6 and 18.2 points for BKP and NSM patients, respectively. However, at one month, there was an improvement for patients randomized to BKP of −8.3 points (95% CI −6.4 to −10.2) whereas those receiving NSM showed no significant change (0.1 points, 95% CI 1.0 to −0.8; p

Description: Destructive vertebral lesions are a common source of morbidity among patients with cancer. Balloon kyphoplasty is a minimally invasive surgical procedure performed for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability and improving quality of life. We report the results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of this procedure. Twenty-one sites in Europe, the United States, Canada and Australia enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with a variety of cancers and ≤ 3 painful VCFs (VAS ≥ 4) were randomly assigned to immediate kyphoplasty (N=70) or nonsurgical supportive care (N=64). Patients with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site were excluded as well as patients with spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire, a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Back pain was also assessed using a validated 0- (no pain) to 10-point (worst pain imaginable) numerical rating scale. Data from a preplanned interim analysis of this ongoing study are now reported. For pain and function, patients with complete data that has been evaluated through one month are included whereas all enrolled patients were analyzed for safety. Mean patient age was 64 years (range 37 to 88), 58% were female, and tumor types included multiple myeloma (36%), cancers of the breast (20%), lung (8%), prostate (6%) and other sites (30%). At study enrollment, 23% of patients were on daily corticosteroids and 48% had received bisphosphonates within 12 months of study entry. Prior to randomization, single VCFs were identified by the local investigators in 43% of patients; an equal proportion (29%) of patients had 2 or 3 fractures. Among the kyphoplasty and nonsurgical cohorts, 59 and 56 subjects, respectively were evaluable for the efficacy analysis. At baseline, average Roland-Morris scores were similar between the groups; 17.7 and 18.3 points for kyphoplasty and non-surgical-treated patients, respectively. However, at one month, there were marked differences between the two groups with a mean improvement for patients randomized to kyphoplasty of −8.3 points (95% CI −6.2 to −10.5) whereas those receiving non-surgical care showed no significant change (−0.1 points, 95% CI 0.9 to −1.0; p