Back to Search
Start Over
Cancer Risk After Use of Recombinant Bone Morphogenetic Protein-2 for Spinal Arthrodesis
- Source :
- Journal of Bone and Joint Surgery. 95:1537-1545
- Publication Year :
- 2013
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2013.
-
Abstract
- Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a growth factor known to have in vitro effects on the growth and invasiveness of cancer. It has been approved by the U.S. Food and Drug Administration in limited doses for single-level anterior spinal arthrodesis, but it is commonly used off-label and at high doses. The effect of rhBMP-2 on the risk of cancer has been a concern. We sought to evaluate the risk of new cancers in patients receiving high-dose rhBMP-2. Methods: We used publicly available data from a pivotal, multicenter, randomized controlled trial of patients with degenerative lumbar spine conditions who underwent a single-level instrumented posterolateral arthrodesis with either high-dose rhBMP-2 in a compression-resistant matrix (CRM) (rhBMP-2/CRM; n = 239) or autogenous bone graft (control group; n = 224). We compared the risks of new cancers in the rhBMP-2/CRM and control groups at two and five years after surgery. Results: At two years, with 86% follow-up, there were fifteen new cancer events in eleven patients in the rhBMP-2/CRM group compared with two new cancer events in two patients in the control group treated with autogenous bone graft. The incidence rate of new cancer events per 100 person-years was 3.37 (95% confidence interval [CI], 1.89 to 5.56) in the rhBMP-2/CRM group at two years compared with 0.50 (95% CI, 0.06 to 1.80) in the control group. The incidence rate ratio was 6.75 (95% CI, 1.57 to 60.83; p = 0.0026) at two years. Calculated in terms of the number of patients with one or more cancer events two years after the surgery, the incidence rate per 100 person-years was 2.54 (95% CI, 1.27 to 4.54) in the rhBMP-2/CRM group compared with 0.50 (95% CI, 0.06 to 1.82) in the control group at two years; the incidence rate ratio was 5.04 (95% CI, 1.10 to 46.82; p = 0.0194). At five years, there was a 37% loss of follow-up, but a significantly greater incidence of cancer events was still observed in the rhBMP-2/CRM group. Conclusions: A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
- Subjects :
- Adult
Male
medicine.medical_specialty
Arthrodesis
medicine.medical_treatment
Bone Morphogenetic Protein 2
Rate ratio
law.invention
Lumbar
Randomized controlled trial
law
Neoplasms
medicine
Humans
Orthopedics and Sports Medicine
Aged
Randomized Controlled Trials as Topic
Bone Transplantation
Lumbar Vertebrae
business.industry
Incidence
Incidence (epidemiology)
Cancer
Spinal arthrodesis
General Medicine
Middle Aged
medicine.disease
Recombinant Proteins
Confidence interval
Surgery
Spinal Fusion
Female
Spinal Diseases
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 15351386 and 00219355
- Volume :
- 95
- Database :
- OpenAIRE
- Journal :
- Journal of Bone and Joint Surgery
- Accession number :
- edsair.doi.dedup.....003f6057ca365d5af3772a2e4f73c4ed