Incidence of Cancer in Spinal Deformity Patients Receiving High-Dose (≥40 mg) Bone Morphogenetic Protein (rhBMP-2)

Spine
Christine BaldusKeith H Bridwell

Abstract

Level III, Retrospective observational study. To determine if there is an increased risk of developing cancer after exposure to high-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) and if risk is dose and/or exposure-dependent. Concerns have been raised regarding a relationship between rhBMP-2 and cancer. A total of 642 adult deformity patients from a single institution receiving a cumulative rhBMP-2 dose ≥40 mg from July, 2002 to July, 2009 were identified. Patients with a history of surveillance, epidemiology, and end result (SEER) cancer before rhBMP-2 exposure were excluded. To determine the occurrence of a cancer event, questionnaires were mailed and telephone follow up attempted for nonresponders. Only cancers tracked by the National Cancer Institute (NCI) SEER registry were included. Observed cancer counts were compared to expected cancer counts based on general population incidence rates within 5-year age strata. Cumulative incidence competing risk (CICR) modeling was used to evaluate the association between rhBMP-2 exposure and cancer controlling for potential confounding variables. Forty-nine patients were lost-to-follow up, leaving 593 patients (92.4%; 138 males/455 females) available for analysis. Mean...Continue Reading

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