‘No evidence’ that bone-growth agent for spinal fusion increases cancer risk

A new study may alleviate concerns regarding increased cancer risk for patients undergoing spinal fusion surgery with recombinant human bone morphogenetic protein (rhBMP). The study appears in the November issue of Spine.

“Our study provides further evidence of rhBMP’s efficacy as a fusion agent with no evidence of a significantly increased risk of cancer,” write Gregory Malham of Epworth Hospital, Melbourne, Victoria, Australia, and colleagues. But they emphasise that additional, larger studies will be needed to definitively establish the safety and effectiveness of using rhBMP products to promote bone growth for spinal fusion surgery.

Study Refutes Increased Cancer Risk after rhBMP for Spinal Fusion

The researchers analysed 527 patients, who underwent lumbar spinal fusion surgery using rhBMP between 2002 and 2011. All procedures were performed by Dr Malham or coauthor Graeme Brazenor. Fusions were performed using rhBMP alone (ALIF and LLIF) or a combination of rhBMP and local bone (PLIF and posterolateral fusions).

The patients, average age 58 years, had no previous history of invasive cancer. The risk of developing new cancer after spinal fusion with rhBMP was independently assessed by Graham Giles and Roger Milne of Cancer Council Victoria by linking patient data to a population-wide mandatory cancer registry.

Since their introduction in 2002, rhBMPs have been widely used to stimulate new bone formation in patients undergoing spinal fusion: a common procedure to treat spinal pain or instability. But subsequent reports raised questions about potential safety issues and industry relationships of some experts involved in rhBMP research. Those concerns prompted further analyses of manufacturer data on rhBMP, sponsored by the Yale University Open Data Access (YODA) Project.

In the new analysis, Malham and Brazenor