Eugene J. Carragee |
CHICAGO — An analysis presented here by Eugene J. Carragee, MD,
indicates that use of
recombinant
bone morphogenetic protein-2 in posterior lumbar fusion could be associated
with an increase in cancer rates.
Carragee’s work involved an analysis of a Medtronic-funded Amplify
product study with a 518-patient cohort. The patients all underwent posterior
lumbar fusion; 239 patients received recombinant bone morphogenetic protein-2
(BMP-2) and a control group of 224 patients received conventional local grafts.
The study had 70% follow-up for the first 3 years.
The investigators examined the number of patients with any cancer event
at years 2 and 3 after surgery, and analyzed this by both the number of
patients enrolled and followed. The secondary analysis looked at the number of
cancer events as well as the number of patients with multiple cancer events.
Specific attention was paid to those years with greater than 70% follow-up.
“The summary of this is that at study closure there were 20 cancers
in the BMP-2 group, with five in the control group,” Carragee said.
“There were multiple cancers in three patients in the BMP-2 group. There
were none in the control group. There were three deaths due to cancer in the
BMP group, and there was one in the control group.”
He added, “The spine literature … has been silent on this.
There have been reports of the Amplify trial without discussion of this
increased cancer risk.”
Carragee noted that despite the inclusion criteria, which meant the
study was looking at individuals with a low cancer risk, there was still a
strong cancer association visible through several different statistical
methods. He added that patients in the study had an average age of 50 years,
meaning the results could be worse in the general population of 50-year-old
individuals who tend to have a higher rate of previous cancer history.
Reference:
- Carragee EJ. Carcinogenic risk with BMP. Part of the symposium: Current
controversies in spine surgery. Presented at the 2011 Annual Meeting of the
North American Spine Society. Nov. 2-5. Chicago.
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