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

November 12, 2015, Wolters Kluwer Health

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 November 15 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 ," write Dr. Gregory M. Malham of Epworth Hospital, Melbourne, Victoria, Australia, and colleagues. But they emphasize that additional, larger studies will be needed to definitively establish the safety and effectiveness of using rhBMP products to promote bone growth for surgery.

Study Refutes Increased Cancer Risk after rhBMP for Spinal Fusion

The researchers analyzed 527 patients, who underwent lumbar (lower) spinal fusion surgery using rhBMP between 2002 and 2011. All procedures were performed by Dr. Malham or coauthor Dr. Graeme A. 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 Prof. Graham Giles and Dr. 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, Drs. Malham and Brazenor found high rates of successful using rhBMP. Follow-up CT scans showed fusion rates between 90 and 95 percent, depending on which operative approach was used. After one year, the overall rate of successful fusion was 93.5 percent.

At an average follow-up of 4.4 years, 27 of the 527 patients were diagnosed with some form of invasive cancer. Based on the cancer registry, this was not significantly different from the number observed in a population of the same age and sex.

There was no increased prevalence of any one type of cancer. The study also found low rates of other rhBMP-related complications, such as excess (ectopic) .

"Our study represents the first retrospective review of patients treated with rhBMP using verified cancer prevalence from a compulsory state cancer registry," says Dr. Malham. But he notes that the results can't definitively rule out a small increase in . "As powerful as our study is, it is still possible that much longer follow-up may ultimately detect a tendency toward one or more cancers." The authors note that their study was performed "independent of industry."

The researchers also point out that rhBMP has a major advantage in that it doesn't require grafting of the patient's own bone—usually taken from the upper rim of the pelvis (iliac crest). Using rhBMP instead of harvested bone graft avoids pain and a substantial risk of additional complications. Dr. Malham notes that he and Dr. Brazenor have not used iliac crest bone for spinal fusion since they began using rhBMP.

Based on their experience, the surgeons note that they no longer agree with some aspects of a recent North American Spinal Surgery policy document, which recommended against the use of rhBMP for certain types of routine spinal fusion procedures.

Explore further: High-dose rhBMP linked to increased incidence of cancer

More information: "Bone Morphogenetic Proteins in Spinal Surgery: What Is the Fusion Rate and Do They Cause Cancer?" DOI: 10.1097/BRS.0000000000001184)

Related Stories

High-dose rhBMP linked to increased incidence of cancer

October 4, 2013
(HealthDay)—Patients receiving high-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) as part of spine surgery have an increased risk of cancer and may be at risk for major complications, according to two studies ...

rhBMP-2 linked to increased rate of retrograde ejaculation

December 29, 2012
(HealthDay)—For patients with lumbar spondylosis or spondylolisthesis of the lowest lumbar levels who undergo open anterior lumbar interbody fusion (ALIF), use of recombinant human bone morphogenetic protein-2 (rhBMP-2) ...

Previous studies overstated evidence on Medtronic spinal fusion product, review finds

June 18, 2013
An analysis by the Evidence-based Practice Center at Oregon Health & Science University has found that previously published clinical trial studies about a controversial bone growth product used in spinal surgeries overstated ...

More HIV+ patients undergoing spinal fusion

September 25, 2014
(HealthDay)—More HIV-positive patients are undergoing spinal fusions, and these patients have higher rates of complications resulting from the procedures, according to a study published in the Sept. 15 issue of Spine.

Spinal fusion surgery not associated with stroke

December 10, 2012
(HealthDay)—Undergoing spinal fusion surgery does not affect the risk of stroke within the three years after surgery, according to a study published in the December issue of the European Spine Journal.

Use of BMP doesn't impact nonunion rates post spine fusion

October 24, 2014
(HealthDay)—The use of bone morphogenetic protein (BMP) is not associated with operative nonunion rates after spinal fusion, according to a study published in the Oct. 15 issue of Spine.

Recommended for you

Surgical adhesions can be treated, prevented in mice

November 28, 2018
A cellular culprit—as well as a possible treatment—for a common, sometimes life-threating post-surgical complication has been identified by researchers at the Stanford University School of Medicine.

Cost and weight-loss potential matter most to bariatric surgery patients

November 28, 2018
A JAMA Surgery study found that patients are likely to base their weight loss surgery choice on expected out-of-pocket costs, and how much weight they can lose—not risk of complications or recovery time.

Treating spinal pain with replacement discs made of 'engineered living tissue' moves closer to reality

November 21, 2018
For the first time, bioengineered spinal discs were successfully implanted and provided long-term function in the largest animal model ever evaluated for tissue-engineered disc replacement. A new Penn Medicine study published ...

Screening for colorectal cancer spares male patients from intense treatments

November 21, 2018
While screening for colorectal cancer does not reduce mortality, it does reduce the need for chemotherapy and emergency surgeries among male patients, according to a recent Finnish study.

Rapid response inpatient education boosts use of needed blood-thinning drugs

November 16, 2018
A new study designed to reach hospitalized patients at risk shows that a "real-time" educational conversation, video or leaflet can lower the missed dose rates of drugs that can prevent potentially lethal blood clots in their ...

Race plays role in regaining weight after gastric bypass surgery

November 15, 2018
African Americans and Hispanic Americans who have undergone Roux-en-Y gastric bypass (RYGB) are at greater risk to regain weight as compared to Caucasians. To date, no study has addressed the effect of race on weight regain ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.