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(Rhbmp-2): an Analysis Using a Commercially Insured Recombinant Risk of Cancer Following Lumbar Fusion Surgery With Recombinant Human Bone Morphogenic Protein-2 (rhBMP-2): An Analysis Using a Commercially Insured Patient Population GREGORY S. COOPER and TZUYUNG DOUG KOU Int J Spine Surg 2018, 12 (2) 260-268 doi: https://doi.org/10.14444/50323 http://ijssurgery.com/content/12/2/260 This information is current as of September 24, 2021. Email Alerts Receive free email-alerts when new articles cite this article. Sign up at: http://ijssurgery.com/alerts The International Journal of Spine Surgery 2397 Waterbury Circle, Suite 1, Aurora, IL 60504, Phone: +1-630-375-1432 © 2018 ISASS. All RightsDownloaded Reserved. from http://ijssurgery.com/ by guest on September 24, 2021 International Journal of Spine Surgery, Vol. 12, No. 2, 2018, pp. 260–268 https://doi.org/10.14444/50323 ÓInternational Society for the Advancement of Spine Surgery Risk of Cancer Following Lumbar Fusion Surgery With Recombinant Human Bone Morphogenic Protein-2 (rhBMP-2): An Analysis Using a Commercially Insured Patient Population GREGORY S. COOPER, MD,1,2 TZUYUNG DOUG KOU, PhD1 1University Hospitals Cleveland Medical Center, Division of Gastroenterology, Cleveland, Ohio, 2Case Western Reserve University, Case Comprehensive Cancer Center, Cleveland, Ohio Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is frequently used to promote new bone growth after lumbar fusion surgery. However, because BMP receptors are found on cancer cells, there is concern about potential cancer following treatment with rhBMP-2. Data from clinical trials have reported divergent results and have been limited by small sample sizes and relatively short follow-up. We therefore examined the long-term risk of cancer following treatment with rhBMP-2 after lumbar fusion surgery. Methods: Using the MarketScan Commercial Claims and Encounters database, we identified all patients ,65 years without prior cancer who underwent lumbar fusion surgery between October 2003 and December 2009 and were followed at least 3 years after surgery. Development of any Surveillance Epidemiology and End Results malignancy in follow-up was identified through diagnosis and procedure codes. Results: Among 39 448 eligible patients, 2345 (5.9%) received rhBMP at surgery; the median follow-up in this population was 4.87 years. Cancer in follow-up was observed in 49 BMP-treated patients (0.43/100 person years) and 1072 nontreated patients (0.58/100 person years). Use of rhBMP was associated with a cancer risk similar to that of untreated patients in both univariate (hazard ratio, 0.80; 95%, CI 0.54–1.19) and multivariate proportional hazards analyses (hazard ratio, 0.81; 95% CI, 0.54–1.20). Similar findings were observed in a secondary analysis after adjustment for likelihood of rhBMP administration. Conclusions: In this retrospective cohort with at least 3 years of follow-up, administration of rhBMP during lumbar fusion surgery was not associated with an increased risk of subsequent cancer. Level of Evidence: 4 Lumbar Spine Keywords: human BMP-2 protein, spinal fusion, carcinogenesis, claims analysis, MarketScan data INTRODUCTION the preclinical literature concluded that whereas BMP-2 likely does not cause de novo cancers, it Bone morphogenic proteins (BMPs) are growth may have potential to enhance tumor function, and factors that are known, among other properties, to thus more definitive research is needed.3 induce bone formation and thus have been evaluated Although randomized clinical trial data did not as an alternative to iliac crest bone grafting at the time 1 suggest any association of rhBMP with development of fusion of the lumbar spine. Recombinant human 4,5 BMP-2 (rhBMP-2) is indicated for anterior lumbar of cancers, additional analyses of trial data found fusion and is administered via an absorbable collagen a greater frequency of malignancy in patients who sponge carrier known as the Infuse Bone Graft received rhBMP compared with those who received 6–8 (Medtronic Inc, Memphis, Tennessee). In addition, bone grafts, with two analyses achieving statisti- 7,8 rhBMP-7 is available as a mixture with bovine cal significance. In addition, observational studies 9–11 collagen and after reconstitution with saline is using both Medicare and commercial insurance administered as a paste. BMPs are thought to play claims12,13 data did not show an increased cancer a role in apoptosis as well as cell growth and risk, but they were limited by relatively short differentiation, and receptors for BMP are found on duration of follow-up after surgery and/or questions multiple cell types, including cancer cells.2 Areviewof of generalizability to younger patients. A recently Downloaded from http://ijssurgery.com/ by guest on September 24, 2021 Cooper and Kou published study that used a linked tumor-Medicare 4 22558, 22630, 22612. Given potential for incom- database found no risk of second primary cancers or plete claims, patients were excluded if they were not cancer recurrence,14 and a single-center study of listed in the MarketScan database for a minimum of over 500 patients also did not show an increased 2 years before the surgery date. In order to exclude cancer incidence.15 Finally, a review16 of the clinical patients with prevalent cancers, as well as to data found there was no conclusive evidence that differentiate newly diagnosed tumors from recur- rhBMP resulted in a higher risk of subsequent rence, we excluded all patients with a diagnosis code cancer but that the potential risk should be for cancer during the 24-month period prior to considered for each patient. However, because fusion, as well as patients with one or more ICD-9- published studies typically had follow-up of 3 to 4 CM codes for ‘‘personal history of a malignant 13 years and as little as under 2 years, delayed neoplasm’’ (V10.00–10.9) or at least one ICD-9-CM carcinogenic effects may not have been apparent. code for chemotherapy or radiation therapy. Given the conflicting data about cancer risk, we As in previous studies,9,10 we identified exposure performed a retrospective cohort study in a com- to rhBMP through the procedure code (ICD-9-CM mercially insured population of patients less than 65 84.52) that was recorded on the lumbar fusion years of age, which would complement previous 9–11 surgery date. Higher doses of rhBMP (ie, .40 mg) studies on the Medicare population and evaluate have been proposed to be associated with an a population that was at lower baseline cancer risk. increased risk of cancer compared with lower In addition, we restricted our analysis to patients doses.8 Because rhBMP dose was not available in with at least 3 years of follow-up. We hypothesized the database, we used indicator variables for two that the incidence of cancer in follow-up after procedures more likely to be associated with higher surgery would be similar in the rhBMP-treated and doses, multiple level procedures, and refusion untreated patients. procedures. METHODS Measures Database The primary outcome was a diagnosis of any of TheTruvenHealthMarketScanCommercial the 26 malignant neoplasms included in the Surveil- Claims and Encounters database was established lance Epidemiology and End Results (SEER) in 1988 and contains inpatient and outpatient registries,17 and this was ascertained through the records, with all patients purchasing insurance via presence of at least one of the ICD-9-CM codes large employers that are mostly self-insured. Since present in any files beginning at 3 years after the establishment, the database has included approxi- after the surgery date10 (Appendix). Thus, cancers mately 138 million unique, deidentified patients. that occurred within 3 years of surgery were not Data are available for purchase directly from the included. We used as a case definition 2 codes for vendor. the same malignancy on different service dates and 1 procedure code consistent with site-specific Patients treatment (where applicable), chemotherapy, and/ The cohort consisted of all patients between 18 or radiation therapy. This definition most closely and 65 years who underwent lumbar spine fusion approximated the standardized incidence ratio for between October 2003, which was when reimburse- any cancer in both the non-BMP and BMP-treated 10 ment was first provided for rhBMP administration, groups in a previous study. and December 2009. Data sources included claims Other relevant variables included age in years (at from hospitals, physicians, ambulatory surgery the surgery date), gender, and length of follow-up. centers, and institutional outpatient providers. Data on race were not included in MarketScan files. Eligibility criteria included fusion of the lumbar To measure comorbidity, we used a previously spine as evidenced by the following International validated, weighted index that included diagnoses Classification of Diseases, Ninth Revision, Clinical contained in any of the files.18 In addition, as Modification (ICD-9-CM)orCurrent Procedural previously recommended to differentiate postoper- Terminology, 4th Edition (CPT-4) codes: ICD-9-CM ative complications from preexisting comorbidi- 81.06, 81.07, 81.08, 81.09, 81.36, 81.37, 81.38, CPT- ties,18 we only included diagnoses that were Downloaded from http://ijssurgery.com/ by guest on September 24, 2021 International Journal of Spine Surgery, Vol. 12, No. 2 261 BMP2 and Risk of Cancer contained in the files between 24 months and 30 surgical approach, and use of a multilevel or redo days prior to the surgical date. procedure. The propensity score was then added as We followed all patients from 3 years after the a covariate to the model, and risk of cancer was surgical date through the earliest of cancer diagnosis compared with the non-BMP group using Cox (excluding cancers diagnosed within 3 years), death, regression. disenrollment from the insurer, or end of the We also performed a secondary Cox regression observation period (December 31, 2012). analysis that was limited to patients who underwent multiple level procedures or redo procedures, both Analysis of which are associated with higher rhBMP dose.
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