Beachler Daniel C, Yanik Elizabeth L, Martin Brook I, Pfeiffer Ruth M, Mirza Sohail K, Deyo Richard A, Engels Eric A
Division of Cancer Epidemiology & Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Division of Cancer Epidemiology & Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
J Bone Joint Surg Am. 2016 Jul 6;98(13):1064-72. doi: 10.2106/JBJS.15.01106.
Recombinant bone morphogenetic proteins (BMPs) are growth factors utilized in lumbar arthrodeses. Limited data from randomized trials suggest that BMP may increase cancer risk. We sought to evaluate cancer risk and mortality following the use of BMP in lumbar arthrodesis.
Within the linked Surveillance, Epidemiology, and End Results (SEER) Program-Medicare cohort, we conducted a case-cohort study of 7,278 individuals who were ≥65 years of age and had undergone a lumbar arthrodesis from 2004 to 2011. Of these patients, 3,627 were individuals in a 5% random subcohort of Medicare enrollees in SEER areas including 191 who developed cancer, and there were 3,651 individuals outside the subcohort who developed cancer. Weighted Cox proportional-hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for cancer on the basis of exposure to BMP.
In the SEER-Medicare subcohort, 30.7% of individuals who underwent a lumbar arthrodesis received BMP. BMP was not associated with overall cancer risk in univariate analyses (HR, 0.92 [95% CI, 0.82 to 1.02]) or after adjustment for demographic characteristics, comorbidities, hospital size, history of cancer, and calendar year (adjusted HR, 0.94 [95% CI, 0.84 to 1.05]). Individual cancer types were also not significantly elevated (p > 0.05 for all) in BMP users compared with nonusers. In addition, BMP use was not associated with a new cancer in people who had cancer prior to undergoing lumbar arthrodesis (adjusted HR, 1.04 [95% CI, 0.71 to 1.52]) or with mortality after a cancer diagnosis (adjusted HR, 1.05 [95% CI, 0.93 to 1.19]).
In a large population of elderly U.S. adults undergoing lumbar arthrodesis, BMP use was not associated with cancer risk or mortality.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
重组骨形态发生蛋白（BMPs）是用于腰椎融合术的生长因子。随机试验的有限数据表明，BMP可能会增加癌症风险。我们试图评估在腰椎融合术中使用BMP后的癌症风险和死亡率。
在关联的监测、流行病学和最终结果（SEER）计划-医疗保险队列中，我们对2004年至2011年期间年龄≥65岁且接受过腰椎融合术的7278名个体进行了病例队列研究。在这些患者中，3627名是SEER地区医疗保险参保者5%随机子队列中的个体，其中191人患癌，子队列外有3651人患癌。采用加权Cox比例风险回归，根据BMP暴露情况估计癌症的风险比（HRs）和95%置信区间（95% CIs）。
在SEER-医疗保险子队列中，接受腰椎融合术的个体中有30.7%使用了BMP。在单因素分析中，BMP与总体癌症风险无关（HR，0.92 [95% CI，0.82至1.02]），在调整人口统计学特征、合并症、医院规模、癌症病史和日历年之后也无关（调整后HR，0.94 [95% CI，0.84至1.05]）。与未使用者相比，BMP使用者的个体癌症类型也没有显著升高（所有p>0.05）。此外，在接受腰椎融合术之前患有癌症的人群中，使用BMP与新发癌症无关（调整后HR，1.04 [95% CI，0.71至1.52]），与癌症诊断后的死亡率也无关（调整后HR，1.05 [95% CI，0.93至1.19]）。
在美国接受腰椎融合术的大量老年成年人中，使用BMP与癌症风险或死亡率无关。
治疗水平III。有关证据水平的完整描述，请参阅作者指南。
