Skolarus Ted A, Lee Eugene W, Virgo Katherine S, Katz Matthew D, Hudson M'liss A, Kibel Adam S, Grubb Robert L
Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine and Barnes Jewish Hospital, St Louis, MO 63110, USA.
J Am Coll Surg. 2009 Aug;209(2):248-53. doi: 10.1016/j.jamcollsurg.2009.04.014. Epub 2009 Jul 9.
Recent studies provide conflicting evidence about the association of statin use and decreased efficacy of intravesical bacille Calmette-Guérin (BCG) therapy for bladder cancer. Because statin drugs have immunomodulatory properties that could reduce the effectiveness of BCG, we investigated whether concurrent use of statin drugs was associated with worsened clinical outcomes in patients undergoing BCG treatment for non-muscle-invasive bladder cancer.
We retrospectively analyzed records of 120 patients undergoing BCG treatment during 1997 through 2007 at a single Department of Veterans Affairs Medical Center. Tumor-progression events, total recurrences, disease-specific and overall mortality were the outcomes relative to statin use. Fisher's exact, Student's t-tests, and logistic regression were used to compare the groups.
Among the 90 evaluable patients, there were no significant differences between groups with regard to tumor grade and stage distribution or smoking status. Statins were used during BCG therapy by 47.8% of patients. Comparing patients with no use versus use of statins, 8.5% versus 11.6% had local tumor progression (p = 0.44); 10.6% versus 9.3% underwent cystectomy, chemotherapy, or radiation therapy (p = 0.56); and metastatic disease developed in 6.7% versus 11.6% (p = 0.33). Of the 27 patients who died of any cause, 12.5% (2 of 16) versus 27.3% (3 of 11) in the nonstatin versus statin groups, respectively, died of disease (p = 0.32).
Concurrent statin use was not associated with adverse outcomes for patients undergoing BCG treatment for bladder cancer. While statins have a plausible biologic mechanism to reduce BCG efficacy, no differences were seen in this small pilot study.
近期研究对于他汀类药物的使用与卡介苗(BCG)膀胱内灌注治疗膀胱癌疗效降低之间的关联提供了相互矛盾的证据。由于他汀类药物具有免疫调节特性,可能会降低BCG的有效性,我们调查了同时使用他汀类药物是否与非肌层浸润性膀胱癌接受BCG治疗患者的临床结局恶化相关。
我们回顾性分析了1997年至2007年期间在一家退伍军人事务医疗中心接受BCG治疗的120例患者的记录。肿瘤进展事件、总复发率、疾病特异性死亡率和总死亡率是与他汀类药物使用相关的结局指标。采用Fisher精确检验、Student t检验和逻辑回归对各组进行比较。
在90例可评估患者中,两组在肿瘤分级、分期分布或吸烟状况方面无显著差异。47.8%的患者在BCG治疗期间使用了他汀类药物。比较未使用他汀类药物与使用他汀类药物的患者,局部肿瘤进展的比例分别为8.5%和11.6%(p = 0.44);接受膀胱切除术、化疗或放疗的比例分别为10.6%和9.3%(p = 0.56);发生转移性疾病的比例分别为6.7%和11.6%(p = 0.33)。在27例因任何原因死亡的患者中,非他汀类药物组和他汀类药物组分别有12.5%(16例中的2例)和27.3%(11例中的3例)死于疾病(p = 0.32)。
同时使用他汀类药物与膀胱癌接受BCG治疗患者的不良结局无关。虽然他汀类药物有合理的生物学机制可降低BCG疗效,但在这项小型初步研究中未观察到差异。