Background: Statins are commonly used cholesterol-lowering drugs with evidence of additional chemoprotective and immunomodulatory effects resulting from the inhibition of DNA replication, cell proliferation, and TH1-cell inhibition. There are conflicting reports regarding the potential benefit of concurrent statin treatment on non-muscle invasive bladder cancer (NMIBC) and specifically on intravesical Bacillus Calmette–Guerin (BCG) outcomes. We therefore aimed to analyze the effects of concurrent BCG and statin use in patients with NMIBC.Methods: National Veterans Affairs databases were used to retrospectively identify men with NMIBC between 2000 and 2010 who were treated with BCG. Pharmacy data was interrogated, and patients were divided according to statin therapy status. Statins had to be given at the beginning of BCG treatments and continued for at least 6 months. Cox proportional hazard ratios after inverse propensity score-weighted and competing risks adjustments were calculated for recurrence, secondary events (e.g., progression), cancer-specific survival, and overall survival.Results: Among 8814 patients, with a median follow-up of 11.3 years, statins were used by 38% of the patients. Patients taking statins were older (71 vs. 68,p< 0.0001), had more comorbidities (Charlson Comorbidity Index (CCI > 2; 38.6% vs. 31.4%,p< 0.0001), and had a higher-grade disease (40.2% vs. 34.3%,p< 0.0001) compared to those not on statins. After adjusting for stage, grade, age, race, CCI, agent orange exposure, and year of diagnosis, Cox proportional hazard analysis revealed no association with recurrence (HR 1.05, 95% CI 0.97–1.15,p= 0.23), secondary events (HR 0.91, 95% CI 0.80–1.05,p= 0.189), or bladder cancer specific survival (HR 0.88, 95% CI 0.76–1.02,p= 0.09) of statin use. However, statins were associated with improved overall survival (HR 0.89, 95% CI 0.83–0.96,p= 0.002).Conclusions: Concurrent statin and BCG use in patients with NMIBC was associated with improved overall survival, but not recurrence, secondary events, or bladder cancer-specific survival. These results confirm the real-world well-established cardiovascular benefit of statin treatment and primary preventive care. However, this large population study did not find any association between statins and the outcomes of patients with NMIBC treated with BCG immunotherapy.
背景：他汀类药物是常用的降胆固醇药物，已有证据表明其通过抑制DNA复制、细胞增殖和TH1细胞活性，具有额外的化学保护和免疫调节作用。关于他汀类药物联合治疗对非肌层浸润性膀胱癌（NMIBC）的潜在益处，特别是对膀胱内卡介苗（BCG）治疗效果的影响，现有报告存在矛盾。因此，本研究旨在分析NMIBC患者同时使用BCG和他汀类药物的效果。 方法：利用美国退伍军人事务部国家数据库，回顾性识别2000年至2010年间接受BCG治疗的男性NMIBC患者。通过查询药房数据，根据他汀类药物治疗状态对患者进行分组。他汀类药物需在BCG治疗开始时使用，并持续至少6个月。采用逆概率加权和竞争风险调整后的Cox比例风险模型，计算复发、次要事件（如进展）、癌症特异性生存期和总生存期的风险比。 结果：在8814名患者中（中位随访时间11.3年），38%的患者使用了他汀类药物。与他汀类药物未使用者相比，使用者年龄更大（71岁 vs. 68岁，p < 0.0001），合并症更多（查尔森合并症指数CCI > 2；38.6% vs. 31.4%，p < 0.0001），且疾病分级更高（40.2% vs. 34.3%，p < 0.0001）。在对分期、分级、年龄、种族、CCI、橙剂暴露史和诊断年份进行调整后，Cox比例风险分析显示，他汀类药物的使用与复发（HR 1.05，95% CI 0.97–1.15，p = 0.23）、次要事件（HR 0.91，95% CI 0.80–1.05，p = 0.189）或膀胱癌特异性生存期（HR 0.88，95% CI 0.76–1.02，p = 0.09）均无显著关联。然而，他汀类药物与总生存期的改善相关（HR 0.89，95% CI 0.83–0.96，p = 0.002）。 结论：在NMIBC患者中，同时使用他汀类药物和BCG与总生存期的改善相关，但与复发、次要事件或膀胱癌特异性生存期无关。这些结果证实了他汀类药物治疗和初级预防在现实世界中已确立的心血管益处。然而，这项大规模人群研究未发现他汀类药物与接受BCG免疫治疗的NMIBC患者预后之间存在任何关联。
肿瘤(癌症)患者之家