Department of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Canadian Cancer Trials Group (CCTG), Queen's University, Kingston, ON, Canada.
Eur Urol. 2021 Apr;79(4):446-452. doi: 10.1016/j.eururo.2020.12.031. Epub 2020 Dec 31.
Studies have conflicting results regarding the association between statin use and biochemical recurrence for prostate cancer (PCa). A limited number of studies examining statins in advanced stages report positive results, with a few specifically examining statins and androgen deprivation therapy (ADT).
To perform a post hoc secondary analysis of a randomised controlled trial (RCT) of men initiating ADT to examine the association between statin use and outcomes.
DESIGN, SETTING, AND PARTICIPANTS: Patients with prostate-specific antigen (PSA) >3 ng/ml >1 yr following primary/salvage radiotherapy were enrolled in an RCT of intermittent androgen deprivation (IAD) versus continuous ADT (NCT00003653). Baseline and on-study statin use was modelled as a time-dependent covariate.
The primary endpoint was overall survival. Models were adjusted for age, time from radiotherapy to ADT, baseline PSA, and prior ADT.
Of 1364 patients, statin users (585; 43%) were younger (72.7 vs 73.8 yr, p = 0.001) and less likely to have PSA >15 ng/ml (20% vs 25%, p = 0.04). After a median follow-up of 6.9 yr, statin use was associated with reduced overall (hazard ratio [HR]: 0.64; 95% confidence interval [CI] 0.53-0.78, p < 0.001) and PCa-specific (HR: 0.65, 95% CI 0.48-0.87, p = 0.004) mortality. Statin users had 13% longer time to castration resistance, but this did not reach statistical significance (p = 0.15). As an exploratory endpoint, in the IAD arm, statin users had longer time off treatment (median: 0.85 vs 0.64 yr, p = 0.06). Limitations include potential for residual confounding between statin users and nonusers, and confounding by indication.
In men treated with ADT following primary or salvage radiotherapy, statin use was associated with improved overall and PCa-specific survival. In patients treated with IAD, statin use was associated with a trend towards longer time off treatment. A prospective trial of statins in men commencing ADT is warranted.
We found a favourable association between statin use and survival outcomes in patients initiating androgen deprivation therapy.
关于他汀类药物使用与前列腺癌（PCa）生化复发之间的关系，已有研究得出了相互矛盾的结果。少数研究检查了晚期阶段的他汀类药物，报告了阳性结果，其中一些专门研究了他汀类药物和雄激素剥夺疗法（ADT）。
对 ADT 起始男性的随机对照试验（RCT）进行事后二次分析，以研究他汀类药物使用与结局之间的关系。
设计、地点和参与者：前列腺特异性抗原（PSA）>3ng/ml>1yr 后接受原发/挽救性放疗的患者被纳入间歇性雄激素剥夺（IAD）与连续 ADT 的 RCT（NCT00003653）。基线和研究期间的他汀类药物使用被建模为一个时间依赖性协变量。
主要终点是总生存。模型调整了年龄、放疗至 ADT 的时间、基线 PSA 和先前 ADT。
在 1364 名患者中，他汀类药物使用者（585 名；43%）年龄较小（72.7 岁与 73.8 岁，p=0.001），PSA>15ng/ml 的可能性较小（20%与 25%，p=0.04）。中位随访 6.9 年后，他汀类药物使用与总生存（风险比[HR]：0.64；95%置信区间[CI]：0.53-0.78，p<0.001）和前列腺癌特异性死亡（HR：0.65，95%CI：0.48-0.87，p=0.004）显著降低相关。他汀类药物使用者发生去势抵抗的时间延长了 13%，但无统计学意义（p=0.15）。作为一个探索性终点，在 IAD 组中，他汀类药物使用者的无治疗时间更长（中位数：0.85 年与 0.64 年，p=0.06）。局限性包括他汀类药物使用者和非使用者之间可能存在残余混杂，以及指征混杂。
在接受原发或挽救性放疗后接受 ADT 治疗的男性中，他汀类药物使用与总生存和前列腺癌特异性生存改善相关。在接受 IAD 治疗的患者中，他汀类药物使用与治疗中断时间延长趋势相关。需要进行前瞻性他汀类药物治疗开始 ADT 的男性试验。
我们发现开始接受雄激素剥夺疗法的患者中，他汀类药物使用与生存结果呈有利关联。
