Department of Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
BJU Int. 2010 Aug;106(3):357-61. doi: 10.1111/j.1464-410X.2009.09137.x. Epub 2009 Dec 11.
To determine the influence of gender on the outcome of patients with high-risk non-muscle-invasive bladder cancer treated with intravesical bacille Calmette-Guérin (BCG) therapy, as the role of hormone status in the pathogenesis of urothelial carcinoma and the response to treatment remains subject to debate.
We reviewed 1021 consecutive patients (756 men and 265 women) who were treated with induction BCG between 1978 and 2006 for multiple or recurrent high-grade Ta, T1, and/or carcinoma in situ (CIS) bladder cancer. All patients had > or = 5 years of follow-up. The endpoints of initial response to BCG and the time to disease recurrence and progression were correlated with gender using Kaplan-Meier methods and multivariate Cox regression models.
Men were significantly more likely to present with high grade (P = 0.003) tumours and with CIS (P < 0.001), while age and clinical stage at presentation were similar between men and women. There was no significant difference in the initial response to BCG by gender, as 593/756 (78.4%) men and 219/265 (82.6%) women had no evidence of disease at 6 months after BCG treatment (P = 0.14). The median time to recurrence after BCG therapy was also similar for men and women (20 vs 21 months, P = 0.51). Likewise, there was no evidence of a significant association between gender and the risk of disease progression after BCG therapy, such that the 5-year estimated freedom from progression was 77% and 82%, respectively, for men and women (P = 0.08). Moreover, on a multivariate analysis controlling for patient age and tumour stage, grade and CIS, gender was not associated with the risk of recurrence (hazard ratio 0.94, 95% confidence interval 0.79-1.11; P = 0.44) or progression (1.18, 0.85-1.63; P = 0.33) after BCG. When the outcomes for women treated with BCG were stratified by age <50 years (the median age of menopause in the USA) vs > or = 50 years, again there were no differences in the risk of tumour recurrence (P = 0.95) or progression (P = 0.35).
These data suggest that the outcomes of men and women with high risk non-muscle-invasive urothelial carcinoma treated with BCG are similar. As such, further studies are required to determine the clinical relevance of preclinical evidence that has suggested a potential role for sex steroids in the pathophysiology of bladder cancer.
确定性别对接受膀胱内卡介苗（BCG）治疗的高危非肌肉浸润性膀胱癌患者预后的影响，因为激素状态在尿路上皮癌发病机制和治疗反应中的作用仍存在争议。
我们回顾了 1978 年至 2006 年间接受诱导 BCG 治疗的 1021 例连续患者（756 名男性和 265 名女性），这些患者患有多发性或复发性高级别 Ta、T1 和/或原位癌（CIS）膀胱癌。所有患者均随访> 5 年。使用 Kaplan-Meier 方法和多变量 Cox 回归模型，将初始 BCG 反应的终点以及疾病复发和进展的时间与性别相关联。
男性更有可能出现高级别肿瘤（P = 0.003）和 CIS（P < 0.001），而男性和女性的年龄和临床分期在就诊时相似。性别对 BCG 的初始反应没有显著差异，因为 756 名男性中的 593 名（78.4％）和 265 名女性中的 219 名（82.6％）在 BCG 治疗后 6 个月时没有疾病证据（P = 0.14）。BCG 治疗后复发的中位时间在男性和女性之间也相似（20 个月与 21 个月，P = 0.51）。同样，在 BCG 治疗后，性别与疾病进展的风险之间也没有明显的关联，因此，男性和女性的 5 年无进展估计分别为 77％和 82％（P = 0.08）。此外，在控制患者年龄和肿瘤分期、分级和 CIS 的多变量分析中，性别与复发（风险比 0.94，95％置信区间 0.79-1.11；P = 0.44）或进展（1.18，0.85-1.63；P = 0.33）的风险无关。当根据年龄<50 岁（美国绝经中位数）与≥50 岁将接受 BCG 治疗的女性的结果分层时，肿瘤复发（P = 0.95）或进展（P = 0.35）的风险也没有差异。
这些数据表明，接受 BCG 治疗的高危非肌肉浸润性尿路上皮癌的男性和女性的预后相似。因此，需要进一步的研究来确定临床前证据的临床意义，该证据表明性激素在膀胱癌发病机制中的潜在作用。
