Calò B, Sanguedolce F, Fortunato F, Stallone G, d'Altilia N, Chirico M, Falagario U, Mancini Vito, Carrieri G, Cormio L
Department of Urology and Renal Transplantation.
Department of Pathology.
Medicine (Baltimore). 2019 Aug;98(31):e16223. doi: 10.1097/MD.0000000000016223.
Intravesical instillation of Bacille Calmette-Guèrin (BCG) is the standard adjuvant treatment for high-risk non muscle invasive bladder cancer (NMIBC). Since its mechanism of action is supposed to be linked to the immune system efficiency and senescence could negatively affect this efficiency, BCG efficacy in the elderly has been questioned. This study aimed to assess the impact of age on BCG efficacy and safety in patients with high-grade T1 bladder cancer (BC).Among 123 patients with high-grade T1 BCG scheduled for BCG treatment, 82 were <75 year-old (group A) and 41 were ≥75 year-old (group B). Follow-up: urine cytology and cystoscopy every 3 months for the first 2 years, every 6 months for the third year, and then yearly. Tumor recurrence was defined as pathological evidence of disease at the bladder biopsy; tumor progression was defined as pathological shift to muscle invasive disease at the bladder biopsy or the imaging techniques showing recurrent BC and distant metastasis likely related to it.The median follow-up was 65 months (range 11-152). Recurrence occurred in 35 patients, 19 (23.2%) in the group A and 16 (39%) in the group B. Progression occurred in 18 patients, 12 (14.6%) in the group A and 6 (14.6%) in the group B. Recurrence free rate was similar in both groups up to 2 years. The 5 years progression rate was almost the same in both groups A and B (85.9% vs 84.7%), whereas the 5 years cancer-specific survival (CSS) was 92.6% in the group A and 85.4% in the group B. Of the 18 patients with progression, 11 underwent cystectomy; 12 patients died because of their BC. Kaplan-Meier plots pointed out no difference in recurrence-free, progression-free, and CSS between the 2 groups. Adverse events were similar in the 2 groups. Only 4 (3.3%) patients, 2 (2.4%) in the group A and 2 (4.8%) in the group B, experienced mild adverse reactions compatible with treatment.Elderly patients with high-grade T1 BC are not poorer candidates to BCG treatment, as they had similar benefit and adverse reactions than those aging ≥75 years.
膀胱内灌注卡介苗（BCG）是高危非肌层浸润性膀胱癌（NMIBC）的标准辅助治疗方法。由于其作用机制被认为与免疫系统效率有关，而衰老可能会对这种效率产生负面影响，因此BCG在老年患者中的疗效受到质疑。本研究旨在评估年龄对高级别T1期膀胱癌（BC）患者BCG疗效和安全性的影响。在123例计划接受BCG治疗的高级别T1期BC患者中，82例年龄<75岁（A组），41例年龄≥75岁（B组）。随访：前2年每3个月进行一次尿液细胞学检查和膀胱镜检查，第3年每6个月进行一次，之后每年进行一次。肿瘤复发定义为膀胱活检时有疾病的病理证据；肿瘤进展定义为膀胱活检时病理转变为肌层浸润性疾病，或影像学检查显示复发性BC且可能与之相关的远处转移。中位随访时间为65个月（范围11 - 152个月）。35例患者出现复发，A组19例（23.2%），B组16例（39%）。18例患者出现进展，A组12例（14.6%），B组6例（14.6%）。两组在2年内的无复发生存率相似。A组和B组的5年进展率几乎相同（85.9%对84.7%），而A组的5年癌症特异性生存率（CSS）为92.6%，B组为85.4%。在18例出现进展的患者中，11例接受了膀胱切除术；12例患者因膀胱癌死亡。Kaplan - Meier曲线显示两组在无复发生存率、无进展生存率和CSS方面无差异。两组的不良事件相似。只有4例（3.3%）患者出现轻度不良反应，A组2例（2.4%），B组2例（4.8%），这些不良反应与治疗相符。高级别T1期BC的老年患者并非BCG治疗的较差候选者，因为他们与年龄≥75岁的患者相比，有相似的获益和不良反应。
