Surlemont L, Nouhaud F-X, Dupuis H, Delcourt C, Defortescu G, Cornu J-N, Pfister C
Service urologie, CHU de Rouen, hôpital Charles-Nicolle, 1, rue de Germont, 76031 Rouen cedex, France.
Service urologie, CHU de Rouen, hôpital Charles-Nicolle, 1, rue de Germont, 76031 Rouen cedex, France.
Prog Urol. 2021 May;31(6):324-331. doi: 10.1016/j.purol.2020.12.012. Epub 2021 Jan 27.
BCG instillations are the gold-standard treatment for high-risk non-muscle-invasive bladder cancer (NMIBC) with a decreased risk of tumor recurrence and muscle infiltration. From 2012 to 2014, a stock shortage of the Connaught strain has led to the cessation of supply for immucyst in France. The objective of this study was to evaluate the potential impact of BCG shortage on the management of patients with NMIBC.
We conducted a retrospective single-center study including patients followed from May 2005 to May 2015 with a high-risk NMIBC (primo-diagnosis). Patients were separated into two groups: not impacted by the shortage (NISG: 56 patients) and impacted by the shortage (ISG: 53 patients). Data on tumour recurrence (RFS), muscle progression (PFS) and overall and specific survival (OS and SS) were also analysed.
The BCG induction schedule could not be carried out in 20.8% of cases in the ISG compared to only 5.3% of cases in NISG (P=0.02). Similarly, the maintenance treatment was incomplete for 56.6% of cases versus 37.5% in NISG (P=0.047). Nevertheless, it should be underlined that very high-risk NMIBC received a complete induction BCG schedule. The ISG seems to have benefited with the evolution of the guidelines with the use of diagnosis bladder fluorescence but without significant difference on the rate of second look bladder trans-uretral resection. The cystectomy rate was higher in ISG. No significant difference in RFS, PFS, OS, and SS between the two groups.
In our experience, RFS, PFS, OS or SS were not impacted by the BCG shortage. These data may be explained by a better selection of very high-risk patients including the recommended BCG schedule and more frequently the use of diagnosis bladder fluorescence.
卡介苗灌注是高危非肌层浸润性膀胱癌（NMIBC）的金标准治疗方法，可降低肿瘤复发和肌肉浸润的风险。2012年至2014年期间，法国的康诺特菌株库存短缺导致免疫膀胱（Immucyst）供应中断。本研究的目的是评估卡介苗短缺对NMIBC患者管理的潜在影响。
我们进行了一项回顾性单中心研究，纳入2005年5月至2015年5月期间初诊为高危NMIBC的患者。患者分为两组：未受短缺影响的组（NISG：56例患者）和受短缺影响的组（ISG：53例患者）。还分析了肿瘤复发（RFS）、肌肉进展（PFS）以及总生存和特异性生存（OS和SS）的数据。
ISG组中20.8%的病例无法进行卡介苗诱导方案，而NISG组仅为5.3%（P = 0.02）。同样，ISG组中56.6%的病例维持治疗不完整，而NISG组为37.5%（P = 0.047）。然而，应该强调的是，极高危NMIBC患者接受了完整的卡介苗诱导方案。ISG组似乎受益于指南的演变，采用了诊断性膀胱荧光检查，但二次经尿道膀胱肿瘤切除术的比例没有显著差异。ISG组的膀胱切除术率更高。两组之间的RFS、PFS、OS和SS没有显著差异。
根据我们的经验，卡介苗短缺并未影响RFS、PFS、OS或SS。这些数据可能是由于对极高危患者的选择更好，包括推荐的卡介苗方案以及更频繁地使用诊断性膀胱荧光检查。
3级。
