Galliot I, Le Gall S, Rigaud J, Saint F, Colombel M, Guy L, Wallerand H, Fantoni J C, Staerman F, Irani J, Soulie M, Pfister C
Service d'urologie, CHU Charles-Nicolle, 1, rue de Germont, 76031 Rouen cedex, France.
Prog Urol. 2013 Apr;23(5):336-46. doi: 10.1016/j.purol.2012.12.010. Epub 2013 Feb 1.
Intravesical instillations of BCG remains the gold standard for intermediate and high risk NMIBC management. Maintenance treatment is recommended, however, the frequency of side effects responsible for the discontinuation of maintenance therapy over four out of five patients before the third year suggest a reduction or even spacing instillations. The objective of the study URO-BCG-4 was the evaluation of a new maintenance schedule by intravesical instillations of BCG combined reduced dose (third dose) and a decrease number of instillations per cycle (two or three).
Multicenter study of the French Association Oncologic Committee (12 university hospital centers), randomized, prospective, comparing reference diagram of BCG maintenance therapy one third of usual dose (group I) to a regimen combining third dose and decrease the number of instillations per cycle (two instead of three) (group II). We present the preliminary results at 1year of this Program of Clinical Research (CHU Rouen Promoter 2003-081).
The rate of recurrence was respectively 9 and 7% (P=0.678) in groups I and II. The rate of tumor progression are 3 and 2.8% in groups I and II (P=1). Tolerance of intravesical instillations of BCG scored according to the WHO classification (Geneva 1979) was similar in the two groups.
The decrease in the BCG dose (third dose) and the changes in the number and rate of instillations did not alter free tumor recurrence survival. The toxicity of intravesical instillations of BCG was identical in both groups. The use of the WHO classification has shown its limitations in the study of side effects of BCG as too complex and often not exhaustive. The rate of increase muscle was comparable in the two groups; however, a larger clinical experience is required.
膀胱内灌注卡介苗仍然是中高危非肌层浸润性膀胱癌（NMIBC）治疗的金标准。推荐进行维持治疗，然而，在第三年之前，五分之四以上的患者因副作用而停止维持治疗，这表明需要减少甚至延长灌注间隔。URO-BCG-4研究的目的是评估一种新的维持方案，即膀胱内灌注卡介苗联合降低剂量（第三剂量）并减少每个周期的灌注次数（两次或三次）。
法国肿瘤学委员会的多中心研究（12个大学医院中心），随机、前瞻性，将卡介苗维持治疗的参考方案（常规剂量的三分之一，第一组）与一种联合第三剂量并减少每个周期灌注次数（两次而非三次，第二组）的方案进行比较。我们展示了这项临床研究项目（鲁昂大学医院发起，2003 - 081）1年时的初步结果。
第一组和第二组的复发率分别为9%和7%（P = 0.678）。第一组和第二组的肿瘤进展率分别为3%和2.8%（P = 1）。根据世界卫生组织（1979年，日内瓦）分类对膀胱内灌注卡介苗的耐受性在两组中相似。
卡介苗剂量的降低（第三剂量）以及灌注次数和频率的改变并未改变无肿瘤复发生存率。两组中膀胱内灌注卡介苗的毒性相同。在卡介苗副作用研究中，世界卫生组织分类的使用显示出其局限性，因为它过于复杂且往往不够详尽。两组中肌肉增加率相当；然而，需要更多的临床经验。
