INTRAVESICAL BACILLUS-CALMETTE-GUERIN FOR SUPERFICIAL BLADDER CANCER - EXPERIENCE WITH DANISH-1331 STRAIN
INTRAVESICAL BACILLUS-CALMETTE-GUERIN FOR SUPERFICIAL BLADDER CANCER - EXPERIENCE WITH DANISH-1331 STRAIN
复制标题
DOI：
10.1016/s0022-5347(17)32436-9
复制
发表时间：
1994-11-01
影响因子：
6.6
通讯作者：
DALAL, AV
中科院分区：
文献类型：
--
作者：
KAMAT, MR;KULKARNI, JN;DALAL, AV
根据肿瘤复发和进展的标准高风险标准，共有95例Ta/T1期浅表性膀胱癌患者符合膀胱内卡介苗（BCG）免疫预防的条件。在这些患者中，50例同意接受治疗，而其余45例拒绝任何膀胱内治疗，并作为同期非随机对照。两组患者的患者和肿瘤特征相同。所有患者均接受了膀胱肿瘤的完全经尿道切除术。治疗包括120 mg。每周滴注BCG（丹麦1331菌株），持续6周。50例患者中33例初次接受卡介苗治疗，17例在膀胱灌注化疗失败后接受卡介苗治疗，根据标准标准评价疗效。BCG组24例（48%）复发，对照组38例（84.4%）复发。每年和每100名患者的复发率-与对照组相比，BCG组的平均复发间隔时间和平均复发间隔时间显著延长。BCG组复发的相对风险为0.62，对照组为1.63。亚组分析显示，BCG对患有单个以及多个、Ta和T1期以及II和III级肿瘤的患者。与BCG治疗前对照组相比，BCG治疗后患者的复发率显着降低，而对照组则没有。BCG的益处见于最初接受BCG的患者以及膀胱内化疗失败后接受BCG的患者。预后因素的多因素分析显示，BCG组的这种获益仅与治疗有关，而其他预后参数，如肿瘤分期、分级、数量等不是独立的预后变量。两个治疗组中进展至肌肉浸润的发生率无显著差异。60个月时，BCG组的无复发生存率为35.4%，而对照组为11.2%（p < 0.001）。BCG治疗副作用轻、时间短，经保守治疗后易控制。
A total of 95 patients with stage Ta/T1 superficial bladder cancer was eligible for intravesical bacillus Calmette-Guerin (BCG) immunoprophylaxis according to the standard high risk criteria for tumor recurrence and progression. Of these patients 50 agreed to undergo treatment while the remaining 45 refused any intravesical therapy and served as concurrent nonrandomized controls. The patient and tumor characteristics in the 2 groups of patients were identical. All patients underwent complete transurethral resection of the bladder tumor. Therapy consisted of 120 mg. weekly instillations of BCG (Danish 1331 strain) for 6 weeks. Among the 50 patients 33 received BCG initially while 17 received it after failure of intravesical chemotherapy.Responses were evaluated according to standard criteria. Recurrence was noted in 24 patients (48%) in the BCG group compared to 38 (84.4%) in the control group. The recurrence rates per year and per 100 patient-months were significantly reduced in the BCG arm compared to the control arm. The mean interval to first recurrence and the mean recurrence interval were significantly increased in the BCG arm compared to the control arm. The relative risk of recurrence in the BCG group was 0.62 versus 1.63 in the control group.Subgroup analysis showed significant benefit of BCG for patients with single as well as multiple, stages Ta and T1, and grades II and III tumors. Comparison with pretreatment controls in the BCG group revealed a significant reduction in the recurrence rate in those patients after treatment with BCG, which was not seen in the control group. The benefit of BCG was seen in those who received BCG initially as well as in those who received it after failure of intravesical chemotherapy. Multivariate analysis of prognostic factors showed that this benefit in the BCG group was related only to the treatment, while other prognostic parameters, such as tumor stage, grade, number and so forth were not independent prognostic variables. The rate of progression to muscle invasion was not significantly different in the 2 treatment groups. The relapse-free survival in the BCG group was 35.4% at 60 months compared to 11.2% in the control group (p < 0.001). The side effects of BCG therapy were mild, brief and easily controlled with conservative measures.