A RANDOMIZED TRIAL OF INTRAVESICAL DOXORUBICIN AND IMMUNOTHERAPY WITH BACILLE CALMETTE-GUERIN FOR TRANSITIONAL-CELL CARCINOMA OF THE BLADDER
A RANDOMIZED TRIAL OF INTRAVESICAL DOXORUBICIN AND IMMUNOTHERAPY WITH BACILLE CALMETTE-GUERIN FOR TRANSITIONAL-CELL CARCINOMA OF THE BLADDER
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DOI：
10.1056/nejm199110243251703
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发表时间：
1991-10-24
影响因子：
158.5
通讯作者：
COLTMAN, CA
中科院分区：
文献类型：
--
作者：
LAMM, DL;BLUMENSTEIN, BA;COLTMAN, CA
背景。在膀胱癌中，膀胱内化疗和免疫治疗均可诱导肿瘤消退并降低复发率，但这两种疗法的相对优点尚不清楚。我们进行了一项多机构研究来解决这个问题。方法。患有快速复发性膀胱移行细胞癌（Ta 或 T1 期）或原位移行细胞癌的患者被随机分配接受膀胱内注射阿霉素或膀胱内和经皮注射卡介苗（BCG）。对 262 名符合条件的患者进行了中位随访 65 个月。通过尿液活检和细胞学分析证实对原位癌治疗的完全反应。结果。对于没有原位癌的 Ta 和 T1 肿瘤患者，阿霉素治疗后 5 年内无病的估计概率为 17%，而 BCG 免疫治疗后为 37%（P = 0.015）。治疗失败（由于疾病持续、复发或进展而终止治疗）的中位时间分别为 10.4 个月和 22.5 个月。对于原位癌患者，阿霉素的完全缓解概率估计（即记录的疾病消失的估计概率）为 34%（67 名患者中的 23 名），卡介苗为 70%（64 名患者中的 45 名）（P < 0.001）；治疗失败的中位时间分别为 5.1 个月和 39 个月。原位癌患者在接受阿霉素治疗后五年内无病生存的概率为 18%，在接受卡介苗治疗后为 45%。与阿霉素治疗的患者相比，卡介苗治疗的患者全身毒性反应发生率较高，局部刺激症状较多，但严重不良反应很少。结论。与膀胱内注射阿霉素相比，卡介苗免疫疗法可以更好地防止浅表性膀胱癌复发。
Background. In carcinoma of the bladder, both intravesical chemotherapy and immunotherapy can induce tumor regression and reduce the rate of recurrence, but the relative merits of these two therapies are unclear. We conducted a multi-institutional study to address this question.Methods. Patients with rapidly recurrent (stage Ta or T1) or in situ transitional-cell carcinoma of the bladder were randomly assigned to receive either doxorubicin administered intravesically or bacille Calmette-Guerin (BCG) administered both intravesically and percutaneously. The 262 eligible patients were followed for a median of 65 months. Complete responses to treatment of carcinoma in situ were confirmed by biopsy and cytologic analysis of the urine.Results. For patients with Ta and T1 tumors without carcinoma in situ, the estimated probability of being disease free at five years was 17 percent after doxorubicin, as compared with 37 percent after immunotherapy with BCG (P = 0.015). The median times to treatment failure (termination of treatment due to persistence, recurrence, or progression of disease) were 10.4 and 22.5 months, respectively. For patients with carcinoma in situ the complete-response probability estimates (i.e., the estimated probability of documented disappearance of disease) were 34 percent for doxorubicin (23 of 67 patients) and 70 percent for BCG (45 of 64 patients) (P < 0.001); the median times to treatment failure were 5.1 and 39 months, respectively. The probability of being disease-free at five years' survival among the patients with carcinoma in situ was 18 percent after treatment with doxorubicin and 45 percent after BCG therapy. Patients treated with BCG had a higher incidence of toxic systemic effects and a larger number of local irritative symptoms than patients treated with doxorubicin, but few of these adverse reactions were severe.Conclusions. As compared with intravesical doxorubicin, immunotherapy with BCG provides improved protection against the recurrence of superficial bladder cancer.