Twelve-year follow up of a randomized prospective trial comparing bacillus Calmette-Guerin and epirubicin as adjuvant therapy in superficial bladder cancer
Twelve-year follow up of a randomized prospective trial comparing bacillus Calmette-Guerin and epirubicin as adjuvant therapy in superficial bladder cancer
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DOI：
10.1111/j.1442-2042.2005.01064.x
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发表时间：
2005-05-01
影响因子：
2.6
通讯作者：
Li, ML
中科院分区：
文献类型：
--
作者：
Cheng, CW;Chan, SFP;Li, ML
目的：比较卡介苗（BCG）与表柔比星辅助治疗浅表性膀胱移行细胞癌的复发、进展和生存情况。还评估了预后因素。 方法：1991 年 10 月至 1999 年 9 月期间，所有患有浅表性膀胱癌（Ta 或 T1）且符合任何相关标准（> a 期、> 1 级、大小 > 1 cm、多发性或复发性肿瘤）的浅表性膀胱癌患者，在经尿道完全切除术后随机接受 81 mg 康诺菌株卡介苗或 50 mg 表阿霉素。复发的患者有资格交叉，甚至反复交叉，直到进展。分析复发、进展和生存与初始治疗、患者特征和肿瘤特征的关系。结果：研究纳入 209 名患者，其中 149 名男性和 60 名女性。平均年龄为 69.9 岁（范围：24-92 岁）。 BCG 组有 102 名患者，表阿霉素组有 107 名患者。最终分析是在中位随访时间分别为 23、47 和 61 个月时进行的复发、进展和生存情况。卡普兰-迈耶 (Kaplan-Meier) 估计 BCG 组的 10 年无复发、无进展和疾病特异性生存率分别为 61%、78% 和 80%。表柔比星组的相应数字分别为 32%、74% 和 92%。两个治疗组之间的复发时间存在显着差异（P = 0.0004）。多重性增加了复发风险，而分级则影响复发、进展和疾病特异性生存。结论：与表柔比星相比，卡介苗延长了复发时间。分级被证明是复发、进展和疾病特异性生存的通用预后因素。
Aim: To compare bacillus Calmette-Guerin (BCG) with epirubicin in adjuvant therapy of superficial bladder transitional cell carcinoma, with respect to recurrence, progression and survival. Prognostic factors are also evaluated.Methods: Between October 1991 and September 1999, all patients harboring superficial bladder cancers (Ta or T1) with any of the relevant criteria (stage > a, grade > 1, size > 1 cm, multiple or recurrent tumors), after complete transurethral resection were randomized to receive either 81 mg Connaught strain BCG or 50 mg epirubicin. Patients with recurrences were eligible to crossover, even repeatedly, until progression. Recurrence, progression and survival were analyzed in relation to initial treatment, patient characteristics and tumor characteristics.Results: There were 209 patients included in the study, 149 men and 60 women. The mean age was 69.9 years (range, 24-92). The BCG group consisted of 102 patients and the epirubicin group contained 107 patients. Final analysis was made at a median follow up of 23, 47 and 61 months for recurrence, progression and survival, respectively. The 10-year Kaplan-Meier estimates for recurrence-free, progression-free and disease-specific survival were 61%, 78% and 80%, respectively, for the BCG group. The corresponding figures were 32%, 74% and 92%, respectively, for the epirubicin group. Time to recurrence differed significantly between two treatment groups (P = 0.0004). Multiplicity increased the risk of recurrence, while grading influenced recurrence, progression and disease specific survival.Conclusions: Bacillus Calmette-Guerin prolonged time to recurrence when compared with epirubicin. Grading was shown to be a universal prognostic factor for recurrence, progression and disease specific survival.