Okamura K, Kinukawa T, Tsumura Y, Otani T, Itoh H, Kobayashi H, Matsuura O, Kobayashi M, Fukatsu T, Ohshima S
Department of Urology, Nagoya University School of Medicine, Japan.
Eur Urol. 1998;33(3):285-8; discussion 289. doi: 10.1159/000019581.
A prospective randomized study was undertaken to determine whether prophylactic maintenance instillation of epirubicin following induction treatment is beneficial in patients with superficial bladder cancer.
One hundred and forty-eight patients with resectable superficial bladder cancer (Ta-1, single, multiple, primary or recurrent with, however, no recurrence during the last year) were enrolled in this study. In both arms, epirubicin (40 mg/ml in normal saline) was administered six times within 4 weeks after a transurethral resection of the bladder tumor(s). In arm A, the patients received 11 additional monthly instillations of epirubicin.
Of the 148 patients, 138 (93.2%) were eligible and followed for an average of 29.6 months. 93 (67.4%) had a solitary tumor. No significant difference in the recurrence-free curve was observed between the two arms (p = 0.62). The recurrence rate per year was 0.16 in arm A and 0.17 in arm B. Toxicity included vesical irritability in 10 (7.2%) and hematuria in 1 patient. No significant difference in the frequency or degree of toxicity was observed between the two arms.
These data suggest that maintenance instillation of epirubicin does not reduce superficial bladder cancer recurrence.
开展一项前瞻性随机研究，以确定诱导治疗后预防性维持灌注表柔比星对浅表性膀胱癌患者是否有益。
148例可切除的浅表性膀胱癌患者（Ta-1期，单发、多发、原发性或复发性，但过去一年无复发）纳入本研究。两组均在经尿道膀胱肿瘤切除术后4周内给予表柔比星（生理盐水配置为40mg/ml）灌注6次。A组患者每月额外接受11次表柔比星灌注。
148例患者中，138例（93.2%）符合条件并平均随访29.6个月。93例（67.4%）有单个肿瘤。两组间无复发生存曲线差异有统计学意义（p = 0.62）。A组每年复发率为0.16，B组为0.17。毒性反应包括10例（7.2%）膀胱刺激征和1例血尿。两组间毒性反应的频率或程度无显著差异。
这些数据表明，表柔比星维持灌注不能降低浅表性膀胱癌的复发率。
