Solsona Eduardo, Climent Miguel A, Iborra Inmaculada, Collado Argimiro, Rubio José, Ricós José V, Casanova Juan, Calatrava Ana, Monrós Jose L
Urology, Instituto Valenciano de Oncología, Valencia, Spain.
Eur Urol. 2009 Apr;55(4):911-9. doi: 10.1016/j.eururo.2008.08.027. Epub 2008 Aug 15.
Many phase 2 bladder-sparing programmes using transurethral resection of the bladder (TURB) plus chemotherapy or radio-chemotherapy have been undertaken, but some controversies remain.
To determine the efficacy of complete TURB plus three cycles of cisplatin-based chemotherapy in selected patients with muscle-invasive bladder cancer (MIBC).
DESIGN, SETTING, AND PARTICIPANTS: A phase 2 nonrandomized trial was designed that included patients with MIBC who underwent complete TURB with positive biopsies of the tumour bed. Patients with negative biopsies of the tumour bed, with macroscopically residual tumour, with hydronephrosis, or with distant metastasis were excluded from this trial. Patients included in this trial were offered three cycles of systemic chemotherapy or radical cystectomy (RC). Clinical response (cR) was denoted by either no tumour or the presence of Ta1-Tis bladder tumour at 3-mo evaluation; clinical non-response (cNR) was denoted by cases of muscle-invasive tumour or distant metastasis. Of 146 patients who entered this trial, 75 choose the bladder-sparing programme and 71 chose RC.
At 5 yr and 10 yr, the cancer-specific survival (CSS) rate was 64.5% and 59.8%, respectively, with no significant difference compared to the RC arm (p=0.544). The progression-free survival with bladder preserved was 52.6% and 34.5%, respectively. In multivariate analysis, cR was the only predictive factor for survival (p=0.001) and bladder preservation (p=0.000).
This was not a randomized trial, and patients were included over 16 yr. However, no modifications were made to the therapy schedule except from chemotherapy schemes considered standard at the time.
Patients with microscopic residual cancer after complete TURB seem to be good candidates for the bladder-sparing programme using three cycles of systemic chemotherapy, with CSS comparable to RC.
已经开展了许多使用经尿道膀胱肿瘤切除术（TURB）加化疗或放化疗的2期膀胱保留方案，但仍存在一些争议。
确定在选定的肌层浸润性膀胱癌（MIBC）患者中，完整TURB加三个周期基于顺铂的化疗的疗效。
设计、地点和参与者：设计了一项2期非随机试验，纳入了接受完整TURB且肿瘤床活检阳性的MIBC患者。肿瘤床活检阴性、有肉眼残留肿瘤、有肾积水或有远处转移的患者被排除在本试验之外。本试验纳入的患者接受三个周期的全身化疗或根治性膀胱切除术（RC）。临床缓解（cR）定义为在3个月评估时无肿瘤或存在Ta1-Tis膀胱肿瘤；临床无缓解（cNR）定义为肌层浸润性肿瘤或远处转移病例。在进入本试验的146例患者中，75例选择膀胱保留方案，71例选择RC。
在5年和10年时，癌症特异性生存率（CSS）分别为64.5%和59.8%，与RC组相比无显著差异（p = 0.544）。保留膀胱的无进展生存率分别为52.6%和34.5%。在多变量分析中，cR是生存（p = 0.001）和膀胱保留（p = 0.000）的唯一预测因素。
这不是一项随机试验，患者入组时间超过16年。然而，除了当时被认为是标准的化疗方案外，治疗方案没有进行修改。
完整TURB后有微小残留癌的患者似乎是使用三个周期全身化疗的膀胱保留方案的良好候选者，其CSS与RC相当。
