Urology Centre, Guys Hospital, Guys and St Thomas' NHS Foundation Trust, London, UK.
Eur Urol. 2011 Oct;60(4):703-10. doi: 10.1016/j.eururo.2011.05.064. Epub 2011 Jun 12.
Standard treatment for upper urinary tract urothelial carcinoma (UUTUC) is nephroureterectomy. Subsequently, around 40% of patients will develop a bladder tumour potentially because of implantation from the primary tumour.
To prevent bladder tumour after nephroureterectomy with a single postoperative dose of intravesical mitomycin C (MMC).
DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomised, nonblinded trial (ODMIT-C: One Dose Mitomycin C) was undertaken in 46 British centres between July 2000 and December 2006. The study recruited 284 patients with no previous or concurrent history of bladder cancer undergoing nephroureterectomy for suspected UUTUC.
A single postoperative intravesical dose of MMC (40 mg in 40 ml saline) or standard management on removal of the urinary catheter.
Bladder tumour formation was judged by visual appearance at cystoscopy at 3, 6, and 12 mo following nephroureterectomy.
One hundred forty-four patients were randomised to receive MMC and 140 patients to receive standard care. In the MMC arm, 105 of 144 patients (73%) and 115 of 140 patients (82%) in the standard care arm received their allocated treatment. Thirteen of 105 patients who received MMC and 20 of 115 patients allocated to standard treatment did not complete follow-up. By modified intention-to-treat analysis, 21 of 120 patients (17%) in the MMC arm developed a bladder recurrence in the first year compared to 32 of 119 patients (27%) in the standard treatment arm (p=0.055). By treatment as per protocol analysis, 17 of 105 patients (16%) in the MMC arm and 31 of 115 patients (27%) in the standard treatment arm developed a recurrence (p=0.03). No serious adverse events were reported. A limitation is that histologic proof of recurrence was not required in this trial.
A single postoperative dose of intravesical MMC appears to reduce the risk of a bladder tumour within the first year following nephroureterectomy for UUTUC. The absolute reduction in risk is 11%, the relative reduction in risk is 40%, and the number needed to treat to prevent one bladder tumour is nine.
上尿路尿路上皮癌（UUTUC）的标准治疗方法是肾输尿管切除术。随后，约 40%的患者会出现膀胱肿瘤，这可能是由于原发性肿瘤的植入。
通过单次术后膀胱内丝裂霉素 C（MMC）预防肾输尿管切除术后的膀胱肿瘤。
设计、地点和参与者：一项前瞻性、随机、非盲试验（ODMIT-C：单次丝裂霉素 C）于 2000 年 7 月至 2006 年 12 月在英国 46 个中心进行。该研究招募了 284 名无先前或同时期膀胱癌病史的患者，他们因疑似 UUTUC 而行肾输尿管切除术。
单次术后膀胱内 MMC（40mg 溶于 40ml 生理盐水）或导尿管拔除后的标准治疗。
在肾输尿管切除术后 3、6 和 12 个月，通过膀胱镜检查判断膀胱肿瘤的形成情况。
144 名患者随机分为 MMC 组和标准治疗组，140 名患者。MMC 组 144 例患者中，105 例（73%）和标准治疗组 140 例患者中，115 例（82%）接受了分配的治疗。105 名接受 MMC 的患者中有 13 名和 115 名接受标准治疗的患者中有 20 名未完成随访。经改良意向治疗分析，MMC 组 120 例患者中有 21 例（17%）在第 1 年内出现膀胱复发，标准治疗组 119 例患者中有 32 例（27%）（p=0.055）。按方案分析，MMC 组 105 例患者中有 17 例（16%）和标准治疗组 115 例患者中有 31 例（27%）出现复发（p=0.03）。未报告严重不良事件。该试验的一个局限性是没有要求对复发进行组织学证实。
肾输尿管切除术后单次膀胱内 MMC 给药似乎可降低 UUTUC 患者术后 1 年内膀胱癌的风险。绝对风险降低 11%，相对风险降低 40%，预防 1 例膀胱癌所需的治疗人数为 9 人。
