Department of Urology, Zagazig University, Zagazig, Egypt.
BJU Int. 2011 May;107(10):1605-10. doi: 10.1111/j.1464-410X.2010.09564.x. Epub 2010 Sep 3.
• To evaluate the efficacy of a bladder preservation multimodality protocol for patients with operable carcinoma invading bladder muscle.
• In this prospective study, we included 33 patients with transitional cell carcinoma (TCC) (T2 and T3, Nx, M0) who were amenable to complete transurethral resection. • These patients refused radical cystectomy as their first treatment option. After maximum transurethral resection of bladder tumour (TURBT), all patients received three cycles of adjuvant chemotherapy in the form of methotrexate, vinblastin, adriamycin and cisplatin (MVAC) followed by radical radiotherapy. • Four weeks later, all cases had radiological and cystoscopical re-evaluation. • Complete responders were considered to be those patients who had no evidence of residual tumour. All patients were subjected to a regular follow-up by cystoscopy and tumour site biopsy conducted every 3 months. Abdomino-pelvic computed tomography and chest X-ray were conducted every 6 months. • The study endpoint was the response to treatment after completion of the first year of follow-up after therapy.
• Out of 33 eligible patients, a total of 28 patients completed the study treatment protocol. Their mean ± SD age was 56.7 ± 6 years. Trimodal therapy was well tolerated in most of cases, with no severe acute toxicities. After 12 months of follow-up, a complete response was achieved in 39.3% and a partial response in 7.1%, with an overall response rate of 46.4%. • By the end of the first year, disease-free survival was reported in 39.3%, whereas 25% were still alive with their disease, giving an overall survival of 64.3% for all patients who maintained their intact, well functioning bladders. • Tumour stage and completeness of transurethral resection of bladder tumour were the most important predictors of response and survival. T2 lesions had complete and partial response rates of 69.2% and 23%, respectively, whereas T3 lesions had rates of 40% and 13.3%, respectively (P = 0.001). • The response rate in patients who had complete TURBT was 82.6% vs 20% in those with cystoscopic biopsy only (P = 0.001). In addition, disease-free survival was 72.7% in T2 patients and 27.3% in T3 patients (P = 0.001).
• In the present study, bladder preservation protocol with MVAC and radical radiotherapy achieved suboptimal response rates at 1 year in patients with localized TCC invading bladder muscle. Patients with solitary T2 lesions that are amenable to complete TURBT achieved the best response rates. Longer follow-up is needed to verify these results. Patients with localized disease should be encouraged for radical cystectomy, which achieved better results.
• 评估膀胱保留多模式方案对可手术浸润性膀胱癌患者的疗效。
• 在这项前瞻性研究中,我们纳入了 33 名接受顺铂、甲氨蝶呤、长春碱和阿霉素(MVAC)辅助化疗的可接受完全经尿道膀胱肿瘤切除术(TURBT)的移行细胞癌(TCC)(T2 和 T3,Nx,M0)患者。• 这些患者拒绝将根治性膀胱切除术作为其首选治疗方案。在最大限度的 TURBT 后,所有患者均接受 MVAC 辅助化疗 3 个周期,然后进行根治性放疗。• 4 周后,所有病例均进行影像学和膀胱镜复查。• 完全缓解的患者被认为是没有残留肿瘤证据的患者。所有患者均通过定期膀胱镜检查和肿瘤部位活检进行随访,每 3 个月进行一次。每 6 个月进行一次腹盆腔计算机断层扫描和胸部 X 线检查。• 研究终点是治疗完成后第一年随访时的治疗反应。
• 在 33 名符合条件的患者中,共有 28 名患者完成了研究治疗方案。他们的平均年龄±标准差为 56.7±6 岁。大多数患者对三联疗法耐受良好,无严重急性毒性。在 12 个月的随访后,完全缓解率为 39.3%,部分缓解率为 7.1%,总缓解率为 46.4%。• 在第一年结束时,39.3%的患者无疾病生存,而 25%的患者仍患有疾病,所有保留完整、功能良好膀胱的患者总生存率为 64.3%。• 肿瘤分期和 TURBT 的完整性是反应和生存的最重要预测因素。T2 病变的完全和部分缓解率分别为 69.2%和 23%,而 T3 病变的缓解率分别为 40%和 13.3%(P=0.001)。• 完全 TURBT 的患者的反应率为 82.6%,而仅进行膀胱镜活检的患者为 20%(P=0.001)。此外,T2 患者的无疾病生存率为 72.7%,T3 患者为 27.3%(P=0.001)。
• 在本研究中,MVAC 和根治性放疗的膀胱保留方案在局部浸润性膀胱癌患者中 1 年时的反应率不理想。可接受完全 TURBT 的单发 T2 病变患者获得了最佳的反应率。需要更长时间的随访来验证这些结果。应鼓励局部疾病患者进行根治性膀胱切除术,因为其结果更好。