Azuma Haruhito, Inamoto Teruo, Takahara Kiyoshi, Nomi Hayahito, Hirano Hajime, Ibuki Naokazu, Uehara Hiroshi, Komura Kazumasa, Minami Koichiro, Uchimoto Taizo, Saito Kenkichi, Takai Tomoaki, Tanda Naoki, Yamamoto Kazuhiro, Narumi Yoshihumi, Kiyama Satoshi
Department of Urology, Osaka Medical College, Takatsuki City, Osaka 569-8686, Japan.
Department of Radiology, Osaka Medical College, Takatsuki City, Osaka 569-8686, Japan.
Int J Oncol. 2014 Jun;44(6):1895-903. doi: 10.3892/ijo.2014.2378. Epub 2014 Apr 10.
We have developed a novel bladder preservation therapy for patients with muscle-invasive bladder cancer and lymph node metastasis: balloon-occluded arterial infusion (BOAI) of cisplatin/gemcitabine, with concomitant hemodialysis and irradiation [the so-called 'OMC (Osaka Medical College) regimen']. The OMC regimen delivers an extremely high concentration of anticancer agent to the site of the tumor, as well as the pelvic area, without causing any adverse systemic effects. In this study, we investigated the efficiency of the OMC regimen in 34 patients who underwent BOAI with cisplatin (100, 200 or 300 mg) along with 60 Gy of irradiation; patients who failed to achieve CR underwent secondary BOAI with gemcitabine (1,600 mg). The overall clinical response was 73.5% (CR: 35.3%; PR: 17.6%; SD: 20.6%). The 5-year overall and progression-free survival rates were 54.4% and 52.5%, respectively. For treatment failure, N2 stage was selected as a significant risk factor by simple and multiple logistic regression analyses. Cox proportional hazards analyses showed that N2 stage, T4 stage and the presence of hydronephrosis were significant risk factors for overall survival. Indeed, 55.6% of patients with N1 stage achieved a complete response (CR) (vs. 12.5% for N2 patients, p=0.0151), and 90% (9/10) of the CR patients survived without recurrence with an intact bladder after a mean follow-up of 85 (range 7-193) weeks. The 3-year progrssion-free survival rate with an intact bladder was 65.8% (vs. 37.5% for N2, p=0.034), and the 5-year overall survival rate was 71.8% (vs. 30.6% for N2, p=0.004). No patients suffered severe toxicities of Grade II or more; the oldest patient, aged 85 years, successfully completed this therapy. In conclusion, the OMC regimen can be regarded as a new option for patients with macroscopic lymph node involvement, especially those at stage N1. Therapy will improve the feasibility of radical cure even without the need for cystectomy in patients for whom surgery after neoadjuvant chemotherapy would otherwise be necessary, and also facilitate potential cure in patients for whom, otherwise, merely palliative treatment would seem the only option.
顺铂/吉西他滨的球囊阻塞动脉灌注（BOAI），同时进行血液透析和放疗[即所谓的“大阪医科大学（OMC）方案”]。OMC方案可将极高浓度的抗癌药物输送至肿瘤部位以及盆腔区域，且不会引起任何不良全身影响。在本研究中，我们调查了34例接受顺铂（100、200或300mg）BOAI联合60Gy放疗的患者中OMC方案的疗效；未达到完全缓解（CR）的患者接受了吉西他滨（1600mg）的二次BOAI。总体临床缓解率为73.5%（CR：35.3%；部分缓解（PR）：17.6%；疾病稳定（SD）：20.6%）。5年总生存率和无进展生存率分别为54.4%和52.5%。对于治疗失败，通过单因素和多因素逻辑回归分析选择N2期作为显著危险因素。Cox比例风险分析表明，N2期、T4期和肾积水的存在是总生存的显著危险因素。事实上，N1期患者中有55.6%达到了完全缓解（CR）（N2期患者为12.5%，p = 0.0151），CR患者中有90%（9/10）在平均随访85周（范围7 - 193周）后膀胱完整且无复发存活。膀胱完整的3年无进展生存率为65.8%（N2期为37.5%，p = 0.034），5年总生存率为71.8%（N2期为30.6%，p = 0.004）。没有患者出现二级或更高级别的严重毒性反应；最年长的患者为85岁，成功完成了该治疗。总之，OMC方案可被视为有肉眼可见淋巴结受累患者的一种新选择，尤其是N1期患者。对于那些新辅助化疗后原本需要手术的患者，该疗法将提高根治的可行性，甚至无需进行膀胱切除术，对于那些原本似乎只能进行姑息治疗的患者，也有助于实现潜在治愈。
