Poortmans Philip M, Richaud Pierre, Collette Laurence, Ho Goey S, Pierart Marianne, Van Der Hulst Marleen, Bolla Michel
Department of Radiation Oncology, Dr. Bernard Verbeeten Institute, Tilburg, The Netherlands.
Acta Oncol. 2008;47(5):937-40. doi: 10.1080/02841860801888799.
We prospectively evaluated concomitant radiotherapy and chemotherapy for advanced bladder cancer in a phase II EORTC trial to test whether it could be further studied as a potential treatment of bladder cancer.
Patients up to 75 years of age with invasive transitional-cell carcinoma of the bladder up to 5 cm, stage pT2 to pT3b, N0M0, without residual macroscopical tumour after transurethral excision were eligible. Radiotherapy consisted of 2 fractions of 1.2 Gy daily up to 60 Gy delivered in a period of 5 weeks. During the first and the last week, cisplatin 20 mg/m(2)/day and 5 FU 375 mg/m(2)/day were given concomitantly.
The study was interrupted early due to poor recruitment. Nine patients of the originally 43 planned were treated. Mean age was 63 years. Five patients had tumour stage pT2, 1 stage pT3a and 3 stage pT3b. All patients completed radiotherapy and chemotherapy as scheduled. Only one grade 3 and no grade 4 toxicity was seen. All patients were evaluated 3 months after treatment: eight patients had no detectable tumour and one had para-aortic lymph nodes. During further follow-up, a second patient got lymph node metastases and two patients developed distant metastases (lung in the patient with enlarged lymph nodes at the first evaluation and abdominal in one other). Those three patients died at respectively 19, 14, and 18 months after registration. Late toxicity was limited and often temporary. After 26 to 57 months of follow-up, no local recurrences were seen. Six patients remained alive without disease.
Despite the small cohort, this combination of concomitant chemotherapy and accelerated hyperfractionated radiotherapy for invasive bladder cancer seemed to be well tolerated and to result in satisfactory local control with limited early and late toxicity. It could therefore be considered for study in further clinical trials.
在一项欧洲癌症研究与治疗组织（EORTC）的II期试验中，我们对晚期膀胱癌同步放化疗进行了前瞻性评估，以测试其是否可作为膀胱癌的一种潜在治疗方法进一步研究。
年龄达75岁、膀胱浸润性移行细胞癌最大直径达5 cm、分期为pT2至pT3b、N0M0、经尿道切除术后无肉眼残留肿瘤的患者符合条件。放疗包括每天2次，每次1.2 Gy，共5周，总剂量达60 Gy。在第一周和最后一周，同步给予顺铂20 mg/m²/天和5-氟尿嘧啶（5-FU）375 mg/m²/天。
由于入组情况不佳，研究提前中断。原计划的43例患者中9例接受了治疗。平均年龄为63岁。5例患者肿瘤分期为pT2，1例为pT3a，3例为pT3b。所有患者均按计划完成了放疗和化疗。仅观察到1例3级毒性反应，无4级毒性反应。所有患者在治疗后3个月接受评估：8例患者未检测到肿瘤，1例有主动脉旁淋巴结转移。在进一步随访中，又有1例患者出现淋巴结转移，2例患者发生远处转移（首次评估时淋巴结肿大的患者为肺转移，另1例为腹部转移）。这3例患者分别在登记后19、14和18个月死亡。晚期毒性反应有限且多为暂时性。随访26至57个月后，未见局部复发。6例患者无病存活。
尽管队列规模较小，但这种同步化疗与加速超分割放疗联合治疗浸润性膀胱癌的方案似乎耐受性良好，能实现令人满意的局部控制，且早期和晚期毒性反应有限。因此，可考虑在进一步的临床试验中进行研究。
