Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Hospital and Urological Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Urol. 2013 Oct;190(4):1192-9. doi: 10.1016/j.juro.2013.04.077. Epub 2013 May 3.
We evaluated the effectiveness of photodynamic therapy using Radachlorin in patients with high grade, nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Guérin therapy who refused radical cystectomy.
Between July 2009 and December 2011 photodynamic therapy was performed in 22 men and 12 women. Radachlorin (0.5 to 0.6 mg/kg) was injected intravenously 2 to 3 hours before photodynamic therapy. After complete transurethral resection, a diffuser using a 22Fr cystoscope was placed in the bladder for irradiation with a 662 nm laser. Output beam power was adjusted to 1.8 W and the light dose was 15 J/cm(2). Photodynamic therapy was performed for 16 to 30 minutes. Recurrence after photodynamic therapy was followed by regular cystoscopy at 1, 2 and 3 months, and at 3-month intervals thereafter for up to 2.8 years. Efficacy was assessed by cystoscopy, cytology and histology, and defined as the number of patients who were tumor free after initial photodynamic therapy.
Mean ± SD patient age was 62.94 ± 8.71 years. Average followup was 26.74 ± 6.34 months (median 28.12). As the primary efficacy outcome, the recurrence-free rate was 90.9% at 12 months, 64.4% at 24 months and 60.1% at 30 months. As the secondary efficacy outcome, there was no statistical difference in mass size, carcinoma in situ, number of previous bacillus Calmette-Guérin administrations, number of transurethral bladder resections or tumor multiplicity on Kaplan-Meier analysis (each p >0.05). No evidence of severe adverse effects was detected after photodynamic therapy.
Photodynamic therapy with Radachlorin is a safe, effective treatment for nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Guérin therapy in select patients.
我们评估了光动力疗法（使用 Radachlorin）对卡介苗治疗无效或不耐受、拒绝根治性膀胱切除术的高级别非肌肉浸润性膀胱癌患者的疗效。
2009 年 7 月至 2011 年 12 月，我们对 22 名男性和 12 名女性患者进行了光动力疗法。Radachlorin（0.5 至 0.6mg/kg）在光动力疗法前 2 至 3 小时内静脉注射。在完全经尿道膀胱肿瘤切除术后，使用 22Fr 膀胱镜将扩散器放置在膀胱中，并用 662nm 激光进行照射。输出光束功率调整为 1.8W，光剂量为 15J/cm²。光动力疗法进行 16 至 30 分钟。光动力疗法后随访复查膀胱镜，第 1、2 和 3 个月各一次，此后每 3 个月一次，最长随访 2.8 年。疗效通过膀胱镜、细胞学和组织学评估，并定义为初始光动力疗法后无肿瘤的患者数量。
患者平均年龄为 62.94±8.71 岁。平均随访时间为 26.74±6.34 个月（中位数为 28.12 个月）。作为主要疗效指标，12 个月时无复发生存率为 90.9%，24 个月时为 64.4%，30 个月时为 60.1%。作为次要疗效指标，Kaplan-Meier 分析显示肿块大小、原位癌、卡介苗治疗次数、经尿道膀胱肿瘤切除术次数或肿瘤多发性均无统计学差异（p>0.05）。光动力疗法后未发现严重不良反应的证据。
Radachlorin 光动力疗法是一种安全、有效的治疗方法，适用于卡介苗治疗无效或不耐受的选择患者的非肌肉浸润性膀胱癌。
