Efficacy and safety of photodynamic therapy in recurrent high-grade non-muscle-invasive bladder cancer refractory or intolerant to bacille Calmette-Guérin immunotherapy
Lee JY, Diaz RR, Cho KS, Lim MS, Chung JS, Kim WT, Ham WS, Choi YD. J Urol. 2013 May 3. pii: S0022-5347(13)04262-6. doi: 10.1016/j.juro.2013.04.077. [Epub ahead of print]

Source

Department of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.

Abstract

PURPOSE:

To evaluate Photodynamic therapy (PDT) effectiveness using Radachlorin® in patients with high-grade non-muscle-invasive bladder cancer (NMIBC) refractory or intolerant to bacille Calmette-Guérin (BCG) therapy, for which radical cystectomy was refused.

MATERIALS AND METHODS:

Between July 2009 and December 2011, PDT was performed in 34 patients (22 men/12 women). Radachlorin (0.5-0.6 mg/kg) was intravenously injected 2-3 hours before PDT. After complete transurethral resection, a diffuser using a 22 Fr. cystoscope was placed into the bladder for irradiation with a 662 nm laser. The output beam power was adjusted to 1.8 W, light dose was 15 J/cm2, and PDT was performed for 16-30 minutes. Recurrence after PDT was followed by regular cystoscopy at 1, 2, and 3-months, and thereafter at 3-month intervals for u p to 2.8 years. Efficacy was assessed by cystoscopy, cytology, and histology, and was defined as the number of patients who were tumor-free after initial PDT.

RESULTS:

Mean patient age was 62.94±8.71 years. Average follow-up was 26.74±6.34 months (median 28.12 months). In primary efficacy outcome, recurrence-free rates were 90.9% at 12-months, 64.4% at 24 months, and 60.1% at 30 months. In secondary efficacy outcome, there were no statistical differences in mass size, carcinoma in situ number of previous BCG or transurethral resection of bladder therapies and multiplicity (P>0.05 in all comparisons), using Kaplan-Meier analyses. No evidence of severe adverse effects was detected after PDT.

CONCLUSIONS:

PDT with Radachlorin is a safe and effective treatment for NMIBC refractory or intolerant to BCG therapy in selected patients.