Purpose: This multicentre phase III study was designed to compare the efficacy of Bacillus Calmette Guérin (BCG) instillations and photodynamic therapy (PDT) in the treatment of patients with intermediate and high-risk nonmuscle invasive bladder cancer VSports手机版. .

Material and methods: Inclusion criteria were multifocal pTaG1-G2 tumours, recurrent pTaG1-2 tumours, pTa / 1G3 tumours, and primary or recurrent carcinoma in situ (CIS) V体育安卓版. All patients were centrally randomised after transurethral resection (TUR) to receive BCG induction and maintenance therapy or a single PDT with Photofrin. The primary endpoint of the trial was recurrence-free survival. Secondary endpoints were the 2-year recurrence rate, the 2-year progression rate, survival, and quality of life. .

Results: 124 patients (63 PDT group, 61 BCG group) were enrolled at 7 institutions in Germany and Austria. Each patient had a follow-up for 2 years. Of the 124 enrolled patients 105 were eligible for this analysis V体育ios版. Kaplan-Meier curves demonstrated no statistically significant differences between the two therapy arms with respect to recurrence-free survival after randomisation (p = 0. 4598). After intention-to-treat analysis and after as-treated analysis, the estimated median recurrence-free survival periods were 24. 9 (BCG) versus 16. 6 months (PDT) and 25. 8 (BCG) versus 14. 7 (PDT) months, respectively. .

Conclusions: A single PDT with Photofrin(R) in intermediate and high-risk nonmuscle invasive bladder cancer patients could not be shown to be superior to BCG maintenance therapy VSports最新版本. Vice versa, the results of this study cannot exclude a superiority of BCG. .