[BCG versus photodynamic therapy (PDT) for nonmuscle invasive bladder cancer-a multicentre clinical phase III study].

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.

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). 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. 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. Vice versa, the results of this study cannot exclude a superiority of BCG.