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


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.
Jocham
D
D
Die Institutsangaben sind am Ende des Beitrags gelistet. Prof.Jocham.MUL@t-online.de
von Wietersheim
J
J
Pflüger
H
H
Steiner
H
H
Doehn
C
C
Büttner
H
H
Böhle
A
A
Kausch
I
I
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D002291:Carcinoma, Papillary / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003558:Cystoscopy; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006414:Hematoporphyrin Photoradiation; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000401:mortality; D009367:Neoplasm Staging; D011788:Quality of Life; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery
D001500:BCG Vaccine