[Mitoxantrone chemoprophylaxis for multirecurrent multifocal superficial bladder tumours: results of a phase 2 controlled study]. / Mitoxantrone chemoprophyaxis for multirecurrent multifocal superficial bladder tumours: results of a phase 2 controlled study.

Twenty-three patients with multifocal superficial bladder cancer (stage Ta - T1) unresponsive to at least 3 different intravesical agents, were enrolled in a phase II study in order to evaluate the prophylactic effects of intravesical Mitoxantrone (20 mg) after complete endoscopic resection (TUR) of any papillary tumor. The median follow-up was 6 months; 19 patients (82%) experienced superficial tumor recurrence, 1 patient (4%) progression to muscle invasion and 3 (13%) were disease-free, respectively. Six patients (26%) experienced local side-effects. The progression rate is acceptable; the side effects are at least similar to those available in the literature, but in our experience, Mitoxantrone has no prophylactic effects against superficial bladder cancer unresponsive to previous treatment.

Delayed high-dose intravesical epirubicin therapy of superficial bladder cancer. A way to reduce the side effects and increase the efficacy--a phase 2 trial.

INTRODUCTION: Intravesical epirubicin is a widely used agent for the treatment of superficial bladder cancer. A direct relationship between dose and activity has been reported: unfortunately the dose increase also increased the frequency and the intensity of treatment-related side effects. MATERIALS AND METHODS: A phase 2 trial was designed to evaluate the toxicity and the activity of a delayed (biweekly) high-dose (80 mg) epirubicin therapy of superficial bladder cancer. Thirty patients with intermediate risk superficial bladder cancer (stage mTa, G2) have been treated with transurethral resection and epirubicin intravesical therapy: the patients were given 80 mg epirubicin in 50 ml sterile saline every 2 weeks for 6 times (delayed regimen). The follow-up ranged from 3 to 26 months. Eleven of 30 (37%) patients experienced a local adverse reaction to intravesical epirubicin requiring specific medication (grade > or = 2 according to NCI-CTC v.2.0, 1999). No systemic toxicity related to the treatment was observed. RESULTS: Out of the 29 evaluable patients, 22 (76%) were free of disease after the induction course, 6 (21%) had superficial bladder cancer recurrences and 1 (3%) experienced tumor progression. CONCLUSION: A delayed (biweekly instillation) high-dose (80 mg) intravesical epirubicin regimen was acceptable in terms of side effects and showed a worthwhile therapeutical impact in patients with intermediate risk superficial bladder cancer.