Introduction & Objectives: Carcinoma in situ (CIS) is an aggressive form of non invasive bladder cancer with a more than 50% 5 year progression rate and an even a higher recurrence rate. Current standard therapy is at least 2 courses of intravesical BCG with an approximately 60-80% initial response rate. There are no real proven conservative alternatives for BCG. Although the combination of BCG and interferon-alpha 2b has been reported in BCG refractory CIS, results should be confirmed, and so far cystectomy remains the treatment of choice in these patients. We report on our results with the combination of intravesical hyperthermia and chemotherapy in patients with (BCG refractory) CIS of the urinary bladder.

Material & Methods: Patients with biopsy proven and histologically confirmed CIS, and complete resection of all visible papillary tumours (when possible) were eligible for inclusion. Treatment was done with the Synergo® system SB-TS 101. The hyperthermia range is between 41°C and 44°C. Treatment is given on an outpatient basis weekly for 6 to 8 weeks, followed by 4 to 6 monthly sessions. Treatment is done with two 30 minutes cycles of MMC. The dose of MMC used was twice 20 mg (prophylactic schedule) or twice 40 mg (therapeutic schedule).

Results: In total 57 patients were treated between 1997 and 2005, from 18 European centres. Mean age was 69.5 years. On average the patients had 2.9 previous TUR procedures, and 40 were previously treated with BCG. 29 patients had concommitant papillary tumors. The average total number of hyperthermia/MMC treatments was 8.9. 48 patients were evaluable for response, of which 45 had a biopsy and cytology proven complete response. In 2 patients CIS disappeared, but they had persistence of papillary tumours. Follow up of 38 complete responders shows recurrences in 12 patients after an average follow up of 13.6 months: 9x CIS, 1x T1, 2x T2. (Kaplan-Meier estimated 1 year recurrence rate of 30%). Side effects (pain during treatment and bladder irritation during and 1 to 2 days after treatment) were generally mild and transient.

Conclusions: In patients with primary or even BCG refractory CIS treatment with intravesical hyperthermia and MMC appears a safe and effective treatment. The initial CR rate is very high (94%), and after 1 year the recurrence rate still is low (30%). Additional studies to confirm the value of maintenance hyperthermia/MMC are currently done

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