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EDITORIAL COMMENT

This study evaluates the role of microwave hyperthermia and intravesical mitomycin C for recurrent superficial transitional cell

1 carcinoma of the bladder no longer amenable to transurethral resec- I

1 tion due to extent of disease. This group, which represents a small minority (approximately 1 to 3%) of patients with bladder cancer, has traditionally been treated with radical cystectomy because treat- ment options have been limited.

All 19 patients in this series had extensive disease involving greater than 30% of the bladder wall that was judged to be unresectable. After the &week course of therapy initial followup biopsies were negative in 9 patients (47%) and in 7 with residual disease transurethral resection was believed to be feasible. Overall only 3 patients required radical cystectamy. Ofthe 16 responders disease recurred in 8 and the authors state that there was no evidence of tumor progression.

Unfortunately th is study leaves many questions unanswered. Most importantly, the study populations are not well defined. It is not clear how many patients had stage TA versus T1 disease at therapy and how many had associated carcinoma in situ. One does not have a clear conception of the risk of recurrence and progression without these data. In addition, the main entry and response crite- rion (whether transurethral resection was feasible before or after therapy) is too subjective. One oRen finds that transurethral resec- tion of a bladder tumor can be performed with some effort in such patients, although staged procedures may be required. The morbid- ity of treatment is also incompletely defined. One wonders how patients would rate discomfort, since tissue sloughing was noted in many and irritative voiding symptoms were common. Another issue is the cost of therapy because advanced technology is required for therapy administration. This issue may be particularly relevant, since startup costs could be substantial and the number of patients who would qualfy for treatment would be relatively small.

I certainly agree with the authors that a well designed, prospec- tive, randomized trial is needed to establish the efficacy of this treatment protocol. Such a trial would ideally control for the effect of intravesical therapy alone, incorporate more objective response cri- teria and include routine questionnaires to evaluate patient percep- tion of treatment related morbidity.

Steven C. Campbell Department of Urology Northwestern University Medical School Chicago, Illinois

REPLY BY AUTHORS

Due to the large number of tumors and superficial extension on the bladder surface, it was not possible tn define how many patients had stage TA versus T1 disease and how many had carcinoma in situ. Nevertheless it is clearly reported that all patients had at least 1 stage T1 recurrence following standard chemoprophylaxis or immunoprophy- laxis and they had undergone at least 2 resections before entering the study with an average disease-free interval of 5 months. We agree that the entry and response criteria were subjective, and that transient macroscopic complete resection of m u l t i f d bladder tumors often can be obtained by staged transurethd procedures in such patients but we do not consider this a valid alternative to radical cystectomy. Moreover, no more than 3 residual tumors of a large and not precisely definitive primitive number were present in those patients defined as partial responders. Treatment morbidity was evaluated and compared to stan- dard treatment with intravesical mitomycin C in a previous study (reference 10 in article) using questionnaires to evaluate patient per- ception of treatment and related morbidity.

Therapy cost (mainly start-up costs) although not yet precisely defined, is a relevant issue. We believe that the combination of local hyperthermia and intravesical chemotherapy using the SB-TS 101 system also can be economically competitive with repeat transure- thral resections of bladder tumors or radical cystectomy. Treatment of this rare subset of patients with superficial bladder cancer is one but not the only field of application of local hyperthermia and che- motherapy. Results of larger series treated in a neoadjuvant setting have been reported previously (references 9 and 10 in article). A randomized multicenter study is ongoing to establish the effects of this treatment as prophylaxis of bladder tumor recurrence.l Prelim- inary results are exciting and, if confirmed, the indications for such novel therapy could be extended to a large number of patients as prophylaxis of high risk superficial bladder tumors.

1. Leib, Z., Baniel, J., Servadio, C., Colombo, R., Da Pozzo. L. F., Lev, A., Rigatti. P., Caldarera. E. and Pavone Macaluso, M.: Mitomycin C (MMC) vs. MMC combined with local microwave hyperthermia (LMWH) 88 prophylaxis of recurrence of superficial transitional blad- der cancer. a preliminary report. Eur. Urol., suppl. 2, So: 7254 a b stract, 198, 1996.