ADJUVANT MITOMYCIN C FOR TRANSITIONAL CELL CARCINOMA 2077

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EDITORIAL COMMENT

The authors present anecdotal observational followup on a hetero- geneic group of patients treated with ureteroscopic tumor ablation followed by, in most cases, a single administration of 40 mg. mito- Wcin C via ureteral catheter 1 to 3 days later. Since these are quite often patients with disease that is difficult to manage, adjunctive techniques, in addition to surgery are desirable.

The authors state that they had a '62% response rate," by com- bining patients who were disease-free after this treatment with those in whom some tumor shrinkage was thought to have occurred. However, the percentage of patients who were disease-free atter endoscopic treatment alone (6 of 19) is essentially the same as the 9 of 19 said to have a 'complete response." Since 13 patients had residual disease &er tumor resection and others were treated be-

( cause of high risk of recurrence. it is impossible to assem efficacy in either of these 2 small groups treated for therapeutic purposes or prophylaxis.

Furthermore, with 21 renal units receiving 28 treatments of mit- omycin, the large majority received only a single instillation. Since this is analogous to a single post-bladder tumor resection instillation of intravesical chemotherapy, its greatest efficacy would be antici- pated to be in patients undergoing complete resection in whom implantation or seeding from surgical resection is effectively pre- vented by this treatment.13 It is unlikely that a single treatment would have any impact at all on existing disease, and success would not be substantially increased by using up to only 4 instillations.

The authors state that "none of the patients suffered local progres- sion of disease." They infer that this is due to this treatment tech- nique, and state that "without randomization, we have no accurate way of knowing how many of these patients would have become tumor-free or suffered recurrences without mitomycin C." However, randomization alone is not the key. Adequate trial design based on statistical considerations aimed at demonstrating a decrease in pro- gression would require 400 or more patients divided between 2 different treatment arms.

The authors did not state whether all patients were kept in the hospital simply to accomplish this instillation. although one would assume this to be the case. If so, the cost of increased hospitalization should be noted. From a practical standpoint, unless clear efficacy of this technique is proved by a prospective phase I1 trial of a homoge- neous group of patients treated for residual disease, or a phase 111 comparative trial of prophylaxis of recurrent disease, the increased cost of hospitalization to accomplish this cannot be justified by the data presented. The authors and others working in the endoscopic field should be encouraged to perform a multicenter trial with strict criteria for entry and uniform treatment so that potential efficacy could be better and more adequately assessed.

Michael F. Sarosdy Division of Urology University of Texas Health Science Center San Antonio, Texas

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REPLY BY AUTHORS

The editorial comment accurately reflects the flaws of this limited study. However, we should emphasize that we have used and docu- mented a reproducible technique for mitomycin C instillation that requires additional hospitalization but causes minimal morbidity. h f of efficacy is indeed a more demanding task. The data on the grade I1 tumors (table 2 in article) are encouraging but inconclusive. We now need a larger, better study.