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DISCUSSION PAPER: TREATMENT OF SUPERFICIAL BLADDER CANCER IN MAN *

We have undertaken a therapeutic trial of immunotherapy with Bacillus Calmette-GuCrin (BCG) in patients with recurrent superficial tumors of the bladder. Ten patients, eight males and two females who varied in age from 43 to 81 years, were selected for the trial. These patients exhibited a clinical history of tumor recurrence that averaged every 6 months, which was treated by fulguration or instillations of thio-TEPA and Epodyls, without apparent effect in altering the recurrence rate. In the pre-BCG period, the number of lesions designated in the time period were observed on three separate endoscopic examinations performed at 3-month intervals during that period. BCG treatment consisted of instillations of 120 mg of BCG contained in 50 ml of saline via an indwelling urethral catheter every week for a total of 6 weeks. Systemic immunization was accomplished simultaneously by weekly administrations of 5 mg of BCG via scarification with a multipuncture heaf gun. The patients were instructed to retain the BCG suspension for at least 3 hr. All patients were purified protein derivative (PPD) negative prior to commencement of therapy and rapidly converted to PPD-positive skin test reactions within 2-3 weeks after cornmencement of therapy. The side effects were mild and consisted of mild dysuria and suprapubic discomfort for 1-2 days. Two patients described a brief febrile episode after each treatment, which was of short duration. There were no adverse effects over the longer term; in fact, two patients reported a decrease in urinary frequency and urgency associated with a lack of recurrence of bladder tumor. Of the 10 patients, one died of unrelated medical causes, and two others are still under treatment. The data from seven patients, in most of whom the period of post-BCG follow-up has equalled or exceeded the recurrence rate for that particular patient, are summarized in TABLE 1. In the post-BCG period, at least two, and in many instances three, endoscopic examinations have been performed. Multiple biopsies in regions that corresponded to previously located tumors have been performed. Initial biopsies taken within 6 weeks of completion of the course of treatment revealed extensive infiltration with rnononuclear cells, giant cells, and epithelioid cells. In two cases where tumors had not been fulgurated prior to BCG treatment, biopsies revealed necrotic tumor cells. Later biopsies were characterized by massive mononuclear cell infiltrates but no tumor cells. In total, 35 lesions were observed over a period of 67 patientmonths in the pre-BCG period, while there have been no recurrences observed to date in 47 patient-months after BCG treatment. It should be noted that no