We evaluated 104 patients with superficial bladder tumors for response to intravesical bacillus Calmett-Guerin therapy. Patients received 6 weekly intravesical bacillus Calmette-Guerin instillations and they were followed for response every 3 months with urinary cytology, cystoscopy and bladder biopsy. Patients were considered treatment failures if either the cytology studies or biopsies were positive for tumor. Of 65 patients who failed the initial treatment course 57 were given an additional 6-week course of therapy. One 6-week course of bacillus Calmette-Guerin was successful in 20 of 55 patients (36 per cent) treated for prophylaxis, 12 of 32 (37 per cent) treated for carcinoma in situ and 7 of 17 (41 per cent) treated for residual tumor. The response rate for the total patient population treated with 1, 6-week course was 37.5 per cent (39 of 104). A second 6-week course was successful in 19 of 29 patients (65 per cent) treated for prophylaxis, 11 of 18 (71 per cent) treated for carcinoma in situ and 4 of 10 (40 per cent) treated for residual tumor. The response rate for all patients receiving a second course of bacillus Calmette-Guerin was 59.6 per cent (34 of 57). Of 6 patients who refused another 6-week course of bacillus Calmette-Guerin 4 had additional recurrences and 3 of these 4 suffered invasive disease. The over-all therapeutic response rate for patients treated with either 6 or 12 weeks of therapy was 70 per cent. These results suggest that 6 weeks of intravesical bacillus Calmette-Guerin do not provide optimal therapy for superficial bladder tumors. The data further suggest that more intensive regimens may increase therapeutic efficacy.
Several factors were evaluated for prognostic significance in 104 patients with a history of recurrent superficial bladder cancer treated with a 6-week course of intravesical bacillus Calmette-Guerin. Purified protein derivative skin test reactivity, tumor stage, tumor grade and number of previous tumor recurrences were evaluated in all patients. In addition, the prognostic value of a granulomatous response in the bladder was evaluated in 62 of the 104 patients. A significant correlation was reconfirmed between purified protein derivative reactivity and status free of tumor (p equals 0.041) after additional followup on 62 patients from a previous report. A significant correlation also was observed in the total patient population (p equals 0.054). Over-all, 60 per cent of the 62 patients and 52 per cent of the 104 patients whose purified protein derivative test converted from negative to positive remained free of tumor, compared to only 28 per cent of the 62 patients and 28 per cent of the 104 whose test failed to convert to positive. Mean followup was 29.3 +/- 5.7 months in the 62 patient subgroup and 23.5 +/- 5.8 months in the total 104 patients. Bladder granuloma data were available only for the 62 patient subgroup in the previous report. With extended followup, the significant correlation previously reported between status free of tumor and granulomatous response on bladder biopsy was lost. Over-all, 29 of 37 patients (51 per cent) with granulomas compared to 8 of 25 (32 per cent) without granulomas remained free of tumor (p equals 0.132). Tumor stage and grade, and number of previous tumor recurrences failed to show a significant correlation to status free of tumor. These results show that with extended followup, granulomatous response in the bladder lost its statistical correlation with status free of tumor, while a significant correlation was maintained for purified protein derivative responsiveness. This level of statistical significance was borderline and the purified protein derivative skin test response should not be considered useful as a prognostic indicator in individual patients.
Transrectal prostatic ultrasonography is a potentially valuable means to evaluate the prostate of men with suspected carcinoma. We studied 118 patients with this modality before histological evaluation of the prostate (20 underwent radical prostatectomy, 75 core needle biopsy and aspiration cytology, and 23 transurethral resection of the prostate). Transrectal ultrasonography was more efficient than digital rectal examination in the staging of carcinoma of the prostate before radical prostatectomy. The value of transrectal ultrasonography in the diagnosis of prostatic cancer in men with an abnormal-feeling prostate on digital rectal examination is less certain, since 10 of 75 patients (13 per cent) in this group had a falsely positive scan. The predictive value of a scan positive for malignancy was 37 per cent. Further refinements in the technique of transrectal prostatic ultrasonography are needed to realize fully the diagnostic potential of this imaging modality.
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