Neoadjuvant treatment of cancer of the bladder with M-VAC/M-VEC, and bladder-sparing policy: preliminary report of a non-randomized study.

The life expectancy of patients with invasive bladder cancer is limited by the age of incidence and by the natural history of the cancer. Careful selection of patients, independent of age but linked to a neoadjuvant chemotherapy, should be useful for a bladder-sparing policy. Between January 1991 and December 1994, we selected 36 patients with invasive, transitional bladder cancer, but showing good performance status, after a transurethral resection biopsy performed with cytoreductive intention, and after a complete staging. Patients (median age, 65 years) were treated with neoadjuvant M-VAC/M-VEC and then selected for conservative surgery if the downstaging, topography, absence of in situ carcinoma, and residual bladder capacity allowed. At restaging, nine patients (27%) were in complete pathological response; 13 (39%) were in partial pathological response, with a total rate of 67%; and 11 patients (33%) were non-responders, i.e. non-downstaged. Thirty nine percent were treated with radical cystectomy and 60% with limited surgery. Thirteen patients relapsed and seven died of disease during a median follow-up period of 23.5 months. At the end of the study, 68% of patients were alive, with a progression-free survival of 49.8% and a median survival of 32.9 months. Twenty one patients were alive at 31 December 1995, 14 with their bladder. No statistical differences were observed for overall survival and progression-free survival between the two surgery groups. Results were independent of age. A statistically significant difference was found (p = 0.0001) only between non-responders and all the downstaged patients, independent of surgery. These results confirm the feasibility of conservative treatment after a careful selection of patients, even in patients over 65 years, compared with standard available treatments.

Increased accuracy of biopsy Gleason score obtained by extended needle biopsy.

PURPOSE: Accurate tumor grading is critical for adequate prostate cancer treatment. Nonetheless, the Gleason score of standard sextant biopsy correctly predicts the Gleason score of the radical prostatectomy specimen in about 50% of cases. We investigated if extended needle biopsy could improve biopsy Gleason score accuracy. MATERIALS AND METHODS: Laparoscopic transperitoneal radical prostatectomy was performed in 135 patients. Prostate cancer was diagnosed in 89 cases by standard sextant transrectal (6 to 8 cores) biopsy and in 46 by extended needle (12 core transperineal under transrectal guidance) biopsy. Preoperative evaluation included digital rectal examination, prostatic specific antigen measurement, transrectal ultrasonography and endorectal coil magnetic resonance imaging in all patients. All biopsy and prostatectomy specimens were reviewed by a single pathologist. RESULTS: Clinical characteristics were similar in the 2 groups. The concordance between prostate biopsy and radical prostatectomy Gleason score was 32 of 46 cases (70%) and 44 of 89 (49%) for 12 core and standard transrectal biopsy, respectively (z test p = 0.0127). Biopsy under grading was found in 11 of 46 cases (24%) and 35 of 89 (39%) (z test p = 0.0366), and biopsy over grading was found in 3 of 46 (6%) and 10 of 89 (11%) (z test p = 0.1894) with 12 core and standard transrectal biopsy, respectively. Primary Gleason pattern was predicted exactly by biopsy in 40 of 46 cases (87%) and 56 of 89 (63%) with 12 core and standard sextant biopsy, respectively (z test p = 0.0018). CONCLUSIONS: Extended needle biopsy significantly increases the accuracy of biopsy Gleason score for assessing final prostate cancer grade.

3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot) in advanced prostate cancer: results from an Italian, open, multicenter trial.

OBJECTIVES: To determine the endocrine effects, efficacy and tolerability of the 3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot; 'Zoladex' is a trade mark of the AstraZeneca group of companies) in the treatment of patients with advanced prostate cancer. METHODS: Between February 1996 and October 1997, this open, multicentre study enrolled 120 patients with locally advanced (T3/4) or metastatic (N+ or M1) disease, or an increase in prostate-specific antigen (PSA) level after radical prostatectomy. Patients received goserelin acetate 10.8-mg depot every 12 weeks until clinical progression or interruption for adverse events or other reasons. RESULTS: The mean testosterone concentrations were suppressed to the castration range (< or =2 nmol/l) after 4 weeks of treatment and remained suppressed throughout the study. In total, 99/115 (86%) patients had a serum PSA response, and the mean PSA value decreased significantly during treatment (p = 0.006). The mean PSA level at baseline was significantly lower in patients without disease progression compared to those who experienced disease progression (p = 0.0002). Goserelin acetate 10.8-mg depot was well tolerated and there were no injection site reactions. CONCLUSIONS: The goserelin acetate 10.8-mg depot is well tolerated with no injection site reactions. It produces PSA responses and provides reliable suppression of serum testosterone.