Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial.

OBJECTIVES: To study the efficacy and safety of a new transurethral microwave thermotherapy device (the Urowave) in the treatment of men with clinical benign prostatic hyperplasia (BPH) in a randomized, double-blind, sham-controlled trial. METHODS: A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association symptom index (AUA SI) of 13 points or more, and a peak flow rate of 12 mL/s or less were enrolled and randomized 2:1 for active versus sham treatment. All treatments were conducted as an outpatient procedure under local anesthesia, with oral sedation and analgesia only. Patients were followed up at 1 week and 1, 3, and 6 months after treatment. RESULTS: The treatments were well tolerated, and no patient received general or spinal anesthesia. The AUA SI dropped from 23.6 to 12.7 points at 6 months (P < 0.05) in the active group and from 23.9 to 18.0 points in the sham-treated group (P < 0.05, between-group difference). Statistically significant improvements were also noted for peak flow rate (7.7 to 10.7 mL/s at 6 months for active treatment, 8.1 to 9.8 mL/s for sham treatment, P < 0.05, between-group difference) and for average flow rate. A decrease in AUA SI of more than 30% was achieved in 72% versus 38% of patients (active versus sham treatment, respectively) and more than 50% in 50% versus 19% of patients. In general, active Urowave-treated patients perceived "a lot" of improvement, whereas sham-treated patients perceived "a little" to "some" improvement. More of the actively treated patients had dysuria and urgency after treatment, and ejaculatory dysfunction (e.g., hematospermia) was more common in actively treated patients as well. Secondary urinary retention after removal of the catheter occurred in 8 patients (5.4%). CONCLUSIONS: The Dornier Urowave transurethral microwave thermotherapy device for treatment of clinical BPH is effective in decreasing symptoms and bother and improving quality of life and flow rate and is superior to sham treatment. Patients perceive a great deal of improvement, independent of their baseline symptom severity. Adverse events are in general transient and mild in nature. Extended follow-up is necessary to document long-term durability of improvements.

Adjuvant chemotherapy combination of vinblastine, actinomycin D, Bleomycin, and Chlorambucil following retroperitoneal lymph node dissection for stage II testis tumor.

In an attempt to reduce recurrence of nonseminomatous germ cell tumors of testis stage II, 62 patients were treated with vinblastine, actinomycin D, bleomycin, and chlorambucil after retroperitoneal lymph node dissection. Of the patients, 84% have remained in complete remission with median follow-up of three years: 33/33 stage II-A (N-1,N-2A) and 19/29 (66%) stage II-B (N-2B,N3). The relapse rate in patients who had histologic evidence of extranodal extension of the tumor (N-3) was 54% (7/13). This program did not cause any serious toxicity. Adjuvant chemotherapy is effective in reducing relapses. More recently, with the current availability of chemotherapy with a high efficacy for control of disseminated disease, patients with resected stage II-A (N-1,N2A) have been followed closely and treated only if they developed evidence of recurrence. Patients with resected stage II-B (N-2B,N-3) have been placed on a more aggressive adjuvant program.

A critical analysis of response criteria in patients with prostatic cancer treated with cis-diamminedichloride platinum II.

Cis-diamminedichloride platinum II (DDP), 50--70 mg/m2 iv, q 3w was administered to 25 patients with Stage D adenocarcinoma of the prostate. Since the assessment of tumor regression in a disease-oriented phase II study demands a clear end-point of response, case selection was restricted to patients who had objectively measurable lesions, i.e., nodes, skin, lung, and liver metastasis. Partial remission occurred in 3 (12%) and stabilization of disease in 1 patient. Responders lived 53 weeks vs. 20 weeks for non-responders. In the dosage and schedule used in this protocol, DDP was not an active agent in the treatment of prostatic cancer. Various patient characteristics are examined and correlations made between remission rates and survival in this study vs. 4 other response schemata. A critical analysis of patient selection, "lead time" -- diagnosis to chemotherapy, and the definitions of the terms "measurable" lesions, "evaluable" parameters, "objective response", stabilization of disease and response criteria employed in the 4 schemata are also discussed.

Complications of 125iodine implantation and pelvic lymphadenectomy in the treatment of prostatic cancer.

The operative, postoperative and late complications experienced by 300 consecutive patients who underwent 125iodine implantation and pelvic lymphadenectomy for localized prostatic cancer were analyzed. Of the patients reviewed 68 per cent had clinical stage B lesions, while 32 per cent had clinical stage C lesions. The incidence of intraoperative complications was 6 per cent. There were 2 postoperative deaths and 23 per cent of the patients had postoperative complications. Of 177 patients followed postoperatively for 6 months or more (mean 29.3 months) late morbidity was experienced by 49 (28 per cent). The incidence of impotence in 109 patients who were potent preoperatively and who were followed for a minimum of 15 months was 7 per cent.

Radical cystectomy with or without planned preoperative irradiation in the treatment of bladder cancer.

A retrospective analysis of 342 patients with carcinoma of the bladder treated by radical cystectomy at Memorial Sloan Kettering Cancer Center with or without planned preoperative irradiation revealed that preoperative irradiation significantly improved survival of patients with deeply infiltrating tumours (pathological Stage B2 and C), and reduced the prognostic importance of distinctions between pathological B1 and B2 neoplasms. Preoperative irradiation had no discernible effect on the survival of patients with superficially infiltrating neoplasms.

Prostatic adenocarcinoma: relationship of grade and local extent to the pattern of metastases.

In 100 consecutive cases of prostatic adenocarcinoma treated by pelvic lymphadenectomy and interstitial implantation of 125I the relationship of tumor stage, size and grade was analyzed relative to the incidence and site of metastases, and the response of the primary tumor to irradiation. High stage, large size and poor histological differentiation were associated with a significantly higher probability of pelvic node metastases. The response of the primary tumor to irradiation was significantly higher among patients with small stage B tumors and/or those with negative pelvic lymph nodes. Important determinants of metastases subsequent to 125I implantation were the large size of the primary tumor, poor histological differentiation, seminal vesicle invasion, large (more than 3 cc) volume of lymph node metastases and absence of local prostatic response to irradiation.