Should all patients with non-muscle-invasive bladder cancer receive early intravesical chemotherapy after transurethral resection? The results of a prospective randomised multicentre study.

BACKGROUND: To decrease recurrences in non-muscle-invasive bladder cancer (NMIBC), the European Association of Urology (EAU) guidelines recommend immediate, intravesical chemotherapy after transurethral resection (TUR) for all patients with Ta/T1 tumours. OBJECTIVE: To study the benefits of a single, early, intravesical instillation of epirubicin after TUR in patients with low- to intermediate-risk NMIBC. DESIGN, SETTING, AND PARTICIPANTS: In this prospective randomised multicentre trial, 305 patients with primary as well as recurrent low- to intermediate-risk (Ta/T1, G1/G2) tumours were enrolled between 1997 and 2004. Patients were randomly allocated to receive 80 mg of epirubicin in 50 ml of saline intravesically within 24 h of TUR or no further treatment after TUR. MEASUREMENTS: The primary end point was time to first recurrence. RESULTS AND LIMITATIONS: A total of 219 patients remained for analysis after exclusions. The median follow-up time was 3.9 yr. During the study period, 62% (63 of 102) of the patients in the epirubicin group and 77% (90 of 117) in the control group experienced recurrence (p=0.016). In a multivariate model, the hazard ratio (HR) for recurrence was 0.56 (p=0.002) for early instillation of epirubicin versus no treatment. In a subgroup analysis, the treatment had a profound recurrence-reducing effect on patients with primary, solitary tumours, whereas it provided no benefits in patients with recurrent or multiple tumours. Furthermore, patients with a modified European Organisation for Research and Treatment of Cancer (EORTC) risk score of 0-2 with and without single instillation had recurrence rates of 41% and 69%, respectively (p=0.003), whereas the corresponding rates for those with a risk score of > or = 3 were 81% and 85%, respectively (p=0.35). CONCLUSIONS: A single, early instillation of epirubicin after TUR for NMIBC reduces the likelihood of tumour recurrence; however, the benefit seems to be minimal in patients at intermediate or high risk of recurrence. Future trials will determine the value of early instillation in addition to serial instillations in NMIBC.

Interstitial laser coagulation versus transurethral resection of the prostate for benign prostatic enlargement--a prospective randomized study.

OBJECTIVE: Interstitial laser coagulation (ILC) of the prostate is a minimally invasive method for treating symptomatic benign prostatic enlargement (BPE). We performed a prospective randomized study to compare the clinical outcomes of ILC and transurethral resection of the prostate (TURP). MATERIAL AND METHODS: Between December 1997 and February 2000, 38 patients with moderate-to-severe symptomatic BPE were included in the study. Seven were subsequently excluded due to intercurrent disease or protocol violation and the remaining 31 were randomized to either TURP (n=11) or ILC (n=20). A suprapubic tube was inserted in all ILC-treated patients, and ILC was performed as an outpatient procedure when feasible. Data were recorded preoperatively and at 3-month and 1-year follow-up. The assessment parameters were International Prostate Symptom Score (IPSS), uroflow, prostate volume determined by means of transrectal ultrasound and postvoid residue. RESULTS: At 1-year follow-up, uroflowmetry indicated a more pronounced increase in peak urinary flow rate (Qmax) in the TURP patients than in the ILC subjects (p<0.02). Differences in postvoid residue, IPSS and prostate volume between the two treatments could not be evaluated due to the small number of patients in each group. Postoperative urinary tract infections occurred in 13 ILC patients but in only one TURP subject, and catheterization was done for 24 days after ILC and for 2 days after TURP. The study was ended prematurely due to the prolonged postoperative catheterization and the high rate of urinary tract infections in the ILC patients. CONCLUSIONS: At 1-year follow-up, the increase in Qmax was smaller in the ILC subjects than in the TURP patients. The ILC subjects had comparatively more postoperative urinary tract infections and more prolonged postoperative catheterization than the TURP patients.