Bacillus Calmette-Guérin Is Superior to a Combination of Epirubicin and Interferon-alpha2b in the Intravesical Treatment of Patients with Stage T1 Urinary Bladder Cancer. A Prospective, Randomized, Nordic Study.
BACKGROUND: Bacillus Calmette-Guérin (BCG) instillation is regarded as the most effective bladder-sparing treatment for patients with high-grade T1 tumours and carcinoma in situ (CIS). The major problem with this therapy is the side-effects, making maintenance therapy difficult, even impossible, in a proportion of patients. Thus, alternative schedules and drugs have been proposed. OBJECTIVE: To compare BCG to the combination of epirubicin and interferon-alpha2b as adjuvant therapy of T1 tumours. DESIGN, SETTING, AND PARTICIPANTS: This is a Nordic multicenter, prospective, randomised trial in patients with primary T1 G2-G3 bladder cancer. Initial transurethral resection (TUR) was followed by a second-look resection. Patients were randomised to receive either regimen, given as induction for 6 wk followed by maintenance therapy for 2 yr. MEASUREMENTS: The drugs were compared with respect to time to recurrence and progression. Also, side-effects were documented. RESULTS AND LIMITATIONS: A total of 250 patients were randomised. At the primary end point, 62% were disease free in the combination arm as opposed to 73% in the BCG arm (p=0.065). At 24 mo, there was a significant difference in favour of the BCG-treated patients (p=0.012) regarding recurrence, although there was no difference regarding progression. The subgroup analysis showed that the superiority of BCG was mainly in those with concomitant CIS. In a multivariate analysis of association with recurrence/progression status, significant variables for outcome were type of drug, tumour size, multiplicity, status at second-look resection, and grade. A corresponding analysis was performed separately in the two treatment arms. Tumour size was the only significant variable for BCG-treated patients, while multiplicity, status at second-look resection, and grade were significant for patients treated with the combination. CONCLUSIONS: For prophylaxis of recurrence, BCG was more effective than the combination. There were no differences regarding progression and adverse events between the two treatments.
Objective. There is an impression that ureteric injuries have become more common during the past decade, and therefore this study aimed to determine the incidence, aetiology, features, treatment and outcomes of ureteric injuries over an extended period. Material and methods. Records of patients treated for ureteric injury in 1986-2006, divided into three 7-year periods, were reviewed retrospectively. The numbers of open and laparoscopic gynaecological, surgical and endourological operations were ascertained. Results. All 72 ureteric injuries recorded were iatrogenic, being diagnosed in 60 females and 11 males (mean age 52 years). Only five injuries occurred during the first 7-year period (1986-1992), but the incidence was markedly higher during the following two 7-year periods, 28 (1993-1999) and 39 (2000-2006), respectively. The injuries were mostly secondary to gynaecological procedures (64%) or general surgery (25%). Only 11% occurred in association with a urological procedure. The cause was mostly laparoscopic (56%) or open surgery (33%), and the injury was in most cases located in the lower ureter (89%). The diagnosis was usually delayed (in 79%), with a median time to diagnosis of 6 days. The injuries were managed by ureteroneocystostomy (49%), a ureteral stent (19%) or end-to-end anastomosis (12%). The complication rate was 36%. Conclusions. Iatrogenic ureteric injuries have increased markedly during the past two decades. Gynaecological laparoscopic procedures account for more than half of the injuries, and the most common location is the lower ureter. Most injuries are treated by ureteroneocystostomy, but endourological treatment yields acceptable results. To improve the management of ureteric injury there must be a high index of suspicion, especially during laparoscopic operations.