ABSTRACT
Bacillus Calmette-Guerin [BCG] therapy is the standard treatment for nonmuscle-invasive bladder cancer [NMIBC]. However, its toxicity is a major concern. If we reduce the number of BCG doses by half and replace the second half with epirubicin, we may have a lower toxicity while maintaining the same efficacy of BCG. To test this hypothesis, we conducted this study as an update of our previous report. The study included 607 patients with Ta and T1 NMIBC between January 1994 and December 2008. After transurethral resection of bladder tumor [TURBT], the patients received weekly doses of 120 mg BCG alternating with 50 mg epirubicin for six weeks [three weekly doses of each]. Maintenance was given. Recurrence, progression rates, and toxicity were assessed. End points were progression, recurrence, and cancer-specific survival. A total of 532 patients were eligible for evaluation [mean age: 58 years; median follow-up: 45 months]. Of these, 291 [55%] were free, 157 [29.5%] showed recurrence, and 84 [15.8%] showed muscle-invasive progression. Toxicity developed in 221 patients. These were mild in the majority [167], whereas 10 developed hematuria, 30 severe cystitis, and five systemic complications. The rate of permanent therapy discontinuation was 3.8%. SPSS package version 16 and Kaplan-Meier curves were used to evaluate survival. Reducing the frequency of BCG instillations by half and replacing the second half with epirubicin results in a similar efficacy and a lower toxicity compared with historical cases receiving BCG alone. However, further trials are required to support these results
Subject(s)
Humans , Male , Female , BCG Vaccine , Epirubicin , Administration, Intravesical , BCG Vaccine/toxicityABSTRACT
The optimal time of cystectomy for nonmuscle invasive bladder cancer [NMIBC] is controversial. This study aims at comparing cancer-specific survival in primary versus deferred cystectomy for T1 bladder cancer. Between 1990 and 2004, a retrospective cohort of 204 patients was studied. Primary cystectomy at the diagnosis of NMIBC was performed in 134 patients [group 1] and deferred cystectomy was done after failed conservative treatment in 70 [group 2] Both groups were compared regarding patient and tumor characteristics and cancer-specific survival. Cancer-specific survival was calculated using the Kaplan-Meier method. Mean follow-up was 79 and 66 months, respectively, in the two groups. Tumor multiplicity was more frequent in group 2; otherwise, both groups were comparable in all characteristics. The definitive stage was T1 in all patients. Although the 3-year [84% in group 1 vs. 79% in group 2], 5-year [78% vs. 71%] and 10-year [69% vs. 64%] cancer-specific survival rates were lower in the deferred cystectomy group, the difference was not statistically significant. In group 2, survival was significantly lower in cases undergoing more than three transurethral resections of bladder tumors [TURBT] than in cases with fewer TURBTs. Cancer-specific survival is statistically comparable for primary and deferred cystectomy in T1 bladder cancer, although there is a non-significant difference in favor of primary cystectomy. In the deferred cystectomy group, the number of TURBTs beyond three is associated with lower survival. Conservative treatment should be adopted for most cases in this category
ABSTRACT
The aim of this work is to evaluate the hemodynamic changes of leptin administration to rabbits. A total of 18 male New Zealand rabbits, weighing from 1 to 1.5 kg were included in this study. After induction of anesthesia, basal arterial blood pressure [Am, sodium [Na+], potassium [K+] and creatinine concentrations in both blood and urine samples were evaluated. The animals were then randomly assigned to 3 groups of 6 each. Group I [control] received isotonic saline by intravenous infusion. Group II [study group] received intra-arterial injection of leptin [10 micro g/kg] for one Hour followed by a 10-Jold higher dose of leptin. Group III [negative control] received intravenous bolus injection of propranolol [0.1 mg] for one hour followed by a similar dose for the next hour. Administration of leptin resulted in slight increase in mean arterial pressure [MAP] that reached significance after 90 min and persisted above the basal level for the recording period of 2 hours. There were no parallel changes, at either doses, infraction reabsorption of Na+, K+, H20 and glomerular filtration rate [GFR] as compared to both basal values and to control animals. It was concluded that the elevation in MAP induced by leptin was most probably not related to renal mechanism, as there were no significant changes in renal parameters studied. This suggests another mechanism for the rise in MAP, a suggestion which needs further studies
ABSTRACT
Sequential immuno-chemotherapy using bacillus Calmette-Guerin [BCG] and epirubicin has been found to be as effective as and less toxic than BCG alone in recurrence prophylaxis of superficial bladder tumors. Some investigators speculated that: if intravesical chemotherapy is instilled before immunotherapy it will produce inflammation and denudation of the mucosa so that the submucosa will be ready for a potentiated effect of the immunotherapy. To test this hypothesis we conducted this study. Between Jan. 1993 and July 1999 a prospective randomized trial was performed on 159 patients who underwent transurethral resection [[TURBT] of bladder transitional cell carcinoma [stages pTa and pTl]. Following TURBT, patients were randomly allocated to 2 treatment arms. Patients in arm I [78] received weekly doses of 150 mg BCG alternating with 50 mg epirubicin for 6 weeks. Maintenance was carried out by a monthly course of the same doses of BCG alternating with epirubicin for 10 months. Patients in arm II [81] received thy same protocol, but with a reversed order with epirubicin being used initially. 154 patients; 108 men and 36 women, mean age 59 years, were evaluable. 5 patients were excluded in view of severe side effects [3 in arm 1 and 2 in arm II]. Follow up ranged from 12 to 74 months [mean 38 +/- 16.9]. Recurrence rate was] comparable in the 2 arms: 11/75 [14.7%] and 13/79 [16.5%], respectively. Recurrence rate per 12 patient months was again; comparable: 0.08 and 0.09, respectively. Interval to first recurrence and progression rate were also comparable. Toxicity developed in 29% and 26.6% of patients, respectively [p > 0.05]. Both treatment policies were comparable in terms of efficacy and loxicity