Bladder cancer mortality in the Epirus district population (Greece).

OBJECTIVE: To describe the pattern of bladder cancer mortality in the Epirus district population (North-Western Greece) and to establish some relationships with cigarette smoking. PATIENTS AND METHODS: Mortality rates of bladder cancer in the Epirus district population were analysed according to the official data from the Department of Statistics of the University Hospital of Ioannina during the last decade (January 1990-January 2000). Age standardization of death rates was done by the direct method, using the world population as a standard. Fisher's test was used as a significance test for linear regression coefficient in time trend analysis of mortality. RESULTS: The average annual standardized mortality rates from bladder cancer during the study period were 5.23 per 100,000 population (96% Confidence Interval--Cl 4.02-5.63) in males and 1.63 per 100,000 population (96% Confidence Interval--CI 1.18-1.96) in females. Significantly increasing trends of the rates were observed in males (y = 2.421 + 0.231x; p < 0.01), but not in females (y = 1.263 + 0.027x: p > 0.05). The greatest increase in age - specific rates in males was observed in the age group of 70 and more years (y = 25.602 + 3.673x; p < 0.01). In females, all age--specific rates except for the group 60-69 years showed significantly increasing tendency. The increasing tendency of bladder cancer mortality is followed by the rise of per capita cigarette consumption among the Epirus district population. CONCLUSION: Further studies are needed for the explanation of the irregularities in the age-specific rates.

Intravesical bacillus Calmette-Guérin versus epirubicin in the prophylaxis of recurrent and/or multiple superficial bladder tumours.

A prospective, randomized trial was conducted to evaluate and compare the effects of modified adjuvant intravesical bacillus Calmette-Guérin (BCG) and epirubicin regimens in patients with superficial bladder cancer. One hundred thirty-two individuals with recurrent and/or multiple neoplasms, i.e. at high risk for tumour recurrence and progression, were enrolled. After complete transurethral resection of their tumours, the patients received a 6-week course of BCG instillations or an early 4-week course of epirubicin instillations as their initial therapy. Those with stage Ta and grade 1 neoplasms who remained free of recurrences received maintenance therapy consisting of single quarterly instillations. However, for those with stage T1 cancer of any grade or stage Ta of grade 2 or 3 neoplasms who also remained free of recurrences, the treatment schedules were modified: they received, instead of single maintenance doses, 3 weekly instillations of epirubicin at months 3 and 6 of follow-up, or a 3-week course of BCG at month 6 of follow-up. The recurrence-free rates did not differ significantly between the two study groups (44% for epirubicin versus 55% for BCG), for an identical median follow-up of 43 months. However, in terms of relative risk of recurrences, disease-free intervals and recurrence rate per 100 patient-months, a significant benefit in favour of BCG when compared with epirubicin was demonstrated in patients who had stage T1 or grade 3 neoplasms.

BCG versus epirubicin in the prophylaxis of multiple superficial bladder tumours: results of a prospective randomized study using modified treatment schemes.

A prospective randomized trial on 94 eligible patients evaluated and compared the efficacy of adjuvant intravesical epirubicin and bacillus Calmette-Guérin (BCG) after complete resection of multifocal superficial bladder cancer. BCG treatment schedule consisted of an induction 6-week course of instillations (150 mg Pasteur BCG per instillation) and single maintenance doses to patients who remained free of recurrences at follow-up examinations for a total treatment period of 2 years. These initial responders received additionally a separate 4-week course of therapy 6 months after the start of treatment. Chemoprophylaxis included an early (on the second postoperative day) instillation followed by 4 weekly treatments with epirubicin (50 mg per instillation) and then by 10 monthly treatments for the initial responders during the first year of follow-up and at every follow-up examination for a total treatment period of 2 years. The overall treatment results did not differ significantly between the 2 arms (54% of patients of the epirubicin group remained free of recurrences compared to 65% of those treated with BCG) for an identical mean follow-up of 35.1 months. However, a significant benefit in favour of BCG when compared with epirubicin was shown in patients who had stage T1 and grade 3 tumours and in terms of relative risk of recurrences, disease-free interval and recurrence rate per 100 patient-months. Both drugs were proved to be safe with manageable toxicity.

Intravesical 4'-epi-doxorubicin (epirubicin) versus bacillus Calmette-Guérin. A controlled prospective study on the prophylaxis of superficial bladder cancer.

BACKGROUND: The selection of the most appropriate antineoplastic agent and optimal treatment schedule for the prophylaxis of superficial bladder cancer against tumor recurrences is the subject of continual investigations. METHODS: A controlled prospective trial involving 161 patients evaluated and compared the efficacy of intravesical epirubicin and bacillus Calmette-Guérin (BCG) administration as prophylaxis against recurrences after complete transurethral resection of superficial bladder cancer. The treatment schedule, consisting of one 6- or 8-week course of instillations (50 mg epirubicin or 150 mg BCG per instillation) followed by single maintenance doses to the responders at follow-up examinations, was modified for those of the initial responders who were at high risk for recurrence and who received an additional separate 4-week course of treatment 6 months after the start of therapy. RESULTS: Sixty percent of the patients treated with epirubicin, 68% of the patients treated with BCG, and 41% of the control subjects, who underwent resection only, remained free of recurrences for a mean follow-up of 32.9 months. The only significant difference was found between patients treated with BCG and control subjects, in favor of the former. Conversely, recurrence rate per 100 patient-months and mean interval to recurrence showed both drugs to be superior to resection alone regarding several tumor characteristics. However, a significant benefit in favor of BCG when compared with epirubicin was shown in those patients who had Stage T1 and Grade 3 tumors at presentation. CONCLUSIONS: Intravesical epirubicin and BCG were superior to transurethral resection alone in the prophylaxis of superficial bladder cancer, but with respect to superficially invasive and high-grade tumors, BCG demonstrated a remarkable advantage.

Intravesical bacillus Calmette-Guerin immunoprophylaxis of superficial bladder cancer: results of a controlled prospective trial with modified treatment schedule.

A controlled prospective trial on 94 patients evaluated the efficacy of intravesical Pasteur strain bacillus Calmette-Guerin (BCG) administration as prophylaxis against tumor recurrences after complete endoscopic resection of superficial bladder cancer. The treatment schedule, consisting of an initial 6-week course of instillations and a single quarterly maintenance dose to the responders, was modified to those of the latter who were at high risk for recurrence and who received an additional separate 4-week course of therapy. The percentage of the patients treated prophylactically with BCG and who remained free of recurrences (68%, mean followup 33.8 months) was significantly higher than that of the controls who underwent transurethral resection only (41%, mean followup 30.2 months). In terms of relative risk of recurrences, recurrence rate per 100 patient-months and disease-free interval, comparisons between the 2 groups of patients revealed a significant benefit for the BCG group overall as for those subjects having stages Ta and T1 tumors, multifocal tumors, a history of disease, and grades 2 and 3 carcinoma. Drug-induced toxicity was acceptable. Our study suggests that our modified treatment protocol is notably safe and effective against recurrent superficial bladder cancer.

Intravesical instillations of 4-epi-doxorubicin (epirubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study.

A controlled prospective study in 65 patients was done to evaluate the efficacy of intravesical epirubicin administration as prophylactic treatment in regard to the pattern of tumor recurrences after complete endoscopic resection of superficial transitional cell carcinoma of the bladder. Intravesical instillations of the drug were given weekly for 6 consecutive weeks and to the responders an intermittent maintenance therapy was administered for the first 2 years after each followup examination. Of the patients treated prophylactically with epirubicin 37% had recurrence within a total of 1,136 patient-months compared to 55% of the controls who were followed for a total of 436 months, a difference that was not statistically significant (p greater than 0.05). However, examining the results in another manner, the control patients demonstrated a significantly shorter mean interval to recurrence and higher recurrent tumor rate per 100 patient-months. To clarify further the efficacy of epirubicin therapy, comparisons of the treatment outcome according to several tumor factors were done. These comparisons revealed a significant benefit for those who received epirubicin with respect to history of tumor recurrences and multiplicity at presentation. Drug-induced toxicity was acceptable. Our study suggests that epirubicin is safe and effective against the recurrence of superficial bladder cancer.