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PubMed1989

Cystectomy: the treatment of choice in patients with carcinoma in situ of the urinary bladder?

Patients (n = 46) with carcinoma in situ (Tis) of the urinary bladder were treated by intravesical chemotherapy. The complete remission rate was 75%. After a mean interval of 17 months recurrent tumours were diagnosed in 47%. Radical cystectomy with urethrectomy was performed in eight patients. Distal ureterectomy and uretercystoneostomy was done in six patients because of a distal ureteric tumour. Based on this group of 46 patients and the current literature, the following criteria are essential in indicating cystectomy: (1) micro-invasion; (2) persistent Tis after adequate intravesical treatment; (3) progressive tumour; (4) Tis of ureter and/or prostate; (5) tumour recurrence at more advanced stage.

Administration, Intravesical↗
PubMed1996

Up-front intravesical chemotherapy for low stage, low grade recurrent bladder cancer.

PURPOSE: We evaluated the ablative and prophylactic potential of short schedule, up-front topical chemotherapy on low stage and grade recurrent bladder tumors. MATERIALS AND METHODS: The study design consisted of 4 weekly instillations followed by transurethral resection during week 5. Mitomycin C was administered initially and mitoxantrone was administered following the same schedule if disease recurred during followup. RESULTS: After up-front mitomycin C, 29 of 42 patients (69%) had a complete response with no need for transurethral resection, whereas residual disease was resected in the remaining 13 (31%). Disease recurred during followup in 22 of the 42 patients (52.4%), who were then treated with up-front mitoxantrone with a complete response in 14 (63.7%). Residual disease was resected in 8 patients (36.3%) with progression to grade 3 in 2. CONCLUSIONS: Short schedule intravesical chemotherapy can completely ablate small volume recurrent superficial bladder cancer in a relevant number of patients but it is not adequate prophylaxis.

Administration, Intravesical↗
PubMed1999

[Postoperative prophylactic intravesical instillation of tetrahydropyranyl-adriamycin (THP) for superficial bladder cancer].

Intravesical instillation of tetrahydropyranyl-adriamycin (THP) was performed on 51 patients with superficial bladder cancer after transurethral resection (TUR) for prophylaxis of recurrence. The instillation was carried out with 20 mg of THP dissolved in 40 ml of distilled normal saline. Instillation was performed once 24 hours postoperatively, 9 times every 2 weeks, and 8 times every 4 weeks. These drugs were instilled for 30 to 60 minutes. The recurrence-free survival at 1, 2 and 3 years was 74.5%, 64.6% and 58.0%, respectively. Side effects of THP instillation were observed in only 4 cases (7.8%) as slight urinary frequency or micturition pain. Cases involving 5 or more tumors, or tumors measuring 3 cm or larger, more frequently demonstrated recurrence. The cases that did not respond to preoperative intravesical instillation of THP demonstrated a high frequency of recurrence. Intravesical instillation of THP as a prophylaxis against recurrence of superficial bladder cancer was effective in selected patients.

Administration, Intravesical↗
PubMed1991

Long-term complete remission in bladder carcinoma in situ with intravesical TICE bacillus Calmette Guerin. Overview analysis of six phase II clinical trials.

Carcinoma in situ is a form of superficial transitional cell carcinoma, which is characterized by a lateral spread along the bladder epithelium, with high-grade malignancy and poor prognosis. Early radical cystectomy is considered the definitive treatment even in the absence of associated invasive cancer. In six prospective phase II studies, 123 carcinoma in situ patients were administered intravesical TICE bacillus Calmette-Guerin (BCG). Treatment consisted of at least six weekly instillations (induction) followed by twelve monthly instillations (maintenance) of BCG (50 mg: 1 to 8 x 10(8) colony-forming units). Of 119 evaluable patients, 90 (76%) achieved complete remission including 45 of 63 (71%) patients who received prior intravesical chemotherapy. Forty-five responders (50%) remain in complete remission with negative urine cytology with a median duration of response projected to be greater than or equal to forty-eight months. There is no difference in survival between BCG responders and nonresponders, but there is a significant difference in cystectomy rates: 10 of 90 (11%) responders vs. 16 of 29 (55%) nonresponders (P less than 0.0001, Fisher's exact test) and time to cystectomy (31 vs. 74 mos.) (P less than 0.001, log-rank test). Delaying cystectomy does not seem to affect survival and improves quality of life. Treatment was well tolerated with some major adverse effects. Intravesical TICE BCG is an effective treatment for bladder carcinoma in situ patients with or without prior chemotherapy.

Administration, Intravesical↗
PubMed2006

Remitting seronegative symmetrical synovitis pitting oedema after BCG instillation.

Remitting seronegative symmetrical synovitis pitting oedema (RS3PE) is a distinct form of seronegative rheumatoid arthritis like polyarthritis. It is characterized by late onset symmetrical joint involvement and pitting oedema of hands and feet (JAMA 254(19):2763-2767, [1]). Polyarthritis secondary to intravesical Bacillus Calmette Guerin (BCG) therapy has been reported (Clin Rheumatol 21:536-537, [2]). To our knowledge, about 0.5% of patients receiving BCG instillation presented polyarthritis, but only one case of RS3PE has been reported (J Rheumatol 28:1699-1701, [3]). We described the second case of RS3PE following intravesical BCG instillation of bladder carcinoma.

Adjuvants, Immunologic↗
PubMed1989

Renal failure after intravesical mitomycin C.

Severe side effects, local or systemic, are uncommon with intravesically administered mitomycin C. Bladder fibrosis and contracture, with resultant renal failure, are unusual but possible.

Acute Kidney Injury↗
PubMed1992

Management of stage T1 superficial bladder cancer with intravesical bacillus Calmette-Guerin therapy.

We reviewed our results with 86 patients who had a pretreatment history of a stage T1 tumor. All patients were treated with transurethral resection of all visible tumor followed by intravesical bacillus Calmette-Guerin (BCG) and many patients received additional maintenance therapy. Local recurrences were treated with repeat transurethral resection followed by additional BCG. Median followup was 59 months, with a range of 9 to 149 months. Overall, 78 of 86 patients (91%) were free of tumor recurrence with BCG therapy. This result includes 69% of the patients who responded to the initial transurethral resection and intravesical BCG, and 22% who ceased having tumors after additional treatments for local recurrences. Only 7% of the patients had progression to stage T2 tumors after BCG therapy. Grade of the stage T1 tumor, concurrent carcinoma in situ and tumor multiplicity before BCG did not predict tumor recurrence or progression. Of patients with recurrences after BCG therapy, those with stage T1 tumors had a higher rate of progression compared to those with stage Ta tumors but the difference was not statistically significant (p = 0.086). These data clearly support the efficacy of transurethral resection plus intravesical BCG immunotherapy in the treatment of stage T1 tumors as well as in the prevention of disease progression.

Administration, Intravesical↗
PubMed2003

Contemporary management of superficial bladder cancer in the United States: a pattern of care analysis.

OBJECTIVES: To assess the practice preferences among urologists treating superficial bladder cancer in the United States. METHODS: We surveyed 226 urologists using a specially designed survey instrument. The type of practice, number of urologists in group practice, annual volume of patients with bladder cancer, and those treated with intravesical therapy were assessed. We also obtained information on the American Urological Association section and year of graduation from urology residency training. RESULTS: Of the 226 contacted urologists, 105 (46%) returned a completed survey instrument. Seventeen percent were practicing in academic institutions and 63% were in independent community practice. Forty-five percent had graduated from urology training in or before 1985. Thirty-six percent were in small and 37% were in moderate-size groups. Thirty-five percent were treating a moderate number of patients with bladder cancer, and 44% were treating a large number of patients annually. Thirty-two percent had a moderate number and 40% had a large number of patients receiving intravesical therapy annually. Immunotherapy was preferred in patients at high risk of recurrence. Intravesical chemotherapy was preferred by many for immunotherapy failure. The type of practice and year of graduation were the factors most frequently affecting treatment choice. CONCLUSIONS: Practice preferences for the management of superficial bladder cancer are in general agreement with the American Urological Association Bladder Cancer Guidelines Panel recommendations. However, 81% of surveyed urologists were still reluctant to refer patients with high-grade Ta-T1 disease with failure after intravesical immunotherapy twice for more aggressive therapy such as cystectomy or radiotherapy.

Administration, Intravesical↗
PubMed1996

Determination and reversal of resistance to epirubicin intravesical chemotherapy. A confocal imaging study.

OBJECTIVE: To evaluate the use of confocal microscopy in the study of resistance to epirubicin and to determine the effect of temperature, viability and a resistance-reversing agent on the intracellular distribution of this drug in sensitive and resistant derivatives of a superficial bladder cancer cell line. MATERIALS AND METHODS: Viable and non-viable adherent cells were incubated in epirubicin solutions under various conditions. After incubation, the distribution of intracellular epirubicin fluorescence was visualized using confocal microscopy and a x50 water-immersion lens. RESULTS: There was a striking and consistent difference between resistant and sensitive cells in the intracellular distribution of the drug. In addition to having greater overall levels of epirubicin fluorescence, sensitive cells accumulated epirubicin predominantly in the nucleus. Epirubicin fluorescence in resistant cells was cytoplasmic and granular in appearance. When incubated at 0 degrees C, both cell lines showed no nuclear uptake and thus resembled resistant cells at 37 degrees C. However, dead cells rapidly acquired brightly fluorescent nuclei. The resistance-reversing agent verapamil appeared to cause reversion of the resistant to the sensitive phenotype. CONCLUSION: Confocal microscopy allows epirubicin-sensitive and resistant cultured tumour cells to be differentiated reliably and provides information about the mechanisms of action of, and resistance to, epirubicin. Applying this technique to clinical specimens should enable patients who have the resistant phenotype to be detected and the efficacy of intravesical resistance-reversing agents to be evaluated in such cases.

Administration, Intravesical↗
PubMed2005

Bacillus calmette-guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials.

PURPOSE: We determined the short-term and long-term efficacy of bacillus Calmette-Guerin (BCG) and chemotherapy in the treatment of patients with carcinoma in situ (CIS). MATERIALS AND METHODS: A meta-analysis was performed on published results of randomized clinical trials comparing intravesical BCG to intravesical chemotherapy. RESULTS: Nine randomized trials including 700 patients with CIS compared BCG to either mitomycin C (MMC), epirubicin, adriamycin, or sequential MMC/adriamycin. Of 298 patients on BCG 203 (68.1%) had a complete response compared with 158 of 307 patients on chemotherapy (51.5%), a reduction of 47% in the odds of nonresponse on BCG (OR 0.53, p =0.0002). Based on a median followup of 3.6 years, 161 of 345 patients on BCG (46.7%) had no evidence of disease compared with 93 of 355 patients on chemotherapy (26.2%), a reduction of 59% in the odds of treatment failure on BCG (OR 0.41, p <0.0001). Although the long-term benefit of BCG was smaller in trials with MMC, BCG was superior to MMC in trials with maintenance BCG (OR 0.57, p =0.04). The reduction of 26% in the risk of progression on BCG (p =0.20) is consistent with the reduction of 27% (p =0.001) previously reported in a larger superficial bladder cancer meta-analysis. CONCLUSIONS: Intravesical BCG significantly reduces the risk of short and long-term treatment failure compared with intravesical chemotherapy. Therefore, it is considered to be the intravesical agent of choice in the treatment of CIS.

Adjuvants, Immunologic↗
PubMed1989

HLA-DR expression by high grade superficial bladder cancer treated with BCG.

The local immune response to intravesical BCG therapy for widespread carcinoma in situ and superficial bladder tumour was assessed using immunohistochemical methods on serial biopsies obtained during treatment. The main findings were the induction of a strong level of HLA-DR expression by urothelial cells which persisted for several months after completion of therapy. This coincided with a mononuclear cell infiltrate in the bladder wall consisting predominantly of activated helper T lymphocytes. Smaller numbers of macrophages, suppressor cytotoxic T lymphocytes and B lymphocytes were also found. These new findings confirm that the inflammatory response to BCG involves the urothelium in an immunological reaction and suggest that the success of immunotherapy with intravesical BCG may be due to enhanced tumour antigen recognition.

Administration, Intravesical↗
PubMed1990

Histopathological effects and recovery rate of rat bladders following intravesical instillation of thiotepa, doxorubicin and mitomycin C.

A study was made of the local reactions and systemic effects induced by intravesical instillations of thiotepa, doxorubicin and mitomycin C in rats. The control group received normal saline. In the 1-dose short-term experiments, rats treated with doxorubicin and mitomycin C had a high incidence of chemical reactions, including congestion of the mucosa with methylene blue stain, increased bladder weight with oedematous changes either in the mucosa (doxorubian) or the muscle layer (mitomycin C), and infiltration of polymorphonuclear cells 3 days after instillation. These local changes disappeared within 10 days. In long-term experiments with weekly instillations of chemotherapeutic drugs, the rats showed no significant change in weight, methylene blue staining or mucosal congestion. A high percentage of pyuria and microscopic haematuria with submucosal/muscular fibrosis was noted in rats receiving doxorubicin or mitomycin C. A severe dysplastic change in the urothelium was noted in rats treated with mitomycin C. These results suggest that careful follow-up is required in patients receiving intravesical doxorubicin or mitomycin C because of possible severe side effects in the bladder.

Administration, Intravesical↗
PubMed1991

Intravesical BCG therapy in bladder carcinoma. Effect on cytotoxicity, IL-2 production and phenotype of peripheral blood mononuclear cells.

The purpose of the study was to examine the effects of intravesical BCG treatment on the cytotoxicity, interleukin-2 (IL-2) production and distribution of the subsets of peripheral blood mononuclear cells (PBMC) in patients with carcinoma in situ of the bladder. Treatments were made in 6 patients during a conventional BCG treatment schedule. Four patients showed a complete response, one a partial response and one had a progressive disease after BCG treatment. Intravesical BCG did not induce significant changes in the cytotoxicity of PBMC. The distribution of NK-cells and T-cells also remained unchanged and so did the lectin induced production of IL-2. The results suggest that the effects of intravesical BCG on the immune system should be studied in lymphocytes isolated from the bladder.

Administration, Intravesical↗
PubMed1993

[The role of lymphocytes and histiocytes as mechanism of action of BCG for bladder cancer].

Antitumor activity of BCG for transitional cell carcinoma of the urinary bladder was evaluated in 103 patients from October, 1983 to October, 1989 at Hirosaki University Hospital. At the same time, the role of various inflammatory cells infiltrating in the bladder wall after intravesical BCG instillation as mechanism of action of BCG was studied. Of 72 patients with superficial bladder cancer, 19 showed a complete response and 28 showed a partial response. The effective rate was 65.3 percent. Significant efficacy was obtained in patients received more than 5 times instillation of BCG. Before intravesical BCG instillation, a small number of lymphocytes or plasma cells infiltrated in the stroma of the tumor. But histiocytes, neutrophils or eosinophils were hardly found. After BCG instillation, the degree of infiltration of each of them tended to increase. The mean degree of infiltration of those inflammatory cells almost all significantly increased in the stroma of the tumor, while only lymphocyte and histiocyte counts significantly increased in both the basal areas of the advancing margin of tumor cells and the tumor free submucosa after BCG instillation. Epithelioid granulomas were recognized almost in the basal areas of the advancing margin of tumor cells and the tumor free submucosa after BCG therapy. Langhans' giant cells were occasionally found within these lesions. In 2 patients marked central necrosis (caseation) was noticed in epithelioid granulomas. In BCG effective cases with superficial bladder cancer lymphocytes and histiocytes increased significantly in all of the stroma of the tumor, the basal areas of the advancing margin of tumor cells and the tumor free submucosa. On the other hand, in BCG noneffective cases they increased significantly only in the stoma of the tumor. Subsets of lymphocytes which increases after intravesical BCG instillation were mainly T pan cells with the predominance of T helper/inducer cells (Th/Ts ratio always > 1).

Administration, Intravesical↗
PubMed1998

[Intravesical instillation of epirubicin in the prophylactic treatment of recurrent superficial bladder cancer].

A retrospective study was performed to determine the efficacy of intravesical instillation of epirubicin in the prophylactic treatment for recurrent superficial bladder cancer when compared with no treatment controls. Seventeen patients with recurrent superficial bladder cancer received epirubicin (30 mg/40 ml in normal saline) seventeen times after transurethral resection (TUR). Historical controls consist of sixteen patients with recurrent superficial bladder cancer who received no adjuvant treatment after TUR. In the epirubicin group, 1-, 2- and 3-year recurrence free rates were 64.7%, 41.2% and 5.9%, respectively. In controls all of them recurred and 1- and 2-year recurrence free rates were 17.6% and 0%, respectively. The recurrence-free rate was significantly higher in the epirubicin group than in the controls (p < 0.05). We investigated whether intravesical instillation of epirubicin prolonged recurrence-free intervals when compared with recurrence-free intervals without adjuvant treatment after TUR in each patient. The 1- and 2-year recurrence free rates after initial TUR were 25% and 12.5%, respectively, and those with epirubicin treatment after TUR were 62.5% and 37.5%, respectively. Recurrence-free intervals were significantly prolonged by intravesical instillation of epirubicin as compared with those without adjuvant treatment in each patient. This study demonstrated the efficacy of intravesical instillation of epirubicin in the prophylactic treatment for superficial recurrent bladder cancer.

Administration, Intravesical↗
PubMedDate not supplied

P53 mutation predicts intravesical adriamycin instillation failure in superficial transitional cell carcinoma of bladder.

BACKGROUND: We studied whether p53 status has any predictive value on the outcome of intravesical adriamycin (ADR) instillation for superficial transitional cell carcinoma (TCC) of the bladder. MATERIALS AND METHODS: Paraffin-embedded specimens were obtained from 70 consecutive patients by transurethral resection (TUR). All patients received intravesical instillation with either Epirubicin (n = 45) or Pirarubicin (n = 25). P53 mutation and overexpression were examined for single-strand conformation polymorphism (SSCP) and immunohistochemistry (IHC), respectively. RESULTS: In 18.2% of tumors, mutation was observed, including exon 5, 6 or 7. P53 overexpression was observed in 22.9% of tumors. High concordance between SSCP and IHC was shown (p = 0.0001), while there was a certain number of discrepant cases. The recurrence-free rate was significantly different between the group with and without p53 mutation, but not stage, grade or p53 IHC. CONCLUSION: P53 mutation predicts the failure of intravesical ADR instillation. Aggressive therapeutic approaches following initial TUR should be considered for patients with p53 mutation.

Administration, Intravesical↗
PubMedDate not supplied

[Topical immunotherapy with BCG in the adjuvant treatment of superficial bladder tumors--15-year-experience].

Between September 1984 and June 1999 we applied a long-term (3 years) protocol treatment (Pasteur strain produced by Cantacuzino Institute) in superficial bladder tumors (SBT) recurrence prophylaxis. In 1014 cases (pTa--11 cases, pT1G1--607 cases, pT1G2--149 cases, pT1G3--247 cases) our retrospective analysis used a personal protocol: 8 weekly intravesical instillations, then monthly instillations until 1 year, then 3 monthly instillations during the following 2 years. Pathologic bladder mucosa (simple, moderate and severe dysplasia, carcinoma in situ) was associated in over 80% of cases. Mean follow-up period was 118 months (range 174 to 6 months). Our results demonstrated the efficiency of this protocol (29.5% recurrences on 840 cases who had complete therapy). The importance of tumoral grading was clearly found: 13% recurrence rate for pT1G1, 39.5% for pT1G2 and 49% for pT1G3. Side-effects (local--78%, systemic--4%) and complications (3%) were treated by symptomatic or antituberculous drugs. Our significative study revealed that intravesical immunotherapy (with BCG vaccine) can be considered the first choice in the complementary treatment of SBT.

Adjuvants, Immunologic↗