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At least 667 records · Page 37Linked to original sources
PubMed1997

Intravesical epirubicin versus doxorubicin for superficial bladder tumors (stages pTa and pT1): a randomized prospective study.

PURPOSE: We performed a prospective, randomized, controlled study to compare intravesical epirubicin and doxorubicin as adjuvant therapy after endoscopic resection of superficial bladder tumor. MATERIALS AND METHODS: We randomly allocated 253 eligible patients to 4 study arms. Seven to 14 days after transurethral bladder tumor resection instillation of the intravesical agent was instituted, including 50 and 80 mg. epirubicin in study arms 1 and 2, respectively, and 50 mg. doxorubicin in arm 3. Control arm 4 included patients who underwent transurethral bladder tumor resection alone. Instillation was repeated weekly for 8 weeks and monthly thereafter to complete 1 year of treatment. All patients were followed every 3 months by cystourethroscopy, urine cytology and deoxyribonucleic acid flow cytometry for 12 to 48 months (mean 30.1). RESULTS: Rates of recurrence were significantly lower in the chemotherapy groups than in controls (p < 0.001) and in the epirubicin groups than in the doxorubicin group (p = 0.02). In arms 1 to 4 recurrence rates were 25, 17.6, 36.7 and 65.6%, respectively. Recurrence rates per 100 patient months were 0.83, 0.60, 1.18 and 2.73, respectively, which were significant statistically, and lower after chemotherapy in general and epirubicin in particular (p < 0.05). Mean interval to first recurrence was 16, 15.4, 18.9 and 6.3 months, respectively, with a significant difference between the chemotherapy and control groups (p < 0.05). Progression to muscle invasive disease occurred in 7 (10.9%), 3 (4.4%), 6 (10%) and 5 patients (8.2%), respectively, in arms 1 to 4 (p > 0.05). We studied the relationships among different risk factors, and patterns of recurrence and progression. For pT1 tumors recurrence rates in arms 1 to 4 were 26.3, 17.8, 39.3 and 70.9%, respectively, which were significantly lower in the chemotherapy group than in controls (p < 0.001) and in the epirubicin groups than in the doxorubicin group (p = 0.01). Toxic and untoward side effects developed in 10 (15.6%), 16 (23.5%) and 25 (41.7%) patients in chemotherapy arms 1 to 3, respectively, with a marginal insignificant difference between low and high dose epirubicin (p = 0.3), and significantly lower toxicity rates in arms 1 and 2 than in 3 (p = 0.002). A contracted bladder developed in 2.1% of all patients who received chemotherapy. CONCLUSIONS: This study demonstrates that epirubicin has better efficacy and lower toxicity than doxorubicin when used as an intravesical agent.

Administration, Intravesical↗
PubMed1997

Influence of intravesical bacillus Calmette-Guérin therapy on systemic immunological status.

BACKGROUND: Intravesical bacillus Calmette-Guérin (BCG) therapy for superficial bladder cancer induces obvious local immunological responses. The purpose of this study was to examine the systemic immunological influences induced by intravesical BCG therapy. METHODS: We measured peripheral blood lymphocyte subsets (PBLS) and monocyte counts in 30 patients with superficial bladder carcinoma by two-colored flow cytometry before, during, and after intravesical BCG treatment. Comparisons were made between 24 good treatment responders and 6 poor responders. RESULTS: From 3 to 12 months after the beginning of treatment, PBLS and monocyte counts changed, as evidenced by an increase of suppressor T cells and a decrease of helper T cells. The good responders had higher cell counts than the poor responders, with differences in cell counts between good and poor responders more marked 1 month after beginning treatment, particularly of natural killer cells, cytotoxic T cells, and inducer T cells. These differences disappeared 3 months after the onset of treatment. CONCLUSION: Intravesical BCG therapy caused a marked and persistent alteration of the systemic immunological status.

Administration, Intravesical↗
PubMed2004

Clinical study of bladder cancer: Proteinuria as a predictor of recurrence and efficacy of intravesical bacille Calmette-Guerin therapy.

AIM: We studied the clinical characteristics of bladder cancer, with special attention to the clinical and pathological variables that affect tumor stage, relapse and efficacy of intravesical therapy. METHODS: We reviewed the medical records of 152 patients of the Saiseikai Central Hospital who had been diagnosed as having bladder cancer between 1981 and 2001. RESULTS: The age of the patients ranged from 24 to 88 years, with a median of 63.5 years. The median follow up was 52.4 months (range, 0.5-259.5 months). There was no difference in the incidence of gross hematuria as a presenting symptom among the patients with invasive cancer, superficial cancer and carcinoma in situ (CIS). However, the incidence of urinary frequency and painful urination did differ significantly between patients. Although patients with invasive cancer had a longer time to hospital visit than those with superficial cancer, this time difference was not statistically significant. Presence of proteinuria, multifocality and intravesical bacille Calmette-Guerin (BCG) therapy were the significant predictors of relapse after transurethral resection (TUR). Presence of proteinuria was shown to adversely affect the efficacy of intravesical BCG therapy. In the BCG-treated group, 3-year relapse-free survival was 78.4% for patients without proteinuria and 40.0% for those with proteinuria; this difference was statistically significant (P = 0.0277). CONCLUSIONS: Time to hospital visit did not influence the pathological stage of cancer in patients included in the present study. Presence of proteinuria, multifocality and BCG therapy were the significant predictors of relapse after TUR. Presence of proteinuria was shown to adversely affect the efficacy of intravesical BCG therapy. Proteinuria might be helpful in predicting tumor relapse and efficacy of intravesical BCG therapy in clinical settings, along with other markers.

Adjuvants, Immunologic↗
PubMed2006

Intravesical mitomycin C for superficial transitional cell carcinoma.

Intravesical instillation of mitomycin C after a transurethral resection of a bladder tumor constitutes a standard treatment modality in the management of superficial transitional cell carcinoma in the urinary bladder. An immediate instillation of mitomycin C after transurethral resection has been shown to reduce the recurrence rate of superficial transitional cell carcinoma. Intravesical mitomycin C is generally considered to be a safe treatment option, but the past few years have seen the publication of a number of case reports on severe complications following mitomycin C instillation. This article reports on the mode of action, as well as the intravesical effects and current indications for mitomycin C instillation. This review will summarize the oncological benefits of mitomycin C in comparison with other intravesical treatments, such as bacillus Calmette-Guérin, and elucidate the incidence and types of possible complications associated with intravesical mitomycin C chemotherapy.

Administration, Intravesical↗
PubMed1990

[Usefulness of ATP-sensitivity-assay of intravesical instillation therapy of anti-cancer agents for superficial bladder cancer].

Intravesical instillation of anti-cancer drugs for superficial urinary bladder cancer is generally carried out with the aim of prophylaxis against recurrence and chemotherapy against tumor. But since sensitivity of tumor cells to each anti-cancer drug differs individually, the anti-cancer drug to be used should also be decided individually. We selected a new sensitivity test, ATP-sensitivity-assay, which measures intracellular adenosine triphosphate (ATP) volume by Luciferin-Luciferase reaction, for the decision of the anti-cancer drug. In this paper, we evaluated the direct anti-tumor activity of the drugs that were decided by ATP-sensitivity-assay of intravesical chemotherapy. Six drugs, that are Doxorubicin (ADM), Mitomycin C (MMC), Pirarubicin (THP-ADM), Cytarabine (Ara-C), Bleomycin (BLM) and Cisplatin (CDDP) were tested in this research and size of tumors of six patients reduced to 34-93% after 6 times' installation. A woman got cystitis induced by ADM after 3 times' instillation but instillation was completed. ATP-sensitivity-assay is useful for deciding the anti-cancer drugs for intravesical chemotherapy and prophylaxis for superficial bladder cancer.

Adenosine Triphosphate↗
PubMed2003

[Miliary pulmonary tuberculosis following intravesical BCG-therapy].

A patient given intravesical BCG immunotherapy developed miliary pulmonary tuberculosis. After resection of a superficial bladder tumor, the patient was given weekly intravesical BCG infusions. After the 4th session, the patient developed fever (40 degrees C), shivers, dry cough, profuse sweating, and weight loss. Initially, the chest x-ray was normal. The patient was given isoniazid (5 mg/kg) in a single-drug regimen. Rapid degradation of the general status led to a new chest x-ray, 10 days later, which demonstrated a reticulonodular syndrome. High-resolution thoracic CT confirmed the diagnosis of miliary pulmonary tuberculosis. A three-drug antituberculosis regimen associated with corticosteroids was followed by restoration of the general status. Antituberculosis therapy was continued for 9 months. The 9-month thoracic CT revealed a smaller number of micronodules in the pulmonary parenchyma. This case illustrates the discussion concerning the appropriate treatment for patients who develop a systemic infection after intravesical BCG-therapy.

Adjuvants, Immunologic↗
PubMedDate not supplied

Cryoglobulinemia vasculitis following intravesical instillations of bacillus Calmette-Guerin.

Infections and/or immune-mediated reactions may occur after intravesical instillation of bacillus Calmette-Guérin for the treatment of bladder carcinoma. We report herein a cryoglobulinemia vasculitis occurring after intravesical BCG instillation for a superficial papillary transitional cell bladder carcinoma. The patient, an 80-year-old man, presented peripheral ischemia 10 days after the second course of intravesical BCG instillation. Biological evaluation revealed autoimmune thrombocytopenia, hypergammaglobulinemia, low C3 and C4 complement fraction levels related to mixed cryoglobulinemia and lupus anticoagulant. The patient was treated with heparin and prostacyclins with a good outcome. All of the immune anomalies spontaneously regressed within 3 months. To our knowledge, cryoglobulinemia has only been reported once in the literature and lupus anti-coagulant has never been reported as a complication of intravesical BCG instillation.

Adenocarcinoma↗
PubMed1994

Intravesical RTNF therapy of superficial bladder cancer. A phase I study of recombinant tumor necrosis factor administered intravesically to patients with superficial bladder cancer.

OBJECTIVE: A phase I/II study was initiated in patients with refractory localized superficial bladder cancer to establish the tolerance and toxicity of recombinant tumor necrosis factor (rTNF) given intravesically. A preliminary evaluation of patient responses to therapy was noted; however, the small trial size precluded extensive statistical assessment of the data. SETTING: A large teaching hospital, where patients were referred for treatment of recurrent superficial bladder cancer. PATIENTS: A referred sample consisting of 16 patients with a primary diagnosis of histologically documented superficial bladder cancer (stage Ta, T1, TIS), refractory to at least 1 previous therapy, were entered on the study. Eligibility criteria Included: 1) cystoscopy in last 42 days, 2) no contraindications to chemotherapy, 3) life expectancy of 3 months, and 4) informed consent. INTERVENTION: Patients were given rTNF intravesically twice weekly for 4 weeks at doses ranging from 10 to 500 mcg/m2. MAIN OUTCOME MEASURES: Adverse effects were recorded as minimal, moderate, severe, or intolerable. Patient responses were measured on the basis of clinical and laboratory signs, symptoms, and tumor size. RESULTS: We observed no severe or intolerable toxicities associated with the treatment. Two patients had complete responses, 9 had partial responses, 2 had minor responses, 1 was diagnosed with progressive disease, and 2 were not evaluated. No maximum tolerated dose was determined because rTNF was well tolerated at a maximum dose of 500 mcg/m2. CONCLUSIONS: The study drug rTNF was well tolerated up to a dose of 500 mcg/m2 and exhibited some antitumor effects against transitional cell carcinoma, but a biologically active dose was not determined. On the basis of this trial, further studies of intravesical treatment of superficial bladder cancer with rTNF appear warranted.

Administration, Intravesical↗
PubMed1987

Comparative analysis of short-term and long-term prophylactic intravesical chemotherapy of superficial bladder cancer. Prospective, randomized, controlled studies of the Japanese Urological Cancer Research Group.

The Japanese Urological Cancer Research Group has conducted three randomized clinical studies on intravesical chemoprophylaxis of superficial bladder cancers. This paper presents a comparative analysis of the first and second of these. The protocol used in the first study was a so-called short-term schedule in which drugs (for group A, ADM 30 mg/30 ml; group B, ADM 20 mg/40 ml; group C, MMC 20 mg/40 ml; and group D, control) were administered twice a week for 4 weeks after transurethral resection (TUR), and in the second study a long-term schedule was used, in which drugs (for group E, ADM 30 mg/30 ml; group F, ADM 20 mg/40 ml; group G, MMC 20 mg/40 ml; and group H, control) were administered twice a week for 1 week, every 2 weeks for 7 weeks, monthly for 8 months, and finally once every 3 months for 1 year. In the first study 575 patients were evaluated and followed up for 5 years. The second study started 28 months later, and 607 patients were evaluated. A generally good prophylactic effect was obtained in the second study when the patients' backgrounds were adjusted in combination with the history and number of the tumors. The second study did not reveal any promoting or inhibitory effect on the progression of the recurrent tumors. There were no significant side effects in either study. The indications and the schedule for prophylactic intravesical chemotherapy should be more carefully studied.

Administration, Intravesical↗
PubMed2000

Weekly mitomycin C followed by monthly bacillus Calmette-Guerin or alternating monthly interferon-alpha2B and bacillus Calmette-Guerin for prophylaxis of recurrent papillary superficial bladder carcinoma.

PURPOSE: We evaluated alternatives to bacillus Calmette-Guerin (BCG) monotherapy using a new combination of chemotherapy and immunotherapy for recurrent superficial bladder carcinoma. MATERIALS AND METHODS: A total of 236 patients with frequently recurrent stage Ta or T1 bladder tumors were enrolled in our prospective, randomized, multicenter Finnbladder IV study. The initial mitomycin C instillation was instilled in all patients perioperatively after transurethral resection, followed by 4 weekly instillations of mitomycin C. Thereafter patients were randomized to receive monthly for up to 1 year BCG only or interferon-alpha2b and BCG alternating monthly. Primary end points were time to initial recurrence, recurrence rate (number of recurrences per patient-year) and recurrence index (number of recurrent tumors per patient-year). RESULTS: Of the 236 randomized patients 205 were eligible for study with a median overall followup of 30.7 months. Monthly BCG was superior to alternating monthly interferon-alpha and/or BCG with respect to time to initial recurrence (log rank test p <0.00001) as well as recurrence rate (0.4 versus 0.9, p <0.00001) and index (0.9 versus 3.0, p <0.00001). Side effects were limited. CONCLUSIONS: Monthly BCG given for up to 1 year preceded by perioperative and an additional 4 weekly mitomycin C instillations is a well tolerated mode of instillation therapy, providing excellent tumor control comparable to that of the best reported instillation regimens. No benefit was obtained by alternating interferon-alpha2b with BCG.

Adjuvants, Immunologic↗
PubMed1995

[The use of intravesical oxybutynin hydrochloride in patients with neurogenic bladder managed by intermittent catheterization].

Nine patients with persistent urinary incontinence due to neurogenic bladder and intolerable systemic side effects on oral anticholinergic agents were treated with intravesical instillation of oxybutynin hydrochloride. Two tablets (6 mg) dissolved in 10 ml of physiological saline or sterile water were instilled into the bladder two times daily via self intermittent catheterization. The mean bladder capacity increased from 128 to 212 ml 1 month after intravesical instillation of oxybutynin hydrochloride, although this difference was not significant. The bladder was augmented more efficaciously in patients with overactive detrusor than patients with an underactive detrusor. Subjective improvement was recognized in 4 patients. Among 5 patients who discontinued therapy due to ineffective results, maximum urethral closure pressure below 50 cmH2O was seen in 4. Intravesical instillation of oxybutynin hydrochloride was considered to be ineffective clinically in patients with underactive detrusor and low urethral closure pressure. Although no systemic side effects were observed, a decrease of bladder capacity was recognized in 2 patients.

Administration, Intravesical↗
PubMed1992

Recurrence of superficial bladder tumours after transurethral resection.

From 1979 to January 1990, 48 patients with newly diagnosed superficial bladder tumours were treated by transurethral resection (TUR) at Toyama Medical and Pharmaceutical University Hospital. The relationship between tumour recurrence and the stage, grade, number, or size of the tumours was investigated. The 1-, 2-, 3-, 4- and 5-year non-recurrence rates were 72%, 63%, 47%, 40%, and 40%, respectively. Non-recurrence rate for pTa tumours was significantly higher than that for pT1 tumours (p < 0.05). There was no relationship between tumour grade and recurrence. The rate of recurrence of multiple tumours was higher than that of single ones. There was no difference in non-recurrence rate between tumours smaller than 1 cm and those of 1 cm or larger. Non-recurrence rate in the instillation therapy group was significantly higher than in the non-instillation group (p < 0.05). It was concluded that patients with multiple or high-stage tumours have the risk of a high rate of recurrence and that intravesical chemotherapy is effective in preventing local recurrence in some patients.

Administration, Intravesical↗
PubMed1998

Quantitative studies of the kinetics of 5-aminolaevulinic acid-induced fluorescence in bladder transitional cell carcinoma.

Photodynamic therapy is a potential treatment for superficial bladder cancer that utilizes photosensitizer drugs, which are activated by light to cause tissue destruction. However, first-generation photosensitizers cause prolonged phototoxicity, have poor tumour specificity and can accumulate within detrusor muscle, resulting in permanent loss of bladder capacity following treatment. A newer drug, called 5-aminolaevulinic acid (ALA), generates a sensitizer called protoporphyrin IX (PpIX) in situ and has been shown, qualitatively, to be more tumour specific. The fluorescence kinetics of ALA-induced PpIX was investigated in patient biopsies of bladder tumour, normal urothelium and detrusor muscle, both in vitro after incubation of specimens in ALA-rich culture medium for various times and in vivo after instillation of intravesical ALA before endoscopic resection. The fluorescence in tumour tissue was twice that of normal urothelium in vitro and up to tenfold in vivo. There was little ALA-induced fluorescence in detrusor muscle, both in vitro and in vivo. Most importantly, no patients experienced phototoxicity or other adverse events following intravesical instillation of ALA.

Administration, Intravesical↗