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PubMed1999

Intravesical drug delivery. Pharmacokinetic and clinical considerations.

Intravesical drug administration is widely used in the treatment of patients with superficial bladder cancer, and aims to optimise drug delivery in the vicinity of the tumour and reduce systemic availability. The most commonly employed intravesical agents in patients with superficial bladder cancer are mitomycin (mitomycin C), thiotepa, ethoglucid (ethoglucid), anthracyclines such as doxorubicin, bacille Calmette-Guérin (BCG) and, more recently, taxol and the new mitomycin derivative KW-2149. Recurrence rates in patients with superficial bladder cancer have been substantially reduced by combined transurethral resection and intravesical pharmacotherapy. The high concentration of cytotoxics in urine and tumour tissue explain the high efficacy rates. Furthermore, the low systemic availability of most intravesical agents is consistent with the low frequency of acute and delayed systemic adverse effects. Systemic toxicity is almost negligible, except in the case of thiotepa, and local toxicity is transient and tolerable. Pharmacokinetic models of drug absorption from the bladder have been developed, both in animals and humans. These have led to the identification of optimal intravesical treatment regimens.

Absorption↗
PubMedDate not supplied

Treatment of superficial bladder cancer with intravesical chemotherapy.

Proper care of patients with superficial bladder cancer requires the assessment of multiple factors, including an understanding of the natural history of this disease, accurate clinical staging, and the expected efficacy of each drug. The pharmacology of intravesical mytomycin C is discussed in detail, as many of this drug's pharmacological principles are applicable to all intravesical chemotherapeutic agents, including doxorubicin, thiotepa, bacillus Calmette-Guérin, epirubicin, and ethoglucid. The bladder wall, bladder cavity, chemical properties of intravesical chemotherapeutic agents, and tumor considerations are discussed. Suggestions based on pharmacological studies are presented to optimize the efficacy of intravesical chemotherapy.

Administration, Intravesical↗
PubMed1977

Treatment of Condyloma acuminata in male patients.

The treatment of 101 male patients with venereal warts is described. Prior to the study 33 patients had been treated unsuccessfully with podophyllin. 57 of the patients showed urethral lesions while 2 also showed venereal warts in the bladder. The primary treatment was electrocoagulation in 100 patients, 58 of these being cured. Chemical agents such as ethoglucid, Verruxin and thiotepa seemed to be effective in the treatment of resistant, especially intraurethral condylomas. In 8 patients autogenous vaccination was used, 6 responding completely to the vaccination alone while the remaining 2 were cured after vaccination and excision.

Adult↗
PubMed1980

Intracavitary Epodyl for multiple non-invasive, highly differentiated bladder tumours.

Multiple, recurrent cancer of the bladder grade I-II (WHO), stage T1 (UICC) was treated with regular intravesical instillation of ethoglucid (Epodyl) in 39 patients. In ten of them cystitis necessitated withdrawal of the treatment. The therapeutic schedule could be followed in 29 cases, with eradication of the tumours in 27. Nine patients who continued the treatment on a prophylactic basis were still recurrence-free after 18-60 (mean 37) months. Myelosuppression did not occur, but cystitis was a serious problem that frequently jeopardized therapy.

Aged↗
PubMed1992

Complications of intravesical chemotherapy.

A variety of intravesical chemotherapeutic agents are now available for the treatment of superficial transitional-cell carcinoma of the bladder. The toxicities associated with these agents may make one more appealing than another in the face of similar efficacies. Intravesical instillations of thiotepa have resulted in incidences of leukopenia of 8% to 54%, of thrombocytopenia of 3% to 31%, and of irritative voiding symptoms of 12% to 69%. Close monitoring of blood counts prior to weekly instillations remains vital in preventing myelosuppressive complications. The complications associated with the intravesical use of mitomycin C are mainly chemical cystitis and contact dermatitis. Additionally, allergic reactions have been documented. Most of these complications respond to cessation of therapy with application of topical steroids as needed. Complications of reduced bladder capacity, bladder-wall calcifications, and myelosuppression are uncommon. Toxicities associated with the use of doxorubicin, epirubicin, and ethoglucid are almost exclusively local and usually described as mild to moderate dysuria, frequency, or urgency. Case reports of systemic reactions to doxorubicin are notable in that the patients responded well to diphenhydramine and, in one severe case, epinephrine. Other adverse effects such as reduced bladder capacity, fever, and nausea and vomiting are very uncommon. New agents, such as mitoxantrone, are undergoing phase I and phase II studies. The ideal agent, which would be highly effective and minimally toxic, remains to be developed.

Administration, Intravesical↗
PubMed1985

Intravesical cytostatics: pH-dependence of antitumour activity.

The effects of pH on the antitumour activity of six cytostatics--cisplatin, doxorubicin, ethoglucid, mitomycin C, thiotepa and VM-26--used in intravesical instillations were tested in vitro. The activity of cytostatics was determined on the Walker 256 carcinosarcoma cell line by using ATP-bioluminescence method. Cytostatics were incubated at different pH's (5.0-7.4) for 2 and 4 h. The activity of most of the cytostatics was not affected by pH, but mitomycin C had somewhat lower activity at pH 5.0 at 4 h and cisplatin at pH 6-7 at 2 and 4 h. Because the pH of normal urine is within the range used in this test, the use of a buffer solution during the intravesical instillation therapy is not necessary. However, according to our clinical experience, buffering is recommended to avoid chemical cystitis.

Adenosine Triphosphate↗
PubMed1983

Bacterial mutagenicity investigation of epoxides: drugs, drug metabolites, steroids and pesticides.

Although it has been observed that many epoxides are ultimate mutagens, surprisingly little is known about epoxides to which man may be extensively exposed, e.g., physiological compounds, drugs, drug metabolites and pesticides. We have now investigated 35 such and related epoxides for mutagenicity, using reversion of his- Salmonella typhimurium TA98 and TA100 as biological end-point. None of the tested steroids (12 compounds), vitamin K epoxides (3 compounds) and pesticides (dieldrin, endrin, HEOM (1,2,3,4,9,9-hexachloro-6,7-epoxy-1,4,4a,5,6,7,8, 8a-octahydro-1,4-methanonaphthalene), heptachlor epoxide) showed any mutagenic activity. Negative results were also obtained with the antibiotics oleandomycin, anti-capsin and asperlin, the cardiotonic drug resibufogenin, the widely used parasympatholytic drugs butylscopolamine and scopolamine, the sedatives valtratum, didovaltratum and acevaltratum, the tranquilizer oxanamide as well as with the drug metabolites carbamazepine 10,11-oxide and diethylstilbestrol alpha,beta-oxide. Three barbiturate epoxides, formed by metabolism of allobarbital, alphenal and secobarbital, caused weak but reproducible mutagenic effects at high concentrations. The cytostatic agent ethoglucide was the only drug having substantial mutagenic activity. Its mutagenic potency was similar to those of the control epoxides styrene 7,8-oxide, p-bromostyrene 7,8-oxide and m-bromostyrene 7,8-oxide, but much lower than those of benzo[a]pyrene 4,5-oxide, benzo[e]pyrene 4,5-oxide and 7,12-dimethylbenz[a]anthracene 5,6-oxide. Some epoxides were also tested in other Salmonella typhimurium strains or in the presence of rat-liver S9 mix. Positive results were only obtained with compounds that had already been detected as mutagens in the direct test with strain TA100.

Animals↗
PubMed1991

Adjuvant intravesicular pharmacotherapy for superficial bladder cancer.

In 1990, bladder cancer, excluding carcinoma in situ, was estimated to contribute 49,000 cases of cancer. In men 75 years old or older, it became the fifth leading cause of cancer deaths. Of patients with bladder cancer, 75%-80% initially present with superficial bladder tumors. Treatment of these tumors has three objectives: 1) to eradicate existing disease, 2) to provide prophylaxis against tumor recurrence, and 3) to avoid deep invasion into the muscle layers of the bladder. Transurethral resection is the primary treatment to eradicate superficial bladder tumors, but 40%-80% of these tumors recur. Because of these high recurrence rates, adjuvant intravesicular pharmacotherapy with cytotoxic and immunomodulatory drugs has gained widespread use. The past two decades of clinical investigations in superficial bladder cancer have provided valuable information on the biology and treatment of the disease. Multivariate analyses have indicated that tumor grade and stage are the most important prognostic variables commonly available to the clinician to identify the patient at greatest risk of developing muscle-invasive or metastatic bladder cancer. These studies have also identified groups at low risk for tumor recurrence and invasive bladder cancer. Randomized trials have shown that recurrence rates are decreased by adjuvant intravesicular pharmacotherapy with a number of drugs: bacillus Calmette-Guérin vaccine (BCG), doxorubicin, ethoglucid (Epodyl), mitomycin-C, teniposide, and thiotepa. However, few studies indicate that adjuvant intravesicular pharmacotherapy can prevent progression to invasive bladder cancer in the high-risk patient with superficial bladder cancer. Additional clinical trials are needed to determine whether such therapy can prevent invasive and metastatic bladder cancer and improve disease-free survival in this group. In addition, the identification of tests (e.g., monoclonal antibody tests, chromosomal analyses, and tumor marker assays) that can help to identify high-risk patients is needed to better develop therapeutic strategies for superficial bladder cancer.

Antineoplastic Agents↗
PubMed1992

Diagnosis and treatment of bladder cancer.

The primary key to diagnosis of bladder cancer is cystoscopic examination of the bladder, followed by biopsy of suspicious lesions. Bimanual examination under anesthesia is also important for staging, and urinary cytology and intravenous urography provide valuable additional information. Surgical resection in the form of excisional transurethral biopsy is diagnostic, therapeutic and essential for accurate staging, and assessment of tumor grade is vital for determining prognosis and management strategies. Intravesical chemotherapy with Thiotepa, doxorubicin, mitomycin C or ethoglucid has been shown to reduce the incidence of short-term tumor recurrence by 17% but not long-term recurrence or rate of disease progression. Immunotherapy, as exemplified by Bacillus Calmette-Guérin (BCG), has achieved better results: long-term reduction in tumor recurrence, reduction in disease progression and prolongation of patient survival. Newer immunotherapies using interferon-alpha appear to produce response rates comparable to BCG but without the considerable toxicity of BCG. Further research with combination therapies and other immunotherapeutic agents should lead to improved treatment options in the future.

BCG Vaccine↗