Introduction: The aim of this study was to analyze the reasons for intravesical BCG interruption in clinical practice. BCG for at least one year is advocated as the best regimen to treat high-risk non-muscle invasive bladder cancer (NMIBC). However, almost 50% of patients don't complete it. Toxicity accounts for 10% of dropouts in international trials. Materials and Methods: Patients with T1HG NMIBC undergoing 1-year BCG were enrolled in this study. BCG was administered for one year. Toxicity and causes of treatment interruption were recorded. Results: A total of 411 patients were enrolled in the study. Out of these total number of patients, 380 (92.5%) completed the induction cycle and 215 (52.3%) completed one year. Toxicity requiring interruption or postponement was recorded in 25 (6.1%) and 60 (14.6%) patients. Ninety-three patients (30.2%) stopped BCG, 9 (9.7%) for recurrence and 14 (15.1%) for grade-3 toxicity. Intriguingly, 55 (59.1%) patients refused BCG due to mild discomfort and deterioration in quality of social life. Conclusions: Grades 2-3 toxicity causes BCG interruption in a few cases. Almost 60% of interruptions are attributable to persistent grade-1 toxicity, which is inadequately treated.
Mitomycin C (MMC) intravesical therapy for "superficial" papillary bladder tumors was firstly introduced in the early seventies with promising results. In the following years, several pharmacokinetic studies investigated its mechanism of action to optimize the intravesical administration. Numerous studies confirmed thereafter both the ablative and the prophylactic efficacy and the low toxicity of MMC when intravesically given. In 1984, a complete response rate of 42% in 60 patients not responsive to thiotepa was reported with intravesical MMC at the dose of 40 mg diluted in 40 ml for 8 weeks. In the following decades, many large randomized studies showed the benefit of intravesical prophylaxis with MMC versus transurethral resection (TUR) alone. Since 2002, the role of adjuvant intravesical chemotherapy and of an early MMC instillation in preventing recurrence compared with TUR alone has been confirmed by large meta-analyses and stated by the European Association of Urology (EAU) guidelines. The need for further intravesical chemotherapy after the early instillation in patients at intermediate-high risk of recurrence has been proved by several trials. Although intravesical Bacillus Calmette-Guerìn (BCG) is considered the best choice for high-risk patients and MMC for the low-risk group, both MMC and BCG can be given to prevent recurrence in intermediate-risk patients. However, the higher efficacy of BCG over MMC is evident only if maintenance regimen is administered. Despite its proven efficacy, immediate intravesical MMC is not yet fully entered in common clinical practice and efforts should be made by the urologists to optimize its adoption.
Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Peyronie's disease (PD) is an acquired curvature of the penis attributable to progressive fibromatosis of the tunica albuginea (TA). It is frequently associated with Dupuytren's contracture and those of Ledderhose. More recently it was found that patients suffering from PD also often suffer from diabetes mellitus and gout. Cigarette smoking and the intake of large amounts of alcohol are considered risk factors for PD.The exact aetiology of the disease is unknown, however, the trauma hypothesis is shared by most authors. According to this theory, repeated sexual microtrauma in people genetically predisposed could cause PD. The inflammatory process leads to the formation of fibrosis and plaques. Plaque can lead to penile curvature and may reduce its functionality. Pain is the most common symptom of early‐stage disease. In the late stages the pain disappears, but erectile dysfunction may occur. Surgical treatment is available, but this exposes the patient to a greater risk of erectile dysfunction and it is most frequently associated with a reduction in the length of the penis. The rationale for local medical therapy is to use a treatment that acts on the initial phase of the disease by reducing and stopping the processes that lead to fibrosis, thus stabilizing the disease. Systemic medical therapy is usually accompanied by high rates of recurrence. Many authors consider local drug therapy more appropriate. Local treatment consists of several types of medication, but results are often sub‐optimal. Anti‐inflammatory or immunoregulatory therapy, either systemic or topical, has shown some efficacy when administered early in the disease by modulating the inflammatory response and attenuating the alteration of tissue repair. Unfortunately, in most cases, patients are first seen when the plaque is chronically inflamed, stabilized and sometimes already calcified. We have tested a biological drug for intralesional administration for the first time. We chose iloprost, an analogue of prostacyclin I2, for its theoretically favourable properties. If used i.v., it has been shown to be effective in treating vascular ischaemic disease such as thromboangioitis obliterans, peripheral arterial occlusive disease, Raynaud's phenomenon and systemic sclerosis. The rationale for the therapeutic use of iloprost in the late stages of PD is based on the assumption that activation of fibrinolysis induced by the drug would be able to determine a regression of the plaque with a consequent reduction of the curvature on erection. The main purpose of this phase I study was to evaluate the safety and tolerability of this drug injected in the context of the fibrous plaque on a small number of patients before designing a large‐scale randomized trial. According to the results,therapy with intralesional iloprost in Peyronie's disease seems to be safe and tolerated and is a possible alternative to surgery. OBJECTIVE To assess the safety and t...
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