Prognostic factors in superficial bladder tumours are highly correlated with each other. In this study, their relative importance is examined and grouping of patients in three different prognostic groups suggested. 576 patients (from EORTC protocols 30790 and 30782) were analysed. They have been followed from 3 months to 8.6 years with a median of 4 years. 76 patients developed an invasive tumour (>:T2); the shortest time to invasion was 12 weeks, the longest was 6.6 years. Time from invasion to death ranged from 3 weeks to 4.4 years with a median of 2 years. Prognostic factors contributing to recurrence, invasion and survival were investigated: age, sex, size of largest tumour, number of tumours, T-category, G-grade, time from diagnosis (years), prior recurrence rate/year, site of involvement. The relative importance of these factors was measured by performing a multivariate analysis based on Cox's proportional hazards regression model. Based on the most important prognostic factors and their association with invasion and death, an index was computed reflecting the risk of both invasion and death due to malignant disease, respectively. The index was used to assign patients to one of three prognostic groups. Three main factors determined patient's prognosis: tumour size, G-grade and prior recurrence rate/year. The model coefficients for invasion were 0.51 (recurrence rate 3/year), 0.84 (grade 1, 2, 3), 0.48 (size <1.5, 1.5-3, > 3 cm) and for death due to malignant disease 0.89 (recurrence rate), 0.73 (grade) and 0.44 (size), respectively. Risk groups are suggested based on the index. Additional treatment in patients with superficial transitional cell carcinoma of the bladder may be decided depending on the risk group to which the patient belongs.
• Recently, the files of these patients have been updated for long-term outcome definition. Data on general health, follow-up examinations, tumour relapse or progression, and cause of death were collected and analysed.
RESULTS• Updated complete data collection was available for 65/75 (87%) of the original patients.• The median follow-up for tumour-free patients was 91 months. The 10-year disease-free survival rate for thermochemotherapy and chemotherapy alone were 53% and 15%, respectively ( P < 0.001).• An intent-to-treat analysis performed to overcome the potential bias introduced by the asymmetrical discontinuation rate still showed a significant advantage of the active treatment over the control treatment.Bladder preservation rates for thermochemotherapy and chemotherapy alone were 86% and 79%, respectively.
CONCLUSION• This is the first analysis of long-term follow-up of patients treated with intravesical thermochemotherapy. The high rate (53%) of patients who were tumourfree 10 years after treatment completion, as well as the high rate (86%) of bladder preservation, confirms the efficacy of this adjuvant approach for NMIBC at long-term follow-up, even in patients with multiple tumours.
KEYWORDSbladder cancer, non-muscle-invasive bladder cancer (NMIBC), treatment, local hyperthermia, chemotherapy, mitomycin-C What's known on the subject? and What does the study add? Microwave-induced hyperthermia and mitomycin C is a device-assisted approach used to treat non-muscle invasive bladder cancer (NMIBC) either in the adjuvant (prophylactic) set-up or in an ablative regimen. Until recently, around 20 different studies have been published with data on the short term results of treatment. Previous prospective randomized studies showed the superiority of the chemo-hyperthermia regimen when compared to intravesical chemotherapy alone in terms of recurrence-free survival in intermediate and high-risk NMIBC patients at minimum 24-month follow-up. The current study confirmed the result also in long-term (minimum 10 years) follow-up. It also represents one of a few to show such extended follow-up periods for any intravesical therapy for NMIBC.Study Type -Therapy (RCT) Level of Evidence 1b
OBJECTIVE• To present long-term efficacy data of intravesical thermochemotherapy vs chemotherapy alone with mitomycin-C (MMC) randomly administered to patients with non-muscle-invasive bladder cancer (NMIBC) as an adjuvant treatment after complete transurethral resection.
PATIENTS AND METHODS• In all, 83 patients with intermediate-/ high-risk NMIBC, following complete transurethral resection, were randomly assigned to receive either intravesical thermochemotherapy by means of Synergo® (Medical Enterprises, Amsterdam, The Netherlands) or intravesical chemotherapy alone, for prophylaxis of tumour recurrence.• Two doses of MMC (20 mg dissolved in 50 mL distilled water administered throughout two consecutive sessions) was used as the chemotherapeutic agent in both arms.• In all, 75 patients completed the original study (35 of 42 in the treat...
In our series, endovesical thermochemotherapy appears to be more effective than standard endovesical chemotherapy as an adjuvant treatment for superficial bladder tumors at 24-month follow-up, despite an increased but acceptable local toxicity.
Patients with previously untreated category T3 to T4 Mo or Ml prostatic cancer were allocated randomly to receive 250 mg. cyproterone acetate per day, a loading dose of 500 mg. medroxyprogesterone acetate intramuscularly 3 times weekly for 8 weeks followed by 100 mg. orally twice daily, or 1 mg. diethylstilbestrol 3 times daily in a phase III trial (protocol 30761) performed by the genitourinary tract cooperative group of the European Organization for Research on the Treatment of Cancer. Of 236 patients entered 210 were eligible: 75 received cyproterone acetate, 71 medroxyprogesterone acetate and 64 diethylstilbestrol. Local and distant tumor response, time to progression, survival and toxicity were assessed. Patients treated with medroxyprogesterone acetate had a less favorable course with a shorter duration of survival and time to progression than those treated with the other 2 drugs. There was no significant difference between diethylstilbestrol and cyproterone acetate. Cardiovascular side effects were reported more often in patients treated with diethylstilbestrol than in those treated with cyproterone acetate but severe and lethal cardiovascular toxicity was relatively low in all groups. Other side effects were negligible. Further studies are required to establish the influence of effective hormonal treatment upon survival.
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