Intravesical gemcitabine therapy for superficial transitional cell carcinoma: results of a Phase II prospective multicenter study.
Urology
; 66(4): 726-31, 2005 Oct.
Article
em En
| MEDLINE
| ID: mdl-16230125
ABSTRACT
OBJECTIVES:
To determine the tolerability and efficacy after 1 year of weekly intravesical gemcitabine therapy in patients with intermediate-risk and high-risk superficial transitional cell carcinoma.METHODS:
A total of 116 patients with intermediate-risk and high-risk bladder cancer who had undergone transurethral resection were treated with one cycle (once a week for 6 weeks) of gemcitabine 2000 mg. Local and systemic tolerability and efficacy were evaluated.RESULTS:
In terms of the tolerability of gemcitabine, 14 patients (12.0%) reported urgency, 6 (5.1%) dizziness and slight fever (less than 38 degrees C), 1 (0.8%) severe abdominal pain, with ulcerative lesions of the bladder mucosa at cystoscopy, and 1 (0.8%) parosmia. The remaining 94 patients (81.3%) did not report any local side effects during the treatment period. In terms of efficacy, recurrence developed in 29 patients (25.4%) a mean of 7 months after transurethral resection; 85 patients (74.6%) were disease free after 12 months. The univariate analysis showed a greater level of efficacy in patients with a first occurrence (P = 0.0408), patients who had had no previous treatment (P = 0.0368), and patients with Stage pTa superficial transitional cell carcinoma (P = 0.0018). The multivariate analysis did not reveal any significant data. No significant differences were found between the intermediate-risk and high-risk patients in tolerability or efficacy. No recurrence developed in 18 (75%) of 24 intermediate-risk bacille Calmette-Guérin-refractory or 7 (43.7%) of 16 high-risk bacille Calmette-Guérin-refractory patients.CONCLUSIONS:
The results of our study have confirmed the good tolerability and 1 year efficacy of intravesical gemcitabine. The treatment schedule proposed resulted in high patient compliance, and the results can be compared with the results of studies using other intravesical treatments.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Bexiga Urinária
/
Carcinoma de Células de Transição
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Desoxicitidina
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Antimetabólitos Antineoplásicos
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2005
Tipo de documento:
Article