Intravesical gemcitabine therapy for superficial transitional cell carcinoma: Results of a Phase II prospective multicenter study
| Autor: | Gianluca Giubilei, Riccardo Bartoletti, T. Tony Cai, Mauro Gacci, Giorgio Santelli, Paolo Ghezzi, Michele Sisani, Fabio Repetti, Stefano Nerozzi, Fabrizio Viggiani |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
Male
Antimetabolites Antineoplastic Abdominal pain medicine.medical_specialty Urology Deoxycytidine Risk Factors Humans Medicine Prospective Studies Aged Carcinoma Transitional Cell Univariate analysis Urinary bladder Bladder cancer medicine.diagnostic_test business.industry Cystoscopy Middle Aged medicine.disease Gemcitabine Surgery Administration Intravesical medicine.anatomical_structure Transitional cell carcinoma Urinary Bladder Neoplasms Tolerability Female medicine.symptom business Follow-Up Studies medicine.drug |
| Zdroj: | Urology. 66:726-731 |
| ISSN: | 0090-4295 |
| DOI: | 10.1016/j.urology.2005.04.062 |
| Popis: | 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°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-Guerin-refractory or 7 (43.7%) of 16 high-risk bacille Calmette-Guerin-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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect