Neo-adjuvant treatment of infiltrating transitional-cell carcinoma of the bladder with paclitaxel and cisplatin: a phase II trial.
Autor: | Sousa-Escandon A; Department of Urology, Comarcal Hospital of Monforte, 27400 Monforte de Lemos, Lugo, Spain., Vazquez S, Quintero-Aldana G, Picallo JA, Neira J, Garcia-Novio F, Mateo A, Rico M, Mel JR |
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Jazyk: | angličtina |
Zdroj: | International journal of urology : official journal of the Japanese Urological Association [Int J Urol] 2002 Mar; Vol. 9 (3), pp. 162-6. |
DOI: | 10.1046/j.1442-2042.2002.00443.x |
Abstrakt: | Background: A phase II multicentric trial of paclitaxel and cisplatin was conducted in previously untreated patients, with locally advanced transitional-cell carcinoma (TCC) of the bladder, to assess its toxicity and efficiency in preserving the bladder. Methods: Forty-four patients with locally advanced TCC of the bladder (seven with T3a, 27 with T3b, and eight with T4a) were treated with paclitaxel 175 mg/m(2) over 3 h, and cisplatin 75 mg/m(2) over 30 min, on the first day of each 21-day treatment cycle. Therapy was continued for three cycles. Patients were re-evaluated and scheduled for radiotheraphy or radical surgery depending on tumoral response. Tumoral response was measured by citology, computed tomographical scans, and deep randomized biopsies of the bladder. Results: Thirty-two out of 42 patients (76%; 95% confidence interval 45-93%) showed a major response (22 complete, and 10 partial). Response times ranged from 18 to 54 months. Three patients with T4 bladder primary tumors experienced a pathological CR. At a median follow-up of three years, 20 patients remain free of disease (47.6%), six patients are alive with disease (14.3%), 12 patients died of disease (28.5%), and four others died of unrelated causes (9.5%). Hematological toxicity included anemia, thrombocytopenia, and neutropenia. No grade four febrile neutropenia was observed. Non-hematological toxicity included alopecia (93.2%), diarrhea (11.4%), vomiting (18.5%) mucosytis (4.6%), and neuropathy (4.6%). Drug omissions or dose delay for adverse events were only necessary in one patient (2.2%), and three patients (6.8%), respectively. Conclusions: Paclitaxel and cisplatin is an active and well-tolerated neo-adjuvant regimen for previously untreated patients with pure TCC of the bladder, achieving a vesical preservation rate of 52%. |
Databáze: | MEDLINE |
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