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Neo‐adjuvant treatment of infiltrating transitional‐cell carcinoma of the bladder with paclitaxel and cisplatin: A phase II trial
Author(s) -
SOUSAESCANDÓN ALEJANDRO,
VAZQUEZ SERGIO,
QUINTEROALDANA GUILLERMO,
PICALLO JOSE A,
NEIRA JAVIER,
GARCIANOVIO FRANCISCO,
MATEO A,
RICO MANUEL,
MEL JOSE R
Publication year - 2002
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1046/j.1442-2042.2002.00443.x
Subject(s) - medicine , neutropenia , febrile neutropenia , transitional cell carcinoma , toxicity , cisplatin , surgery , gastroenterology , anemia , cystectomy , urology , paclitaxel , progressive disease , chemotherapy , bladder cancer , cancer
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%.