Neo‐adjuvant treatment of infiltrating transitional‐cell carcinoma of the bladder with paclitaxel and cisplatin: A phase II trial

Abstract

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%.

A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder

“…[14][15][16][17] Taxanes in combination with cisplatin have also been evaluated in the neoadjuvant setting in bladder cancer. [18][19][20] Cabazitaxel, a novel taxane, is well-tolerated and effective in tumors both sensitive and resistant to other taxanes. 21 Single-agent cabazitaxel has been used in trials with patients with cisplatinintolerant advanced MIBC.…”