Cacciari, Nicoletta, Martoni, Andrea, Rossi, Andrea Paolo, Turci, Paola, Lelli, Giorgio, Martinelli, Augusto, Maver, Paolo, Corrado, Francesco, Mannini, Daniele, Reggiani, Alberto, Concetti, Sergio, Martelli, Aldo, Melotti, Barbara, Cricca, Antonia, Zamagni, Claudio, and Pannuti, Franco
In this phase II study, 41 patients with locally advanced urothelial bladder cancer (T2-4, NO, MO) were treated with primary chemotherapy (cisplatin, epirubicin, methotrexate: PEM-3). All the patients were assessable for response and toxicity. Clinical monitoring was performed with computerized tomography and cystoscopy. Nineteen clinical complete remissions (46%) and 10 partial remissions (24.5%) were obtained (CR + PR, 70.5%; 95% confidence interval, 57%-85%). Ten patients were considered to have clinically stable disease (24.5%), and 2 patients progressed (5%). Surgery after chemotherapy was performed in 22 cases: in 6 patients (27%) a pathologic complete response was achieved. The pathologic stage was lower than the initial clinical stage in 13 patients (59%). After a median follow-up of 3 years (range, 1-4), the median time to progression was 104 weeks. At this writing, 20 patients, 12 of which were submitted to surgery and 8 were not operated, are disease-free. The 3-year survival rate is 52%. No one had to interrupt the treatment because of toxicity. In conclusion, the PEM-3 regimen is a very active and well-tolerated regimen in locally advanced bladder cancer.