Amsacrine and cisplatin in poor prognosis patients with metastatic transitional cell carcinoma of the urothelium: A phase-II study

Objectives. Amsacrine,. as, a single agent, was reported to be effective in patients with metastatic transitional cell carcinoma of the urinary bladde r. Amsacrine is also associated with a lower toxicity than cyclophosphamide , doxorubicin and cisplatin therapy and has similar activity. But amsacrine has been forgotten in clinical studies of transitional cell Carcinoma of t he urinary bladder. The aim, of present study was to investigate the toxici ty and efficacy of amsacrine and cisplatin in chemotherapy-naive patients w ith metastatic transitional cell carcinoma of the urinary bladder. Methods. We have treated 54 patients (41 males/13 females) with a median ag e of 62 (38-72) years. Performance status was 0/2,I/27 II/17 and III/8. The treatment included: amsacrine 85 mg/ m(2), days 1-2, and cisplatin 30 mg/m (2), days 2-5. Cycles were repeated every 4 weeks. We applied 169 cycles, ( median 3/patient). Of 54 patients, 39 had previous surgery and 12 had previ ous radiotherapy. Histological tumor grade was I/7,II/27 and III/20. Results. 51 patients were evaluable for response (3 patients refused furthe r treatment during the first cycle): 2 complete remission (4%); 15 partial remission (29%); 23 stable disease (45%), and 11 progressive disease (22%). The response rate was 33% (95% Cl 21-46). On an intent-to-treat basis, the response was, 32%,(95%, Cl 19-44). Durations of complete and partial respo nses were 14 (range 12-16) and 6.5 (range 3-11) months, respectively. Media n survival was 9 (range 3-21) months. All patients, were evaluable for toxi city. Grades III-IV toxicity was as follows: anemia 11%; neutropenia 37%, a nd thrombocytopenia 20%. None of the patients was excluded from. the study because of toxicity Conclusion.-The combination of amsacrine and cisplatin is a regimen with mi ld and manageable toxicity. The present regimen seems to be active. Randomi zed study of the present regimen versus another low-toxicity regimens are n ecessary, especially for poor prognosis patients including those with a low , performance status. Copyright (C) 2001 S. Karger AG, Basel.