Primary methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy and bladder preservation in locally invasive bladder cancer: a 5-year followup.

A phase 2 protocol was designed for conservative treatment of muscle invasive transitional cell carcinoma of the bladder and consisted of primary methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy followed by bladder sparing surgical reevaluation and surveillance. Of 36 patients 30 completed the protocol and were followed for at least 5 years. Initial complete response to chemotherapy was noted in 14 patients (47%, 95% confidence interval 30 to 64%) and complete responses were more common with low stage tumors. After chemotherapy the bladder was preserved in 18 patients (60%) but at 5 years only 6 (20%, 95% confidence interval 6 to 34%) were alive with the bladder intact. Bladder preservation was possible only in the complete response group. The long-term followup showed that after 5 years 16 patients (53%) were alive and 15 (50%, 95% confidence interval 32 to 68%) were disease-free. When patients were stratified according to the type of response to chemotherapy, the 5-year disease-free survival was 79% versus 25% for the complete response and the partial or no response groups, respectively (p < 0.01). According to these results and considering the highly selective nature of our study, primary methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy compared to standard treatments does not improve the overall survival rate, nor does it allow for bladder preservation in most cases of locally invasive transitional cell carcinoma of the bladder. This approach seems only to segregate patients with a greater chance for long-term survival in the complete response group and a poor outcome for partial/no response patients regardless of early salvage bladder extirpation.