Intensified M-VEC chemotherapy with G-CSF support as outpatient treatment for advanced bladder cancer.

The M-VAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) is widely used in the treatment of advanced or metastatic bladder cancer. In the present trial, an alternate week regimen of M-VEC (with epidoxorubicin instead of doxorubicin) supported by G-CSF (filgrastim) was evaluated. Eligible patients had metastatic or surgically unresectable bladder cancer, not previously treated with systemic chemotherapy. Treatment consisted of methotrexate 30 mg/m2 day 1, vinblastine 3 mg/m2 day 2, epidoxorubicin 60 mg/m2 day 2 and cisplatin 35 mg/m2 days 2 and 3. G-CSF was administered s.c. at the dose of 300 mcg from day 4 to day 11: the treatment was repeated every 2 weeks for six cycles. Twenty-one patients entered the study, and 19 received more than 1 cycle: 78.9% were able to receive full doses of M-VEC as scheduled. The treatment resulted feasible on an outpatient basis, with mild toxicity. Three complete responses (15.8%) and 9 partial responses (47.4%), with an overall objective response rate of 63.2%, were observed.