M-CAVI, A NEOADJUVANT CARBOPLATIN-BASED REGIMEN FOR THE TREATMENT OF T2-4NOMO CARCINOMA OF THE BLADDER

Carboplatin, methotrexate, and vinblastine (M-CAVI) is an active and w ell-tolerated regimen for bladder cancer patients ineligible for cispl atin-based regimens, We treated 47 T2-4 NO MO bladder cancer patients with M-CAVI in a neoadjuvant phase II trial. These 47 patients are eva luable for clinical response and toxicity. Clinical overall response r ate was 34%, for a 95% confidence interval (CI95%) of 21-49%. Patholog ical response was seen in 40% of the patients (CI95%, 26-56%) with a 2 6.5% rate of pathological complete response (CI95%, 15-42%), Factors a ssociated with the achievement of a response to therapy were the initi al TNM stage (pT3a or lower, greater than pT3a, p = 0.001) and a Karno fsky score greater or equal than 90%, which was marginally significant (p = 0.08). With a median follow-up of 14 months, the disease-specifi c actuarial survival at 7 years is 42%. No patient has relapsed beyond 21 months of follow-up in a disease-free status. Toxic effects have b een moderate. In conclusion, M-CAVI is an active and well-tolerated re gimen that should be compared in terms of response rate and survival w ith a cisplatin-based regimen for invasive bladder cancer.