M-CAVI, A Neoadjuvant Carboplatin-based Regimen for the Treatment of T2-4N0M0 Carcinoma of the Bladder

Abstract

Carboplatin, methotrexate, and vinblastine (M-CAVI) is an active and well-tolerated regimen for bladder cancer patients ineligible for cisplatin-based regimens. We treated 47 T2-4 N0 M0 bladder cancer patients with M-CAVI in a neoadjuvant phase II trial. These 47 patients are evaluable for clinical response and toxicity. Clinical overall response rate was 34%, for a 95% confidence interval (CI95%) of 21-49%. Pathological response was seen in 40% of the patients (CI95%, 26-56%) with a 26.5% rate of pathological complete response (CI95%, 15-42%). Factors associated with the achievement of a response to therapy were the initial TNM stage (pT3a or lower, greater than pT3a, p = 0.001) and a Karnofsky score greater or equal than 90%, which was marginally significant (p = 0.08). With a median follow-up of 14 months, the disease-specific actuarial survival at 2 years is 42%. No patient has relapsed beyond 21 months of follow-up in a disease-free status. Toxic effects have been moderate. In conclusion, M-CAVI is an active and well-tolerated regimen that should be compared in terms of response rate and survival with a cisplatin-based regimen for invasive bladder cancer.

Carboplatin Based Induction Chemotherapy for Nonorgan Confined Bladder Cancer—A Reasonable Alternative for Cisplatin Unfit Patients?

“…In this setting a gem/carbo combination proved to be an active, effective alternative in unfit patients but inferior to a cisplatin based regimen. [15][16][17][18][19] Carboplatin based chemotherapy in the metastatic setting was investigated by De Santis et al 18 In a phase II/III study they compared the efficacy and toxicity of 2 carboplatin based chemotherapy regimens (gem/carbo vs methotrexate/ carboplatin/vinblastine) in patients with advanced UC who were unfit for CBCC. Each treatment arm was active and safe in this group of unfit patients and no significant differences were found in response and survival.…”

Neoadjuvant chemotherapy in bladder cancer

“…A separate Phase II trial in cisplatin-eligible patients evaluated the efficacy of methotrexate, carboplatin and vinblastine in the neoadjuvant setting and therefore serves as a potential reference for a similar regimen in cisplatin-ineligible patients [53]. In this trial, patients with T2-4N0M0 bladder cancer received the three-drug regimen on a 28-day schedule for four cycles with primary outcome of pCR.…”