title: 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.
authors.affiliation: Medical Oncology Section, Hospital General Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Bellmunt
authors.forename: A
authors.initials: A
authors.lastname: Ribas
authors.forename: J
authors.initials: J
authors.lastname: Albanell
authors.forename: B
authors.initials: B
authors.lastname: Bermejo
authors.forename: R
authors.initials: R
authors.lastname: Vera
authors.forename: J A
authors.initials: JA
authors.lastname: De Torres
authors.forename: J
authors.initials: J
authors.lastname: Morote
authors.forename: M A
authors.initials: MA
authors.lastname: Lopez-Pacios
authors.forename: J M
authors.initials: JM
authors.lastname: Banus
authors.forename: A
authors.initials: A
authors.lastname: Rovirosa
authors.forename: J
authors.initials: J
authors.lastname: Carulla
authors.forename: L A
authors.initials: LA
authors.lastname: Sole
mesh_terms: D000206:Actuarial Analysis; D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009367:Neoplasm Staging; D012074:Remission Induction; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D014747:Vinblastine / Q000008:administration & dosage*
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D016190:Carboplatin; D008727:Methotrexate