title: [Preliminary results of a phase II randomized controlled trial comparing M-VAC and M-CAVI in patients with bladder cancer (T2-4 N0-1 M0)].
abstract: OBJECTIVE
  The combination of carboplatin, methotrexate and vinblastine (M-CAVI) is an active and well-tolerated regimen for patients with bladder cancer who are ineligible for cisplatin-based regimens. We have prospectively randomized patients with locally advanced (T2-4 N0 M0) or locoregional (Tx N1 M0) bladder cancer suitable for subsequent surgical treatment to M-VAC or M-CAVI chemotherapy.
  
  
  METHODS
  M-CAVI consisted of carboplatin (300 mg/m2 on day 1 and later adjusted to 4.5 mg/dl/min according to Calvert's formula), methotrexate (30 mg/m2 on days 1, 15 and 22) and vinblastine (3 mg/m2 on days 1, 15 and 22). After 3-4 cycles, the patients were assessed for surgical resection.
  
  
  RESULTS
  To date, 60 patients have been included. There were 58 completely evaluable patients, 27 were randomized to M-VAC and 31 to M-CAVI. The overall response rates were similar for M-VAC (48%; confidence interval 95%, 26%-67%) and M-CAVI (45%; confidence interval 95%, 28%-62%). The pathological complete responses were similar for the M-VAC and M-CAVI regimens for both the group with locally advanced (27% vs 39%, p = NS) and locoregional (14% vs 14%, p = NS) bladder cancer. The median actuarial survival for the M-VAC treated group was 23 months and 18 months for the M-CAVI. M-VAC therapy was statistically significantly associated with more events of granulocytopenic fever, grade 2-3 nausea and vomiting, grade 2 alopecia and grade 3-4 mucositis.
  
  
  CONCLUSIONS
  The results achieved in the 60 patients included in the study indicate that M-CAVI is better tolerated than M-VAC, although both treatment regimens have similar overall response rates, pathological response rates and survival in patients with locally advanced and locoregional bladder cancer.
authors.affiliation: Sección de Oncología Médica y Servicio de Urología, Hospital General Universitario Vall d'Hebron, Barcelona, España.
authors.forename: J
authors.initials: J
authors.lastname: Bellmunt Molins
authors.forename: A
authors.initials: A
authors.lastname: Ribas
authors.forename: J
authors.initials: J
authors.lastname: Albanell
authors.forename: J A
authors.initials: JA
authors.lastname: Lorente Garín
authors.forename: J A
authors.initials: JA
authors.lastname: de Torres Mateos
authors.forename: J
authors.initials: J
authors.lastname: Morote Robles
authors.forename: M A
authors.initials: MA
authors.lastname: López Palacios
authors.forename: J M
authors.initials: JM
authors.lastname: Banús Gassol
authors.forename: S
authors.initials: S
authors.lastname: Casado Cobo
authors.forename: N
authors.initials: N
authors.lastname: Eres
authors.forename: L A
authors.initials: LA
authors.lastname: Solé Calvo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D014747:Vinblastine; D004317:Doxorubicin; D016190:Carboplatin; D002945:Cisplatin; D008727:Methotrexate
vernacular_title: Resultados preliminares de un ensayo randomizado en fase II comparando M-VAC y M-CAVI en pacientes con cáncer de vejiga (T2-4 N0-1 M0).