title: Carboplatin, methotrexate, vinblastine, and epirubicin (M-VECa) as salvage treatment in patients with advanced bladder cancer: a phase II study.
abstract: The primary objective of this study was to determine the activity and safety of carboplatin, methotrexate, vinblastine, and epirubicin (the M-VECa regimen) in patients with advanced bladder cancer after failure of at least one chemotherapy line. Treatment consisted of carboplatin 250 mg/m on day 1, methotrexate 30 mg/m on days 1 and 22, vinblastine 3 mg/m on days 2 and 22, and epirubicin 50 mg/m on day 2 every 28 days until disease progression or death. Response rate was the main end-point. Twenty-five patients were enrolled: the median age was 67 years (range 42-83) and there were 14 patients aged at least 70 years (56%). Fourteen patients had previously received vinflunine as a second-line treatment. Complete remission occurred in one patient (4%), partial remission in five patients (20%), and stable disease in eight patients (32%). The overall response rate was 24% [95% confidence interval (CI), 9.3-45.1%] and the overall disease control rate was 56% (95% CI, 34.9-75.5%). The median progression-free survival was 5.1 months (95% CI, 3.9-6.4) and the median overall survival was 9.5 months (95% CI, 7.1-11.2). Treatment was well tolerated: grade 3 neutropenia was documented in five patients and grade 3 nausea and vomiting in two patients. The M-VECa regimen seems to be feasible as second-line or third-line treatment in patients with advanced bladder cancer who have been pretreated with one or more chemotherapy lines, and may achieve encouraging results in terms of disease control rate, progression-free survival, and overall survival.
authors.affiliation: aMedical Oncology Unit bPharmacology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena cMedical Oncology Unit, Department of Medicine, Policlinico Umberto I Hospital, University of Rome, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Petrioli
authors.forename: Giandomenico
authors.initials: G
authors.lastname: Roviello
authors.forename: Anna Ida
authors.initials: AI
authors.lastname: Fiaschi
authors.forename: Letizia
authors.initials: L
authors.lastname: Laera
authors.forename: Salvatora Tindara
authors.initials: ST
authors.lastname: Miano
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Bianco
authors.forename: Edoardo
authors.initials: E
authors.lastname: Francini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016879:Salvage Therapy; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D015251:Epirubicin; D014747:Vinblastine; D016190:Carboplatin; D008727:Methotrexate