@article{3109529,
    title = "Prospective, open-label, randomized, phase iii study of two dose-dense regimens MVAC versus gemcitabine/ cisplatin in patients with inoperable, metastatic or relapsed urothelial cancer: A hellenic cooperative oncology group study (HE 16/03)",
    author = "Bamias, A. and Dafni, U. and Karadimou, A. and Timotheadou, E. and Aravantinos, G. and Psyrri, A. and Xanthakis, I. and Tsiatas, M. and Koutoulidis, V. and Constantinidis, C. and Hatzimouratidis, C. and Samantas, E. and Visvikis, A. and Chrisophos, M. and Stravodimos, K. and Deliveliotis, C. and Eleftheraki, A. and Pectasides, D. and Fountzilas, G. and Dimopoulos, M.A.",
    journal = "Annals of Oncology",
    year = "2013",
    volume = "24",
    number = "4",
    pages = "1011-1017",
    issn = "0923-7534, 1569-8041",
    doi = "10.1093/annonc/mds583",
    keywords = "cisplatin;  doxorubicin;  gemcitabine;  granulocyte colony stimulating factor;  methotrexate;  vinblastine, adult;  advanced cancer;  aged;  anemia;  article;  bone marrow toxicity;  chemotherapy induced emesis;  controlled study;  dose densification;  drug efficacy;  drug fatality;  drug tolerability;  drug withdrawal;  fatigue;  febrile neutropenia;  female;  follow up;  hearing disorder;  human;  infection;  inoperable cancer;  major clinical study;  male;  metastasis;  multiple cycle treatment;  nausea;  nephrotoxicity;  neuropathy;  neurotoxicity;  neutropenia;  open study;  ototoxicity;  outcome assessment;  overall survival;  phase 3 clinical trial;  priority journal;  progression free survival;  prospective study;  randomized controlled trial;  recurrent cancer;  sepsis;  stomatitis;  survival time;  thrombocytopenia;  transitional cell carcinoma;  treatment response;  urogenital tract cancer;  vascular disease, Adult;  Aged;  Antineoplastic Agents;  Antineoplastic Combined Chemotherapy Protocols;  Cisplatin;  Deoxycytidine;  Disease-Free Survival;  Doxorubicin;  Female;  Humans;  Male;  Methotrexate;  Middle Aged;  Neoplasm Staging;  Prospective Studies;  Urinary Bladder Neoplasms;  Urothelium;  Vinblastine",
    abstract = "Background: The combinations of methotrexate, vinblastine, Adriamycin, cisplatin (Pharmanell, Athens, Greece) (MVAC) or gemcitabine, cisplatin (GC) represent the standard treatment of advanced urothelial cancer (UC). Dosedense (DD)-MVAC has achieved longer progression-free survival (PFS) than the conventional MVAC. However, the role of GC intensification has not been studied. We conducted a randomized, phase III study comparing a DD-GC regimen with DD-MVAC in advanced UC. Patients and methods: One hundred and thirty patients were randomly assigned between DD-MVAC: 66 (M 30 mg/ m2, V 3 mg/m2, A 30 mg/m2, C 70 mg/m2 q 2 weeks) and DD-GC 64 (G 2500 mg/m2, C 70 mg/m2 q 2 weeks). The median follow-up was 52.1 months (89 events). Results: The median overall survival (OS) and PFS were 19 and 8.5 months for DD-MVAC and 18 and 7.8 months for DD-GC (P = 0.98 and 0.36, respectively). Neutropenic infections were less frequent for DD-GC than for DD-MVAC (0% versus 8%). More patients on DD-GC received at least six cycles of treatment (85% versus 63%, P = 0.011) and the discontinuation rate was lower for DD-GC (3% versus 13%). Conclusions: Although DD-GC was not superior to DD-MVAC, it was better tolerated. DD-GC could be considered as a reasonable therapeutic option for further study in this patient population. Clinical Trial Number: ACTRN12610000845033, www.anzctr.org.au. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved."
}