TY - JOUR
TI - 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)
AU - Bamias, A.
AU - Dafni, U.
AU - Karadimou, A.
AU - Timotheadou, E.
AU - Aravantinos, G.
AU - Psyrri, A.
AU - Xanthakis, I.
AU - Tsiatas, M.
AU - Koutoulidis, V.
AU - Constantinidis, C.
AU - Hatzimouratidis, C.
AU - Samantas, E.
AU - Visvikis, A.
AU - Chrisophos, M.
AU - Stravodimos, K.
AU - Deliveliotis, C.
AU - Eleftheraki, A.
AU - Pectasides, D.
AU - Fountzilas, G.
AU - Dimopoulos, M.A.
JO - Annals of Oncology
PY - 2013
VL - 24
TODO - 4
SP - 1011-1017
PB - 
SN - 0923-7534, 1569-8041
TODO - 10.1093/annonc/mds583
TODO - 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
TODO - 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.
ER -