Τίτλος:
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)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Bamias, A.
Dafni, U.
Karadimou, A.
Timotheadou, E.
Aravantinos, G.
Psyrri, A.
Xanthakis, I.
Tsiatas, M.
Koutoulidis, V.
Constantinidis, C.
Hatzimouratidis, C.
Samantas, E.
Visvikis, A.
Chrisophos, M.
Stravodimos, K.
Deliveliotis, C.
Eleftheraki, A.
Pectasides, D.
Fountzilas, G.
Dimopoulos, M.A.
Περιοδικό:
Annals of Oncology
Λέξεις-κλειδιά:
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
DOI:
10.1093/annonc/mds583
