[HTML][HTML] Prospective, open-label, randomized, phase III study of two dose-dense regimens MVAC versus gemcitabine/cisplatin in patients with inoperable, metastatic …
Annals of oncology, 2013•Elsevier
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). Dose-dense (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 …
(Pharmanell, Athens, Greece)(MVAC) or gemcitabine, cisplatin (GC) represent the standard
treatment of advanced urothelial cancer (UC). Dose-dense (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 …
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). Dose-dense (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.
Elsevier
以上显示的是最相近的搜索结果。 查看全部搜索结果