TY - JOUR
TI - Docetaxel and cisplatin with granulocyte colony-stimulating factor
(G-CSF) versus MVAC with G-CSF in advanced urothelial carcinoma: A
multicenter, randomized, phase III study from the Hellenic Cooperative
Oncology Group
AU - Bamias, A
AU - Aravantinos, G
AU - Deliveliotis, C
AU - Bafaloukos, D and
AU - Kalofonos, C
AU - Xiros, N
AU - Zervas, A
AU - Mitropoulos, D
AU - Samantas,
AU - E
AU - Pectasides, D
AU - Papakostas, P
AU - Gika, D
AU - Kourousis, C and
AU - Koutras, A
AU - Papadimitriou, C
AU - Bamias, C
AU - Kosmidis, P and
AU - Dimopoulos, MA
JO - Journal of Clinical Oncology
PY - 2004
VL - 22
TODO - 2
SP - 220-228
PB - AMER SOC CLINICAL ONCOLOGY 2318 MILL ROAD, STE 800, ALEXANDRIA, VA 22314 USA
SN - 0732-183X, 1527-7755
TODO - 10.1200/JCO.2004.02.152
TODO - null
TODO - Purpose The combination of methotrexate, vinblastine, doxorubicin, and
cisplatin (MVAC) represents the standard regimen for inoperable or
metastatic urothelial cancer, but its toxicity is significant. We
previously reported a 52% response rate (RR) using a docetaxel and
cisplatin (DC) combination. The toxicity of this regimen compared
favorably with that reported for MVAC. We thus designed a randomized
phase III trial to compare DC with MVAC.
Patients and Methods Patients with inoperable, or metastatic urothelial
carcinoma; adequate bone marrow, renal, liver, and cardiac function; and
Eastern Cooperative Oncology Group performance status : 2 were randomly
assigned to receive MVAC at standard doses or docetaxel 75 mg/m(2) and
cisplatin 75 mg/m(2) every 3 weeks. All patients received prophylactic
granulocyte colony-stimulating factor (G-CSF) support.
Results Two hundred twenty patients were randomly assigned (MVAC, 109
patients; DC, 111 patients). Treatment with MVAC resulted in superior RR
(54.2% v 37.4%; P = .017), median time to progression (TTP; 9.4 v 6.1
months; P = .003) and median survival (14.2 v 9.3 months; P = .026).
After adjusting for prognostic factors, difference in TTP remained
significant (hazard ratio [HR], 1.61; P = .005), whereas survival
difference was nonsignificant at the 5% level (HR, 1.31; P = .089).
MVAC caused more frequent grade 3 or 4 neutropenia (35.4% v 19.2%; P =
.006), thrombocytopenia (5.7% v 0.9%; P = .046), and neutropenic
sepsis (11.6% v 3.8%; P = .001). Toxicity of MVAC was considerably
lower than that previously reported for MVAC administered without G-CSF.
Conclusion MVAC is more effective than DC in advanced urothelial cancer.
G-CSF-supported MVAC is well tolerated and could be used instead of
classic MVAC as first-line treatment in advanced urothelial carcinoma.
ER -