Τίτλος:
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
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Bamias, A
Aravantinos, G
Deliveliotis, C
Bafaloukos, D and
Kalofonos, C
Xiros, N
Zervas, A
Mitropoulos, D
Samantas,
E
Pectasides, D
Papakostas, P
Gika, D
Kourousis, C and
Koutras, A
Papadimitriou, C
Bamias, C
Kosmidis, P and
Dimopoulos, MA
Περιοδικό:
Journal of Clinical Oncology
Εκδότης:
AMER SOC CLINICAL ONCOLOGY 2318 MILL ROAD, STE 800, ALEXANDRIA, VA 22314 USA
DOI:
10.1200/JCO.2004.02.152
