Affiliation:
1. From the Departments of Clinical Therapeutics, Urology, Hygiene, and Epidemiology, University of Athens School of Medicine; the Medical Oncology Department, Agii Anargyri; Hygia Hospital; the Second Department of Internal Medicine, Evangelismos Hospital; the Oncology Department, Ippokration Hospital, Athens; the Department of Internal Medicine, University of Patra, Patra; the School of Medicine, Rio; the Department of Medical Oncology, Herakleion University Hospital, Herakleion; and Metaxa Hospital,...
Abstract
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/m2 and cisplatin 75 mg/m2 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.
Publisher
American Society of Clinical Oncology (ASCO)
Cited by
158 articles.
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