Originally published as JCO Early Release 10.1200/JCO.2004.02.152 on December 9 2003

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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

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, Piraeus, Greece

Address reprint requests to Aristotle Bamias, MD, 31 Komninon St, Haidari 124 62 Athens, Greece; e-mail: abamias{at}med.uoa.gr

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.

Preliminary analysis presented at the 39th American Society of Clinical Oncology Annual Meeting, May 29-June 3, 2003, Chicago, IL.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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