title: Seven year update of an EORTC phase III trial of high-dose intensity M-VAC chemotherapy and G-CSF versus classic M-VAC in advanced urothelial tract tumours.
abstract: EORTC protocol 30924 is an international randomized trial reporting a 7.3 year update of a 2 weekly regimen of high-dose intensity chemotherapy with M-VAC plus granulocyte colony stimulating factor (HD-M-VAC) compared to classic M-VAC in advanced transitional cell carcinoma (TCC). Two hundred and sixty three untreated patients with bidimensionally measurable TCC were included. In an intention to treat analysis, there were 28 complete responses (CR) (21%) and 55 partial responses (PR) (41%), for an overall response rate (RR) of 64% on the HD-M-VAC arm. On M-VAC, there were 12 CR (9%) and 53 PR (41%), for an overall RR of 50% . The P-value for the difference in CR was 0.009; and for RR, was 0.06. After a median follow-up of 7.3 years, 24.6% are alive on the HD-M-VAC arm vs. 13.2% on the M-VAC arm. Median progression-free survival was better with HD-MVAC (9.5 months) vs. M-VAC (8.1 months). The mortality hazard ratio (HR) was 0.76. The 2-year survival rate for HD-M-VAC was 36.7% vs. 26.2% for M-VAC. At 5 years, the survival rate was 21.8% in the HD-M-VAC vs. 13.5%. Median survival was 15.1 months on HD-MVAC and 14.9 months on M-VAC. There was one death from toxicity in each arm; and more patients died to malignant disease in the M-VAC arm (76%) than in the HD-M-VAC arm (64.9%). With longer follow-up initial results have been confirmed, and shows that HD-M-VAC produces a borderline statistically significant relative reduction in the risk of progression and death compared to M-VAC.
authors.affiliation: Department of Medical Oncology, San Camillo Forlanini Hospital, Nuovi Padiglioni, 4th floor, Circonvallazione Gianicolense 87, Rome 00152, Italy. cstern@mclink.it
authors.forename: C N
authors.initials: CN
authors.lastname: Sternberg
authors.forename: P
authors.initials: P
authors.lastname: de Mulder
authors.forename: J H
authors.initials: JH
authors.lastname: Schornagel
authors.forename: C
authors.initials: C
authors.lastname: Theodore
authors.forename: S D
authors.initials: SD
authors.lastname: Fossa
authors.forename: A T
authors.initials: AT
authors.lastname: van Oosterom
authors.forename: J A
authors.initials: JA
authors.lastname: Witjes
authors.forename: M
authors.initials: M
authors.lastname: Spina
authors.forename: C J
authors.initials: CJ
authors.lastname: van Groeningen
authors.forename: B
authors.initials: B
authors.lastname: Duclos
authors.forename: J T
authors.initials: JT
authors.lastname: Roberts
authors.forename: C
authors.initials: C
authors.lastname: de Balincourt
authors.forename: L
authors.initials: L
authors.lastname: Collette
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D016019:Survival Analysis; D014571:Urologic Neoplasms / Q000188:drug therapy*; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D014747:Vinblastine; D004317:Doxorubicin; D002945:Cisplatin; D008727:Methotrexate