Randomized phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924
| Autor: | A. van Oosterom, L. Collette, C. de Balincourt, Sophie D. Fosså, C.J. van Groeningen, Jan H. Schornagel, F. Witjes, Christine Theodore, Michele Spina, P.H.M. de Mulder, Cora N. Sternberg |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Filgrastim medicine.drug_class medicine.medical_treatment Urology Urological oncology Vinblastine Antimetabolite Disease-Free Survival Drug Administration Schedule Experimental diagnostics and therapy of malignancies Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Humans Urologische oncologie Neoplasm Metastasis Aged Cisplatin Aged 80 and over Chemotherapy business.industry Middle Aged medicine.disease Recombinant Proteins Granulocyte colony-stimulating factor Surgery Europe Transitional cell carcinoma Methotrexate Oncology Urinary Bladder Neoplasms Doxorubicin Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology, 19, 10, pp. 2638-46 Journal of Clinical Oncology, 19, 2638-46 |
| ISSN: | 0732-183X |
| Popis: | PURPOSE: This randomized trial evaluated antitumor activity of and survival asociated with high–dose-intensity chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) plus granulocyte colony-stimulating factor (HD-MVAC) versus MVAC in patients with advanced transitional-cell carcinoma (TCC). PATIENTS AND METHODS: A total of 263 patients with metastatic or advanced TCC who had no prior chemotherapy were randomized to HD-MVAC (2-week cycles) or MVAC (4-week cycles). RESULTS: Using an intent-to-treat analysis, at a median follow-up of 38 months, on the HD-MVAC arm there were 28 complete responses (CRs) (21%) and 55 partial responses (PRs) (41%), for an overall response of 62% (95% confidence interval [CI], 54% to 70%). On the MVAC arm, there were 12 CRs (9%) and 53 PRs (41%), for an overall response of 50% (95% CI, 42% to 59%). The P value for the difference in CR rate was .009; and for the overall response, it was .06. There was no statistically significant difference in survival (P = .122) or time to progression (P = .114). Progression-free survival was significantly better with HD-MVAC (P=.037; hazard ratio .75; 95% CI .58 to .98). The median progression-free survival time was 9.1 months on the HD-MVAC arm versus 8.2 months on the MVAC arm. The 2-year progression-free survival rate was 24.7% for HD-MVAC (95% CI, 17.1% to 32.3%) versus 11.6% for MVAC (95% CI, 5.9% to 17.4%). CONCLUSION: With HD-MVAC, it was possible to deliver twice the doses of cisplatin and doxorubicin in half the time, with fewer dose delays and less toxicity. Although a 50% difference in median overall survival was not detected, a benefit was observed in progression-free survival, CR rates, and overall response rates with HD-MVAC. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|