| Autor: |
F, Mornex, L, Thomas, P, Mohr, A, Hauschild, M M, Delaunay, T, Lesimple, W, Tilgen, B B, Nguyen, B, Guillot, J, Ulrich, S, Bourdin, M, Mousseau, D, Cupissol, J, Bonneterre, C, de Gislain, J R, Bensadoun, M, Clavel |
| Jazyk: |
francouzština |
| Rok vydání: |
2003 |
| Předmět: |
|
| Zdroj: |
Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique. 7(1) |
| ISSN: |
1278-3218 |
| Popis: |
The main objective of this prospective multicenter randomised phase III study was to compare a combined regimen of fotemustine plus whole brain irradiation versus fotemustine alone in terms of cerebral response and time to cerebral progression in patients with melanoma brain metastases.Seventy-six patients (instead of the 106 planned patients; study was stopped after the interim analysis) were randomised receiving either fotemustine (arm A, n = 39) or fotemustine and whole brain irradiation (arm B, n = 37). Fotemustine was administered intravenously at 100 mg m(-2) on day 1, 8 and 15, followed by a 5-week rest period, then every 3 weeks in non-progressive patients. In arm B, a concomitant whole brain irradiation was performed at the total dose of 37.5 Gy (2.5 Gy/d(-1), days 1-5, 3 consecutive weeks).Although patients who received fotemustine alone had worse prognostic factors, there was no significant difference in brain response (arm A: 7.4%, B: 10.0%) or control rates (objective response plus stable disease) after seven weeks (arm A: 30%, B: 47%) and overall survival (arm A: 86d, B: 105d). However, there was a significant difference in favour of arm B for the time to brain progression (p = 0.028, Wilcoxon test).Fotemustine plus whole brain irradiation delayed the time to brain progression of melanoma cerebral metastases compared to fotemustine alone but without a significant improvement in terms of objective control or overall survival. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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