[Randomised phase III trial of fotemustine versus fotemustine plus whole brain irradiation in cerebral metastases of melanoma]. / Essai de phase III randomisé comparant la fotémustine seule ou associée à une irradiation encéphalique dans les métastases cérébrales de mélanome.

PURPOSE: 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. PATIENTS AND METHODS: 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). RESULTS: 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). CONCLUSION: 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.

Toxicity of a combination of ABVD chemotherapy and mediastinal irradiation for Hodgkin's disease patients with massive initial mediastinal involvement.

The authors report on 5 Hodgkin's disease (HD) patients with a mediastinothoracic ratio greater than or equal to 0.35 treated by ABVD chemotherapy (adriamycin, bleomycin, vindesine, DTIC) and irradiation. All 5 patients developed complications and there was 1 death. Administration of adriamycin and bleomycin in combination with irradiation may have been responsible for this poor treatment tolerance. Use of such protocols, and especially use of ABVD after mediastinal irradiation, should probably be avoided in the management of patients with massive mediastinal involvement.