Radiotherapy followed by temozolomide in the treatment of patients with melanoma metastatic to the brain: An Italian multicentre study

7558 Background: Whole Brain Radiotherapy (WBRT) and systemic chemotherapy remain the mainstays of therapy for metastatic brain melanoma not amenable to surgical resection. The proven efficacy of Temozolomide (TMZ) on both primary and metastatic brain tumors prompted us to conduct this phase II study to determine the activity of TMZ treatment following WBRT in patients (pts) with untreated brain metastases from melanoma. Methods: Single CNS metastases eligible to surgery and/or stereotactic radiosurgery, prior treatment for CNS metastases, severe medical conditions interfering with oral intake were the main exclusion criteria. Treatment plan included : WBRT at 6 Gy/day administered over a two-week period (on wks 1–2) for 4 fractions (total dose 24 Gy), followed, on wk 7, by orally TMZ at a dose of 150 mg/m2/day × 5 days every 4 wks, for up to 6 cycles. Pts who received at least one cycle of TMZ were assessable for response. Results: Twenty-seven pts (15 M and 12 F, ages 26 to 72) entered the study. Number of CNS metastases was 1 (6 pts), ≥ 2 (21 pts, range 2–6). In most of the pts (85%), extracerebral disease sites were detected (range, 1–5). Ten pts (37%), after received RT as initial management, dropped out due to death or general physical impairment. Among 17 pts who started TMZ chemotherapy, 2 pts lost to follow-up, 6 pts prematurely withdrew from study due to cerebral progression, 9 pts received ≥ 3 cycles, and 5 pts completed treatment plan. The median number of TMZ cycles/pt was 3 (range, 1–6). Among 15 evaluable pts, 5 stabilization of disease and 3 partial responses on cerebral sites were achieved. The median survivals of pts who received RT alone or RT plus TMZ, were 35 days (range, 5–80 days) and 180 days (range, 56–360 days), respectively. Treatment related toxicity was minimal with only two dose-modifications required due to thrombocytopenia and vomiting. Conclusions: Compared with historical data, these preliminary results show that some of the pts who received complete treatment plan could achieve prolonged disease control and survival. Final data analysis will be presented. No significant financial relationships to disclose.