[Temozolomide as therapeutic option for patients with metastatic melanoma and poor prognosis].

BACKGROUND AND OBJECTIVE

Stage IV melanoma patients with a very advanced disease are usually excluded from clinical trials. We treated 25 stage IV patients with temozolomide - a cytostatic drug with 100% oral bioavailability and considerable penetration of CNS tissue.

PATIENTS/METHODS: 25 patients (17 female, 8 male) between 24 and 82 years (mean: 55.5 years) were included in this retrospective study. 19 patients had received at least one and up to four previous chemotherapy regimens during the course of stage IV disease. 11 (44%) patients showed cerebral metastases prior to therapy with temozolomide. 200 mg/m2 temozolomide were given orally at home on day 1 to 5 in week 1 and in week 5, respectively.

RESULTS

Out of 23 evaluable patients 2 (8.7%) showed a partial remission, 2 (8,7%) a minor response, 6 (26.1%) had stable disease, 1 (4,3%) a mixed response, and 12 (52.1%) patients experienced disease progression. Sites of remission included brain, lung, liver, lymph nodes and muscle. Two patients interrupted therapy due to severe leuko- and thrombocytopenia (WHO grade 3 and 4). All other patients tolerated treatment with temozolomide well and no dose reduction was necessary. The median overall survival was 7 months (2-28+ months) since beginning of therapy and 15 months (4-63+ months) since onset of stage IV disease.

CONCLUSION

Temozolomide represents a safe treatment option in patients with metastatic melanoma and poor prognosis.