A phase II study of biochemotherapy for advanced melanoma incorporating temozolomide, decrescendo interleukin-2 and GM-CSF.

摘要: Metastatic malignant melanoma remains a very difficult disease to treat. Previous phase II studies using biochemotherapy (combination of platinum-containing chemotherapy with IL-2 and IFNalpha) have shown response rates about 50%. However, site frequent relapse is in the central nervous system (CNS). Temozolomide an oral alkylating agent that has equivalent activity dacarbazine, but it advantage CNS penetration. We report results study novel regimen containing temozolomide, cisplatin, decrescendo IL-2, IFNalpha, GM-CSF treatment stage IV melanoma. Seventy-one patients histologically confirmed metastatic were enrolled between June 1998 October 1999. Prior or was not permitted. The median age 54 years (range 22-72). Twenty-one (30%) had history treated brain metastases. Patients received temozolomide 150 mg/m2 orally days 1-5, cisplatin 30 1-3, IFNalpha 5 MU/m2 SQ on administered fashion according following schedule: day 1: 18 continuous infusion over 6 hours; 2: 12 3: 9 subcutaneously q12 4: 4.5 x 1. also given 250 microg 6-25. cycles repeated every 4 weeks. Partial responses seen 10 71 (14%) duration 9.4 months. There no complete responses. survival for all 8.6 Further this are indicated. Other schedules incorporate and/or further define optimal method delivering should be pursued.