Temozolomide (TMZ) plus thalidomide (THAL) as adjuvant therapy in patients with stage III and stage IV malignant melanoma

7574 Background: TMZ plus THAL is effective and well tolerated in patients (pts) with unresectable stage III and IV melanoma (JCO 2003;21:3351). We investigated this combination as adjuvant therapy in pts with stage III and IV melanoma who were free of disease but at high risk for recurrence. Methods: Pts were rendered clinically disease-free by surgery or radiation before treatment. TMZ was given at 75 mg/m2/day for 6 weeks followed by a 2-week break. Pts<70 years old received THAL 200 mg/day, while those ≥ 70 years old received THAL 100 mg/day with escalation to 200 mg/day. Imaging studies were performed after each 8-week cycle. Treatment continued for 3 cycles unless the tumor recurred earlier. Results: 26 pts were treated; 15 stage III (8 IIIb, 7IIIc) and 11 stage IV (4 M1a, 5M1b, 2M1c); 19 men/7 women; median age 59 (range 28–78). All pts underwent surgical resection except 1 who received RT for a bone metastasis. 21 pts completed 3 cycles. Of the remaining 5, 2 had recurrence after 1 cycle, 2 were r...