Temozolomide and thalidomide in the treatment of advanced melanoma, a phase II study

• Published in: Journal of clinical oncology Vol. 23; no. 16_suppl; p. 7573
• Main Authors: Okeke, I. R., Laber, D. A., Bev, T., McMasters, K. M., Miller, D. M.
• Format: Journal Article
• Language: English
• Published: 01.06.2005
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2005.23.16_suppl.7573

7573 Background: Temozolomide and thalidomide (TT) are active agents in the treatment of melanoma. The optimal dose and schedule have not been defined.METHODSTemozolomide was administered at 75 mg/m2/day for 6 out of 8-weeks cycle. Thalidomide was given at 200 mg daily for the first two weeks and increased by 100 mg/day weekly up to a maximum of 400 mg/day without interruption. Responses were assessed every 2 cycles by using the RECIST guidelines.RESULTSFrom May 2002 through December 2004, 30 patients with advanced and symptomatic melanoma were enrolled. 17 subjects are evaluable for toxicity and 9 for response. Median age 59.3 years (39-79), PS 1 (0-2). Sites of metastasis: 3 skin, 8 lymph nodes, 4 brain, 3 liver, 2 bones, 3 adrenals, 15 lungs, 1 kidney, 2 spleen, 1 heart 2 mesenteric and 1 tongue. Prior therapies: 5 surgeries (3 local, 2 brain), 2 brain radiotherapy, 3 adjuvant interferon, 7 biochemotherapy, 2 vaccine. 47 cycles of TT have been administered (range 1-8 cycles). 70% of the patients received the maximum thalidomide dose whereas 17% had dose reduction due to fatigue and neuropathy, the rest could not be escalated. Out of 9 patients, 1 had a complete response after 2 cycles, 1 partial response, 1 stable disease after 2 cycles and 6 patients progressed after 1 cycle of TT. Toxicity grade 3: anemia 5%, thrombocytopenia 17%, thromboembolic disease 5% and shingles 5%; grade 2: constipation 17%, fatigue 17%. 1 patient with brain metastasis developed seizures attributed to a low level of antiepileptic and 1 had gastrointestinal bleed due to gastric melanoma. No other hematologic or non-hematologic toxicities were observed. Results will be updated for the meeting.CONCLUSIONSTT is an active and well tolerated treatment for patients with advanced melanoma. [Table: see text].