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Temozolomide plus thalidomide in patients with brain metastases from melanoma
A Phase II study
Article first published online: 28 APR 2005
Copyright © 2005 American Cancer Society
Volume 103, Issue 12, pages 2590–2597, 15 June 2005
How to Cite
Hwu, W.-J., Lis, E., Menell, J. H., Panageas, K. S., Lamb, L. A., Merrell, J., Williams, L. J., Krown, S. E., Chapman, P. B., Livingston, P. O., Wolchok, J. D. and Houghton, A. N. (2005), Temozolomide plus thalidomide in patients with brain metastases from melanoma. Cancer, 103: 2590–2597. doi: 10.1002/cncr.21081
- Issue published online: 2 JUN 2005
- Article first published online: 28 APR 2005
- Manuscript Accepted: 10 JAN 2005
- Manuscript Revised: 4 DEC 2004
- Manuscript Received: 27 SEP 2004
- Schering-Plough Corporation
- Celgene Corporation
- brain metastasis;
Temozolomide plus thalidomide is a promising oral combination regimen for the treatment of metastatic melanoma. The current Phase II study examined the efficacy and safety of this combination in chemotherapy-naive patients with brain metastases.
Patients with histologically confirmed metastatic melanoma and measurable brain metastases received temozolomide (75 mg/m2 per day for 6 weeks with a 2-week break between cycles) plus concomitant thalidomide (200 mg/day escalating to 400 mg/day for patients < 70 years or 100 mg/day escalating to 250 mg/day for patients ≥ 70 years). The primary end point was tumor response in the brain assessed every 8 weeks.
Twenty-six patients with a median age of 60 years were treated. All patients had progressive brain metastases: 16 were symptomatic and 25 had extensive extracranial metastases. Eight patients had received whole-brain radiotherapy, 4 had received stereotactic radiotherapy, and 8 had received craniotomy with resection of hemorrhagic lesions. Fifteen patients completed ≥ 1 cycle (median, 1 cycle; range, 0–4 cycles), and 11 discontinued treatment before completing 1 cycle (7 for intracranial hemorrhage, 2 for pulmonary embolism, 1 for deep vein thrombosis, and 1 for Grade 3 rash). Of 15 patients assessable for response, 3 had a complete or partial response (12% intent to treat) and 7 had minor response or stable disease in the brain. However, 5 of these 10 patients had disease progression at extracranial sites. The median survival period was 5 months for all 26 patients and 6 months for the 15 assessable patients.
Temozolomide plus thalidomide was an active oral regimen for patients with brain metastases from malignant melanoma. Cancer 2005. © 2005 American Cancer Society.