PURPOSE: To assess the efficacy and tolerability of extended dose temozolomide and continuous thalidomide in patients with advanced metastatic cutaneous melanoma. PATIENTS AND METHODS: Eligibility criteria included adults with histologic diagnosis of metastatic melanoma with adequate organ function and performance status. Temozolomide (75 mg/m(2)/day) was administered for 6 weeks followed by a 2-week rest. Thalidomide (200 mg/day) was given for the first 2 weeks and increased by 100 mg/day at weekly intervals up to a maximum of 400 mg/day, if no toxicity. For patients older than 70 years, thalidomide was started at 100 mg/day and the dose was increased by 50 mg/day up to a maximum of 250 mg/day. RESULTS: Twenty-six extensively pretreated subjects, with poor prognostic factors, were entered into this study and included in all analyses. According to the RECIST criteria, one (4%) subject achieved a complete response (CR), two (8%) partial response (PR), and five (19%) stable disease (SD), for a response rate (CR + PR) of 12% [95% confidence interval (CI), 0-24.7%] and a clinical benefit (CR + PR + SD) of 31%. Median time to progression was 1.8 months (95% CI, 1.2-2.4 months) and median survival was 5.2 months (95% CI, 4.1-6.2 months). CONCLUSIONS: The combination of temozolomide and thalidomide is well tolerated in patients with very advanced heavily pretreated metastatic melanoma. It has modest activity in this population with grave prognosis.
PURPOSE: To assess the efficacy and tolerability of extended dose temozolomide and continuous thalidomide in patients with advanced metastatic cutaneous melanoma. PATIENTS AND METHODS: Eligibility criteria included adults with histologic diagnosis of metastatic melanoma with adequate organ function and performance status. Temozolomide (75 mg/m(2)/day) was administered for 6 weeks followed by a 2-week rest. Thalidomide (200 mg/day) was given for the first 2 weeks and increased by 100 mg/day at weekly intervals up to a maximum of 400 mg/day, if no toxicity. For patients older than 70 years, thalidomide was started at 100 mg/day and the dose was increased by 50 mg/day up to a maximum of 250 mg/day. RESULTS: Twenty-six extensively pretreated subjects, with poor prognostic factors, were entered into this study and included in all analyses. According to the RECIST criteria, one (4%) subject achieved a complete response (CR), two (8%) partial response (PR), and five (19%) stable disease (SD), for a response rate (CR + PR) of 12% [95% confidence interval (CI), 0-24.7%] and a clinical benefit (CR + PR + SD) of 31%. Median time to progression was 1.8 months (95% CI, 1.2-2.4 months) and median survival was 5.2 months (95% CI, 4.1-6.2 months). CONCLUSIONS: The combination of temozolomide and thalidomide is well tolerated in patients with very advanced heavily pretreated metastatic melanoma. It has modest activity in this population with grave prognosis.
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Authors: Wen-Jen Hwu; Susan E Krown; Jennifer H Menell; Katherine S Panageas; Janene Merrell; Lynne A Lamb; Linda J Williams; Carolyn J Quinn; Theresa Foster; Paul B Chapman; Philip O Livingston; Jedd D Wolchok; Alan N Houghton Journal: J Clin Oncol Date: 2003-09-01 Impact factor: 44.544
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Authors: Martin L Ashdown; Andrew P Robinson; Steven L Yatomi-Clarke; M Luisa Ashdown; Andrew Allison; Derek Abbott; Svetomir N Markovic; Brendon J Coventry Journal: F1000Res Date: 2015-07-13