PURPOSE: To further investigate the efficacy and safety of temozolomide plus thalidomide in patients with metastatic melanoma without brain metastases. PATIENTS AND METHODS: Patients with histologically confirmed advanced-stage metastatic melanoma were enrolled in an open-label, phase II study. The primary end point was response rate. Patients received temozolomide (75 mg/m2/d x 6 weeks with a 2-week rest between cycles) plus concomitant thalidomide (200 mg/d with dose escalation to 400 mg/d for patients < 70 years old, or 100 mg/d with dose escalation to 250 mg/d for patients >/= 70 years old). Treatment was continued until unacceptable toxicity or disease progression occurred. RESULTS: Thirty-eight patients (median age, 62 years) with stage IV (three patients with M1a, eight with M1b, and 26 with M1c) or stage IIIc (one patient) melanoma and a median of four metastatic sites were enrolled, and received a median of two cycles of therapy. Twelve patients (32%) had an objective tumor response, including one with an ongoing complete response of 25+ months' duration and 11 with partial responses. Five patients achieving partial response with a more than 90% reduction of disease were converted to a complete response with surgery. Treatment was generally well tolerated. Median survival was 9.5 months (95% confidence interval, 6.05 to 19.38 months), with a median follow-up among survivors of 24.3 months. CONCLUSION: The combination of temozolomide plus thalidomide seems to be a promising and well-tolerated oral regimen for metastatic melanoma that merits further study.
PURPOSE: To further investigate the efficacy and safety of temozolomide plus thalidomide in patients with metastatic melanoma without brain metastases. PATIENTS AND METHODS: Patients with histologically confirmed advanced-stage metastatic melanoma were enrolled in an open-label, phase II study. The primary end point was response rate. Patients received temozolomide (75 mg/m2/d x 6 weeks with a 2-week rest between cycles) plus concomitant thalidomide (200 mg/d with dose escalation to 400 mg/d for patients < 70 years old, or 100 mg/d with dose escalation to 250 mg/d for patients >/= 70 years old). Treatment was continued until unacceptable toxicity or disease progression occurred. RESULTS: Thirty-eight patients (median age, 62 years) with stage IV (three patients with M1a, eight with M1b, and 26 with M1c) or stage IIIc (one patient) melanoma and a median of four metastatic sites were enrolled, and received a median of two cycles of therapy. Twelve patients (32%) had an objective tumor response, including one with an ongoing complete response of 25+ months' duration and 11 with partial responses. Five patients achieving partial response with a more than 90% reduction of disease were converted to a complete response with surgery. Treatment was generally well tolerated. Median survival was 9.5 months (95% confidence interval, 6.05 to 19.38 months), with a median follow-up among survivors of 24.3 months. CONCLUSION: The combination of temozolomide plus thalidomide seems to be a promising and well-tolerated oral regimen for metastatic melanoma that merits further study.
Authors: Ravi K Amaravadi; Lynn M Schuchter; David F McDermott; Amy Kramer; Lydia Giles; Kristi Gramlich; Mary Carberry; Andrea B Troxel; Richard Letrero; Katherine L Nathanson; Michael B Atkins; Peter J O'Dwyer; Keith T Flaherty Journal: Clin Cancer Res Date: 2009-12-15 Impact factor: 12.531
Authors: Ilkka Liikanen; Laura Ahtiainen; Mari L M Hirvinen; Simona Bramante; Vincenzo Cerullo; Petri Nokisalmi; Otto Hemminki; Iulia Diaconu; Sari Pesonen; Anniina Koski; Lotta Kangasniemi; Saila K Pesonen; Minna Oksanen; Leena Laasonen; Kaarina Partanen; Timo Joensuu; Fang Zhao; Anna Kanerva; Akseli Hemminki Journal: Mol Ther Date: 2013-04-02 Impact factor: 11.454
Authors: Hong Zhao; Guangxu Jin; Kemi Cui; Ding Ren; Timothy Liu; Peikai Chen; Solomon Wong; Fuhai Li; Yubo Fan; Angel Rodriguez; Jenny Chang; Stephen T C Wong Journal: Cancer Res Date: 2013-10-04 Impact factor: 12.701