PURPOSE: To further investigate the efficacy and safety of @entity2903 plus @entity2816 in @entity1 with @entity320 without brain metastases. @entity1 AND METHODS: @entity1 with histologically confirmed advanced-stage @entity320 were enrolled in an open-label, phase II study. The primary end point was response rate. @entity1 received @entity2903 (75 mg/m2/d x 6 weeks with a 2-week rest between cycles) plus concomitant @entity2816 (200 mg/d with dose escalation to 400 mg/d for @entity1 < 70 years old, or 100 mg/d with dose escalation to 250 mg/d for @entity1 >/= 70 years old). Treatment was continued until unacceptable @entity137 or disease progression occurred. RESULTS: Thirty-eight @entity1 (median age, 62 years) with stage IV (three @entity1 with M1a, eight with M1b, and 26 with M1c) or stage IIIc (one @entity1 ) @entity320 and a median of four metastatic sites were enrolled, and received a median of two cycles of therapy. Twelve @entity1 (32%) had an objective @entity5 response, including one with an ongoing complete response of 25+ months' duration and 11 with partial responses. Five @entity1 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 @entity2903 plus @entity2816 seems to be a promising and well-tolerated oral regimen for @entity320 that merits further study.

Phase II study of @entity2903 plus @entity2816 for the treatment of XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity2816 :: ('MESH:D013792', 'Chemical') :: ['thalidomide'] @entity2903 :: ('MESH:C047246', 'Chemical') :: ['temozolomide'] @entity320 :: ('MESH:D008545', 'Disease') :: ['melanoma', 'metastatic melanoma']
@entity320 :: (MESH:D008545,Disease) :: ['metastatic melanoma']
