title: Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma.
abstract: OBJECTIVE
  To further investigate the efficacy and safety of temozolomide plus thalidomide in patients with metastatic melanoma without brain metastases.
  
  
  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.
  
  
  CONCLUSIONS
  The combination of temozolomide plus thalidomide seems to be a promising and well-tolerated oral regimen for metastatic melanoma that merits further study.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021, USA. hwuw@mskcc.org.
authors.forename: Wen-Jen
authors.initials: WJ
authors.lastname: Hwu
authors.forename: Susan E
authors.initials: SE
authors.lastname: Krown
authors.forename: Jennifer H
authors.initials: JH
authors.lastname: Menell
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Panageas
authors.forename: Janene
authors.initials: J
authors.lastname: Merrell
authors.forename: Lynne A
authors.initials: LA
authors.lastname: Lamb
authors.forename: Linda J
authors.initials: LJ
authors.lastname: Williams
authors.forename: Carolyn J
authors.initials: CJ
authors.lastname: Quinn
authors.forename: Theresa
authors.initials: T
authors.lastname: Foster
authors.forename: Paul B
authors.initials: PB
authors.lastname: Chapman
authors.forename: Philip O
authors.initials: PO
authors.lastname: Livingston
authors.forename: Jedd D
authors.initials: JD
authors.lastname: Wolchok
authors.forename: Alan N
authors.initials: AN
authors.lastname: Houghton
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000556:secondary; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D016019:Survival Analysis; D000077204:Temozolomide; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003606:Dacarbazine; D000077204:Temozolomide