title: Temozolomide plus thalidomide in patients with brain metastases from melanoma: a phase II study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 > or = 70 years). The primary end point was tumor response in the brain assessed every 8 weeks.
  
  
  RESULTS
  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 > or = 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.
  
  
  CONCLUSIONS
  Temozolomide plus thalidomide was an active oral regimen for patients with brain metastases from malignant melanoma.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA. wenjhwu@mdanderson.org
authors.forename: Wen-Jen
authors.initials: WJ
authors.lastname: Hwu
authors.forename: Eric
authors.initials: E
authors.lastname: Lis
authors.forename: Jennifer H
authors.initials: JH
authors.lastname: Menell
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Panageas
authors.forename: Lynne A
authors.initials: LA
authors.lastname: Lamb
authors.forename: Janene
authors.initials: J
authors.lastname: Merrell
authors.forename: Linda J
authors.initials: LJ
authors.lastname: Williams
authors.forename: Susan E
authors.initials: SE
authors.lastname: Krown
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 / Q000188:drug therapy* / Q000556:secondary; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D000077204:Temozolomide; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003606:Dacarbazine; D000077204:Temozolomide