title: Phase II study of nab-paclitaxel and bevacizumab as first-line therapy for patients with unresectable stage III and IV melanoma.
abstract: OBJECTIVE
  This study was an open-label multicenter phase II trial to investigate the efficacy and safety of nab-paclitaxel and bevacizumab as first-line therapy in patients with histologically confirmed unresectable metastatic melanoma.
  
  
  METHODS
  The treatment regimen consisted of a 28-day cycle in which patients received nab-paclitaxel, 150 mg/m through intravenous (IV) infusion weekly for 3 weeks and bevacizumab, 10 mg/kg IV every 2 weeks without a rest period. The 28-day cycle was repeated until there was unacceptable toxicity or disease progression. If 1 drug had to be stopped because of toxicity, treatment was continued with the other drug until disease progression or unacceptable toxicity. The primary endpoint was the progression-free survival rate (PFS) at 4 months.
  
  
  RESULTS
  Fifty patients were enrolled. The PFS rate at 4 months was 75%. The median PFS was 7.6 months and the median overall survival was 16.8 months with a median duration follow-up of 41.6 months. The overall survival rate was 64% at 1 year and 30% at 2 years. Ten patients (20%) remain alive. The objective response rate was 36%. Common adverse events associated with this regimen were peripheral neuropathy, fatigue, alopecia, and gastrointestinal disorders.
  
  
  CONCLUSIONS
  In this phase II multicenter study, this doublet had significant activity in patients with metastatic melanoma, and was well tolerated. These results are promising and follow-up trials to further explore this regimen are warranted.
authors.affiliation: *Northern California Melanoma Center, St. Mary's Medical Center, San Francisco †The Angeles Clinic and Research Institute, Santa Monica ‡Scott Cruickshank and Associates, Santa Barbara, CA.
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Spitler
authors.forename: Peter
authors.initials: P
authors.lastname: Boasberg
authors.forename: Steven
authors.initials: S
authors.lastname: O'Day
authors.forename: Omid
authors.initials: O
authors.lastname: Hamid
authors.forename: Scott
authors.initials: S
authors.lastname: Cruickshank
authors.forename: Shane
authors.initials: S
authors.lastname: Mesko
authors.forename: Robert W
authors.initials: RW
authors.lastname: Weber
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D017239:Paclitaxel