title: Efficacy of nelfinavir as monotherapy in refractory adenoid cystic carcinoma: Results of a phase II clinical trial.
abstract: BACKGROUND
  Adenoid cystic carcinomas (ACCs) are malignant salivary gland tumors noteworthy for high rates of late failure with limited salvage therapy options. We have previously shown increased Akt signaling is common in ACC and the human immunodeficiency virus (HIV) protease inhibitor nelfinavir (NFV) inhibits in vitro tumor growth by suppressing Akt signaling. This phase II trial was conducted to determine progression-free survival in response to NFV in patients with recurrent/endstage ACC who have failed standard therapies.
  
  
  METHODS
  Eligible patients had recurrent or end-stage ACC and measureable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. NFV was provided at 1250 mg twice daily.
  
  
  RESULTS
  Among 15 trial participants, median progression-free survival was 5.5 months (lower 95% bound 4.4 months). No patient achieved a RECIST partial or complete response to therapy.
  
  
  CONCLUSIONS
  NFV monotherapy does not result in a meaningful improvement in clinical outcomes among patients with recurrent ACC.
authors.affiliation: Department of Radiation Oncology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Hoover
authors.forename: Mohammed M
authors.initials: MM
authors.lastname: Milhem
authors.forename: Carryn M
authors.initials: CM
authors.lastname: Anderson
authors.forename: Wenqing
authors.initials: W
authors.lastname: Sun
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Smith
authors.forename: Henry T
authors.initials: HT
authors.lastname: Hoffman
authors.forename: John M
authors.initials: JM
authors.lastname: Buatti
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D003528:Carcinoma, Adenoid Cystic / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D002423:Cause of Death; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006785:Hospitals, University; D006801:Humans; D007484:Iowa; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D019888:Nelfinavir / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D018570:Risk Assessment; D012468:Salivary Gland Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D012737:Sex Factors; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States
chemical_list: D019888:Nelfinavir
keywords: Akt; adenoid cystic carcinoma; head and neck cancer; nelfinavir; salivary gland cancer