title: A mixed-methods feasibility trial of protein kinase C iota inhibition with auranofin in asymptomatic ovarian cancer patients.
abstract: OBJECTIVE
  This trial was undertaken (1) to determine the feasibility of enrolling asymptomatic ovarian cancer patients with CA-125 elevation in a trial with the protein kinase C iota (PKCι) inhibitor auranofin and (2) to understand patients' perceptions of CA-125 monitoring.
  
  
  METHODS
  Asymptomatic ovarian cancer patients with CA-125 elevation received 3 mg auranofin orally twice per day and were evaluated. The patients participated in interviews about CA-125 monitoring.
  
  
  RESULTS
  Ten patients were enrolled in slightly over 6 months, exceeding our anticipated accrual rate. Four manifested stable CA-125 levels for 1 month or longer. The median progression-free survival was 2.8 months (95% CI: 1.3-3.8); auranofin was well tolerated. One patient had baseline and monthly CA-125 levels of 5,570, 6,085, 3,511, and 2,230 U/ml, respectively, stopped auranofin because of radiographic progression at 3 months, and manifested an increase in CA-125 to 7,168 U/ml approximately 3 months later. Patient interviews revealed (1) the important role of CA-125 in cancer monitoring, (2) ardent advocacy of CA-125 testing, and (3) an evolution toward CA-125 assuming a life of its own.
  
  
  CONCLUSIONS
  This study showed the feasibility of enrolling asymptomatic ovarian cancer patients with CA-125 elevation in a trial with auranofin. One patient had a decline in CA-125, suggesting that PKCι inhibition merits further study in ovarian cancer.
authors.affiliation: Department of Oncology, Mayo Clinic, Rochester, Minn., USA.
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Carmen
authors.initials: C
authors.lastname: Radecki Breitkopf
authors.forename: Nathan R
authors.initials: NR
authors.lastname: Foster
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Block
authors.forename: Megan
authors.initials: M
authors.lastname: Grudem
authors.forename: Andrea
authors.initials: A
authors.lastname: Wahner Hendrickson
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Carlson
authors.forename: Brigitte
authors.initials: B
authors.lastname: Barrette
authors.forename: Nina
authors.initials: N
authors.lastname: Karlin
authors.forename: Alan P
authors.initials: AP
authors.lastname: Fields
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001310:Auranofin / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D018394:CA-125 Antigen / Q000378:metabolism; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D010865:Pilot Projects; D011379:Prognosis; D011493:Protein Kinase C / Q000037:antagonists & inhibitors*; D015996:Survival Rate; D000099293:Protein Kinase C-lambda
chemical_list: D018501:Antirheumatic Agents; D001310:Auranofin; D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D007527:Isoenzymes; D011493:Protein Kinase C; D000099293:Protein Kinase C-lambda