title: A phase 2, single-arm study of an autologous dendritic cell treatment against mucin 1 in patients with advanced epithelial ovarian cancer.
abstract: BACKGROUND
  Mucin 1 antigen, highly expressed by epithelial ovarian cancer (EOC), is a potential target for immunotherapy. A previous successful phase 1 trial was conducted in patients with adenocarcinoma who were injected with Cvac, autologous monocyte-derived dendritic cells (DCs) incubated with mannosylated mucin 1 protein (M-FP). The present study was a phase 2 trial of Cvac in patients with advanced EOC.
  
  
  METHODS
  Eligible patients had EOC with progressive disease, defined as an increase in CA125 of ≥ 25% in 1 month. The primary endpoint was CA125 response or stabilization. Peripheral blood mononuclear cells were collected by leukapheresis and cultured to generate DCs. The DC were incubated with M-FP, and after washing were prepared for injection into the patient intradermally every 4 weeks for 3 doses, then every 10 weeks for up to 12 months.
  
  
  RESULTS
  All 28 patients recruited were evaluable for safety and 26 for efficacy. All had undergone surgery and platinum-based chemotherapy, and 57% of patients received ≥ 3 chemotherapy regimens. There were no Grade 3 or 4 toxicities considered related to Cvac. Four patients showed CA125 response or stabilization (2 patients with major responses, 1 minor response, 1 stabilization) of median duration 10.3 months (5.3-16.3 months). An additional patient had > 25% CA125 reduction (not confirmed).
  
  
  CONCLUSIONS
  Cvac immunotherapy was well tolerated. Clinical activity in EOC was evident based on decline or stabilization of CA125 in some patients, supporting ongoing development of Cvac in ovarian carcinoma and planning of additional trials of patients in remission is currently underway.
authors.affiliation: Medical Oncology Unit, Austin Hospital, Olivia Newton-John Cancer and Wellness Centre, 145 Studley Road, Heidelberg, VIC 3084, Australia ; University of Melbourne, Parkville, VIC 3052, Australia.
authors.forename: Paul Lr
authors.initials: PL
authors.lastname: Mitchell
authors.affiliation: Royal Womens Hospital, 20 Flemington Road, Parkville, VIC 3052, Australia ; University of Melbourne, Parkville, VIC 3052, Australia.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Quinn
authors.affiliation: Mercy Hospital for Women, 163 Studley Road, Heidelberg, VIC 3084, Australia ; University of Melbourne, Parkville, VIC 3052, Australia.
authors.forename: Peter T
authors.initials: PT
authors.lastname: Grant
authors.affiliation: Mercy Hospital for Women, 163 Studley Road, Heidelberg, VIC 3084, Australia ; University of Melbourne, Parkville, VIC 3052, Australia.
authors.forename: David G
authors.initials: DG
authors.lastname: Allen
authors.affiliation: Monash Medical Centre, Clayton Road, Clayton, VIC 3168, Australia ; Monash University, Wellington Road, Clayton, VIC 3168, Australia.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Jobling
authors.affiliation: Medical Oncology Unit, Austin Hospital, Olivia Newton-John Cancer and Wellness Centre, 145 Studley Road, Heidelberg, VIC 3084, Australia.
authors.forename: Shane C
authors.initials: SC
authors.lastname: White
authors.affiliation: Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Zhao
authors.affiliation: Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia ; Roche Innovation Center Zurich, 8952 Schlieren, Switzerland.
authors.forename: Vaios
authors.initials: V
authors.lastname: Karanikas
authors.affiliation: Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia.
authors.forename: Hilary
authors.initials: H
authors.lastname: Vaughan
authors.affiliation: Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia ; University of Melbourne, Parkville, VIC 3052, Australia.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Pietersz
authors.affiliation: Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia.
authors.forename: Ian Fc
authors.initials: IF
authors.lastname: McKenzie
authors.affiliation: Prima BioMed, Ltd., 151 Macquarie Street, Sydney, NSW 2001, Australia.
authors.forename: Sharron E
authors.initials: SE
authors.lastname: Gargosky
authors.affiliation: Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia ; Monash University, Wellington Road, Clayton, VIC 3168, Australia.
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Loveland
keywords: CA125; Immunotherapy; Ovarian cancer