title: A pilot study of MUC-1/CEA/TRICOM poxviral-based vaccine in patients with metastatic breast and ovarian cancer.
abstract: OBJECTIVE
  PANVAC is a recombinant poxviral vaccine that contains transgenes for MUC-1, CEA, and 3 T-cell costimulatory molecules. This study was conducted to obtain preliminary evidence of clinical response in metastatic breast and ovarian cancer patients.
  
  
  METHODS
  Twenty-six patients were enrolled and given monthly vaccinations. Clinical and immune outcomes were evaluated.
  
  
  RESULTS
  These patients were heavily pretreated, with 21 of 26 patients having 3 or more prior chemotherapy regimens. Side effects were largely limited to mild injection-site reactions. For the 12 breast cancer patients enrolled, median time to progression was 2.5 months (1-37+) and median overall survival was 13.7 months. Four patients had stable disease. One patient had a complete response by RECIST and remained on study for 37 months or more, with a significant drop in serum interleukin (IL)-6 and IL-8 by day 71. Another patient with metastatic disease confined to the mediastinum had a 17% reduction in mediastinal mass and was on study for 10 months. Patients with stable or responding disease had fewer prior therapies and lower tumor marker levels than patients with no evidence of response. For the ovarian cancer patients (n = 14), the median time to progression was 2 months (1-6) and median overall survival was 15.0 months. Updated data are presented here for one patient treated with this vaccine in a previous trial, with a time to progression of 38 months.
  
  
  CONCLUSIONS
  Some patients who had limited tumor burden with minimal prior chemotherapy seemed to benefit from the vaccine. Further studies to confirm these results are warranted.
authors: Medical Oncology Branch and Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA.
authors: Mahsa
authors: M
authors: Mohebtash
authors: Kwong-Yok
authors: KY
authors: Tsang
authors: Ravi A
authors: RA
authors: Madan
authors: Ngar-Yee
authors: NY
authors: Huen
authors: Diane J
authors: DJ
authors: Poole
authors: Caroline
authors: C
authors: Jochems
authors: Jacquin
authors: J
authors: Jones
authors: Theresa
authors: T
authors: Ferrara
authors: Christopher R
authors: CR
authors: Heery
authors: Philip M
authors: PM
authors: Arlen
authors: Seth M
authors: SM
authors: Steinberg
authors: Mary
authors: M
authors: Pazdur
authors: Myrna
authors: M
authors: Rauckhorst
authors: Elizabeth C
authors: EC
authors: Jones
authors: William L
authors: WL
authors: Dahut
authors: Jeffrey
authors: J
authors: Schlom
authors: James L
authors: JL
authors: Gulley
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000628:therapy*; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002272:Carcinoembryonic Antigen / Q000276:immunology*; D005260:Female; D006801:Humans; D008562:Membrane Glycoproteins / Q000627:therapeutic use*; D008875:Middle Aged; D018396:Mucin-1 / Q000276:immunology*; D009362:Neoplasm Metastasis; D010051:Ovarian Neoplasms / Q000473:pathology / Q000628:therapy*; D010865:Pilot Projects; D011212:Poxviridae / Q000276:immunology; D014614:Vaccines, Synthetic / Q000627:therapeutic use*
chemical_list: D019496:Cancer Vaccines; D002272:Carcinoembryonic Antigen; D008562:Membrane Glycoproteins; D018396:Mucin-1; C518274:Panvac-VF; D014614:Vaccines, Synthetic