title: Clinical outcomes model in renal cell cancer patients treated with modified vaccinia Ankara plus tumor-associated antigen 5T4.
abstract: OBJECTIVE
  We developed an outcomes model to select patients for renal cell cancer vaccine immunotherapy.
  
  
  METHODS
  We examined clinical data from 2 phase II studies of modified vaccinia Ankara as vector to express 5T4 (MVA-5T4), calculated progression-free survival (PFS) and overall survival (OS), and created risk groups based on the number of factors involved.
  
  
  RESULTS
  Median OS was 12.4 months; median PFS was 3.6 months. Significant factors (p&lt;0.05) included neutrophils (both), bone metastases (OS), ECOG performance status (OS), lactate dehydrogenase levels (both), prior therapy with tyrosine kinase inhibitors plus immunotherapy (OS), Fuhrman grade (OS), and 5T4-specific ELISPOT response (PFS). By group, median OS was not reached in patients with favorable risk (censored at cutoff), was 13.7 months in those with intermediate risk and 4.0 months in those with poor risk.
  
  
  CONCLUSIONS
  Further validation of this model will identify the patients most likely to respond to MVA-5T4 and provide a framework for outcomes models for other vaccine therapies.
authors.affiliation: Division of Oncology, Department of Internal Medicine, The University of Texas Health Science Center at Houston (Medical School) and Memorial Hermann Cancer Center, Houston, Texas - USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Amato
authors.forename: Youxin
authors.initials: Y
authors.lastname: Xiong
authors.forename: Hui
authors.initials: H
authors.lastname: Peng
authors.forename: Virginia
authors.initials: V
authors.lastname: Mohlere
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012307:Risk Factors; D016896:Treatment Outcome; D019444:Vaccines, DNA
chemical_list: D019496:Cancer Vaccines; C504058:TroVax; D019444:Vaccines, DNA