title: Survival and human papillomavirus in oropharynx cancer in TAX 324: a subset analysis from an international phase III trial.
abstract: BACKGROUND
  The association between human papillomavirus (HPV) and overall survival (OS) in oropharynx cancer (OPC) was retrospectively examined in TAX 324, a phase III trial of sequential therapy for locally advanced head and neck cancer.
  
  
  METHODS
  Accrual for TAX 324 was completed in 2003 and data updated through 2008. Pretherapy tumor biopsies were studied by PCR for human papillomavirus type 16 and linked to OS, progression-free survival (PFS) and demographics.
  
  
  RESULTS
  Of 264 patients with OPC, 111 (42%) had evaluable biopsies; 56 (50%) were HPV+ and 55 (50%) were HPV-. HPV+ patients were significantly younger (54 versus 58 years, P = 0.02), had T1/T2 primary cancers (49% versus 20%, P = 0.001), and had a performance status of zero (77% versus 49%, P = 0.003). OS and PFS were better for HPV+ patients (OS, hazard ratio = 0.20, P < 0.0001). Local-regional failure was less in HPV+ patients (13% versus 42%, P = 0.0006); at 5 years, 82% of HPV+ patients were alive compared with 35% of HPV- patients (P < 0.0001).
  
  
  CONCLUSIONS
  HPV+ OPC has a different biology compared with HPV- OPC; 5-year OS, PFS, and local-regional control are unprecedented. These results support the possibility of selectively reducing therapy and long-term morbidity in HPV+ OPC while preserving survival and approaching HPV- disease with more aggressive treatment.
authors.affiliation: The Tisch Cancer Institute, Mount Sinai Medical Center, New York. Electronic address: marshall.posner@mssm.edu.
authors.forename: M R
authors.initials: MR
authors.lastname: Posner
authors.affiliation: Dana-Farber Cancer Institute, Harvard Medical School, Boston.
authors.forename: J H
authors.initials: JH
authors.lastname: Lorch
authors.affiliation: Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore.
authors.forename: O
authors.initials: O
authors.lastname: Goloubeva
authors.affiliation: Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore.
authors.forename: M
authors.initials: M
authors.lastname: Tan
authors.affiliation: Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore.
authors.forename: L M
authors.initials: LM
authors.lastname: Schumaker
authors.affiliation: Sanofi-aventis U.S., Bridgewater, USA.
authors.forename: N J
authors.initials: NJ
authors.lastname: Sarlis
authors.affiliation: Dana-Farber Cancer Institute, Harvard Medical School, Boston.
authors.forename: R I
authors.initials: RI
authors.lastname: Haddad
authors.affiliation: Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore.
authors.forename: K J
authors.initials: KJ
authors.lastname: Cullen
mesh_terms: D000328:Adult; D000368:Aged; D014408:Biomarkers, Tumor / Q000378:metabolism; D002294:Carcinoma, Squamous Cell / Q000453:epidemiology / Q000628:therapy / Q000821:virology*; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D005260:Female; D052162:Human papillomavirus 16; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000378:metabolism; D009959:Oropharyngeal Neoplasms / Q000453:epidemiology / Q000628:therapy / Q000821:virology*; D050725:Papillomavirus E7 Proteins / Q000378:metabolism; D030361:Papillomavirus Infections / Q000150:complications* / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic; D012097:Repressor Proteins / Q000378:metabolism; D012189:Retrospective Studies
chemical_list: D014408:Biomarkers, Tumor; C068651:E6 protein, Human papillomavirus type 16; D009856:Oncogene Proteins, Viral; D050725:Papillomavirus E7 Proteins; D012097:Repressor Proteins; C059731:oncogene protein E7, Human papillomavirus type 16