title: Prognostic factors derived from a prospective database dictate clinical biology of anal cancer: the intergroup trial (RTOG 98-11).
abstract: BACKGROUND
  Only 4 prospective randomized phase 3 trials have been reported for anal cancer. A prognostic factor analysis for anal cancer from a prospective database has been published from only 1 study (N = 110). To confirm and uncover new prognostic factors, we analyzed the prospective database of intergroup RTOG 98-11.
  
  
  METHODS
  Univariate and multivariate analyses of the baseline characteristics for 5-year overall survival (OS) and disease-free survival (DFS) were carried out. Various combinations of tumor diameter and clinically positive nodes (N(+)) were analyzed to identify subgroups.
  
  
  RESULTS
  A total of 644 were assessable and analyzed. Tumor diameter >5 cm was associated with poorer 5-year DFS (P = .0003) and poorer 5-year OS (P = .0031), and N(+) was associated with poorer 5-year DFS (P </= .0001) and poorer 5-year OS (P = </= .0001) in the multivariate analysis. In stratified analyses, N(+) had more adverse influence on DFS and OS than did tumor diameter. Patients with >5-cm tumor and N(+) had the worst DFS (only 30% at 3 years compared with 74% for the best group; <5 cm primary and N0) and OS (only 48% at 4 years compared with 81% for the best group; <5 cm primary and N0). Men had worse DFS (P = .02) and OS (P = .016). These factors maintained their influence in each treatment arm.
  
  
  CONCLUSIONS
  This prospective prognostic factor analysis establishes tumor diameter as an independent prognosticator of poorer 5-year DFS and OS and confirms N(+) and male sex as poor prognostic factors. This analysis also uncovers novel subgroups (derived from combining prognostic factors) with incremental worsening of DFS and OS.
authors.affiliation: The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. jajani@mdanderson.org
authors.forename: Jaffer A
authors.initials: JA
authors.lastname: Ajani
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Winter
authors.forename: Leonard L
authors.initials: LL
authors.lastname: Gunderson
authors.forename: John
authors.initials: J
authors.lastname: Pedersen
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
authors.forename: Charles R
authors.initials: CR
authors.lastname: Thomas
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mayer
authors.forename: Michael G
authors.initials: MG
authors.lastname: Haddock
authors.forename: Tyvin A
authors.initials: TA
authors.lastname: Rich
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Willett
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001005:Anus Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D017326:Clinical Trials, Phase III as Topic; D016208:Databases, Factual; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D011379:Prognosis; D012737:Sex Factors
chemical_list: D000970:Antineoplastic Agents