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. 2010 Sep 1;116(17):4007-13.
doi: 10.1002/cncr.25188.

Prognostic factors derived from a prospective database dictate clinical biology of anal cancer: the intergroup trial (RTOG 98-11)

Jaffer A Ajani  1 , Kathryn A Winter, Leonard L Gunderson, John Pedersen, Al B Benson 3rd, Charles R Thomas Jr, Robert J Mayer, Michael G Haddock, Tyvin A Rich, Christopher G Willett
Affiliations

Prognostic factors derived from a prospective database dictate clinical biology of anal cancer: the intergroup trial (RTOG 98-11)

Jaffer A Ajani et al. Cancer. .

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.

Trial registration: ClinicalTrials.gov NCT00003596.

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Figures

Figure 1
Figure 1
Disease-free survival by tumor diameter (n=644)
Figure 2
Figure 2
Overall survival by tumor diameter (n=644)
Figure 3
Figure 3
Disease-free survival by clinical nodal status (n=644)
Figure 4
Figure 4
Overall survival by clinical nodal status (n=644)
Figure 5
Figure 5
Disease-free survival by four subgroups of patients created by combining tumor diameter and nodal designation (n=644)
Figure 6
Figure 6
Overall survival by four subgroups of patients created by combining tumor diameter and nodal designation (n=644)
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