• Emmanouil Fokas, Torsten Liersch, Rainer Fietkau, Werner Hohenberger, Tim Beissbarth, Clemens Hess, Heinz Becker, Michael Ghadimi, Karl Mrak, Susanne Merkel, Hans-Rudolf Raab, Rolf Sauer, Christian Wittekind, and Claus Rödel.
• Emmanouil Fokas and Claus Rödel, University of Frankfurt, Frankfurt; Torsten Liersch, Tim Beissbarth, Clemens Hess, Heinz Becker, and Michael Ghadimi, University Medical Center Göttingen, Göttingen; Rainer Fietkau, Werner Hohenberger, Susanne Merkel, and Rolf Sauer, University of Erlangen, Erlangen; Hans-Rudolf Raab, Oldenburg Hospital, Oldenburg; Christian Wittekind, University Hospital Leipzig, Leipzig, Germany; and Karl Mrak, Krankenhaus der Barmherzigen Brüder, St Veit, Austria. emmanouil.fokas@kgu.de.
• J. Clin. Oncol. 2014 May 20; 32 (15): 1554-62.

PurposeWe previously described the prognostic impact of tumor regression grading (TRG) on the outcome of patients with rectal carcinoma treated with preoperative chemoradiotherapy (CRT) in the CAO/ARO/AIO-94 trial. Here we report long-term results after a median follow-up of 132 months.Patients And MethodsTRG after preoperative CRT was determined in 386 surgical specimens by the amount of viable tumor cells versus fibrosis, ranging from TRG 4 (no viable tumor cells) to TRG 0 (no signs of regression). Clinicopathologic parameters and TRG were correlated to the cumulative incidence of local recurrence, distant metastasis, and disease-free survival (DFS).ResultsTen-year cumulative incidence of distant metastasis and DFS were 10.5% and 89.5% for patients with TRG 4 (complete regression), 29.3% and 73.6% for TRG 2 and 3 (intermediate regression), and 39.6% and 63% for TRG 0 and 1 (poor regression), respectively (P = .005 and P = .008, respectively). On multivariable analysis, residual lymph node metastasis (ypN+) and TRG were the only independent prognostic factors for cumulative incidence of distant metastasis (P < .001 and P = .035, respectively) and DFS (P < .001 and P = .039, respectively), whereas local recurrence was significantly affected by ypN status (P < .001) and lymphatic invasion (P = .026).ConclusionComplete and intermediate tumor regressions were associated with improved long-term outcome in patients with rectal carcinoma after preoperative CRT independent of clinicopathologic parameters. This classification system needs to be prospectively tested in multiple data sets to validate its reproducibility in a wider setting.© 2014 by American Society of Clinical Oncology.

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