Jean-François Delattre1, Romain Cohen1,2, Julie Henriques3,4, Antoine Falcoz3,4, Jean-François Emile5,6, Serge Fratte7, Benoist Chibaudel8, Jérôme Dauba9, Olivier Dupuis10, Yves Bécouarn11, Frédéric Bibeau12, Julien Taieb13, Christophe Louvet14, Dewi Vernerey3,4, Thierry André1,2, Magali Svrcek2,15. 1. Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France. 2. Sorbonne Université, Paris, France. 3. Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France. 4. University Bourgogne Franche-Comté, Institut National de la Santé et de la Recherche Médicale, Etablissement Français du Sang Bourgogne Franche-Comté, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, Besançon, France. 5. Department of Pathology, AP-HP, Hôpital Ambroise Paré, Boulogne, France. 6. EA4340-Biomarqueurs et Essais Cliniques en Cancérologie et Onco-Hématologie, Versailles Saint-Quentin-en-Yvelines University, Boulogne, France. 7. Department of Medical Oncology, Hôpital de Belfort-Montbeliard, Montbeliard, France. 8. Department of Medical Oncology, Institut Franco-Britannique, Levallois-Perret, France. 9. Department of Medical Oncology, Centre Hospitalier Layné, Mont-de-Marsan, France. 10. Clinique Victor Hugo, Le Mans, France. 11. Department of Medical Oncology, Institut Bergonié, Bordeaux, France. 12. Department of Pathology, Centre Hospitalier Universitaire de Caen, Université Caen Normandie, Caen, France. 13. Department of Medical Oncology, Sorbonne Paris Cité, Université Paris Descartes, AP-HP, Hôpital Européen Georges Pompidou, Paris, France. 14. Department of Medical Oncology, Institut Mutualiste Montsouris, Paris, France. 15. Department of Pathology, AP-HP, Hôpital Saint-Antoine, Paris, France.
Abstract
PATIENTS AND METHODS: A post hoc analysis of all pathologic reports from patients with stage III CC included in the IDEA France phase III study (ClinicalTrials.gov identifier: NCT00958737) investigating the duration of adjuvant fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin therapy (3 v 6 months) was performed. The primary objective was to determine the prognostic impact of TD on disease-free survival (DFS). The effect of the addition of TD to LNM count on pN restaging was also evaluated. A multivariable analysis was performed to establish the association between TD and DFS. RESULTS: Of 1,942 patients, 184 (9.5%) had TDs. The pN1a/b and pN1c populations showed similar DFS. TD-positive patients had worse prognosis compared with TD-negative patients, with 3-year DFS rates of 65.6% (95% CI, 58.0% to 72.1%) and 74.7% (95% CI, 72.6% to 76.7%; P = .0079), respectively. On multivariable analysis, TDs were associated with a higher risk of recurrence or death (hazard ratio [HR], 1.36; P = .0201). Other adverse factors included pT4 and/or pN2 disease (HR, 2.21; P < .001), the 3 months of adjuvant treatment (HR, 1.29; P = .0029), tumor obstruction (HR, 1.28; P = .0233), and male sex (HR, 1.24; P = .0151). Patients restaged as having pN2 disease (n = 35, 2.3%) had similar DFS as patients initially classified as pN2. CONCLUSION: The presence of TDs is an independent prognostic factor for DFS in patients with stage III CC. The addition of TD to LNM may help to better define the duration of adjuvant therapy.
PATIENTS AND METHODS: A post hoc analysis of all pathologic reports from patients with stage III CC included in the IDEA France phase III study (ClinicalTrials.gov identifier: NCT00958737) investigating the duration of adjuvant fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin therapy (3 v 6 months) was performed. The primary objective was to determine the prognostic impact of TD on disease-free survival (DFS). The effect of the addition of TD to LNM count on pN restaging was also evaluated. A multivariable analysis was performed to establish the association between TD and DFS. RESULTS: Of 1,942 patients, 184 (9.5%) had TDs. The pN1a/b and pN1c populations showed similar DFS. TD-positive patients had worse prognosis compared with TD-negative patients, with 3-year DFS rates of 65.6% (95% CI, 58.0% to 72.1%) and 74.7% (95% CI, 72.6% to 76.7%; P = .0079), respectively. On multivariable analysis, TDs were associated with a higher risk of recurrence or death (hazard ratio [HR], 1.36; P = .0201). Other adverse factors included pT4 and/or pN2 disease (HR, 2.21; P < .001), the 3 months of adjuvant treatment (HR, 1.29; P = .0029), tumor obstruction (HR, 1.28; P = .0233), and male sex (HR, 1.24; P = .0151). Patients restaged as having pN2 disease (n = 35, 2.3%) had similar DFS as patients initially classified as pN2. CONCLUSION: The presence of TDs is an independent prognostic factor for DFS in patients with stage III CC. The addition of TD to LNM may help to better define the duration of adjuvant therapy.
Authors: R Cohen; Q Shi; J Meyers; Z Jin; M Svrcek; C Fuchs; F Couture; P Kuebler; K K Ciombor; J Bendell; A De Jesus-Acosta; P Kumar; D Lewis; B Tan; M M Bertagnolli; P Philip; C Blanke; E M O'Reilly; A Shields; J A Meyerhardt Journal: Ann Oncol Date: 2021-07-20 Impact factor: 51.769