Jérémie H Lefèvre1, Laurent Mineur2, Marine Cachanado3, Quentin Denost4, Philippe Rouanet5, Cécile de Chaisemartin6, Bernard Meunier7, Jafari Mehrdad8, Eddy Cotte9, Jérome Desrame10, Mehdi Karoui11, Stéphane Benoist12, Sylvain Kirzin13, Anne Berger14, Yves Panis15, Guillaume Piessen16, Alain Saudemont17, Michel Prudhomme18, Frédérique Peschaud19, Anne Dubois20, Jérome Loriau21, Jean-Jacques Tuech22, Guillaume Meurette23, Renato Lupinacci24, Nicolas Goasguen24, Ben Creavin25, Tabassome Simon3, Yann Parc1. 1. Sorbonne Université, Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Paris, France. 2. Oncology, Radiotherapy, Sainte-Camille Institut, 250 Chemin de Baigne Pieds, Avignon, France. 3. Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP, Hôpital Saint Antoine, Paris France. 4. Department of Surgery, CHU Saint-André, 1 Rue Jean Burguet, Bordeaux, France. 5. Department of Oncological Surgery, Val d'Aurelle Institut, Montpellier, France. 6. Department of Oncological Surgery, Paoli-Calmettes Institut, 232 Boulevard de Sainte-Marguerite, Marseille CHU, France. 7. Department of Hepatobiliary and Digestive Surgery, CHU, Rennes, France. 8. Department of Oncological Surgery, Oscar Lambret Center, 3 Rue Frédéric Combemale, Lille, France. 9. Department of Digestive Surgery, CHU Lyon-Sud, 165 Chemin du Grand Revoyet, Pierre-Bénite, France. 10. Department of Gastrology and Hepatology, Jean Mermoz Institut, 55 Avenue Jean Mermoz, Lyon, France. 11. Department of Digestive and Hepatobiliary Surgery, CHU Pitié-Salpétrière, 91 Boulevard de l'Hopital, Paris, France. 12. Department of Digestive and Oncological Surgery, CHU Bicètre, 78 Rue du Général Leclerc, Le Kremlin-Bicêtre, France. 13. Department of Surgery, CHU Purpan, Place du Dr Joseph Baylac, Toulouse, France. 14. Department of Digestive, Oncological and General Surgery, CHU HEGP, Paris, France. 15. Department of Colorectal Surgery, Hôpital Beaujon, Université Paris VII, 100 Boulevard du Général Leclerc, Clichy, France. 16. Department of Digestive Surgery, CHRU, Lille, France. 17. Department of Digestive Surgery and Transplant Surgery, CHRU, Lille, France. 18. Department of Digestive and Oncological Surgery, CHU Carémeau, 4 Rue du Professeur Robert Debré, Nîmes, France. 19. Department of Digestive Surgery, CHU Ambroise-Paré, 9 Avenue Charles de Gaulle, Boulogne-Billancourt, France. 20. Department of Digestive Surgery, CHU Estaing, Clermont-Ferrand, France. 21. Department of Digestive Surgery, St-Joseph Hospital, 185 Rue Raymond Losserand, Paris, France. 22. Department of Digestive Surgery, CHU, 1 Rue de Germont, 76000 Rouen, France. 23. Department of Digestive Surgery, CHU Hôtel-Dieu, 1 Place Alexis-Ricordeau, Nantes, France. 24. Department of Digestive Surgery, Croix Saint-Simon Hospital, 12-18 Rue du Sergent Bauchat, Paris, France. 25. Department of Surgery, St Vincent's University Hospital, Elm Park, Dublin, Ireland.
Abstract
OBJECTIVE: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. SUMMARY BACKGROUND DATA: Current data on the effect of an extended interval between radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown. METHODS: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had receivedRCT (45-50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates. RESULTS: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent amesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ± 8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS (P = 0.8868) or DFS (P = 0.9409). Distant (P = 0.7432) and local (P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1mm [hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17-3.51], ypT3-T4 (HR = 2.69; 95% CI, 1.19-6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89-6.91). CONCLUSION: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.
RCT Entities:
OBJECTIVE: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. SUMMARY BACKGROUND DATA: Current data on the effect of an extended interval between radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown. METHODS: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had received RCT (45-50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates. RESULTS: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent a mesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ± 8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS (P = 0.8868) or DFS (P = 0.9409). Distant (P = 0.7432) and local (P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1 mm [hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17-3.51], ypT3-T4 (HR = 2.69; 95% CI, 1.19-6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89-6.91). CONCLUSION: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.
Authors: Davide Pertile; Marco Gipponi; Alessandra Aprile; Paola Batistotti; Carol Marzia Ferrari; Andrea Massobrio; Domenico Soriero; Lorenzo Epis; Stefano Scabini Journal: In Vivo Date: 2021 Mar-Apr Impact factor: 2.155
Authors: Giulio A Santoro; Ugo Grossi; Sthela Murad-Regadas; Joseph W Nunoo-Mensah; Anders Mellgren; Gian Luca Di Tanna; Gaetano Gallo; Charles Tsang; Steven D Wexner Journal: Surgery Date: 2020-11-17 Impact factor: 3.982
Authors: Sven Lichthardt; Johanna Wagner; Stefan Löb; Niels Matthes; Caroline Kastner; Friedrich Anger; Christoph-Thomas Germer; Armin Wiegering Journal: BMC Cancer Date: 2020-01-20 Impact factor: 4.430