Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6) - Centre Oscar Lambret Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2016

Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6)

Laurent Mineur
  • Fonction : Auteur
Salma Kotti
  • Fonction : Auteur
  • PersonId : 950800
Eric Rullier
  • Fonction : Auteur
  • PersonId : 934472
Philippe Rouanet
Eddy Cotte
  • Fonction : Auteur
  • PersonId : 937059
Jérôme Desramé
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Mehdi Karoui
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  • PersonId : 971452
Anne Berger
  • Fonction : Auteur
  • PersonId : 906062
Yves Panis
Michel Prudhomme
  • Fonction : Auteur
  • PersonId : 907744
Frédérique Peschaud
  • Fonction : Auteur
  • PersonId : 907743
Anne Dubois
  • Fonction : Auteur
Jean-Jacques Tuech
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  • PersonId : 863998

Résumé

Purpose A pathologic complete response (pCR; ypT0N0) of a rectal tumor after neoadjuvant radiochemotherapy (RCT) is associated with an excellent prognosis. Several retrospective studies have investigated the effect of increasing the delay after RCT. The aim of this study was to evaluate the effect of increasing the interval between the end of RCT and surgery on the pCR rate. Methods GRECCAR6 was a phase III, multicenter, randomized, open-label, parallel-group controlled trial. Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT (45 to 50 Gy with fluorouracil or capecitabine) were included. Patients were randomly included in the 7-week or the 11-week (11w) group. Primary end point was the pCR rate defined as a ypT0N0 specimen (NCT01648894). Results A total of 265 patients from 24 centers were enrolled between October 2012 and February 2015. The majority of the tumors were cT3 (82%). After RCT, surgery was not performed in nine patients (3.4%) because of the occurrence of distant metastasis (n = 5) or other reasons. Two patients underwent local resection of the tumor scar. A total of 47 (18.6%) specimens were classified as ypT0 (four had invaded lymph nodes [8.5%]). The primary end point (ypT0N0) was not different (7 weeks: 20 of 133, 15.0% v 11w: 23 of 132, 17.4%; P = .5983). Morbidity was significantly increased in the 11w group (44.5% v 32%; P = .0404) as a result of increased medical complications (32.8% v 19.2%; P = .0137). The 11w group had a worse quality of mesorectal resection (complete mesorectum [I] 78.7% v 90%; P = .0156). Conclusion Waiting 11 weeks after RCT did not increase the rate of pCR after surgical resection. A longer waiting period may be associated with higher morbidity and more difficult surgical resection.

Domaines

Cancer
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Dates et versions

hal-01903754 , version 1 (24-10-2018)

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Citer

Jérémie H. Lefevre, Laurent Mineur, Salma Kotti, Eric Rullier, Philippe Rouanet, et al.. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). Journal of Clinical Oncology, 2016, 34 (31), pp.3773 - 3780. ⟨10.1200/JCO.2016.67.6049⟩. ⟨hal-01903754⟩
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