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)
Jérémie H. Lefevre
(1, 2)
,
Laurent Mineur
,
Salma Kotti
(1, 2)
,
Eric Rullier
(3)
,
Philippe Rouanet
(4)
,
Cécile de Chaisemartin
(5)
,
B. Meunier
(6)
,
Mehrdad Jafari
(7)
,
Eddy Cotte
(8)
,
Jérôme Desramé
,
Mehdi Karoui
(9)
,
Stéphane Benoist
(10)
,
Sylvain Kirzin
(11)
,
Anne Berger
(12)
,
Yves Panis
(13)
,
Guillaume Piessen
(14)
,
Alain Saudemont
(14)
,
Michel Prudhomme
(15)
,
Frédérique Peschaud
(16)
,
Anne Dubois
(17)
,
Jérôme Loriau
(18)
,
Jean-Jacques Tuech
(19)
,
Guillaume Meurette
(20)
,
Renato Lupinacci
(21)
,
Nicolas Goasguen
(21)
,
Yann Parc
(1, 2)
,
Tabassome Simon
(1, 2)
,
Emmanuel Tiret
(1, 2)
1
CHU Saint-Antoine [AP-HP]
2 SU - Sorbonne Université
3 Hôpital Saint-André [Bordeaux]
4 CRLCC Val d'Aurelle - Paul Lamarque
5 IPC - Institut Paoli-Calmettes
6 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
7 UNICANCER/Lille - Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille]
8 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
9 CHU Pitié-Salpêtrière [AP-HP]
10 Hôpital Bicêtre
11 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
12 HEGP - Hôpital Européen Georges Pompidou [APHP]
13 Hôpital Beaujon
14 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
15 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
16 Hôpital Ambroise Paré [AP-HP]
17 CHU Clermont-Ferrand
18 hpsj - Groupe Hospitalier Paris Saint-Joseph
19 CHU Rouen
20 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
21 Groupe Hospitalier Diaconesses Croix Saint-Simon
2 SU - Sorbonne Université
3 Hôpital Saint-André [Bordeaux]
4 CRLCC Val d'Aurelle - Paul Lamarque
5 IPC - Institut Paoli-Calmettes
6 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
7 UNICANCER/Lille - Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille]
8 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
9 CHU Pitié-Salpêtrière [AP-HP]
10 Hôpital Bicêtre
11 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
12 HEGP - Hôpital Européen Georges Pompidou [APHP]
13 Hôpital Beaujon
14 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
15 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
16 Hôpital Ambroise Paré [AP-HP]
17 CHU Clermont-Ferrand
18 hpsj - Groupe Hospitalier Paris Saint-Joseph
19 CHU Rouen
20 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
21 Groupe Hospitalier Diaconesses Croix Saint-Simon
Jérémie H. Lefevre
- Fonction : Auteur
- PersonId : 981296
Laurent Mineur
- Fonction : Auteur
Philippe Rouanet
- Fonction : Auteur
- PersonId : 756875
- ORCID : 0000-0003-0415-3269
Jérôme Desramé
- Fonction : Auteur
Guillaume Piessen
- Fonction : Auteur
- PersonId : 907733
Tabassome Simon
- Fonction : Auteur
- PersonId : 741176
- IdHAL : tabassome-simon
- ORCID : 0000-0002-4550-0450
- IdRef : 070443122
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.