Does A Longer Waiting Period After Neoadjuvant Radio-chemotherapy Improve the Oncological Prognosis of Rectal Cancer?
Jérémie Lefèvre
(1)
,
Laurent Mineur
(2)
,
Marine Cachanado
(3, 1)
,
Quentin Denost
(4)
,
Philippe Rouanet
(5)
,
Cécile de Chaisemartin
(6)
,
B. Meunier
(7)
,
Jafari Mehrdad
(8)
,
Eddy Cotte
(9)
,
Jérôme Desramé
(10)
,
Mehdi Karoui
(11)
,
Stéphane Benoist
(12)
,
Sylvain Kirzin
(13)
,
Anne Berger
(14)
,
Yves Panis
(15)
,
Guillaume Piessen
(16)
,
Alain Saudemont
(16)
,
Michel Prudhomme
(17, 18)
,
Frédérique Peschaud
(19)
,
Anne Dubois
(20)
,
Jérôme Loriau
(21)
,
Jean-Jacques Tuech
(22)
,
Guillaume Meurette
(23)
,
Renato Lupinacci
(24)
,
Nicolas Goasguen
(24)
,
Ben Creavin
(25)
,
Tabassome Simon
(3, 1)
,
Yann Parc
(1)
,
French Research Group of Rectal Cancer Surgery (greccar)
1
CHU Saint-Antoine [AP-HP]
2 Institut Sainte Catherine [Avignon]
3 CIC Paris-Est - Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière]
4 CHU Bordeaux
5 CRLCC Val d'Aurelle - Paul Lamarque
6 IPC - Institut Paoli-Calmettes
7 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
8 UNICANCER/Lille - Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille]
9 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
10 Hôpital privé Jean Mermoz
11 CHU Pitié-Salpêtrière [AP-HP]
12 Hôpital Bicêtre
13 Chirurgie Générale et Digestive [Purpan]
14 Service de chirurgie digestive, générale et cancérologique [CHU HEGP]
15 Hôpital Beaujon
16 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
17 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
18 UM - Université de Montpellier
19 Service de chirurgie générale, digestive et oncologique [CHU Ambroise-Paré]
20 CHU Clermont-Ferrand
21 Centre hospitalier Saint-Joseph [Paris]
22 Service de Chirurgie Digestive [CHU Rouen]
23 CHU Nantes - Centre Hospitalier Universitaire de Nantes
24 Groupe Hospitalier Diaconesses Croix Saint-Simon
25 St Vincent's University Hospital
2 Institut Sainte Catherine [Avignon]
3 CIC Paris-Est - Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière]
4 CHU Bordeaux
5 CRLCC Val d'Aurelle - Paul Lamarque
6 IPC - Institut Paoli-Calmettes
7 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
8 UNICANCER/Lille - Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille]
9 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
10 Hôpital privé Jean Mermoz
11 CHU Pitié-Salpêtrière [AP-HP]
12 Hôpital Bicêtre
13 Chirurgie Générale et Digestive [Purpan]
14 Service de chirurgie digestive, générale et cancérologique [CHU HEGP]
15 Hôpital Beaujon
16 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
17 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
18 UM - Université de Montpellier
19 Service de chirurgie générale, digestive et oncologique [CHU Ambroise-Paré]
20 CHU Clermont-Ferrand
21 Centre hospitalier Saint-Joseph [Paris]
22 Service de Chirurgie Digestive [CHU Rouen]
23 CHU Nantes - Centre Hospitalier Universitaire de Nantes
24 Groupe Hospitalier Diaconesses Croix Saint-Simon
25 St Vincent's University Hospital
Marine Cachanado
- Fonction : Auteur
- PersonId : 767316
- ORCID : 0000-0002-9739-7950
Philippe Rouanet
- Fonction : Auteur
- PersonId : 756875
- ORCID : 0000-0003-0415-3269
Eddy Cotte
- Fonction : Auteur
- PersonId : 762251
- ORCID : 0000-0003-0877-5655
Guillaume Piessen
- Fonction : Auteur
- PersonId : 907733
Michel Prudhomme
- Fonction : Auteur
- PersonId : 907744
Tabassome Simon
- Fonction : Auteur
- PersonId : 741176
- IdHAL : tabassome-simon
- ORCID : 0000-0002-4550-0450
- IdRef : 070443122
French Research Group of Rectal Cancer Surgery (greccar)
- Fonction : Auteur
Résumé
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.