LB2 - Total neoadjuvant treatment with mFolfirinox and chemoradiotherapy versus chemoradiotherapy for rectal preservation : the randomized GRECCAR12 trial.

Monday, May 12, 2025

8:13 AM - 8:21 AM PT

Location: Ballroom 6B, Upper Level

Presenting Author(s)

Quentin Denost, MD, PhD

Professor MD PhD
Bordeaux Colorectal Institute, Clinique Tivoli-Ducos, Bordeaux, France.
BORDEAUX, Aquitaine, France

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.

Author(s)

ER

Eric RULLIER, n/a

Consultant Surgeon
CHU de Bodreaux, Bordeaux , France
BORDEAUX, Aquitaine, France

Disclosure information not submitted.
pr

philippe rouanet, professor of surgery

MD, PhD
ICM
Montpellier, Languedoc-Roussillon, France

Disclosure information not submitted.
jT

jean-jacques Tuech, MD, PhD

Headof the dept of digestive surgery
Rouen University Hospital, France
Rouen, Haute-Normandie, France

Disclosure information not submitted.
EC

Eddy Cotte, n/a

Head of surgical department
Hospices Civils de Lyon
Pierre-Bénite, Rhone-Alpes, France

Disclosure information not submitted.
jeremie h. lefevre (he/him/his)

Colorectal Senior Surgeon
Hopital Saint-Antoine
Sorbonne Université - Hôpital Saint-Antoine
paris, Ile-de-France, France

Disclosure information not submitted.
AG

Adeline GERMAIN, n/a

Consultant Surgeon
CHU de Nancy, Nancy, France
NANCY, Lorraine, France

Disclosure information not submitted.
AD

Anne DUBOIS, n/a

Consultant Surgeon
CHU de Clermont-Ferrand, Clermont-Ferrand, France
Clermont-Ferrand, Auvergne, France

Disclosure information not submitted.
AC

Antoine Camerlo, n/a

Consultant Surgeon
Hôpital Européen de Marseille, Marseille, France
Marseille, Provence-Alpes-Cote d'Azur, France

Disclosure information not submitted.
BL

Bernard LELONG, n/a

Consultant Surgeon
Institut Paoli-Calmettes, Marseille, France
Marseille, Aquitaine, France

Disclosure information not submitted.
AV

Alain Valverde, n/a

Consultant Surgeon
Groupe hospitalier Diaconesses Croix Saint-Simon, Paris, France
Paris, Ile-de-France, France

Disclosure information not submitted.
ZL

Zaher LAKKIS, n/a

Consultant Surgeon
CHU De Besancon, Besancon, France
Besançon, Bourgogne, France

Disclosure information not submitted.
MR

Michel RIVOIRE, n/a

Consultant Surgeon
Centre Léon BERARD, Lyon, France
Lyon, Rhone-Alpes, France

Disclosure information not submitted.
BM

Bernard MEUNIER, n/a

Consultant Surgeon
CHU de Rennes, Rennes, France
RENNES, Haute-Normandie, France

Disclosure information not submitted.
LB

Leonor BENHAIM, n/a

Consultant Surgeon
Hôpital Gustave Roussy
Paris, Ile-de-France, France

Disclosure information not submitted.
TC

Thierry CONROY, n/a

Oncologist
CHRU de Nancy, Vandœuvre-lès-Nancy, France
Vandœuvre-lès-Nancy, Lorraine, France

Disclosure information not submitted.
NF

Nora FRULIO, n/a

Radiologist
CHU de Bordeaux, Bordeaux, France
BORDEAUX, Aquitaine, France

Disclosure information not submitted.
EF

Eric FRISON, n/a

Methodologist
CHU de Bodreaux, Bordeaux , France
BORDEAUX, Aquitaine, France

Disclosure information not submitted.
JA

Julien Asselineau, n/a

Statistician
CHU de Bordeaux, Bordeaux , France
BORDEAUX, Aquitaine, France

Disclosure information not submitted.
VV

Véronique VENDRELY, n/a

Radiation therapist
CHU de Bordeaux, Bordeaux, France
BORDEAUX, Aquitaine, France

Disclosure information not submitted.

All of the relevant financial relationships listed below have been mitigated.

Quentin Denost, MD, PhD: This individual has no financial relationships with ineligible companies.

Purpose/Background: Total neoadjuvant treatment comprising induction or consolidation chemotherapy and chemoradiotherapy (CRT) is recommended for locally advanced rectal cancers. However, induction chemotherapy (ICT) has never been evaluated in an organ preservation (OP) strategy. GRECCAR12 trial aimed to increase the rate of organ preservation in a selective approach, by adding ICT (FOLFIRINOX) to CRT.

Methods/Interventions: In this multicenter superiority open-label randomized phase 3 trial performed in 22 French centers, , 218 patients with cT2T3,N0-1,M0 low and mid rectal cancer ( < 10cm from anal verge), with a tumor size ≤4cm, were randomly assigned (1:1) to received ICT (4 cycles) followed by CRT (50 Gy, capecitabine), or CRT alone. Good responders evaluated by MRI were offered a local excision, with complementary TME in case of ypT3 or ypT2cN1. The primary outcome was the proportion of participants with OP without colostomy 1 year after surgery in the modified intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02514278.

Results/Outcomes: Between January 28, 2016 and November 23, 2020, 218 participants were randomized and 214 analyzed (ICT and CRT n=104 vs CRT alone n=110). The median age was 64 years (IQR 54-71) and 118 (55%) were male. Compliance to ICT was 95 % with grade≥3 adverse events (mainly diarrhea or neutropenia) in 28.8% of patients. Pathological complete response rate (pT0-is) was 54% with ICT compared to 37% with CRT alone (OR: 2.07; 95% CI:1.15-3.70). One-year OP rates were 71.6% with ICT and 63.6% with CRT alone (OR:1.80; 95% CI: 0.95;3.42; p=0.0736) and the difference reached 21.1% [1.7%; 41.4%] in cN1 patients. Three-year overall survival and recurrence-free survival were 95% and 86% respectively without difference between arms.

Conclusion/Discussion: Induction chemotherapy with mFOLFIRINOX increased both 1-year organ preservation in cN1 and the rate of complete response rate (ypT0) in a selective approach at the cost of increased but manageable toxicity.