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Session: Late Breaking Abstracts (NON-CME)

LB6 - Oncological impact of Adjuvant Chemotherapy after rectal cancer excision in the era of TNT from two controlled randomized trials GRECCAR4-PRODIGE23

Monday, May 12, 2025
8:05 AM – 8:13 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)

  • pr

    philippe rouanet, professor of surgery

    MD, PhD
    ICM
    Montpellier, Languedoc-Roussillon, France

    Disclosure information not submitted.

  • JB

    Jean-Francois BOSSET, n/a

    Oncologist
    CHU De Besancon, Besancon, France
    Besancon, Bourgogne, France

    Disclosure information not submitted.

  • BL

    Bernard LELONG, n/a

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

    Disclosure information not submitted.

  • CB

    Christophe BORG, n/a

    Oncologist
    CHU de Besançon, France
    Besancon, Aquitaine, France

    Disclosure information not submitted.

  • PE

    Pierre-Luc ETIENNE, n/a

    Oncologist
    Clinique CARIO, Plérin, France
    Plérin, Bretagne, France

    Disclosure information not submitted.

  • PM

    Philippe Maingon, n/a

    Oncologist
    Hopital de la Pitié Salpétrière, Paris, France
    Paris, Ile-de-France, France

    Disclosure information not submitted.

  • ER

    Emmanuel RIO, n/a

    radiation therapist
    CENTRE RENE GAUDUCHEAU, SAINT-HERBLAIN, France
    Saint-Herblain, Pays de la Loire, 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.

  • SN

    Stéphanie NOUGARET, n/a

    Radiologist
    ICM, Montpellier,France
    Montpellier, Provence-Alpes-Cote d'Azur, France

    Disclosure information not submitted.

  • ET

    Eva TERUEL, n/a

    Statistician
    ICM Montpellier, France
    Montpellier, Provence-Alpes-Cote d'Azur, France

    Disclosure information not submitted.

  • SG

    Sophie GOURGOU, n/a

    Methodologist
    ICM,Montpellier,France
    Montpellier, Provence-Alpes-Cote d'Azur, 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.

All of the relevant financial relationships listed below have been mitigated.
Quentin Denost, MD, PhD: This individual has no financial relationships with ineligible companies.
Image or Table (Do Not add text here):

Purpose/Background: The aim of this study was to evaluate the oncological impact of adjuvant chemotherapy (aCT) in rectal cancer in the era of total neoadjuvant treatment (TNT). The indication of aCT remains controversial, based on colon cancer protocols, without neoadjuvant CT and with recent validation of the equivalence of the 3- and 6-month CT regimens.

Methods/Interventions: We conducted a post hoc analysis of the subpopulations ypN+ and ypN0/cN+ of pooled data from two French multicentre randomized trials GRECCAR 4 (NCT01333709) and PRODIGE 23 (NCT01804790) in which patients received either long-course chemoradiotherapy (CRT) or TNT based on FOLFIRINOX 4-6 cycles followed by CRT. In each subpopulation, we differentiated patients with preoperative CRT or TNT. Patients who received adjuvant CT (aCT+) were compared to those who did not receive (aCT-). The primary outcome was the 3-year Disease-free survival (3y-DFS). Secondary endpoints were 3-year overall survival (3y-OS), distant metastasis and local recurrence free-survival (3y-DMFS and 3y-LRFS). Survivals were adjusted on propensity score.

Results/Outcomes: Among 594 patients included in these 2 RCT, 489 were selected for analysis, 152 in aCT- (25ypN+ and 127ypN0/cN+) versus 337 in aCT+ (119 ypN+ and 218 ypN0/cN+). Pre-treatment tumours characteristics were similar between aCT- and aCT+. The median follow-up was 70 months. The 3y-DFS was 77% and was significantly improved in aCT+ group for ypN+ after CRT (p < 0.001; HR (95%) CI 0.10 (0.04-0.27)), but not after TNT (p=0.96; HR (95%) CI 0.97 (0.29-3.22)). The 3y-DFS was not improved in aCT+ for ypN0/cN+ (p=0.77; HR (95%) CI 0.92 (0.52-1.63)), whatever the neoadjuvant treatment, TNT (p=0.33; HR (95%) CI 1.51 (0.65-3.51)) or CRT (p=0.45; HR (95%) CI 0.72 (0.31-1.69)). Similarly, the aCT+ group had a significantly better 3y-OS (p < 0.001; HR (95%) CI 0.15 (0.05-0.45)), 3y-DMFS (p= < 0.001; HR (95%) CI 0.09 (0.03-0.24)) and 3y-LRFS (p= < 0.001; HR (95%) CI 0.14 (0.05-0.37)) for ypN+ after CRT, but not after TNT. For ypN0/cN+, there was no significant difference between the 2 groups regarding 3y-OS (p=0.74; HR (95%) CI 0.88 (0.42-1.86)), 3y-DMFS (p=0.72; HR (95%) CI 0.90 (0.49-1.64)) and 3y-LRFS (p=0.71; HR (95%) CI 0.87 (0.43-1.77)), whatever the neoadjuvant treatment.

Conclusion/Discussion: Adjuvant chemotherapy improved significantly oncological outcomes, including both DFS, OS, DMFS and LRFS, in patients ypN+ after CRT, but had no impact after TNT, whatever the pathologic nodal status ypN+ or ypN0/cN+. These results should avoid to overtreat patients in adjuvant setting in the era of TNT.