Abstract 59P
Background
Ampullary carcinoma (AC) is a rare GI cancer. Disease recurrence rate is about 40% after curative-intent surgery. However, main prognostic factors and adjuvant treatment decision remain a matter of debate.
Methods
The FFCD cohort is a French nationwide prospective cohort, including patients with a resected non-metastatic AC or presenting a locoregional or metastatic disease recurrence within 2 years after tumor resection. The aim of this study is to describe prognostic factors associated with disease-free survival (DFS) after pancreaticoduodenectomy (PD) to propose a user-friendly score to better estimate the risk of recurrence and the benefit of adjuvant therapy.
Results
370 patients resected AC were included between July 2014 and June 2023 in 50 centers. Median age was 68.5, 199 (53.8%) patients were male and 180 (56.1%) had an ECOG-PS 0. Histological subtype was intestinal, pancreatobiliary or mixed/undetermined in 29/41/30% of patients. Adjuvant chemotherapy was performed in 226 (61.1%) patients. Median follow-up of the cohort was 40.6 months. In multivariable analyses, stage III tumor vs other (HR=2.86 [1.89 ;4.17], p<0.0001), poorly vs well differentiated grade (HR=2.51 [1.42;4.43], p=0.002) and non-intestinal vs intestinal subtype (HR=1.58 [1.00;2.49], p=0.052) were associated with shorter DFS. A score based on these 3 parameters divided patients in low (n=83), intermediate (n=133) and high risk (n=96) with a median DFS not reached (NR), 73.1 and 15.2 months and a median overall survival (OS) NR, 86.1 and 38.2 months. Adjuvant chemotherapy was associated with a longer DFS in high-risk (HR=0.37, p=0.001) and in intermediate risk (HR=0.77, p=0.369) while no benefit was observed in low-risk tumors. Finally, after propensity score analysis, adjuvant therapy was associated with longer DFS (HR=0.57, [0.45;0.72] p<0.0001) and OS (HR=0.57, [0.44;0.74], p<0.0001) in the full cohort.
Conclusions
Lymph node invasion, poorly differentiated grade and non-intestinal subtype seem highly prognostic in resected AC. This integrated score using these parameters needs to be confirmed in an external validation dataset to help adjuvant treatment decision making.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Fédération Francophone de Cancérologie Digestive.
Funding
Fédération Francophone de Cancérologie Digestive.
Disclosure
G. Roth: Financial Interests, Personal, Advisory Board: Servier, AstraZeneca, MSD, BMS, Ipsen, Viatris; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Coordinating PI: Genoscience Pharma; Financial Interests, Personal and Institutional, Coordinating PI: Netris pharma, Alpha Tau. A. Pellat: Financial Interests, Personal, Invited Speaker: Servier; Non-Financial Interests, Member, Academic group: Fondation Française de Cancérologie Digestive, Groupe des Tumeurs Neuroendocrines; Other, Invitation to ENETS: Ipsen. C. Gallois: Financial Interests, Institutional, Invited Speaker: Sanofi Genzyme; Financial Interests, Institutional, Advisory Board: Servier, Pierre Fabre, Merck; Financial Interests, Institutional, Other, French congress invitation: MSD; Financial Interests, Institutional, Other, Congress invitation: Amgen. D. Tougeron: Financial Interests, Personal, Advisory Board: AstraZeneca, Sanofi, Amgen, MSD, Roche, Servier, Pierre Fabre, BMS, Bayer; Non-Financial Interests, Member of Board of Directors: Federation Francophone de Cancérologie Digestive. V. Hautefeuille: Financial Interests, Personal, Invited Speaker: Novartis, Merck, Amgen; Financial Interests, Personal, Advisory Board: AAA, Ipsen, Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Deciphera, Esteve. M. Jary: Financial Interests, Personal, Invited Speaker: Pierre Fabre, Servier, MSD, BMS, Amgen; Financial Interests, Personal, Writing Engagement: Incyte; Other, participation to congresses: Pierre Fabre; Other, Participation to congresses: Roche, Bayer; Other, Participation to Congress: Servier, MSD, BMS. M. Muller: Financial Interests, Institutional, Invited Speaker: Servier. O. Bouche: Financial Interests, Personal, Advisory Board: Amgen, Merck, Apmonia Therapeutics, Deciphera, Astellas, Takeda; Financial Interests, Personal, Invited Speaker: Servier, Pierre Fabre, Bayer. J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Astellas, Merck, Servier, Pierre Fabre, Amgen, BMS, Novartis, Pfizer, Sanofi, Rottapharm, Takeda, Financial Interests, Personal, Invited Speaker: Amgen, BMS, Merck, MSD, Novartis; Financial Interests, Personal, Invited Speaker, symposia: Astellas; Financial Interests, Personal, Other, steering Committee of clinical trial: Novartis; Non-Financial Interests, Leadership Role, President of the scientific committee of the ARCAD foundation until end 2022: ARCAD Foundation; Non-Financial Interests, Leadership Role, Chair of the ARCAD pancreas research group: ARCAD Foundation; Non-Financial Interests, Leadership Role, Member of the administrative council, the scientific committee, the executive board and responsible for the international relationships /partnership for FFCD in the Prodige Intergroup: Federation Francophone de Cancérologie Digestive (FFCD); Non-Financial Interests, Other, steering committee of clinical trials: Pfizer, Servier. All other authors have declared no conflicts of interest.
Resources from the same session
242P - Clinical outcomes in patients (pts) with HR+/HER2− early breast cancer (EBC) by prior systemic treatment (tx): A subgroup analysis of the NATALEE trial
Presenter: Nicholas McAndrew
Session: Poster session 13
243P - Prognosis of patients with hormone receptor-positive/HER2-negative early breast cancer according to monarchE and NATALEE trials risk categories: Patient-level analysis of Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) randomised trials
Presenter: Luca Arecco
Session: Poster session 13
244P - Efficacy and safety of dalpiciclib, exemestane, and goserelin as neoadjuvant therapy in premenopausal HR-positive, HER2-negative breast cancer patients: A phase II clinical trial
Presenter: Yang Zhengjun
Session: Poster session 13
245P - Characteristics of real-world (RW) NATALEE and monarchE eligible populations: A US electronic health records (EHR) database analysis
Presenter: Paolo Tarantino
Session: Poster session 13
246P - Axillary management and outcomes after neoadjuvant endocrine therapy in the randomized PELOPS trial
Presenter: Anna C. Weiss
Session: Poster session 13
247P - Concurrent versus sequential adjuvant chemoradiotherapy in early-stage breast cancer: A systematic review and meta-analysis
Presenter: Luiz Felipe de Almeida
Session: Poster session 13
248P - Impact of unilateral mastectomy with or without immediate breast reconstruction on vertebral alignment
Presenter: Jong-Ho Cheun
Session: Poster session 13
249P - Neoadjuvant chemotherapy in inflammatory breast cancer: A meta-analysis of 10 trials of the German Breast Group (GBG)
Presenter: Laura Michel
Session: Poster session 13
250P - Development and validation of a 19-feature classifier that predicts response to neoadjuvant trastuzumab emtansine (T-DM1) in breast cancer patients
Presenter: Fresia Pareja
Session: Poster session 13