Abstract 292P
Background
Tumor molecular profiling is scheduled in guidelines to improve patient selection for TT in advanced BTC. However, the evaluation of the impact of EMP on prognosis and access to TT is still limited in routine clinical practice.
Methods
ANITA is an observational study, enrolling BTC patients treated at 10 tertiary Italian cancer centers between 2017 and 2023. Primary aim was to assess patient journey and disease management in different settings. Here we report the results of the EMP analyses, describing EMP rate over time, its impact on access to TT and TT-influenced outcomes. The ESMO Scale for Clinical Actionability of Molecular Targets (ESCAT) classification was used to classify molecular alterations. Progression-free (PFS) and overall (OS) survival were calculated since the first cycle of first-line chemotherapy (CT1) for advanced disease.
Results
Of 621 enrolled patients, 388 (62.5%) had EMP: among them, 249 (64.2%) had intrahepatic cholangiocarcinoma (iCCA) and 271 (69.8%) received CT1. EMP was performed by FoundationOne test (n=340), locally available next-generation sequencing platform (n=45) or both (n=3). We reported a significantly progressive increase in the EMP rate over the years, from 41% to 73% (p<0.001). 160 out of 388 (41.2%) patients harboured an ESCAT I-IV alteration and 24 (15%) of them received TT. The latter were more likely to have iCCA and to receive ≥2 lines (p<0.05). After a median follow-up of 19 months (95%CI 16.8-20.3), no differences were seen in OS and PFS according to EMP availability (p>0.05). Indeed, patients with ESCAT I-IV alterations treated with targeted agents had a significantly longer median OS (67.9 months, 95%CI 14.8-68.0) compared to untreated EMP-assessed patients (19.1 months, 95%CI 16.6-23.0) and to those who did not undergo EMP (14.3 months, 95%CI 15.4-19.8) (p=0.002).
Conclusions
Despite an increased use of EMP in advanced BTC in recent years, access to TT remains suboptimal even in referral Institutions. Our results demonstrate the tremendous impact of TT on patient survival in a real-world setting. Strategies aiming at improving the rate of patients receiving TT are warranted.
Legal entity responsible for the study
Fondazione GONO.
Funding
AstraZeneca.
Disclosure
M.D. Rizzato: Financial Interests, Personal, Invited Speaker: AstraZeneca. M. Niger: Financial Interests, Personal, Other, consultant: EMD Serono, Incyte, MSD Italia; Financial Interests, Personal, Advisory Board, consultant: Basilea Pharmaceutica; Financial Interests, Personal, Advisory Board: AstraZeneca, Taiho; Financial Interests, Personal, Invited Speaker: Sandoz, Medpoint SRL, Incyte, Servier, Incyte, Accademia della Medicina; Financial Interests, Personal, Other, Travel Expences for meetings: AstraZeneca. L. Salvatore: Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, Servier, Bayer, Merck, Amgen, Pierre Fabre, GSK, Takeda, Incyte. L. Antonuzzo: Financial Interests, Personal, Invited Speaker, Institutional research funding: AstraZeneca, Novartis; Financial Interests, Personal, Invited Speaker: Roche, Astellas, MSD, BMS, Ipsen, Merk, Amgen, Bayer. C. Vivaldi: Financial Interests, Personal, Advisory Board: AstraZeneca, Taiho; Financial Interests, Personal, Invited Speaker: Terumo, Servier, MSD, AstraZeneca, Roche. L. Rimassa: Financial Interests, Personal, Advisory Board, Consulting and advisory role: AbbVie, AstraZeneca, Basilea, Bayer, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology; Financial Interests, Personal, Invited Speaker, Lecture fees: AstraZeneca, Bayer, BMS, Incyte, Ipsen, Roche, Servier; Financial Interests, Personal, Other, Travel expenses: AstraZeneca; Financial Interests, Personal, Advisory Board: Zymeworks; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Exelixis, Incyte, Ipsen, Nerviano Medical Sciences, Roche, Servier, Agios, Eisai, FibroGen, Lilly, MSD, Roche, Servier; Financial Interests, Institutional, Invited Speaker, National (Italian) coordinating PI: AstraZeneca, BeiGene, Zymeworks; Financial Interests, Institutional, Funding: Ipsen; Financial Interests, Institutional, Invited Speaker, European PI: AstraZeneca; Non-Financial Interests, Leadership Role, Treasurer: ILCA; Non-Financial Interests, Leadership Role, Co-chair: EORTC GITCG HB/NET Task Force; Non-Financial Interests, Other, Special Expert Clinical Trials Europe: NCI HB Task Force. L. Fornaro: Financial Interests, Personal, Invited Speaker: Lilly, MSD, Servier, Incyte; Financial Interests, Personal, Advisory Role: MSD, AstraZeneca/Daiichi Sankyo, Servier, Incyte, Tahio Pharmaceutical, Lilly, Astellas Pharma; Financial Interests, Institutional, Funding: Merck Sharp & Dohme, Astellas Pharma, Incyte, Janssen, AstraZeneca/Daiichi Sankyo, Roche, BeiGene, AstraZeneca, BMS. All other authors have declared no conflicts of interest.