Abstract 126P
Background
BTC constitutes a heterogeneous group of invasive tumors, including intrahepatic, perihilar, and extrahepatic cholangiocarcinoma, and gallbladder carcinoma (GC). We aimed to characterize the epidemiology, clinical management, and survival outcomes of BTC pt in our environment.
Methods
We evaluated a large real-world cohort of pt diagnosed with BTC from 1st January 2017 to 31st December 2022 from the Spanish RETUD registry. We described the demographic and clinical features, therapies received and outcomes. We assessed progression-free survival (PFS) and overall survival (OS) using the Kaplan-Meier method in different settings.
Results
A total of 1,285 evaluable pt were included in 28 Spanish sites. The median age was 69.2 years, and 56.2% were men. At primary diagnosis, tumors were mostly intrahepatic (54.8%), followed by extrahepatic (28.5%), and GC (14.6%). Overall, 48.7%, 22.6%, and 28.6% pt were diagnosed with metastatic, locally advanced, and resectable disease, respectively. Only 29.5% of pt underwent surgical resection and 9.6% locoregional procedures. Most pt (74.8%) received systemic treatment as a first-line strategy (86.2%), mainly gemcitabine-based combinations (90%), with 62.7% of pt receiving cisplatin plus gemcitabine (CISGEM). At the database cut-off, 945 pt had died because of disease progression. The median OS at the advanced setting was 9.2 months (m) (95% confidence interval [95CI]: 8.3-10.3). The median PFS in pt with advanced BTC exposed to first-line CISGEM was 5.5 m (95CI 5.0-6.0) with a median OS of 11.6 m (95IC 10.8-12.5). For pt with resectable BTC, OS was analyzed based on whether they received adjuvant treatment (ADJ) and developed metastases (met) during follow-up (see table) Table: 126P
Group of pt | Median OS (m) | 95% CI | |
No ADJ | No met | 36.6 | 22.8-57.3 |
met | 21.6 | 17.8-29.0 | |
ADJ | No met | 45.7 | 33.7-not reached |
met | 25.4 | 21.4-32.6 |
Conclusions
This study provides insights into the clinical characteristics and management of BTC in the real-world framework in Spain. Our results are consistent with the literature, nevertheless, they must be considered in the context of a currently evolving scenario.
Clinical trial identification
Editorial acknowledgement
Medical writing assistance was provided by Carla Martín Cortázar from Evidenze Health España S.L. during the preparation of this abstract.
Legal entity responsible for the study
This study has been promoted by the Spanish Group of Digestive Tumour Treatment (TTD).
Funding
Incyte and AstraZeneca.
Disclosure
A. Lacasta: Other, Institutional, Other, Travel, Accomodation, Expenses: Roche, Merck. T. Macarulla: Financial Interests, Personal, Advisory Board: Ability Pharmaceutical, SL, AstraZeneca, Basilea Pharma, Batxer, BioLineRX Ltd, Celgene SLU, Eisai, IPSEN Pharma, Incyte; Financial Interests, Personal, Other, Direct research fund: Servier, Merck, Sharp and Dhome, Novocure, QED Therapeutics Inc, Roche, Sanofi-Aventis, Zymeworks; Financial Interests, Personal, Invited Speaker: Lilly, Janssen; Financial Interests, Institutional, Research Grant: Amc Medical Research, Armo Biosciences, Basilea, Biokeralty Research Institute, Merck Sharp & Dohme, Oncomed Pharmaceuticals, QED Therapeutics, VCN Biosciences, AbbVie Farmaceútica, Ability Pharmaceuticals, Agios, Amgen, Aslan, AstraZeneca, Bayer, BeiGene, Biolinerx, Blueprint Medicines, Boston Biomedical, Bristol Myers Squibb (BMS), Cantargia, Celgene, Eisai, Erytech Pharma, F. Hoffmann-La Roche, Fibrogen, Genentech, Hallozyme, Immunomedics, Incyte, Ipsen, Lab. Menarini, Lilly, Loxo Oncology, Medimmune, Merimarck, Novocure, Millenim, Nelum, Novartis, Zymeworks, Pfizer, Pharmacyclics, Roche; Non-Financial Interests, Member: American Society of Clinical Oncology - ASCO, “Sociedad Española de Oncología Médica” – SEOM, Sociedad Europea de Oncología Médica - ESMO. A.J. Munoz Martin: Other, Institutional, Other, Consulting or Advisory role: Sanofi, Pfizer, BMS; Other, Institutional, Officer, Consulting or Advisory role: AstraZeneca, MSD; Other, Institutional, Speaker’s Bureau: Rovi, STADA, Amgen, Merck; Other, Institutional, Research Funding: Rovi, Celgene, Leo Pharma; Other, Patent, royalties or other intellectual property; Other, Institutional, Other, Travel, Accomodation, Expenses: AstraZeneca, Amgen, Merck, Roche. R. Vidal Tocino: Financial Interests, Personal, Invited Speaker: Amgen, Merck, Servier, Bristol Myers Squibb, Bayer, MSD; Financial Interests, Personal, Advisory Board: Servier, GSK; Non-Financial Interests, Member: ACLO- Asociación Castellano-Leonesa de Oncología, SEOM- Sociedad Española de Oncología Médica; Other, Travel and Accommodation: Servier, Roche, MSD. M. Lobo de Mena: Financial Interests, Personal, Invited Speaker: Leo Pharma, Servier. A. Fernandez Montes: Financial Interests, Personal, Other, Invited Speaker: Amgen, AstraZeneca, Eisai, Lilly, MSD, Pierre Fabre, Servier. J. Gallego Plazas: Financial Interests, Personal, Advisory Board: AAA, Amgen, Bayer, BMS, Eisai, Ipsen, Lilly, Merck, MSD, Pierre-Fabre, Roche, Servier; Financial Interests, Personal, Invited Speaker: AAA, Amgen, Bayer, BMS, Ipsen, Lilly, Merck, MSD, Novartis, Servier; Financial Interests, Personal, Other, Educational: Amgen, Ipsen, Merck, Novartis, Pierre-Fabre, Roche; Financial Interests, Institutional, Funding: Astellas, AstraZeneca, BMS, Daiichi Sankyo, Lilly, Servier; Non-Financial Interests, Member of Board of Directors: Spanish Society Medical Oncology, Spanish Group Of Neuroendocrine an Endocrine Tumours; Non-Financial Interests, Project Lead: AGAMENON-SEOM Registry of Esophagohastric Cancer. R. Vera: Financial Interests, Personal, Advisory Board: Roche, Amgen, Sanofi; Financial Interests, Personal, Invited Speaker: Merck, Bayer, Eisai, Servier; Financial Interests, Personal, Other, Program Coordinator: Lilly. I. Ghanem: Other, honoraria: Servier, Merck; Other, Cosulting or Advisory Role: Servier, Pierre Fabre; Other, Consulting or Advisory Role: Merck; Other, Speaker’s Bureau: Servier, Merck, Pierre Fabre, Roche; Other, Travel, Accomodation, Expenses: Servier, Merck, Amgen, Bayer, Pierre Fabre. All other authors have declared no conflicts of interest.
Resources from the same session
97P - Neoadjuvant durvalumab plus gemcitabine and cisplatin (D+GemCis) versus gemcis alone for localized biliary tract cancer (BTC): Results of a randomized, multicenter, open-label, phase II trial (DEBATE)
Presenter: Changhoon Yoo
Session: Poster session 17
101P - Quality of life (QoL) outcomes in patients (pts) with zanidatamab (zani)-treated HER2-positive (HER2+) biliary tract cancer (BTC) in the phase IIb HERIZON-BTC-01 study
Presenter: Harpreet Wasan
Session: Poster session 17
102P - Potentially prognostic factors of overall survival in advanced biliary tract cancer in the randomised phase III TOPAZ-1 study
Presenter: Aiwu Ruth He
Session: Poster session 17
103P - Individual patient data (IPD) meta-analysis of randomised trials to compare efficacy of second-line fluoropyrimidine-based chemotherapy in advanced biliary tract cancer (BTC)
Presenter: Jaewon Hyung
Session: Poster session 17
104P - Final analysis of the prospective, randomized phase II STAMP trial: Adjuvant gemcitabine plus cisplatin (GemCis) versus capecitabine (CAP) in node-positive extrahepatic cholangiocarcinoma (CCA)
Presenter: Hyehyun Jeong
Session: Poster session 17
105P - A phase II study of SHR-1316 plus IBI310 in patients with advanced intrahepatic cholangiocarcinoma after failure of first-line therapy
Presenter: Jia Fan
Session: Poster session 17