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
669P - Patient-reported outcomes with selpercatinib in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial
Presenter: Hyunseok Kang
Session: Poster session 17
670P - Preliminary efficacy and safety of tinengotinib (TT-00420) monotherapy in Chinese patients (pts) with advanced solid tumors: Results from a phase Ib/II study
Presenter: Panpan Zhang
Session: Poster session 17
671P - Safety and efficacy of PM060184 plus gemcitabine in advanced solid tumors
Presenter: Sanjay Goel
Session: Poster session 17
672P - Phase I/II trial of RVU120 (SEL120), CDK8/CDK19 inhibitor in patients with relapsed/refractory metastatic or advanced solid tumors
Presenter: Rafal Dziadziuszko
Session: Poster session 17
673P - A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist brigimadlin (BI 907828) in patients (pts) with solid tumours
Presenter: Patrick Schoeffski
Session: Poster session 17
674P - Response of thrombopoietin receptor agonists in MDM2 inhibitor induced thrombocytopenia
Presenter: Raymond DeMatteo
Session: Poster session 17
675P - A phase I study of safety, pharmacokinetics, and pharmacodynamics of SCR-6920, a protein arginine methyltransferase 5 (PRMT5) inhibitor, in patients with advanced malignant tumors
Presenter: Jinming Yu
Session: Poster session 17
676P - Preclinical characterization of novel peptide binders for EphA2-targeted radiopharmaceutical therapy
Presenter: Renee Clift
Session: Poster session 17
677P - Preliminary findings from a phase I, open-label, dose-finding study of SNB-101 in patients with advanced solid tumors
Presenter: Yun Beom Sang
Session: Poster session 17
678P - ExoDS: A bioengineered exosome-based capsule for targeted delivery of chemotherapy drugs to cancer cells and cancer stem cells
Presenter: Abhishek Dutta
Session: Poster session 17