New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe

Lorenza Rimassa^{1

2}, Angela Lamarca³, Grainne M O'Kane^{4

5}, Julien Edeline⁶, Mairéad G McNamara⁷, Arndt Vogel^{8

9

10}, Matteo Fassan^{11

12}, Alejandro Forner^{13

14}, Timothy Kendall^{15

16

17}, Jorge Adeva¹⁸, Andrea Casadei-Gardini¹⁹, Lorenzo Fornaro²⁰, Antoine Hollebecque²¹, Maeve A Lowery²², Teresa Macarulla²³, David Malka²⁴, Elene Mariamidze²⁵, Monica Niger²⁶, Anu Ustav²⁷, John Bridgewater²⁸, Rocio I R Macias^{14

29}, Chiara Braconi^{17

30

31}

Affiliations

¹ Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, Milan, 20072, Italy.
² Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Via A. Manzoni 56, Rozzano, Milan, 20089, Italy.
³ Department of Medical Oncology, Oncohealth Institute, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Fundación Jimenez Diaz University Hospital, Avda Reyes Católicos 2, Madrid, 28040, Spain.
⁴ University College Dublin, Belfield, Dublin 4, Ireland.
⁵ Department of Medical Oncology, St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland.
⁶ INSERM, Department of Medical Oncology, University Rennes, CLCC Eugène Marquis, COSS [(Chemistry Oncogenesis Stress Signaling)] - UMR_S 1242, Rennes, F-35000, France.
⁷ Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.
⁸ Toronto General Hospital, UHN, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada.
⁹ Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G 2M9, Canada.
¹⁰ Hannover Medical School, Carl-Neuberg Str. 1, Hannover, 30659, Germany.
¹¹ Department of Medicine (DIMED), University of Padua, Via Gabelli 61, Padua, 35121, Italy.
¹² Veneto Institute of Oncology (IOV-IRCCS), Via Gattamelata 64, Padua, 35128, Italy.
¹³ Liver Unit, Barcelona Clinic Liver Cancer (BCLC) Group, ICMDM, Hospital Clinic IDIBAPS, University of Barcelona, Villarroel 170, Barcelona, 08036, Spain.
¹⁴ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Av. Monforte de Lemos, 3-5, Madrid, 28029, Spain.
¹⁵ Centre for Inflammation Research, Institute for Regeneration and Repair, University of Edinburgh, 5 Little France Drive, Edinburgh, EH16 4UU, UK.
¹⁶ Edinburgh Pathology, University of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK.
¹⁷ CRUK Scotland Cancer Centre, Switchback Rd, Glasgow, G61 1BD, UK.
¹⁸ Department of Medical Oncology, Hospital Universitario 12 de Octubre, Av. de Córdoba, s/n, Usera, Madrid, 28041, Spain.
¹⁹ Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital, Via Olgettina 60, Milan, 20132, Italy.
²⁰ Medical Oncology 2 Unit, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, Pisa, 56126, Italy.
²¹ Département de Médecine Oncologique, Gustave Roussy, 114 Rue Edouard Vaillant, Villejuif, F-94805, France.
²² Trinity St James Cancer Institute, Trinity College Dublin, College Green, Dublin 2, Ireland.
²³ Vall d'Hebrón Institute of Oncology (VHIO), Vall d'Hebrón University Hospital, Centre Cellex, Carrer de Natzaret, 115-117, Barcelona, 08035, Spain.
²⁴ Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, Paris, 75014, France.
²⁵ Department of Oncology and Hematology, Todua Clinic, Tevdore Mgvdeli #13, Tbilisi, 0112, Georgia.
²⁶ Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, Milan, 20133, Italy.
²⁷ Clinic of Oncology, North-Estonian Medical Centre, Sytiste Rd 19, Tallinn, 13419, Estonia.
²⁸ UCL Cancer Institute, 72 Huntley St, London, WC1E 6DD, UK.
²⁹ Experimental Hepatology and Drug Targeting (HEVEPHARM) Group, University of Salamanca, IBSAL, CIBERehd, Campus M. Unamuno s/n, Salamanca, 37007, Spain.
³⁰ School of Cancer Sciences, University of Glasgow, Switchback Rd, Glasgow, G61 1QH, UK.
³¹ Beatson West of Scotland Cancer Centre, 1053 Great Western Rd, Glasgow, G12 0YN, UK.

PMID: 40093395
PMCID: PMC11910789
DOI: 10.1016/j.lanepe.2024.101170

Review

New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe

Lorenza Rimassa et al. Lancet Reg Health Eur. 2025.

. 2025 Feb 19:50:101170.

doi: 10.1016/j.lanepe.2024.101170. eCollection 2025 Mar.

Authors

Affiliations

¹ Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, Milan, 20072, Italy.
² Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Via A. Manzoni 56, Rozzano, Milan, 20089, Italy.
³ Department of Medical Oncology, Oncohealth Institute, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Fundación Jimenez Diaz University Hospital, Avda Reyes Católicos 2, Madrid, 28040, Spain.
⁴ University College Dublin, Belfield, Dublin 4, Ireland.
⁵ Department of Medical Oncology, St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland.
⁶ INSERM, Department of Medical Oncology, University Rennes, CLCC Eugène Marquis, COSS [(Chemistry Oncogenesis Stress Signaling)] - UMR_S 1242, Rennes, F-35000, France.
⁷ Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.
⁸ Toronto General Hospital, UHN, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada.
⁹ Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G 2M9, Canada.
¹⁰ Hannover Medical School, Carl-Neuberg Str. 1, Hannover, 30659, Germany.
¹¹ Department of Medicine (DIMED), University of Padua, Via Gabelli 61, Padua, 35121, Italy.
¹² Veneto Institute of Oncology (IOV-IRCCS), Via Gattamelata 64, Padua, 35128, Italy.
¹³ Liver Unit, Barcelona Clinic Liver Cancer (BCLC) Group, ICMDM, Hospital Clinic IDIBAPS, University of Barcelona, Villarroel 170, Barcelona, 08036, Spain.
¹⁴ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Av. Monforte de Lemos, 3-5, Madrid, 28029, Spain.
¹⁵ Centre for Inflammation Research, Institute for Regeneration and Repair, University of Edinburgh, 5 Little France Drive, Edinburgh, EH16 4UU, UK.
¹⁶ Edinburgh Pathology, University of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK.
¹⁷ CRUK Scotland Cancer Centre, Switchback Rd, Glasgow, G61 1BD, UK.
¹⁸ Department of Medical Oncology, Hospital Universitario 12 de Octubre, Av. de Córdoba, s/n, Usera, Madrid, 28041, Spain.
¹⁹ Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital, Via Olgettina 60, Milan, 20132, Italy.
²⁰ Medical Oncology 2 Unit, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, Pisa, 56126, Italy.
²¹ Département de Médecine Oncologique, Gustave Roussy, 114 Rue Edouard Vaillant, Villejuif, F-94805, France.
²² Trinity St James Cancer Institute, Trinity College Dublin, College Green, Dublin 2, Ireland.
²³ Vall d'Hebrón Institute of Oncology (VHIO), Vall d'Hebrón University Hospital, Centre Cellex, Carrer de Natzaret, 115-117, Barcelona, 08035, Spain.
²⁴ Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, Paris, 75014, France.
²⁵ Department of Oncology and Hematology, Todua Clinic, Tevdore Mgvdeli #13, Tbilisi, 0112, Georgia.
²⁶ Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, Milan, 20133, Italy.
²⁷ Clinic of Oncology, North-Estonian Medical Centre, Sytiste Rd 19, Tallinn, 13419, Estonia.
²⁸ UCL Cancer Institute, 72 Huntley St, London, WC1E 6DD, UK.
²⁹ Experimental Hepatology and Drug Targeting (HEVEPHARM) Group, University of Salamanca, IBSAL, CIBERehd, Campus M. Unamuno s/n, Salamanca, 37007, Spain.
³⁰ School of Cancer Sciences, University of Glasgow, Switchback Rd, Glasgow, G61 1QH, UK.
³¹ Beatson West of Scotland Cancer Centre, 1053 Great Western Rd, Glasgow, G12 0YN, UK.

PMID: 40093395
PMCID: PMC11910789
DOI: 10.1016/j.lanepe.2024.101170

Erratum in

Correction to "New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe" [The Lancet Regional Health - Europe, volume 50, March 2025, 101170].
Rimassa L, Lamarca A, O'Kane GM, Edeline J, McNamara MG, Vogel A, Fassan M, Forner A, Kendall T, Adeva J, Casadei-Gardini A, Fornaro L, Hollebecque A, Lowery MA, Macarulla T, Malka D, Mariamidze E, Niger M, Ustav A, Bridgewater J, Macias RIR, Braconi C. Rimassa L, et al. Lancet Reg Health Eur. 2025 Apr 30;53:101306. doi: 10.1016/j.lanepe.2025.101306. eCollection 2025 Jun. Lancet Reg Health Eur. 2025. PMID: 40385615 Free PMC article.

Abstract

In recent years, treatment options for patients with advanced biliary tract cancer (BTC) have increased significantly due to the positive results from phase 2/3 clinical trials of immune checkpoint inhibitors, combined with chemotherapy, and molecularly targeted agents. These advances have led to the need for molecular testing to identify actionable alterations and patients amenable to targeted therapies. However, these improvements have brought with them many questions and challenges, including the identification of resistance mechanisms and therapeutic sequences. In this Series paper we aim to provide an overview of the current systemic treatment options for patients with BTC, highlighting disparities in access to innovative treatments and molecular testing across European countries, which lead to inequalities in the possibilities of treating patients with advanced BTC. We also discuss how ongoing European collaborative projects, such as the COST Action Precision-BTC-Network CA22125, supported by COST (European Cooperation in Science and Technology), linked to the European Network for the Study of Cholangiocarcinoma (ENSCCA), can help overcome these disparities and improve the current scenario.

Keywords: Access to NGS; Access to therapy; Biliary tract cancer; Cholangiocarcinoma; Gallbladder cancer; Immunotherapy; Molecularly targeted therapy; NGS.

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Conflict of interest statement

L.R. reports grant/research funding (to institution) from AbbVie, Agios, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, IPSEN, Jazz Pharmaceuticals, Lilly, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, TransThera Sciences, and Zymeworks; consulting fees from AbbVie, AstraZeneca, Basilea, Bayer, Bristol Myers Squibb, Eisai, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, IPSEN, IQVIA, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, and Zymeworks; lecture fees from AstraZeneca, Bayer, Bristol Myers Squibb, Guerbet, Incyte, IPSEN, Roche, and Servier; and travel expenses from AstraZeneca. She is chair for the EORTC CITCG HBP/NET Task Force, treasurer for the International Liver Cancer Association, and Special Expert Clinical Trials Europe for NCI GISC Hepatobiliary (HB) Task Force (unpaid positions). A.L. declares travel and educational support from Ipsen, Pfizer, Bayer, AAA, SirtEx, Novartis, Mylan, Delcath Advanz Pharma, and Roche; speaker honoraria from Merck, Pfizer, Ipsen, Incyte, AAA/Novartis, QED, Servier, AstraZeneca, EISAI, Roche, Advanz Pharma, and MSD; advisory and consultancy honoraria from EISAI, Nutricia, Ipsen, QED, Roche, Servier, Boston Scientific, Albireo Pharma, AstraZeneca, Boehringer Ingelheim, GENFIT, TransThera Biosciences, Taiho, and MSD; principal investigator-associated institutional Funding form QED, Merck, Boehringer Ingelheim, Servier, AstraZeneca, GenFit, Panbela Therapeutics, Novocure GmbH, Camurus AB, Albireo Pharma, Taiho, TransThera, Jazz Therapeutics, and Roche; she is a member of the Knowledge Network and NETConnect Initiatives funded by Ipsen. G.O.K. declares travel support from MSD, Roche, and Takeda; consulting honoraria from Roche, AstraZeneca, Incyte, Servier; institutional grant support from Roche, AstraZeneca; lecture fees from MSD and Roche. J.E. receives grants from BMS, Beigene, Boston Scientific, Exeliom biosciences, SUMMIT; consulting fees from MSD, Eisai, BMS, AstraZeneca, Bayer, Roche, Ipsen, Basilea, Merck Serono, Incyte, Servier, Beigene, Taiho, Boston Scientific, Guerbet. M.M.N. received research grant support to institution from AstraZeneca, Servier, and NuCana; travel and accommodation support from Ipsen, and speaker honoraria from AstraZeneca. A.V. has consultancy and advisory role for Roche, AstraZeneca, Böhringer-Ingelheim, Ipsen, Incyte, Cogent, EISAI, Zymeworks, Biologix, BMS, Terumo, Elevar, Servier, MSD, Taiho, Jazzpharma, Medivir, Abbvie, Tyra, Falk, Janssen, Lilly; received travel support from Roche, MSD, and Astellas; speaker fees from Roche, AstraZeneca, Böhringer-Ingelheim, Ipsen, Incyte, Cogent, EISAI, Zymeworks, Biologix, BMS, Terumo, Elevar, Servier, MSD, Tahio, Jazzpharma, Medivir, Abbvie, Tyra, Falk, Janssen, Lilly. MF reports grant/research funding (to institution) from Astellas, Roche and Diaceutics; consulting fees from Amgen, Astellas, AstraZeneca, BMS, Diapath, Eli Lilly, Sanofi, GSK, Incyte, IQVIA, Janssen Pharma, MSD, Novartis, Pierre Fabre, Roche, lecture fees from Amgen, Astellas, AstraZeneca, BMS, Diapath, Eli Lilly, GSK, Incyte, IQVIA, Janssen Pharma, Sanofi, MSD, Novartis, Pierre Fabre, Roche. AF declares travel support from AstraZeneca, consulting fees from Taiho, Incyte, and AstraZeneca, and honoraria as speaker from AstraZeneca; he is Scientific Vice-Secretary AEEH. T.J.K. received consulting fees from Resolution Therapeutics, Clinnovate Health, HistoIndex, Fibrofind, Kynos Therapeutics, Perspectum Diagnostics, Concept Life Sciences; speaker fees from Servier Laboratories, Incyte Corporation, Jazz Pharmaceuticals; he is a committee member of the Pathological Society of Great Britain and Ireland, the British Association for the Study of the Liver, Cholangiocarcinoma-UK, UK Liver Pathology Group. A.C.G. received consulting fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, IQVIA, MSD, Roche, Servier; lecture fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, Servier; travel expenses from AstraZeneca and MSD; advisory fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, Servier; equipment from AstraZeneca. E.M. reports lecture fees (to the Georgian School of Oncology) from Novartis, Servier, Roche, AstraZeneca; grants from ESMO; travel expenses from ESMO and ESO; she is the director of the Georgian School of Oncology and of the Georgian Society of Geriatric oncology and she is a member of several ESMO committees. L.F. reports grant/research funding (to institution) from MSD, Bristol Myers Squibb, AstraZeneca, Incyte, BeiGene, Astellas, Daiichi Sankyo, and Roche; consulting fees from MSD, AstraZeneca, Incyte, Taiho Oncology, Servier, Daiichi Sankyo, EliLilly, and BeiGene; lecture fees from Incyte, Bristol Myers Squibb, EliLilly, AstraZeneca, and MSD; travel expenses from Amgen. A.H. reports consulting fees from Amgen, Sanofi, BMS, Basilea, Incyte, Servier, Relay Therapeutics, Taiho, MSD; lecture fees from Servier, Incyte, Seagen; support for attending meetings from Pierre-Fabre; advisory board fees from Basilea, QED therapeutics, Taiho, Relay Therapeutics, MSD. M.L. reports research funding to institution from MSD, Exelixis, Amgen, Zymeworks, Basilea, Daiichi Sankyo, Legend Biotech, Genuity Science, consulting role with funding to institution only from AstraZeneca, Astellas pharma, Servier, Roche/Genentech. T.M. reports consulting or advisory role fees from Ability Pharmaceuticals SL, Arcus Bioscience Inc., AstraZeneca, Basilea Pharma, Baxter, BioLineRX Ltd, Celgene, Eisai, Incyte, Ipsen Bioscience Inc.; grant research funding from MSD, Novocure, QED Therapeutics, Roche Farma, Sanofi-Aventis, Servier, Zymeworks; lecture fees from Janssen, Lilly, Esteve, Daïchi, Biontech, Novartis, Jazz Pharmaceuticals; travel support from Servier, AstraZeneca, Sanofi, Incyte, Lilly, MSD, and Roche. D.M. reports consulting fees from AbbVie, Amgen, AstraZeneca, Bayer, Bionest Partners, BMS, Incyte, Merck Serono, MSD, Pierre Fabre Oncologie, Roche, Sanofi, Simon-Kutcher & Partners, Servier, Taiho; lecture fees from Amgen, AstraZeneca, Bayer, BMS, Foundation Medicine, Incyte, Leo Pharma, Medscape, Merck Serono, MSD, Pierre Fabre Oncologie, Roche, Sanofi, Servier, Veracyte, Viatris; travel expenses from Amgen, Bayer, BMS, Merck Serono, MSD, Pierre Fabre Oncologie, Roche, Sanofi, Servier, Viatris. M.N. received grant funding to the GONO foundation from Rising Tide Foundation For Clinical Cancer Research; travel expenses from AstraZeneca; honoraria for lectures or editorial collaboration from Sandoz, Medpoint SRL, Incyte, AstraZeneca, Accademia della Medicina, and Servier; consulting fees from EMD Serono, Basilea Pharmaceutica, Incyte, MSD Italia, Servier, and AstraZeneca; advisory fees from Servier, AstraZeneca, and Taiho. A.U. received travel support from AstraZeneca. R.I.R.M. reports institutional funds from AstraZeneca, Incyte, Servier, Taiho and Jazz Pharmaceuticals. C.B. received honoraria as speaker from AstraZeneca, Incyte, and Servier; honoraria as consultant from Incyte, Servier, Boehringer Ingelheim, AstraZeneca, Jazz Pharmaceutical, Taiho, Molecular Partners, received research funds from Avacta, Medannex, Servier, and her spouse is an employee of AstraZeneca. All the other authors have no competing interests to declare.

Figures

**Fig. 1**
**Results of the survey on clinical practice in biliary tract cancer in Europe.** Panel a provides information regarding the survey's participants (n = 47 physicians). If more than one physician from a specific country answered to the survey, the exact number of participants from that country is reported on the map. Answers regarding access to systemic and locoregional therapies are reported in panels b, c, d, and f; answers regarding access to genomic profiling are reported in panel e. Panel g provides information regarding access to supportive care. All answers provided in panels b, c, d, e, f, and g are divided by institution (n = 36). Abbreviations: 5-FU, 5-fluorouracil; BTC, biliary tract cancer; ESMO, European Society of Medical Oncology; FA, folinic acid; FISH, fluorescence *in situ* hybridisation; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFOX, folinic acid + 5-FU + oxaliplatin; ICIs, immune checkpoint inhibitors; IHC, immunohistochemistry; NGS, next-generation sequencing; pSACT, palliative systemic anticancer treatment; RFA, radiofrequency ablation; SBRT, stereotactic body radiation therapy; TACE, transarterial chemoembolisation; TARE, transarterial radioembolisation. Created with Adobe Illustrator.

**Fig. 2**
Timeline of approvals of durvalumab (a) and pembrolizumab (b) in combination with chemotherapy, pemigatinib (c), futibatinib (d), and ivosidenib (e) for the treatment of biliary tract cancer in Europe.¹From March 21st, 2022 until February 18th, 2024, durvalumab in association with chemotherapy was available in Italy via a named-patient programme provided by AstraZeneca Italy. ²From October 2022 until July 31st, 2024 durvalumab in association with chemotherapy was available in France via a publicly funded early access programme in the ITT population. ³In France publicly funded early access to pembrolizumab in association with chemotherapy was denied on March 21st, 2023.⁴ In 2020 and 2021 pemigatinib was available in France via publicly funded early access (ATU). Abbreviations: ATU, temporary use authorisation; CisGem, cisplatin and gemcitabine; EMA, European Medicines Agency; ITT, intention-to-treat; KVV, Verordnung über die Krankenversicherung (Ordinance on Health Insurance); UK, United Kingdom. Created with Adobe illustrator.

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References

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New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe

Affiliations

New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe

Authors

Affiliations

Erratum in

Abstract

Conflict of interest statement

Figures

References

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