Factors associated with reaching maintenance therapy in patients with advanced biliary tract cancer treated with durvalumab: Real‐world results from a multicenter and multinational study

Standard of care first-line systemic treatment for advanced biliary tract cancer includes chemo-immunotherapy with gemcitabine, cisplatin, and durvalumab, followed by maintenance durvalumab monotherapy. The present work aims to investigate the differences in baseline clinical and molecular characteristics between patients with early progression during chemo-immunotherapy and those who reach durvalumab maintenance therapy. The study population included patients with unresectable, locally advanced, or metastatic BTC who received treatment at 38 clinical Institutions in 12 countries from July 2021 to December 2023. The primary objective of the study was to investigate whether baseline clinical and molecular characteristics differed between patients with early progression during chemo-immunotherapy versus those reaching durvalumab maintenance therapy. Four hundred forty-eight patients were included in this study. Two hundred twenty-seven patients (50.7%) received maintenance with durvalumab monotherapy, whereas 221 (49.3%) did not receive maintenance therapy due to PD during first-line chemo-immunotherapy before completing 8 cycles. Results show that patients who received maintenance were more likely to be older (≥70 years), have an ECOG = 0, locally advanced disease, and a neutrophil-to-lymphocyte ratio (NLR) <3. A higher proportion of patients with BAP1 mutations received maintenance, while TP53 mutations were more common in those who progressed early. According to the present analysis, a substantial proportion of patients (50.7%) with advanced BTC who were treated with chemotherapy plus durvalumab proceeded to receive maintenance therapy with durvalumab monotherapy, with a median treatment duration of 4.4 cycles. Patients ≥70 years, with ECOG PS 0, with locally advanced disease, and with NLR <3 had a higher likelihood of receiving maintenance therapy.

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Publication Details

Journal
International Journal of Cancer
Published
2025-05-19
DOI
https://doi.org/10.1002/ijc.35481
Citations
2
Primary Topic
Cholangiocarcinoma and Gallbladder Cancer Studies
Type
article
Field-Weighted Citation Impact
4.01

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article

Factors associated with reaching maintenance therapy in patients with advanced biliary tract cancer treated with durvalumab: Real‐world results from a multicenter and multinational study

Chiara Pirrone, Nuno Couto, Lorenzo Antonuzzo, Silvia Camera et al.
2 citations
International Journal of Cancer
Cholangiocarcinoma and Gallbladder Cancer Studies
4.01
article

Factors associated with reaching maintenance therapy in patients with advanced biliary tract cancer treated with durvalumab: Real‐world results from a multicenter and multinational study

Chiara Pirrone, Nuno Couto, Lorenzo Antonuzzo, Silvia Camera, Stefano Tamberi, Tiziana Pressiani, Guido Giordano, Monica Verrico, Oluseyi Abidoye, Francesca Salani, Emiliano Tamburini, Margherita Rimini, Masafumi Ikeda, Anna Lena Saborowski, Fabian Finkelmeier, Federica Lo Prinzi, Alessandro Parisi, Monica Niger, Gerald W. Prager, Lukas Perkhofer, Ricardo Roque, Lorenzo Fornaro, Giovanni Farinea, Caterina Vivaldi, Florian Castet, Gian Paolo Spinelli, Min-Su Kang, Ilario Giovanni Rapposelli, Mario Scartozzi, Francesco Vitiello, Matteo Landriscina, Stephen L. Chan, Chiara Braconi, Marta Schirripa, Anna Diana, Jessica Lucchetti, Sara Lonardi, Jorge Adeva, Vera Himmelsbach, Alessandra Boccaccino, Gianluca Masi, Giuseppe Tonini, Nicola Personeni, Luca Esposito, Maria Grazia Rodriquenz, Ester Oneda, Federico Rossari, Lorenza Rimassa, Hong Jae Chon, Salvatore Corallo, Ingrid Garajová, Daniele Lavacchi, Jeroen Dekervel, Chiara Pircher, Cecilia Melo Alvim, Tanios Bekaii‐Saab, Aitzaz Qaisar, Selma Ahcene Djaballah, Tomoyuki Satake, Rita Balsano, Frederik Peeters, Giulia Tesini, Andrea Casadei‐Gardini, Antonio Avallone, Changhoon Yoo, Jin Won Kim, Il Hwan Kim, Antonio De Rosa, Mario Domenico Rizzato, Silvana Leo, Arndt Vogel
article en
2 citations

Abstract

Standard of care first-line systemic treatment for advanced biliary tract cancer includes chemo-immunotherapy with gemcitabine, cisplatin, and durvalumab, followed by maintenance durvalumab monotherapy. The present work aims to investigate the differences in baseline clinical and molecular characteristics between patients with early progression during chemo-immunotherapy and those who reach durvalumab maintenance therapy. The study population included patients with unresectable, locally advanced, or metastatic BTC who received treatment at 38 clinical Institutions in 12 countries from July 2021 to December 2023. The primary objective of the study was to investigate whether baseline clinical and molecular characteristics differed between patients with early progression during chemo-immunotherapy versus those reaching durvalumab maintenance therapy. Four hundred forty-eight patients were included in this study. Two hundred twenty-seven patients (50.7%) received maintenance with durvalumab monotherapy, whereas 221 (49.3%) did not receive maintenance therapy due to PD during first-line chemo-immunotherapy before completing 8 cycles. Results show that patients who received maintenance were more likely to be older (≥70 years), have an ECOG = 0, locally advanced disease, and a neutrophil-to-lymphocyte ratio (NLR) <3. A higher proportion of patients with BAP1 mutations received maintenance, while TP53 mutations were more common in those who progressed early. According to the present analysis, a substantial proportion of patients (50.7%) with advanced BTC who were treated with chemotherapy plus durvalumab proceeded to receive maintenance therapy with durvalumab monotherapy, with a median treatment duration of 4.4 cycles. Patients ≥70 years, with ECOG PS 0, with locally advanced disease, and with NLR <3 had a higher likelihood of receiving maintenance therapy.

International Journal of CancerVol. 157(6)
University of Foggia (IT), University of Pisa (IT), Champalimaud Foundation (PT), Goethe University Frankfurt (DE), Ulsan College (KR), Marche Polytechnic University (IT), University of Parma (IT), Humanitas University (IT), University of Padua (IT), Vita-Salute San Raffaele University (IT), Università Campus Bio-Medico (IT), Instituto Português de Oncologia de Coimbra Francisco Gentil (PT), University of Cagliari (IT), Chinese University of Hong Kong (HK), Casa Sollievo della Sofferenza (IT), Policlinico Umberto I (IT), Beatson West of Scotland Cancer Centre (GB), Toronto General Hospital (CA), Princess Margaret Cancer Centre (CA), Seoul National University Bundang Hospital (KR), Medizinische Hochschule Hannover (DE), University of Ulsan (KR), Ospedali Riuniti di Foggia (IT), Ospedale "Santa Maria delle Croci" di Ravenna (IT), Ospedale di Cattinara (IT), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Inje University Haeundae Paik Hospital (KR), Istituto Oncologico Veneto (IT), Prince of Wales Hospital (CN), Mayo Clinic in Arizona (US), Vall d'Hebron Hospital Universitari (ES), Ospedale di Belcolle (IT), University Hospital Frankfurt (DE), CHA University Bundang Medical Center (KR), Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT), Campus Bio Medico University Hospital (IT), Spanish Society of Hematology and Hemotherapy (ES), National Cancer Center Hospital East (JP), Ospedale Policlinico San Martino (IT), Fondazione Poliambulanza Istituto Ospedaliero (IT), CHA University (KR), Hospital de Santa Maria (PT), Policlinico San Matteo Fondazione (IT), Ospedale Vito Fazzi (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), University Hospital Ulm (DE), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), IRCCS Humanitas Research Hospital (IT), Azienda Ospedaliera Universitaria Pisana (IT), Vall d'Hebron Institute of Oncology (ES), University of Florence (IT), Medical University of Vienna (AT), University of Glasgow (GB), Sapienza University of Rome (IT)
European Cooperation in Science and Technology
Openalex Percentile: Top 7%
Cholangiocarcinoma and Gallbladder Cancer Studies
4.01
DOIOpen Access PDFOpenAlex
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