PMID- 37452505
OWN - NLM
STAT- MEDLINE
DCOM- 20230717
LR  - 20240126
IS  - 1478-3231 (Electronic)
IS  - 1478-3223 (Linking)
VI  - 43
IP  - 8
DP  - 2023 Aug
TI  - Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An 
      early exploratory analysis of real-world data.
PG  - 1803-1812
LID - 10.1111/liv.15641 [doi]
AB  - BACKGROUND: The TOPAZ-1 phase III trial reported a survival benefit with the 
      anti-programmed death cell ligand 1 (anti-PD-L1) durvalumab in combination with 
      gemcitabine and cisplatin in patients with advanced biliary tract cancer. The 
      present study investigated the efficacy and safety of this new standard treatment 
      in a real-world setting. METHODS: The analysed population included patients with 
      unresectable, locally advanced or metastatic adenocarcinoma of the biliary tract 
      treated with durvalumab in combination with gemcitabine and cisplatin at 17 
      Italian centres. The primary endpoint of the study was progression-free survival 
      (PFS), whereas secondary endpoints included overall survival (OS), overall 
      response rate (ORR) and safety. Unadjusted and adjusted hazard ratios (HRs) by 
      baseline characteristics were calculated using the Cox proportional hazards 
      model. RESULTS: From February 2022 to November 2022, 145 patients were enrolled. 
      After a median follow-up of 8.5 months (95% CI: 7.9-13.6), the median PFS was 
      8.9 months (95% CI: 7.4-11.7). Median OS was 12.9 months (95% CI: 10.9-12.9). The 
      investigator-assessed confirmed ORR was 34.5%, and the disease control rate was 
      87.6%. Any grade adverse events (AEs) occurred in 137 patients (94.5%). Grades 
      3-4 AEs occurred in 51 patients (35.2%). The rate of immune-mediated AEs (imAEs) 
      was 22.7%. Grades 3-4 imAEs occurred in 2.1% of the patients. In univariate 
      analysis, non-viral aetiology, ECOG PS >0 and NLR >/=3 correlated with shorter PFS. 
      CONCLUSION: The results reported in this first real-world analysis mostly 
      confirmed the results achieved in the TOPAZ-1 trial in terms of PFS, ORR and 
      safety.
CI  - (c) 2023 The Authors. Liver International published by John Wiley & Sons Ltd.
FAU - Rimini, Margherita
AU  - Rimini M
AUID- ORCID: 0000-0002-4047-2585
AD  - Medical Oncology Department, IRCSS San Raffaele Scientific Institute, Milan, 
      Italy.
AD  - Department of Oncology, Vita-Salute San Raffaele University, Milan, Italy.
FAU - Fornaro, Lorenzo
AU  - Fornaro L
AD  - Medical Oncology, University Hospital of Pisa, Pisa, Italy.
FAU - Lonardi, Sara
AU  - Lonardi S
AD  - Medical Oncology 3, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
FAU - Niger, Monica
AU  - Niger M
AD  - Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Lavacchi, Daniele
AU  - Lavacchi D
AD  - Clinical Oncology Unit, Careggi University Hospital, Florence, Italy.
FAU - Pressiani, Tiziana
AU  - Pressiani T
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas 
      Research Hospital, Rozzano (Milan), Italy.
FAU - Lucchetti, Jessica
AU  - Lucchetti J
AD  - Division of Medical Oncology, Fondazione Policlinico Universitario Campus 
      Bio-Medico, Rome, Italy.
FAU - Giordano, Guido
AU  - Giordano G
AD  - Unit of Medical Oncology and Biomolecular Therapy, Policlinico Riuniti, Foggia, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
FAU - Pretta, Andrea
AU  - Pretta A
AD  - Medical Oncology, University and University Hospital, Cagliari, Italy.
FAU - Tamburini, Emiliano
AU  - Tamburini E
AD  - Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City 
      Hospital, Tricase, Italy.
FAU - Pirrone, Chiara
AU  - Pirrone C
AD  - Medical Oncology Unit 1, Ospedale Policlinico San Martino - IRCCS, Genoa, Italy.
FAU - Rapposelli, Ilario Giovanni
AU  - Rapposelli IG
AUID- ORCID: 0000-0003-1802-5671
AD  - Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori 
      (IRST) "Dino Amadori", Meldola, Italy.
FAU - Diana, Anna
AU  - Diana A
AD  - Medical Oncology Unit, Ospedale del Mare, Napoli, Italy.
FAU - Martinelli, Erika
AU  - Martinelli E
AD  - Medical Oncology Unit, Department of Precision Medicine, Universita Degli Studi 
      Della Campania "Luigi Vanvitelli", Naples, Italy.
FAU - Garajova, Ingrid
AU  - Garajova I
AD  - Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
FAU - Simionato, Francesca
AU  - Simionato F
AD  - Department of Oncology, San Bortolo General Hospital, Azienda ULSS8 Berica, 
      Vicenza, Italy.
FAU - Schirripa, Marta
AU  - Schirripa M
AD  - Medical Oncology Unit, Department of Oncology and Hematology, Belcolle Hospital, 
      Viterbo, Italy.
FAU - Formica, Vincenzo
AU  - Formica V
AD  - Medical Oncology Unit, Department of Systems Medicine, Tor Vergata University 
      Hospital, Rome, Italy.
FAU - Vivaldi, Caterina
AU  - Vivaldi C
AD  - Medical Oncology, University Hospital of Pisa, Pisa, Italy.
AD  - Department of Translational Research and New Technologies in Medicine and 
      Surgery, University of Pisa, Pisa, Italy.
FAU - Caliman, Enrico
AU  - Caliman E
AD  - Clinical Oncology Unit, Careggi University Hospital, Florence, Italy.
FAU - Rizzato, Mario Domenico
AU  - Rizzato MD
AD  - Medical Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
AD  - Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, 
      Italy.
FAU - Zanuso, Valentina
AU  - Zanuso V
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas 
      Research Hospital, Rozzano (Milan), Italy.
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), 
      Italy.
FAU - Nichetti, Federico
AU  - Nichetti F
AUID- ORCID: 0000-0001-8044-4207
AD  - Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
AD  - Computational Oncology, Molecular Precision Oncology Program, National Center for 
      Tumor Diseases (NCT) and German Cancer Research Center (DKFZ), Heidelberg, 
      Germany.
FAU - Angotti, Lorenzo
AU  - Angotti L
AD  - Division of Medical Oncology, Fondazione Policlinico Universitario Campus 
      Bio-Medico, Rome, Italy.
FAU - Landriscina, Matteo
AU  - Landriscina M
AD  - Unit of Medical Oncology and Biomolecular Therapy, Policlinico Riuniti, Foggia, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
FAU - Scartozzi, Mario
AU  - Scartozzi M
AD  - Medical Oncology, University and University Hospital, Cagliari, Italy.
FAU - Ramundo, Matteo
AU  - Ramundo M
AD  - Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City 
      Hospital, Tricase, Italy.
FAU - Pastorino, Alessandro
AU  - Pastorino A
AD  - Medical Oncology Unit 1, Ospedale Policlinico San Martino - IRCCS, Genoa, Italy.
FAU - Daniele, Bruno
AU  - Daniele B
AD  - Medical Oncology Unit, Ospedale del Mare, Napoli, Italy.
FAU - Cornara, Noemi
AU  - Cornara N
AD  - Medical Oncology Department, IRCSS San Raffaele Scientific Institute, Milan, 
      Italy.
AD  - Department of Oncology, Vita-Salute San Raffaele University, Milan, Italy.
FAU - Persano, Mara
AU  - Persano M
AD  - Oncology Unit, San Martino Hospital, Oristano, Italy.
FAU - Gusmaroli, Eleonora
AU  - Gusmaroli E
AD  - Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Cerantola, Riccardo
AU  - Cerantola R
AD  - Medical Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
AD  - Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, 
      Italy.
FAU - Salani, Francesca
AU  - Salani F
AD  - Medical Oncology, University Hospital of Pisa, Pisa, Italy.
AD  - Institute of Interdisciplinary Research "Health Science", Scuola Superiore 
      Sant'Anna, Pisa, Italy.
FAU - Ratti, Francesca
AU  - Ratti F
AUID- ORCID: 0000-0002-8108-9064
AD  - Hepatobiliary Surgery Division, Vita-Salute San Raffaele University, IRCCS San 
      Raffaele Scientific Institute, Milan, Italy.
FAU - Aldrighetti, Luca
AU  - Aldrighetti L
AD  - Hepatobiliary Surgery Division, Vita-Salute San Raffaele University, IRCCS San 
      Raffaele Scientific Institute, Milan, Italy.
FAU - Cascinu, Stefano
AU  - Cascinu S
AD  - Medical Oncology Department, IRCSS San Raffaele Scientific Institute, Milan, 
      Italy.
AD  - Department of Oncology, Vita-Salute San Raffaele University, Milan, Italy.
FAU - Rimassa, Lorenza
AU  - Rimassa L
AUID- ORCID: 0000-0001-9957-3615
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas 
      Research Hospital, Rozzano (Milan), Italy.
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), 
      Italy.
FAU - Antonuzzo, Lorenzo
AU  - Antonuzzo L
AD  - Clinical Oncology Unit, Careggi University Hospital, Florence, Italy.
AD  - Department of Experimental and Clinical Medicine, University of Florence, 
      Florence, Italy.
FAU - Casadei-Gardini, Andrea
AU  - Casadei-Gardini A
AUID- ORCID: 0000-0001-6289-7202
AD  - Medical Oncology Department, IRCSS San Raffaele Scientific Institute, Milan, 
      Italy.
AD  - Department of Oncology, Vita-Salute San Raffaele University, Milan, Italy.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Liver Int
JT  - Liver international : official journal of the International Association for the 
      Study of the Liver
JID - 101160857
RN  - 0 (Gemcitabine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 28X28X9OKV (durvalumab)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
CIN - Liver Int. 2023 Aug;43(8):1620-1622. PMID: 37452502
MH  - Humans
MH  - *Gemcitabine
MH  - Cisplatin/therapeutic use
MH  - Antibodies, Monoclonal/adverse effects
MH  - *Bile Duct Neoplasms/drug therapy
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
OTO - NOTNLM
OT  - cholangiocarcinoma
OT  - durvalumab
OT  - immunotherapy
EDAT- 2023/07/15 11:42
MHDA- 2023/07/17 06:42
CRDT- 2023/07/15 01:57
PHST- 2023/05/15 00:00 [revised]
PHST- 2023/03/14 00:00 [received]
PHST- 2023/05/27 00:00 [accepted]
PHST- 2023/07/17 06:42 [medline]
PHST- 2023/07/15 11:42 [pubmed]
PHST- 2023/07/15 01:57 [entrez]
AID - 10.1111/liv.15641 [doi]
PST - ppublish
SO  - Liver Int. 2023 Aug;43(8):1803-1812. doi: 10.1111/liv.15641.