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Durvalumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Biliary Tract Cancer: a Real-World Retrospective, Multicenter Study

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Abstract

Background

The TOPAZ-1 phase III trial reported a survival benefit with the anti-programmed cell death ligand 1 (anti-PD-L1) durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer (BTC).

Objective

The present study investigated for the first time the impact on survival of adding durvalumab to cisplatin/gemcitabine compared with cisplatin/gemcitabine in a real-world setting.

Patients and Methods

The analyzed population included patients with unresectable, locally advanced, or metastatic BTC treated with durvalumab in combination with cisplatin/gemcitabine or with cisplatin/gemcitabine alone. The impact of adding durvalumab to chemotherapy in terms of overall survival (OS) and progression free survival (PFS) was investigated with univariate and multivariate analysis.

Results

Overall, 563 patients were included in the analysis: 213 received cisplatin/gemcitabine alone, 350 received cisplatin/gemcitabine plus durvalumab. At the univariate analysis, the addition of durvalumab was found to have an impact on survival, with a median OS of 14.8 months versus 11.2 months [hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.50–0.80, p = 0.0002] in patients who received cisplatin/gemcitabine plus durvalumab compared to those who received cisplatin/gemcitabine alone. At the univariate analysis for PFS, the addition of durvalumab to cisplatin/gemcitabine demonstrated a survival impact, with a median PFS of 8.3 months and 6.0 months (HR 0.57, 95% CI 0.47–0.70, p < 0.0001) in patients who received cisplatin/gemcitabine plus durvalumab and cisplatin/gemcitabine alone, respectively. The multivariate analysis confirmed that adding durvalumab to cisplatin/gemcitabine is an independent prognostic factor for OS and PFS, with patients > 70 years old and those affected by locally advanced disease experiencing the highest survival benefit. Finally, an exploratory analysis of prognostic factors was performed in the cohort of patients who received durvalumab: neutrophil–lymphocyte ratio (NLR) and disease stage were to be independent prognostic factors in terms of OS. The interaction test highlighted NLR ≤ 3, Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0, and locally advanced disease as positive predictive factors for OS on cisplatin/gemcitabine plus durvalumab.

Conclusion

In line with the results of the TOPAZ-1 trial, adding durvalumab to cisplatin/gemcitabine has been confirmed to confer a survival benefit in terms of OS and PFS in a real-world setting of patients with advanced BTC.

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Author information

Author notes

  1. Margherita Rimini, Gianluca Masi, Sara Lonardi, Federico Nichetti are Co-first authors.

  2. Lorenza Rimassa, Lorenzo Antonuzzo, Andrea Casadei-Gardini are Co-last authors.

Authors and Affiliations

  1. Department of Oncology, IRCCS San Raffaele Scientific Institute Hospital, Vita-Salute San Raffaele University, Milan, Italy

    Margherita Rimini, Federico Rossari, Silvia Foti, Cascinu Stefano & Andrea Casadei-Gardini

  2. Division of Medical Oncology, Department of Translational Research and New Technologies in Medicine and Surgery, Pisa University Hospital, Pisa, Italy

    Gianluca Masi, Francesca Salani, Lorenzo Fornaro & Caterina Vivaldi

  3. Dept of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy

    Sara Lonardi, Francesca Bergamo, Antonio De Rosa & Mario Domenico Rizzato

  4. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, ENETS Center of Excellence, Via Venezian 1, 20133, Milan, Italy

    Federico Nichetti, Eleonora Gusmaroli, Monica Niger, Antonio De Rosa & Filippo De Braud

  5. Computational Oncology, Molecular Diagnostics Program, National Center for Tumor Diseases (NCT) and German Cancer Research Center (DKFZ), Heidelberg, Germany

    Federico Nichetti & Antonio De Rosa

  6. Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

    Tiziana Pressiani, Rita Balsano, Valentina Zanuso, Antonio De Rosa & Lorenza Rimassa

  7. Clinical Oncology Unit, Careggi University Hospital, 50134, Florence, Italy

    Daniele Lavacchi, Costanza Winchler, Antonio De Rosa, Filippo De Braud & Lorenzo Antonuzzo

  8. Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Roma, Italy

    Lucchetti Jessica, Angotti Lorenzo, Antonio De Rosa & Filippo De Braud

  9. Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy

    Guido Giordano, Matteo Landriscina, Antonio De Rosa & Filippo De Braud

  10. Medical Oncology, University and University Hospital, Cagliari, Italy

    Mario Scartozzi, Andrea Pretta, Antonio De Rosa & Filippo De Braud

  11. Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City Hospital, Tricase, Italy

    Emiliano Tamburini, Ilaria Toma, Antonio De Rosa & Filippo De Braud

  12. Medical Oncology Unit 1, Ospedale Policlinico San Martino, IRCCS, Genoa, Italy

    Alessandro Pastorino, Chiara Pirrone, Antonio De Rosa & Filippo De Braud

  13. Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy

    Ilario Giovanni Rapposelli, Antonio De Rosa & Filippo De Braud

  14. Medical Oncology Unit, Ospedale del Mare, Napoli, Italy

    Bruno Daniele, Anna Diana, Antonio De Rosa & Filippo De Braud

  15. Medical Oncology Unit, Department of Precision Medicine, Università Degli Studi Della Campania “Luigi Vanvitelli”, Naples, Italy

    Erika Martinelli, Antonio De Rosa & Filippo De Braud

  16. Medical Oncology Unit, University Hospital of Parma, Parma, Italy

    Ingrid Garajova, Antonio De Rosa & Filippo De Braud

  17. Department of Oncology, San Bortolo General Hospital, Vicenza, Italy

    Giuseppe Aprile, Antonio De Rosa & Filippo De Braud

  18. Medical Oncology Unit, Department of Oncology and Hematology, Belcolle Hospital, Viterbo, Italy

    Marta Schirripa, Antonio De Rosa & Filippo De Braud

  19. Medical Oncology Unit, Department of Systems Medicine, Tor Vergata University Hospital, Rome, Italy

    Vincenzo Formica, Rita Balsano, Antonio De Rosa & Filippo De Braud

  20. Division of Medical Oncology, ASL BI, Nuovo Ospedale degli Infermi, Ponderano, BI, Italy

    Francesco Leone, Antonio De Rosa & Filippo De Braud

  21. Istituto Tumori “Giovanni Paolo II” of Bari, IRCCS, Bari, Italy

    Oronzo Brunetti, Antonio De Rosa & Filippo De Braud

  22. Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138, Bologna, Italy

    Giovanni Brandi, Antonio De Rosa & Filippo De Braud

  23. Department of Oncology, Academic Hospital of Udine ASUFC, Piazzale Santa Maria della Misericordia 15, 33100, Udine, UD, Italy

    Silvio Ken Garattini, Antonio De Rosa & Filippo De Braud

  24. Division of Medical Oncology 1, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy

    Maria Antonietta Satolli, Antonio De Rosa & Filippo De Braud

  25. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

    Valentina Zanuso, Antonio De Rosa, Filippo De Braud & Lorenza Rimassa

  26. Department of Surgery, oncology and gastroenterology of Padua, Padua, Italy

    Antonio De Rosa & Filippo De Braud

  27. Hepatobiliary Surgery Division, IRCCS Ospedale San Raffaele, Milan, Italy

    Francesca Ratti & Filippo De Braud

  28. Vita-Salute San Raffaele University, Milan, Italy

    Luca Aldrighetti & Filippo De Braud

  29. Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy

    Filippo De Braud

  30. Department of Medical Oncology, IRCCS San Raffaele Hospital, Via Olgettina n. 60, Milan, Italy

    Andrea Casadei-Gardini

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  1. Margherita Rimini
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  2. Gianluca Masi
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  3. Sara Lonardi
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  4. Federico Nichetti
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  5. Tiziana Pressiani
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  6. Daniele Lavacchi
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  7. Lucchetti Jessica
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  13. Bruno Daniele
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  14. Erika Martinelli
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  18. Vincenzo Formica
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  30. Francesco Leone
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  37. Monica Niger
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  40. Francesca Ratti
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  41. Luca Aldrighetti
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  42. Filippo De Braud
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  43. Silvia Foti
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  44. Mario Domenico Rizzato
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  45. Caterina Vivaldi
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  46. Cascinu Stefano
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  47. Lorenza Rimassa
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  48. Lorenzo Antonuzzo
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  49. Andrea Casadei-Gardini
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Corresponding author

Correspondence to Andrea Casadei-Gardini.

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Funding

No external funding was used in the preparation of this manuscript.

Conflict of Interest

L.R. reports consulting fees from AbbVie, AstraZeneca, Basilea, Bayer, BMS, 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, BMS, Eisai, Incyte, Ipsen, Merck Serono, Roche, and Servier; travel expenses from AstraZeneca; research grants (to institution) from Agios, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Servier, and Zymeworks. T.P. received consulting fees from Bayer, Ipsen, and AstraZeneca; institutional research funding from Roche, Bayer, and AstraZeneca; travel expenses from Roche. A.C.G. reports consulting fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, IQVIA, MSD, Roche, and Servier; lecture fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, and Servier; travel expenses from AstraZeneca; research grants (to institution) from AstraZeneca and Eisai. Margherita Rimini, Gianluca Masi, Sara Lonardi, Federico Nichetti, Daniele Lavacchi, Lucchetti Jessica, Guido Giordano, Mario Scartozzi, Emiliano Tamburini, Alessandro Pastorino, Ilario Giovanni Rapposelli, Bruno Daniele, Erika Martinelli, Ingrid Garajova, Giuseppe Aprile, Marta Schirripa, Vincenzo Formica, Francesca Salani, Costanza Winchler, Francesca Bergamo, Rita Balsano, Eleonora Gusmaroli, Angotti Lorenzo, Matteo Landriscina, Andrea Pretta, Ilaria Toma, Chiara Pirrone, Anna Diana, Francesco Leone, Oronzo Brunetti, Giovanni Brandi, Silvio Ken Garattini, Maria Antonietta Satolli, Federico Rossari, Lorenzo Fornaro, Monica Niger, Valentina Zanuso, Antonio De Rosa, Francesca Ratti, Luca Aldrighetti, Filippo De Braud, Silvia Foti, Mario Domenico Rizzato, Caterina Vivaldi, Cascinu Stefano, and Lorenzo Antonuzzo declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

Ethics Approval and Consent to Participate

The study was conducted in accordance with the Declaration of Helsinki and the protocol was approved by the ethics committee of each institution involved in the project. Under the condition of retrospective archival tissue collection and patient data anonymization, our study was exempt from the acquisition of informed consent from patients by the institutional review board.

Consent to Publish

Not applicable.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code Availability

Not applicable.

Authors’ Contributions

Conception and design: A. Casadei-Gardini, M. Rimini, Lorenza Rimassa, Lorenzo Fornaro, Sara Lonardi, Lorenzo Antonuzzo. Acquisition of data (acquired and managed patients): All authors. Analysis and interpretation of data: A. Casadei-Gardini, M. Rimini, Lorenza Rimassa, Lorenzo Fornaro, Sara Lonardi, Lorenzo Antonuzzo. Writing, review, and/or revision of the manuscript: A. Casadei-Gardini, M. Rimini, Lorenza Rimassa, Lorenzo Fornaro, Sara Lonardi, Lorenzo Antonuzzo. Final approval of manuscript: All authors.

Supplementary Information

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Rimini, M., Masi, G., Lonardi, S. et al. Durvalumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Biliary Tract Cancer: a Real-World Retrospective, Multicenter Study. Targ Oncol 19, 359–370 (2024). https://doi.org/10.1007/s11523-024-01060-1

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