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Clinical Studies

Survival after neoadjuvant and induction FOLFIRINOX versus gemcitabine-nab-paclitaxel in patients with resected localised pancreatic adenocarcinoma: an international multicentre study

British Journal of Cancer volume 133, pages 76–84 (2025)Cite this article

Subjects

Abstract

Background

It remains unclear whether there is a difference in overall survival (OS) benefit between (m)FOLFIRINOX and gemcitabine-nab-paclitaxel as preoperative regimens for localised pancreatic adenocarcinoma. This study aimed to investigate the outcome of patients with resected localised pancreatic adenocarcinoma following (m)FOLFIRINOX versus gemcitabine-nab-paclitaxel.

Methods

International multicentre retrospective study (16 centres, 8 countries, 3 continents), including consecutive patients after pancreatic resection for localised pancreatic adenocarcinoma following 2–6 months preoperative (m)FOLFIRINOX or gemcitabine-nab-paclitaxel (2010–2018). Primary endpoint was OS from start of preoperative chemotherapy. Cox regression analysis was performed to investigate the association of the preoperative chemotherapy regimen with OS, adjusted for confounders at diagnosis.

Results

Overall, 935 patients were included after resection of localised pancreatic adenocarcinoma following preoperative (m)FOLFIRINOX (65%) or gemcitabine-nab-paclitaxel (35%). Preoperative chemotherapy regimen (m)FOLFIRINOX was not associated with OS (HR = 0.83 [95% CI 0.64–1.08]), compared to gemcitabine-nab-paclitaxel. Interaction analysis showed stronger effect of (m)FOLFIRINOX in patients with a lower (i.e., non-elevated/marginally elevated) serum CA19-9 at diagnosis (pinteraction = 0.032).

Conclusion

This international study found no OS benefit of preoperative (m)FOLFIRINOX in patients with resected localised pancreatic adenocarcinoma compared to gemcitabine-nab-paclitaxel.

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Fig. 1: Survival.
Fig. 2: Strength of association of parameters with overall survival.
Fig. 3: Forest plot of the association of preoperative chemotherapy regimen on mortality in subgroups.

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Data availability

The datasets generated during and/or analysed during the current study are not publicly available due to the fact that de-identified data from each participating centres is confidentially shared with the leading institution (University of Colorado), but are available from the corresponding author on reasonable request if all participating centres agree.

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Author information

Author notes

  1. These authors contributed equally: Thomas F. Stoop, Y. H. Andrew Wu, Atsushi Oba.

  2. These authors jointly supervised this work: Richard A. Burkhart, Johanna W. Wilmink, Marco Del Chiaro.

Authors and Affiliations

  1. Division of Surgical Oncology, Department of Surgery, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA

    Thomas F. Stoop, Y. H. Andrew Wu, Atsushi Oba, Salvador Rodriguez Franco, Sohei Satoi, Richard D. Schulick, Marco Del Chiaro, Marco Del Chiaro, Oskar Franklin, Hiroyuki Ishida & Toshitaka Sugawara

  2. Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands

    Thomas F. Stoop, Isabel M. Feld, Ammar A. Javed, Marc G. Besselink, Boris V. Janssen & Olivier R. Busch

  3. Cancer Center Amsterdam, Amsterdam, The Netherlands

    Thomas F. Stoop, Mahsoem Ali, Isabel M. Feld, Ammar A. Javed, Geert Kazemier, Marc G. Besselink, Johanna W. Wilmink, Boris V. Janssen & Olivier R. Busch

  4. Division of Hepatobiliary and Pancreatic Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Y. H. Andrew Wu, Ammar A. Javed, Elisabetta Sereni, Vismaya Bachu, William R. Burns, Zohra Aslami, Jin He & Richard A. Burkhart

  5. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, USA

    Y. H. Andrew Wu, Ammar A. Javed, Elisabetta Sereni, Vismaya Bachu, William R. Burns, Zohra Aslami, Jin He & Richard A. Burkhart

  6. Department of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan

    Atsushi Oba, Keiichi Akahoshi, Minoru Tanabe, Hiroyuki Ishida & Toshitaka Sugawara

  7. Department of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital Japanese Foundation for Cancer Research, Ariake, Tokyo, Japan

    Atsushi Oba, Yuta Ushida, Yosuke Inoue & Yu Takahashi

  8. Amsterdam UMC, Location Vrije Universiteit, Department of Surgery, Amsterdam, The Netherlands

    Mahsoem Ali & Geert Kazemier

  9. Clinical Trials of Office, Department of Surgery, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA

    Mohammed H. Al-Musawi

  10. Division of Surgical Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

    Ajay Jain & Braden N. Miller

  11. Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, Tokyo, Japan

    Akio Saiura & Hirofumi Ishida

  12. Department of HPB Surgery and Liver Transplantation, Hôpital Beaujon, University Paris Cité, INSERM Unité Mixte de Recherche 1149, Clichy, France

    Alain Sauvanet, Jeanne Dembinski & Safi Dokmak

  13. Dipartimento di Chirurgia Sapienza Università di Roma, Rome, Italy

    Alessandro Coppola

  14. Division of Surgical Oncology, Department of Surgery, New York University Medical Center, New York City, NY, USA

    Ammar A. Javed

  15. Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands

    Bas Groot Koerkamp, Jacob L. van Dam, Jacob L. van Dam & Roeland F. de Wilde

  16. Department of Surgery, Kansai Medical University, Osaka, Japan

    Daisuke Hashimoto & Sohei Satoi

  17. Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy

    Damiano Caputo

  18. Research Unit of General Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Rome, Italy

    Damiano Caputo

  19. Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway

    Dyre Kleive & Knut J. Labori

  20. Department of General and Pancreatic Surgery, The Pancreas Institute University of Verona, Hospital Trust, Verona, Italy

    Elisabetta Sereni

  21. Pancreatic Surgery, IRCCS San Raffaele Hospital, Vita-Salute University, Milano, Italy

    Giulio Belfiori, Massimo Falconi & Stefano Crippa

  22. Hepato-Pancreato-Biliary Unit, Department of Surgery, University Hospitals of Birmingham, Birmingham, UK

    Keith J. Roberts, Nikolaos Chatzizacharias & Rupaly Pande

  23. Department of Gastroenterological Surgery II, Hokkaido University, Faculty of Medicine, Hokkaido, Japan

    Kimitaka Tanaka, Satoshi Hirano, Tomohisa Yamamoto & Toru Nakamura

  24. Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA

    Michael G. House & Trang K. Nguyen

  25. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan

    Motokazu Sugimoto & Naoto Gotohda

  26. Department of Surgery and Transplantation, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

    Paul S. Krohn & Stefan K. Burgdorf

  27. Division of Medical Oncology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA

    Wells Messersmith

  28. Amsterdam UMC, Location University of Amsterdam, Department of Medical Oncology, Amsterdam, The Netherlands

    Johanna W. Wilmink

  29. Amsterdam UMC, Location University of Amsterdam, Department of Pathology, Amsterdam, The Netherlands

    Boris V. Janssen

  30. Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden

    Oskar Franklin

Authors
  1. Thomas F. Stoop
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  2. Y. H. Andrew Wu
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  3. Atsushi Oba
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  4. Mahsoem Ali
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  5. Isabel M. Feld
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  6. Mohammed H. Al-Musawi
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  7. Ajay Jain
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  8. Akio Saiura
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  9. Alain Sauvanet
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  10. Alessandro Coppola
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  11. Ammar A. Javed
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  12. Bas Groot Koerkamp
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  13. Braden N. Miller
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  14. Daisuke Hashimoto
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  15. Damiano Caputo
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  16. Dyre Kleive
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  17. Elisabetta Sereni
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  18. Geert Kazemier
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  19. Giulio Belfiori
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  20. Hirofumi Ishida
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  21. Jacob L. van Dam
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  22. Jeanne Dembinski
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  23. Keiichi Akahoshi
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  24. Keith J. Roberts
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  25. Kimitaka Tanaka
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  26. Knut J. Labori
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  27. Massimo Falconi
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  28. Michael G. House
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  29. Motokazu Sugimoto
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  30. Minoru Tanabe
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  31. Naoto Gotohda
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  32. Nikolaos Chatzizacharias
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  33. Paul S. Krohn
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  34. Safi Dokmak
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  35. Salvador Rodriguez Franco
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  36. Satoshi Hirano
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  37. Stefan K. Burgdorf
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  38. Stefano Crippa
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  39. Sohei Satoi
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  40. Trang K. Nguyen
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  41. Tomohisa Yamamoto
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  42. Toru Nakamura
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  43. Yuta Ushida
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Consortia

on behalf of the International Consortium on Pancreatic Cancer Surgery and Oncology (ICON)

  • Thomas F. Stoop
  • , Y. H. Andrew Wu
  • , Atsushi Oba
  • , Mahsoem Ali
  • , Isabel M. Feld
  • , Mohammed H. Al-Musawi
  • , Ajay Jain
  • , Akio Saiura
  • , Alain Sauvanet
  • , Alessandro Coppola
  • , Ammar A. Javed
  • , Bas Groot Koerkamp
  • , Braden N. Miller
  • , Daisuke Hashimoto
  • , Damiano Caputo
  • , Dyre Kleive
  • , Elisabetta Sereni
  • , Geert Kazemier
  • , Giulio Belfiori
  • , Hirofumi Ishida
  • , Jacob L. van Dam
  • , Jeanne Dembinski
  • , Keiichi Akahoshi
  • , Keith J. Roberts
  • , Kimitaka Tanaka
  • , Knut J. Labori
  • , Massimo Falconi
  • , Michael G. House
  • , Motokazu Sugimoto
  • , Minoru Tanabe
  • , Naoto Gotohda
  • , Nikolaos Chatzizacharias
  • , Paul S. Krohn
  • , Safi Dokmak
  • , Salvador Rodriguez Franco
  • , Satoshi Hirano
  • , Stefan K. Burgdorf
  • , Stefano Crippa
  • , Sohei Satoi
  • , Trang K. Nguyen
  • , Tomohisa Yamamoto
  • , Toru Nakamura
  • , Yuta Ushida
  • , Vismaya Bachu
  • , William R. Burns
  • , Yosuke Inoue
  • , Yu Takahashi
  • , Zohra Aslami
  • , Richard D. Schulick
  • , Jin He
  • , Wells Messersmith
  • , Marc G. Besselink
  • , Richard A. Burkhart
  • , Johanna W. Wilmink
  • , Marco Del Chiaro
  • , Boris V. Janssen
  • , Rupaly Pande
  • , Oskar Franklin
  • , Olivier R. Busch
  • , Hiroyuki Ishida
  • , Toshitaka Sugawara
  •  & Roeland F. de Wilde

Contributions

TFS: conception of project, data analysis, interpretation of results, writing the manuscript; YHAW: conception of project, interpretation of results, writing the manuscript, revised the manuscript, approved the final version; AO: conception of project, acquired data, interpretation of results, revised the manuscript, approved the final version; MA: conception of project, data analysis, interpretation of results, writing the manuscript, revised the manuscript, approved the final version; IMF: acquired data, data analysis; interpretation of results, revised the manuscript, approved the final version; MHAM: acquired data, revised the manuscript, approved the final version; AJ: conception of project, acquired data, revised the manuscript, approved the final version; AS: conception of project, revised the manuscript, approved the final version; AS: conception of project, revised the manuscript, approved the final version; AC: conception of project, acquired data, revised the manuscript, approved the final version; AAJ: acquired data, revised the manuscript, approved the final version; BGK: conception of project, revised the manuscript, approved the final version; BNM: acquired data, revised the manuscript, approved the final version; DC: conception of project, acquired data, revised the manuscript, approved the final version; DK: conception of project, acquired data, revised the manuscript, approved the final version; ES: acquired data, revised the manuscript, approved the final version; GK: conception of project, revised the manuscript, approved the final version; GB: conception of project, acquired data, revised the manuscript, approved the final version; HI: conception of project, acquired data, revised the manuscript, approved the final version; JLvD: conception of project, acquired data, revised the manuscript, approved the final version; JD: conception of project, acquired data, revised the manuscript, approved the final version; KA: conception of project, acquired data, revised the manuscript, approved the final version; KJR: conception of project, revised the manuscript, approved the final version; KT: conception of project, acquired data, revised the manuscript, approved the final version; KJL: conception of project, acquired data, revised the manuscript, approved the final version; MF: conception of project, revised the manuscript, approved the final version; MGH: conception of project, revised the manuscript, approved the final version; MS: conception of project, acquired data, revised the manuscript, approved the final version; MT: conception of project, acquired data, revised the manuscript, approved the final version; NG: conception of project, acquired data, revised the manuscript, approved the final version; NC: conception of project, revised the manuscript, approved the final version; PSK: conception of project, revised the manuscript, approved the final version; SD: conception of project, revised the manuscript, approved the final version; SRF: conception of project, acquired data, revised the manuscript, approved the final version; SH: conception of project, revised the manuscript, approved the final version; SKB: conception of project, acquired data, revised the manuscript, approved the final version; SC: conception of project, acquired data, revised the manuscript, approved the final version; SS: conception of project, acquired data, revised the manuscript, approved the final version; DH: acquired data, revised the manuscript, approved the final version; TKN: acquired data, revised the manuscript, approved the final version; TY: conception of project, acquired data, revised the manuscript, approved the final version; TN: conception of project, acquired data, revised the manuscript, approved the final version; YU: conception of project, acquired data, revised the manuscript, approved the final version; VB: acquired data, revised the manuscript, approved the final version; WRB: conception of project, revised the manuscript, approved the final version; YI: conception of project, revised the manuscript, approved the final version; YT: conception of project, revised the manuscript, approved the final version; ZA: acquired data, revised the manuscript, approved the final version; RDS: conception of project, revised the manuscript, approved the final version; JH: conception of project, revised the manuscript, approved the final version; WM: conception of project, revised the manuscript, approved the final version; MGB: conception of project, revised the manuscript, approved the final version, supervision; RAB: conception of project, revised the manuscript, approved the final version, supervision; JWW: conception of project, revised the manuscript, approved the final version, supervision; MDC: conception of project, revised the manuscript, approved the final version, supervision. All coauthors meet the following criteria: 1. Conceived and/or designed the work that led to the submission, acquired data, and/or played an important role in interpreting the results. 2. Drafted or revised the manuscript. 3. Approved the final version. 4. Agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Thomas F. Stoop.

Ethics declarations

Competing interests

MDC has been awarded with an industry grant (Haemonetics, Inc) to conduct a multicenter study to evaluate the prognostic implications of TEG in pancreatic cancer. MDC is co-principal investigator of a Boston Scientific sponsored international multicenter study on the use of intraoperative pancreatoscopy of patients with IPMN. TFS, JWW, and MGB received two grants from Dutch Cancer Society (KWF) and Deltaplan Alvleesklierkanker for the Dutch PREOPANC-4 project on the multidisciplinary management of LAPC. TFS is granted by the Cultuurfonds (Jan de Ruijsscher/Pia Huisman Fonds) and Cancer Center Amsterdam. AO has been awarded with a grant (Bayer Yakuhin, Ltd.) to conduct an observation study to investigate the clinical impact of EOB-MRI. SS discloses receipt of research funding from Nihon Servier, Boston Scientific, and Amino-up co.jp. JWW received research grants from Servier, Nordic, and MSD.

Ethics approval and consent to participate

The study procedures were reviewed and approved by the Colorado Multiple Institutional Review Board (COMIRB) (protocol #19-2972) at the University of Colorado. The need for informed consent was waived because of the retrospective nature of this study. A previously created dataset was used to identify patients for this study [31].

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Stoop, T.F., Wu, Y.H.A., Oba, A. et al. Survival after neoadjuvant and induction FOLFIRINOX versus gemcitabine-nab-paclitaxel in patients with resected localised pancreatic adenocarcinoma: an international multicentre study. Br J Cancer 133, 76–84 (2025). https://doi.org/10.1038/s41416-025-03025-1

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