Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer - The Randomized Multicenter Phase II NEPAFOX Trial

Sep 22, 2026

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Background. Although addition of adjuvant chemotherapy is standard, pancreatic cancer prognosis remains poor. The NEPAFOX trial assessed perioperative FOLFIRINOX in resectable pancreatic cancer. Patients and Methods. In this multicenter phase II study, patients without metastases were randomized to upfront surgery plus adjuvant gemcitabine or perioperative FOLFIRINOX. Results. Due to poor accrual, randomization stopped at 40. About three-quarters were primarily resectable. Partial responses to neoadjuvant FOLFIRINOX occurred in 3 of 12 evaluable patients; resection and toxicity were reported by arm. Conclusions. No safety concerns were seen for perioperative FOLFIRINOX; feasibility and potential effectiveness require further study in selected cohorts.

LanguageEnglish

CategoryHealthcare

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Abstract

Background

Patients and Methods

Results

Conclusions

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Ann Surg Oncol (2024) 31:4073–4083 [https://doi.org/10.1245/s10434-024-15011-7](https://doi.org/10.1245/s10434-024-15011-7) ORIGINAL ARTICLE – PANCREATIC TUMORS Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter Phase II NEPAFOX Trial Thorsten O. Goetze, MD, PhD1,2,3, Alexander Reichart, MD, PhD1, Ulli S. Bankstahl1, Claudia Pauligk, PhD3, Maria Loose, PhD3, Thomas W. Kraus, MD, PhD4, Moustafa Elshafei, MD, PhD4, Wolf O. Bechstein, MD, PhD5, Jörg Trojan, MD, PhD6, Matthias Behrend, MD, PhD7, Nils Homann, MD, PhD8, Marino Venerito, MD, PhD9, Wolfram Bohle, MD, PhD10,11, Michael Varvenne, MD, PhD12, Claus Bolling, MD, PhD13, Dirk M. Behringer, MD, PhD14, Karsten Kratz‑Albers, MD, PhD15, Gabriele M. Siegler, MD, PhD16, Wael Hozaeel, MD, PhD1, and Salah‑Eddin Al‑Batran, MD, PhD1,2,3 1Krankenhaus Nordwest, Institut für Klinisch Onkologische Forschchung IKF, University Cancer Center (UCT) Frankfurt, Frankfurt, Germany; 2University Cancer Center (UCT) Frankfurt, Goethe Universität, Frankfurt, Germany; 3Frankfurter Institut für Klinische Krebsforschung IKF am Krankenhaus Nordwest, Frankfurt, Germany; 4Krankenhaus Nordwest, Allgemein-, Viszeral-und Minimal Invasive Chirurgie, Frankfurt, Germany; 5Klinik für Allgemein- , Viszeral- , Transplantations-und Thoraxchirurgie, Universitätsklinikum Frankfurt, Frankfurt, Germany; 6Gastrointestinale Onkologie, Universitätsklinikum Frankfurt, Frankfurt, Germany; 7Viszeral- , Thorax-und Gefäßchirurgie, DONAUISAR Klinikum Deggendorf, Deggendorf, Germany; 8Medizinische Klinik II, Klinikum Wolfsburg, Wolfsburg, Germany; 9Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum Magdeburg, Magdeburg, Germany; 10Klinik für Gastroenterologie, Gastroenterologische Onkologie, Klinikum Stuttgart, Stuttgart, Germany; 11Hepatologie, Infektiologie und Pneumologie, Stuttgart, Germany; 12Onkologische Schwerpunktpraxis Celle, Celle, Germany; 13Hämatologie/Onkologie, Agaplesion Markus Krankenhaus, Frankfurt, Germany; 14Klinik für Hämatologie, Onkologie und Palliativmedizin, Augusta-Kranken-Anstalt Bochum, Bochum, Germany; 15Gemeinschaftspraxis für Hämatologie und Onkologie Münster, Münster, Germany; 16Klinikum Nürnberg Nord/Paracelsus Medizinische Privatuniversität, Medizinische Klinik, Hämatologie/Onkologie, Nürnberg, Germany ABSTRACT Background. Although addition of adjuvant chemotherapy is the current standard, the prognosis of pancreatic cancers still remains poor. The NEPAFOX trial evaluated perioperative treatment with FOLFIRINOX in resectable pancreatic cancer. Patients and Methods. This multicenter phase II trial randomized patients with resectable or borderline resectable pancreatic cancer without metastases into arm (A,) upfront surgery plus adjuvant gemcitabine, or arm (B,) perioperative © The Author(s) 2024 First Received: 31 August 2023 Accepted: 21 January 2024 Published online: 8 March 2024 T. O. Goetze, MD, PhD [e-mail: Goetze.thortsen@ikf-khnw.de](e-mail: Goetze.thortsen@ikf-khnw.de) FOLFIRINOX. The primary endpoint was overall survival (OS) . Results. Owing to poor accrual, recruitment was prematurely stopped after randomization of 40 of the planned 126 patients (A: 21, B: 19). Overall, approximately three-quarters were classified as primarily resectable (A: 16, B: 15), and the remaining patients were classified as borderline resectable (A: 5, B: 4) . Of the 12 evaluable patients, 3 achieved partial response under neoadjuvant FOLFIRINOX. Of the 21 patients in arm A and 19 patients in arm B, 17 and 7 underwent curative surgery, and R0-resection was achieved in 77% and 71%, respectively. Perioperative morbidity occurred in 72% in arm A and 46% in arm B, whereas non-surgical toxicity was comparable in both arms. Median RFS/PFS was almost doubled in arm B (14.1 months) compared with arm A (8.4 months) in the population with surgical resection, whereas median OS was comp

FAQs

What was the NEPAFOX trial evaluating in resectable pancreatic cancer?

The NEPAFOX trial evaluated perioperative treatment with FOLFIRINOX compared with upfront surgery plus adjuvant gemcitabine in patients without metastases.

Why was the trial stopped earlier than planned?

Recruitment was prematurely stopped due to poor accrual, after randomization of 40 patients instead of the planned 126.

What were the main findings regarding safety and effectiveness?

No safety issues related to surgical complications were observed in the perioperative FOLFIRINOX arm. Median RFS/PFS was higher in the perioperative FOLFIRINOX arm among surgically resected patients, while median OS was comparable between arms.

Sep 22, 2026

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