Activity and safety of NAB-FOLFIRI and NAB-FOLFOX as first-line treatment for metastatic pancreatic cancer (NabucCO study)

Elisa Giommoni, Evaristo Maiello, Vanja Vaccaro, Ermanno Rondini, Caterina Vivaldi, Giampaolo Tortora, Laura Toppo, Guido Giordano, Tiziana Pia Latiano, Cinzia Lamperini, Serena Pillozzi, Luca Boni, Lorenzo Antonuzzo, Francesco Di Costanzo

Research output: Contribution to journalArticlepeer-review


Background: Relevant improvement in first-line treatment of metastatic pancreatic cancer (mPC) was provided by FOLFIRINOX and by gemcitabine (gem) plus nab-paclitaxel (Nab-p) regi-mens. Regardless of the first-line treatment survival benefit, most patients survive less than 1 year. Aim: The objectives of this multicenter phase I/II study were to evaluate as first-line chemotherapy (CT) two modified regimens of FOLFIRINOX, replacing either oxaliplatin (Oxa) or irinotecan with Nab-p, in patients with mPC. Methods: The primary objectives of phase 1 were the definition of the dose limit binations, while for phase II they were the characterization of safety and activity of Nab-FOLFIRI and Nab-FOLFOX in mPC. Results: Sixty-three patients received Nab-FOLFIRI or Nab-FOLFOX in phase I. We defined MTD at 120 mg/m2 for Nab-p with FOLFIRI and 160 mg/m2 with FOLFOX. In phase II, we randomized 42 patients for each arm with the following results: (1) overall response rate (ORR) was 31% for both schedules; (2) a clinical benefit rate (CBR) of 69% and 71%; (3) 1-year survival was 41% and 50%; (4) progression free survival (PFS) was 6 months and 5.6 months; (5) median overall survival (OS) was 10.2 and 10.4 months for Nab-FOLFIRI and Nab-FOLFOX, respectively. (6) Neutropenia was the most common grade ≥3 adverse event in our reg-imens, significantly lower than that reported for the FOLFIRINOX triplet. Conclusion: Nab-FOLFIRI and Nab-FOLFOX might be hopeful first-line CT options for mPC patients, with promising activity and a good safety profile.

Original languageEnglish
Pages (from-to)1761-1772
Number of pages12
JournalCurrent Oncology
Issue number3
Publication statusPublished - Jun 2021


  • Dose finding
  • Metastatic pancreatic cancer
  • Nab-paclitaxel

ASJC Scopus subject areas

  • Oncology


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