Activity and Safety of NAB-FOLFIRI and NAB-FOLFOX as First-Line Treatment for metastatic Pancreatic Cancer (NabucCO Study)

Current Oncology

Luca Boni¹  Caterina Vivaldi²  Laura Toppo³  Giampaolo Tortora⁴  Cinzia Lamperini⁵  Elisa Giommoni⁵  Serena Pillozzi⁵  Francesco Di Costanzo⁵  Lorenzo Antonuzzo⁵  Evaristo Maiello⁶  Tiziana Pia Latiano⁶  Vanja Vaccaro⁷  Ermanno Rondini⁸  Guido Giordano⁹ 

[1] Clinical Trial Coordinating Center, Careggi University Hospital, 50134 Florence, Italy;Medical Oncology Unit 2, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy;Medical Oncology Unit, ASST Cremona, 26100 Cremona, Italy;Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, Italy;Medical Oncology Unit, Careggi University Hospital, 50134 Florence, Italy;Medical Oncology Unit, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy;Medical Oncology Unit, Istituto Nazionale Tumori Regina Elena, 00144 Roma, Italy;Oncology Unit, Ospedale Santa Maria Nuova—IRCCS, 42100 Reggio Emilia, Italy;Oncology Unit, Ospedale “Sacro Cuore di Gesù” Fatebenefratelli, 82100 Benevento, Italy;

关键词: metastatic pancreatic cancer;    nab-paclitaxel;    FOLFIRINOX;    dose finding;   

DOI  :  10.3390/curroncol28030164

来源: DOAJ

【 摘 要 】

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) regimens. 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 regimens, 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.

【 授权许可】

Unknown