Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display

1977 - Gabrinox: A phase I-II of nab-paclitaxel plus gemcitabine followed by folfirinox in metastatic pancreatic adenocarcinoma


08 Oct 2016


Poster Display


Eric Assenat


Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371


E. Assenat1, C. de la Fouchardiere2, C. Mollevi3, E. Samalin1, F. Portales1, F. Desseigne2, C. Carenco1, M. Dupuy4, E. Lopez-Martinez5, C. Fiess6, T. Mazard1, M. Ychou1

Author affiliations

  • 1 Digestive Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 2 Digestive Oncology, Centre Léon Bérard, Lyon/FR
  • 3 Biometrics Unit, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 4 Medical Oncology, Hopital Saint-Eloi (Montpellier), Montpellier/FR
  • 5 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 6 Clinical Research, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR


Abstract 1977


Folfirinox (FFX) and Nab-paclitaxel/Gemcitabine (AG) showed significant improvement in efficacy compared to Gemcitabine alone in metastatic pancreatic cancer (mPC). Alternating AG and FFX may overcome resistance to primary therapy and delay tumor progression. We designed a multicenter phase I-II trial with a new sequential regimen of AG followed by FFX in first-line treatment of mPC. The phase I primary objective was to determine the recommended AG and FFX doses. Primary endpoint was to determine the dose-limiting toxicities (DLTs). The phase II will assess the efficacy of the recommended doses.


AG and FFX were administered sequentially, each AG cycle followed by a FFX cycle. Dose-escalation was:

One cycle D1 = D57 AG (mg/m2) D1, D8, D15 FFX (mg/m2) D29, D43
Dose level Nab-paclitaxel Gemcitabine Oxaliplatin Irinotecan LV 5-FU
1 100 800 70 150
2a 100 800 85 180 Leucovorin: 200
2b 125 1000 70 150 5-FU bolus: 400
3 125 1000 85 180 5-FU infusion: 2400

Chemotherapeutic agents were administered according to standard practice, except for Gemcitabine (10mg/m2/min).


From September 2013 to October 2015, 33 mPC patients were included: 7, 6 and 7 patients in levels 1, 2a and 2b, respectively, and 13 in level 3. 31 patients were evaluable for tolerance (2 not evaluable at levels 1 and 2b). Patients' characteristics at baseline were: male 54.8%, median age 61 years (42-75), ECOG PS 0 (35.5%) or 1 (64.5%). Five DLTs were reported: 1, 2 and 2 in levels 2a, 2b and 3, respectively. All DLTs were grade 4 transient, asymptomatic neutropenia with spontaneous resolution. They occurred at treatment initiation, probably due to the absence of prophylactic GCSF treatment during AG administration. There was no limiting neurotoxicity. Promising efficacy results (response and survival) will be presented at the meeting.


This new regimen alternating AG and FFX shows acceptable toxicity and promising efficacy results. The recommended dose (level 3) is being confirmed in a 12 patient-expansion cohort before starting the phase II accrual.

Clinical trial identification


Legal entity responsible for the study

Institut régional du Cancer de Montpellier (ICM), France


This project was supported by Celgene.


E. Assenat: Honoraria: Ipsen, Novartis, Sanofi Consulting. Advisory Role: Ipsen. Research Funding: Bayer (Institution), Celgene (Institution). Travel, Accomodations, Expenses: Novartis, Celgene.

C. de la Fouchardiere: Consulting or Advisory Role: Bayer, Celgene Research. Funding: Roche/Genentech (Institution). Travel, Accomodations, Expenses: Ipsen, Bayer, Roche. E. Samalin: Honoraria: Lilly, Sanofi, Amgen, Roche. Consulting or Advisory Role: Amgen, Sanofi, Roche. Research funding: Bayer (institution). Travel, Accommodations, Expenses: Novartis, Lilly, Ipsen, Roche. F. Portales: Honoraria: Sanofi Consulting or Advisory Role: Sanofi. Research funding: Celgene (Institution). Travel, Accommodations, Expenses: Ipsen. T. Mazard: Honoraria: Amgen, Sanofi. Research funding: Roche, Parma AG (Institution). Travel, Accomodations, Expenses: Amgen. M. Ychou: Honoraria: Bayer, Merck-Serono, Roche/Genentech, Celgene. Consulting or Advisory Role: Bayer, Celgene, Roche. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings