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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

1229 - Exploratory analyses of 400 patients enrolled in 2 FFCD trials of first line treatment for metastatic pancreatic cancer

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Clinical Research

Tumour Site

Pancreatic Cancer

Presenters

Julien Taieb

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

J. Taieb1, J.M. Phelip2, Y. Rinaldi3, E. Barbier4, O. Bouche5, F. Khemissa Akouz6, A. Gratet7, C. Petorin8, L. Miglianico9, D. Malka10, H. Laharie Mineur11, C. Rebischung12, C. Lepage13, E. Francois14, L. Dahan15

Author affiliations

  • 1 Gastroenterology And Digestive Oncology Department, Georges Pompidou European Hospital, Sorbonne Paris Cité, Paris Descartes University, 75015 - Paris/FR
  • 2 Gastroenterology Department, CHU Nord, 42055 - St. Etienne/FR
  • 3 Gastroenterology Department, European Hospital, 13331 - MARSEILLE/FR
  • 4 Biostatistics, FFCD, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, 21079 - Dijon/FR
  • 5 Gastroenterology Department, Robert Debré Hospital, 51092 - Reims/FR
  • 6 Gastroenterology Department, Saint Jean Hospital, 66046 - Perpignan/FR
  • 7 Oncology Department, Clinique Pasteur, 31000 - Toulouse/FR
  • 8 Digestive Oncology Department, CHU Estaing, 63003 - Clermont-Ferrand/FR
  • 9 Oncology Department, Saint-Grégoire Private Hospital, 35760 - St. Grégoire/FR
  • 10 Gastroenterology Department, Gustave Roussy, 94800 - Villejuif/FR
  • 11 Gastroenterology Department, Clinique Tivoli Ducos, 33000 - Bordeaux/FR
  • 12 Gastroenterology Department, Daniel Hollard Institut, 38000 - Grenoble/FR
  • 13 Hepatogastroenterology And Digestive Oncology Department, University hospital Dijon, University of Burgundy and Franche Comté, EPICAD INSERM LNC-UMR 1231, 21079 - Dijon/FR
  • 14 Medical Oncology Department, Antoine Lacassagne Center, 6100 - Nice/FR
  • 15 Hepatogastroenterology And Oncology Department, CHU La Timone, 13385 - Marseille/FR
More

Resources

Abstract 1229

Background

Chemotherapy is effective in metastatic pancreatic ductal adenocarcinoma (mPDAC) but new approaches are still needed to improve patients (pts) survival and quality of life. We have here made exploratory analyses of 400 pts enrolled in 2 previously reported randomized phase II trials.

Methods

Chemotherapy-naive pts with proven mPDAC, bilirubin levels < 1.5 ULN and performance status (PS) 0-2 were randomized to receive either Gemcitabine + nab-paclitaxel (A: MPACT regimen), FOLFIRINOX (B: PRODIGE 4 regimen), FOLFIRINOX in a stop and go strategy with maintenance LV5FU2 at 4 months (C: PANOPTIMOX regimen), sequential gemcitabine for 2 mo, followed by FOLFIRI.3 (D: FIRGEM regimen) or sequential gemcitabine+nab-paclitaxel for 2 mo, followed by FOLFIRI.3 (E: FIRGEMAX regimen). mITT pts were defined as patients receiving at least one dose of treatment, preplanned per-protocol (PP) pts were defined as patients reaching 2 mo of treatment and analyzed considering the real treatment received.

Results

Between Jan 2015 and Nov 2016, 400 pts were enrolled in the 2 trials. Mean age was 63 (38-76), 56% were men, pts PS was 0/1/2 in 40/56/4%. Groups were comparable regarding baseline characteristics. Grade 3-4 toxicities (at least one event per pt) in arms A/B/C/D/E were 90/85/85/91/89% (p > 0.05), mainly gastrointestinal, hematological and neurological disorders. Efficacy results are summarized in the table.Table: 722P

Gem+ nab (n = 63)FOLFIRINOX (n = 91)PANOPTIMOX (n = 92)FIRGEM (n = 90)FIRGEMAX (n = 64)
mITT - ORR (%) (p#=0.11)2536342340
Median ITT - PFS (mo) (p*=0.12)4.26.35.74.55.7
Median PP - PFS (mo) (p*=0.05)6.07.77.56.37.6
Median ITT - OS (mo) (p*=0.09)11.310.111.27.311.6
Median PP - OS (mo) (p*=0.08)12.412.213.09.815.8
*

Overall Log-rank test # Chi2 test.

Conclusions

FOLFIRINOX seems confirmed as a reference treatment for mPDAC. These exploratory analyses show no major differences between the different treatment options offered in these 2 studies except for the FIRGEM sequential strategy that seems both in ITT and preplanned PP analyses less efficient than the other options. The addition of nab-paclitaxel to this sequential approach seems to dramatically improve patients’ oncological outcomes.

Clinical trial identification

NCT02352337 and NCT02827201.

Legal entity responsible for the study

FFCD.

Funding

Celgene.

Editorial Acknowledgement

Disclosure

J. Taieb: Consulting or advisory role: Roche, Merck KGaA, Amgen, Celgene, Lilly, Baxalta, Servier, Sirtex Medical; Speakers\' bureau: Amgen, Baxalta, Servier, Roche/Genentech, Sanofi, Merck, Lilly. J.M. Phelip: Consulting or advisory role: Roche, Merck, Amgen, Sanofi, Lilly, Bayer, Servier; Travel accommodations expenses: Roche, Merck, Amgen, Sanofi, Lilly, Bayer, Servier. O. Bouche: Consulting or advisory role: Roche, Merck, Amgen, Bayer; Speaker’s bureau: Lilly, Pierre Fabre, Novartis, Servier; Travel accomodations expenses: Lilly, Roche, Merck. F. Khemissa Akouz: Honoraria: Sanofi, Roche, Bayer; Speakers\' bureau: Sanofi, Roche; Travel accommodations expenses: Ipsen, Sanofi, Roche, Bayer. A. Gratet: Travel accommodations expenses: Novartis. L. Miglianico: Honoraria, Consulting or advisory role, Travel accommodations expenses: Pfizer, Merck,Pierre Fabre, Roche, Amgen, Bristol-Myers Squibb K.K. D. Malka: Consulting or advisory role: Roche, Sanofi, Merck Serono, MSD, Servier, Bayer, Incyte, Amgen; Travel, accommodations expenses: Roche, Bayer, Sanofi, Merck Serono, Amgen; Honoraria: Roche, Amgen, Bayer, Merck Serono, Servier, Sanofi. C. Lepage: Consulting or advisory role: Advanced Accelerator Applications; Travel accommodations, expenses: Amgen, Novartis, Ipsen, Bayer; Honoraria: Novartis. E. Francois: Consulting or advisory role: Roche, Merck Travel, accommodations, expenses: Roche, Merck, Servier. L. Dahan: Honoraria: Sanofi, Amgen. All other authors have declared no conflicts of interest.

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