P-0126 - Neonax: Neoadjuvant plus adjuvant or only adjuvant nab-Paclitaxel plus gemcitabine for resectable pancreatic cancer: A phase II study of the AIO pan...

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Thomas Ettrich
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors T. Ettrich1, A. Berger2, R. Muche3, M. Lutz4, N. Prasnikar5, W. Uhl6, A. Tannapfel7, V. Heinemann8, T. Seufferlein2
  • 1Department Of Internal Medicine I, University of Ulm, Ulm/DE
  • 2Department of Internal Medicine I, University of Ulm, Ulm/DE
  • 3Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm/DE
  • 4Caritasklinik St. Theresa, Saarbruecken/DE
  • 5Klinikum Ludwigsburg, Ludwigsburg/DE
  • 6Department of Surgery, Ruhr University Bochum, Bochum/DE
  • 7Department of Pathology, Ruhr-University Bochum, Bochum/DE
  • 8Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians University of Munich, Munich/DE

Abstract

Introduction

Resectable pancreatic cancer still has an unfavourable prognosis. Neoadjuvant or perioperative therapies might improve the prognosis of these patients. Recently, two phase III trials demonstrated for the first time, a substantial improvement in overall response, PFS and OS in patients with metastatic pancreatic cancer compared to standard gemcitabine (FOLFIRINOX and nab-paclitaxel/gemcitabine). The combination of nab-paclitaxel/gemcitabine has a more favourable toxicity profile compared to the FOLFIRINOX protocol and appears applicable in a perioperative setting.

Methods

NEONAX is a study for patients (to be enrolled: n = 166) with resectable ductal adenocarcinoma of the pancreas ≤ T3 in two arms: Arm A (perioperative arm): 2 cycles nab-paclitaxel (125 mg/m2)/gemcitabine (1000 mg/m2, d1, 8 and 15 of an 28 day-cycle) – tumor surgery – 4 cycles nab-paclitaxel/gemcitabine, Arm B (adjuvant only arm): tumor surgery – 6 cycles nab-paclitaxel/gemcitabine. NEONAX is an interventional, prospective, randomized, controlled, open label, two sided phase II study with an unconnected analysis of the results in both experimental arms against a fixed survival probability (38% at 18 month with adjuvant gemcitabine). The randomization (1:1) is eminent to achieve two comparable patient groups. Primary objective is DFS at 18 months after randomization. Key secondary objectives are 3-year OS and DFS, progression during neoadjuvant therapy and QoL. In the perioperative group tumor tissue will be collected prior to and post-surgery and subjected to microdissection and exome sequencing of tumor tissue. Tumor regression will be assessed both in the perioperative and the adjuvant group, respectively. In addition, circulating tumor-DNA will be analyzed in patients with the best and the worst responses to the neoadjuvant treatment.

Conclusion

Start of trial will be in III/2014 in 20 high-volume centers for pancreatic surgery in Germany. (Trial identifier: NCT02047513).