2019 ASCO Annual Meeting!
Session: Gastrointestinal (Noncolorectal) Cancer
Type: Poster Session
Time: Monday June 3, 8:00 AM to 11:00 AM
Location: Hall A
NEONAX trial: Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer, a phase II study of the AIO pancreatic cancer group (AIO-PAK-0313)—Safety interim analysis.
Gastrointestinal (Noncolorectal) Cancer
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #233)
J Clin Oncol 37, 2019 (suppl; abstr 4128)
Author(s): Waldemar Uhl, Thomas Jens Ettrich, Anke C. Reinacher-Schick, Hana Algül, Helmut Friess, Marko Kornmann, Alexander Koenig, Michael Ghadimi, Uwe A Wittel, Eike Gallmeier, Kai Wille, Michael Geissler, Carl Christoph Schimanski, Nicole Prasnikar, Andrea Tannapfel, Lukas Perkhofer, Andreas W. Berger, Thomas Seufferlein; Ruhr-University Bochum, St. Josef Hospital, Bochum, Germany; Ulm University Hospital, Ulm, Germany; Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich, Germany; Technical University Munich, Klinikum rechts der Isar, Surgical Clinic and Policlinic, Munich, Germany; Ulm University Hospital, Department of Surgery, Ulm, Germany; Department of Gastroenterology and Gastrointestinal Oncology, University Medical Center Goettingen, Göttingen, Germany; General, Visceral, and Pediatric Surgery, University Medical Center Goettingen, Göttingen, Germany; General and Visceral Surgery, University Medical Center Freiburg, Freiburg, Germany; Philipps University Marburg, Department of Gastroenterology and Endocrinology, Marburg, Germany; University Hospital Ruhr-University-Bochum, Minden, Germany; Klinikum Esslingen, Department of Internal Medicine, Oncology/Hematology, Gastroenterology, Esslingen, Germany; Klinikum Darmstadt GmbH and Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Darmstadt and Mainz, Germany; Asklepios Klinik Barmbek, Hamburg, Germany; Ruhr-University Bochum, Department of Pathology, Bochum, Germany; Vivantes Klinikum im Friedrichshain, Berlin, Germany; Department of Medicine I, Hospital of the University Ulm, Ulm, Germany
Background: Survival in pancreatic cancer (PDAC) is still poor even after curatively intended resection. Perioperative treatment approaches improve outcome in various tumor entities. Data on perioperative treatment in resectable PDAC are limited and there is a debate whether neoadjuvant treatment might impair subsequent surgery by adding perioperative morbidity or mortality. Methods: NEONAX is a randomized phase II study (planned 166 patients) of perioperative gemcitabine/nab-paclitaxel (Arm A: 2 pre- and 4 post-operative cycles, Arm B: 6 cycles adjuvant) for patients with primarily resectable PDAC. Primary objective is DFS at 18 months after randomization. Secondary objectives are 3-year OS-rate and DFS-rate, progression during neoadjuvant therapy, R0/R1 resection rate and QoL. Results: NEONAX was initiated in March 2015 in 26 centers for PDAC surgery in Germany. The data represent the safety interim analysis (IA) of the first 48 patients. 25 patients were randomized to Arm A and 23 to Arm B. Patients’ median age was 65.3 years (56.3% males, 43.8% females, 85.4% ECOG 0). Out of 25 patients in Arm A 20 patients (80%) underwent surgery, compared to 21 of 23 patients (91.3%) in Arm B with upfront surgery. Reasons for no resection were intraoperatively determined small liver metastases (2 cases, Arm A), withdrawal of informed consent (2 cases in each arm) and 1 patient with uncontrolled cholestasis (arm A). Postoperative complications occurred in 45% of arm A and 42.8% of arm B. (pancreatic fistula: 15% in arm A and 9.5% in arm B, infections: 10% in arm A and 9.5% in arm B) All resected patients were alive 60 days after surgery. At least 1 adverse event (AE) NCI-CTCAE ≥ grade 3 occurred in 60% of the perioperative and 39.1% of adjuvant treatment arm. Most common AEs were neutropenia (16.7%), fatigue (10.4%) and infections (10.4%). Conclusions: There was an increase in NCI-CTCAE ≥ grade 3 events in the perioperative arm, but this was manageable and did not result in increased peri- or postoperative mortality. 8% of patients in the perioperative arm did not get resected due metastases detectable during surgery, but not on preoperative imaging immediately prior to surgery. Therefore, it cannot be determined whether these metastases were preexistent or developed during neoadjuvant treatment. In conclusion, the first interim analysis of the NEONAX trial shows that this protocol can be safely applied to patients with resectable PDAC in a perioperative setting. Clinical trial information: NCT02047513