Abstract A87: Preliminary results of a phase II study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer.

4128 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.

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Neonax: Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer: A Phase II Study of the Aio Pancreatic Cancer Group

Annals of Oncology ◽

10.1093/annonc/mdu165.122 ◽

2014 ◽

Vol 25 ◽

pp. ii52

Author(s):

Ettrich Thomas ◽

Berger Andreas ◽

Muche Rainer ◽

Lutz Manfred ◽

Prasnikar Nicole ◽

...

Keyword(s):

Pancreatic Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Resectable Pancreatic Cancer ◽

Cancer Group

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Neonax (AIO-PAK-0313): Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer: A phase II study of the AIO Pancreatic Cancer Group.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.tps497 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. TPS497-TPS497 ◽

Cited By ~ 1

Author(s):

Thomas Jens Ettrich ◽

Andreas W. Berger ◽

Rainer Muche ◽

Manfred P. Lutz ◽

Nicole Prasnikar ◽

...

Keyword(s):

Pancreatic Cancer ◽

Clinical Trial ◽

Phase Ii ◽

Tumor Tissue ◽

Phase Ii Study ◽

Phase Iii ◽

Tumor Surgery ◽

Resectable Pancreatic Cancer ◽

Post Surgery ◽

Clinical Trial Information

TPS497 Background: 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. Start of trial will be in IV/2014 in 20 high-volume centers for pancreatic surgery in Germany. Clinical trial information: NCT02047513. Clinical trial information: NCT02047513.

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FOLFIRINOX (F-NOX) followed by individualized radiation for borderline-resectable pancreatic cancer: Preliminary toxicity and R0 resection rates from a prospective phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.368 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 368-368 ◽

Cited By ~ 1

Author(s):

Janet E. Murphy ◽

Jennifer Yon-Li Wo ◽

David P. Ryan ◽

Wenqing Jiang ◽

Beow Y. Yeap ◽

...

Keyword(s):

Pancreatic Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Lung Metastases ◽

R0 Resection ◽

Resection Rate ◽

Resectable Pancreatic Cancer ◽

Borderline Resectable ◽

Borderline Resectable Pancreatic Cancer ◽

Short Course

368 Background: F-NOX has been increasingly utilized in borderline resectable pancreatic cancer (BRPC) due to the improved response rate compared to gemcitabine. However, prospective data remains limited, with the largest series being a 22 patient (pt) cooperative group trial (Alliance A021101), in which 14 pts had R0 resection. In this study, we evaluate neoadjuvant F-NOX followed by individualized chemoradiation (CRT) for BRPC. Methods: Pts ECOG PS 0-1 with biopsy-proven BRPC as defined by NCCN criteria (SMV/PV involvement with suitable flow, abutment of SMA < 180 degrees or of hepatic artery) were enrolled in a single institution, NCI-sponsored phase II study (NCT01591733). Pts received F-NOX for 8 cycles. If after chemotherapy, the tumor was radiographically resectable, pts received short course CRT in 5 (protons 25 GyE) or 10 fractions (photons 30 Gy) with capecitabine 825 mg/m2 bid. If the tumor was still abutting vasculature, pts received CRT to 50.4 Gy with a vascular boost to 58.8 Gy. The primary endpoint of the study was R0 resection rate. Results: 50 pts were enrolled from 8/2012 to 8/2016. One pt was ineligible (lung metastases) and 1 pt is still on treatment, thus 48 patients were evaluable for this analysis. Median age was 62y (46-74). Median tumor size was 37 mm (21-56). Tumor location was in the head of pancreas for 36 (75%) pts. Of the evaluable pts, 40 (83%) completed therapy. Reasons for not completing therapy included pt withdrawal (3), physician decision (3), unacceptable toxicity (1) and progression (1). Grade 3 or greater toxicity occurred in 21 (44%) pts, including diarrhea (6, 12%), febrile neutropenia (4, 8.5%), neutropenia (4, 8.5%), elevated AST/ALT (3, 6.2%), thrombocytopenia (2, 4.2%), anemia (2, 4.2%), elevated alkaline phosphatase (2, 4.2%). 27 (56%) had short course CRT, while 13 (27%) had long course CRT. In evaluable pts, R0 resection rate was 28/40 (58%). Conclusions: Preoperative F-NOX followed by individualized chemoradiation results in a high R0 resection rate. Final results including PFS outcomes on the entire cohort will be presented at the meeting. Clinical trial information: NCT01591733.

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