Abstract 326P
Background
Neoadjuvant chemotherapy (NAC) may improve r-PDAC outcomes compared to upfront surgery and adjuvant therapy by allowing for chemosensitivity assessments, improved R0 resection rates, and avoiding nontherapeutic surgery. NeoPancONE a phase II, open-label, Canadian multicentre single arm study has completed accrual with planned clinical outcomes and potential biomarkers of NAC response in r-PDAC, defined by NCCN criteria, treated with perioperative mFFX.
Methods
We report feasibility 2nd endpoints of % completing NAC, % who undergo surgical resection and the feasibility of endoscopic ultrasound (EUS) fine needle biopsy (FNB) to detect biomarkers at diagnosis. Descriptive statistical methods were used. The primary endpoint, disease-free survival, according to baseline GATA6 expression, is expected in late 2024.
Results
146 screened and 84(58%) eligible accrued from 09/20-09/23 in 8 centres. In 62 deemed ineligible, 39 (63%) were recorded as borderline or unresectable at central radiological review (CRR). Baseline characteristics, NAC delivery, RECIST, surgery resection status and SAEs are summarized (Table). NAC associated SAEs include 3 neutropenic infection associated deaths occurring early in cycle 1 (2 x cholangitis, 1 x C. difficile). Table: 326P
| Characteristic n=84 | |
| Age, median (range) yrs | 64 (44, 83) |
| Gender, F/M n | 51/33 |
| Baseline EUS FNB tissue n (%) | 83 (98) |
| NAC completed 6 cycles n (%) | 62 (74) |
| Pre-op RECIST CR/PR/SD/PD/NE n | 1/15/53/5/10 |
| Surgery Completed Y/N n (%) | 73 (87)/11(13) |
| R0/R1 n (%) | 63 (86)/10 (14) |
| NAC associated SAE n (%) | 15 (18) |
Conclusions
High NAC completion and surgical resection rates are achieved, with an 86% R0 resectability rate. The screen failure rate with CRR highlights the challenges in selection and need for expert multidisciplinary review. Baseline EUS FNBs are feasible. The 3 early deaths presented in the setting of recent infection/stenting and should be preventable by protocol. In conclusion, it is feasible, with noted challenges, to conduct peri-operative r-PDAC with tissue collection. In future studies the optimization of biliary stenting and more careful selection is crucial to advance this approach.
Clinical trial identification
NCT044729100.
Legal entity responsible for the study
Ozmosis Research Inc. 65 Queen Street West Suite 2020, Toronto, ON M5H 2M5 Main Line: 416-634-8300 Direct Line: 416-634-8322 Fax: 416-598-4382.
Funding
Pancreatic Cancer Canada and The Princess Margaret Cancer Centre Foundation.
Disclosure
All authors have declared no conflicts of interest.