Abstract 327P
Background
The purpose of this study was to evaluate the margin-negative (R0) resection rate in borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma (PDAC) after induction FOLFIRINOX followed by chemoradiation (CRT).
Methods
In this single-arm, phase 2 clinical trial, patients with locally advanced PDAC underwent CT scan, 18FDG PET-CT scan and staging laparoscopy to detect occult metastases prior to treatment. Patients received four cycles of FOLFIRINOX regimen. Patients without disease progression at restaging proceeded to long-course CRT with concurrent gemcitabine (600 mg/m2 weekly). Four weeks after completion of CRT, patients underwent re-staging. Surgery was considered for patients with technically resectable tumours. The primary objective was R0 resection rate with a prespecified alternate hypothesis of 55%. Secondary objectives included progression-free survival (PFS), overall survival (OS), local progression-free survival (LPFS), metastasis-free survival (MFS) and safety. The trial is registered as NCT05399394.
Results
A total of 65 patients were evaluated. Twenty-two patients (34.9%) were excluded due to evidence of metastatic disease, leaving a total of 40 patients enrolled. Surgical exploration was performed in 19 patients, all of whom underwent radical resection. R0 resection was achieved in all 19 of the 35 eligible patients (54.3%) (Figure 1). Median follow-up was 15.6 months (range, 8.5 to 72.9). Median OS and PFS in patients who completed CRT were 18.6 months and 13.5 months, respectively. OS, PFS, LPFS and MFS at one year were 87.6%, 59.3%, 81.5% and 69%, respectively. Additional survival data are shown in the table. Resected patients showed a significantly longer median OS compared to non-resected patients (28.2 months vs. 13.2 months, p=0.004). Median PFS for resected patients was 17.5 months compared to 9.5 months for unresected patients (p=0.001). Treatment-related grade 3-4 toxicities included piastrinopenia (29.4%), neutropenia (5.7%), nausea and vomiting (5.7%).
Conclusions
FOLFIRINOX followed by long-course CRT in borderline resectable and locally advanced unresectable PDAC resulted in high R0 resection rates and prolonged median PFS and OS.
Clinical trial identification
NCT05399394.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.