Abstract 361P
Background
Pancreatic ductal adenocarcinoma (PDAC) first-line treatment has involved FOLFIRINOX or gemcitabine with nab-paclitaxel; the latter being more favoured due to toxicity profile. The evidence base from the ACCORD study for the utility of FOLFIRINOX relied on a relatively young, non-frail cohort. Modified oxaliplatin, irinotecan, 5-fluorouracil and leucovorin (m-FOLFIRINOX) has been shown to be tolerable in patients with ECOG 0-1 and less than 75 years old. The lack of data supportive of second-line chemotherapy choice is a challenge for clinicians, particularly in the elderly. We have previously reported on the use of m-FOLFIRINOX on 128 patients with PDAC without observed decreased efficacy or increase in adverse events.
Methods
We conducted a retrospective analysis using an electronic database of patients with locally advanced or metastatic PDAC who received second-line m-FOLFIRINOX between January 2013 and March 2023, with outcomes followed to March 2024. All patients had an ECOG performance status of 2 or less. Overall survival (OS) was calculated via the Kaplan-Meier method.
Results
140 patients were included in our analysis with 60% of these having metastatic disease at diagnosis. The median age of our study cohort was 63 years (range, 34 -85 years). The dosage of m-FOLFIRINOX was: 65% for oxaliplatin, 68% for irinotecan, 18% for bolus 5-fluorouracil (5-FU) and 68% for infusional 5-FU. Median OS was 20 months (95% CI, 17-23) with a range of 4-107 months. Within the metastatic cohort OS was 19 months (95% CI, 16-22). Within the locally advanced cohort OS was 28 months (95% CI, 22-34). The vast majority (98.5%) received gemcitabine and nab-paclitaxel as part of first-line regimen. Median maintained time on second line m-FOLFIRINOX was 4 months, with a range of 1-47 months.
Conclusions
This retrospective analysis of 140 patients in Western Australia - the largest reported series of mFOLFIRINOX as demonstrates the safety and efficacy of m-FOLFIRINOX as second-line agent following failure of gemcitabine and nab-paclitaxel in populations with locally advanced or metastatic PDAC. Formal phase three trials are required to further support our hypothesis.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Dean: Financial Interests, Invited Speaker, Speakers' Bureau: Juniper Biologics; Financial Interests, Other, Travel, accommodation, expenses: Servier. All other authors have declared no conflicts of interest.