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. 2024 Sep;31(9):6147-6156.
doi: 10.1245/s10434-024-15579-0. Epub 2024 Jun 15.

Long-Duration Neoadjuvant Therapy with FOLFIRINOX Yields Favorable Outcomes for Patients Who Undergo Surgery for Pancreatic Cancer

Phoebe N Miller  1   2   3 , Fernanda Romero-Hernandez  1   2 , Lucia Calthorpe  1   2 , Jaeyun Jane Wang  1   2 , Sunhee S Kim  4 , Carlos U Corvera  1   2 , Kenzo Hirose  1   2 , Kimberly S Kirkwood  1   2 , Ryutaro Hirose  5 , Ajay V Maker  1   2 , Adnan A Alseidi  1   2 , Mohamed A Adam  1   2 , Grace E Kim  2   6 , Margaret A Tempero  2   7 , Andrew H Ko  2   7 , Eric K Nakakura  8   9
Affiliations

Long-Duration Neoadjuvant Therapy with FOLFIRINOX Yields Favorable Outcomes for Patients Who Undergo Surgery for Pancreatic Cancer

Phoebe N Miller et al. Ann Surg Oncol. 2024 Sep.

Abstract

Background: In 2023 alone, it's estimated that over 64,000 patients will be diagnosed with PDAC and more than 50,000 patients will die of the disease. Current guidelines recommend neoadjuvant therapy for patients with borderline resectable and locally advanced PDAC, and data is emerging on its role in resectable disease. Neoadjuvant chemotherapy may increase the number of patients able to receive complete chemotherapy regimens, increase the rate of microscopically tumor-free resection (R0) margin, and aide in identifying unfavorable tumor biology. To date, this is the largest study to examine surgical outcomes after long-duration neoadjuvant chemotherapy for PDAC.

Methods: Retrospective analysis of single-institution data.

Results: The routine use of long-duration therapy in our study (median cycles: FOLFIRINOX = 10; gemcitabine-based = 7) is unique. The majority (85%) of patients received FOLFIRINOX without radiation therapy; the R0 resection rate was 76%. Median OS was 41 months and did not differ significantly among patients with resectable, borderline-resectable, or locally advanced disease.

Conclusions: This study demonstrates that in patients who undergo surgical resection after receipt of long-duration neoadjuvant FOLFIRINOX therapy alone, survival outcomes are similar regardless of pretreatment resectability status and that favorable surgical outcomes can be attained.

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Conflict of interest statement

Margaret Tempero has held consultancy roles for Astellas Pharma Global Development Inc. (DSMC), AstraZeneca, Bio Ascend-B2ACT Therapeutics Genex, BioSapiens, ElmediX, Debiopharm, Geistlich Pharma, IPSEN Biopharma, Inc., Mirati Therapeutics Inc., Novartis Pharmaceuticals, Oncolytics, Global Bio Access Fund, SAB Peptomyc, S.L., and Geron Corporation; advisory board roles for BeiGene, Biotech Research, Boehringer Ingelheim, Global Bio Access Fund, Merus, and BMS; and served as a Scientific Advisor for Exact Sciences. Phoebe N. Miller, Fernanda Romero-Hernandez, Lucia Calthorpe, Jaeyun Jane Wang, Sunhee S. Kim, Carlos U. Corvera, Kenzo Hirose, Kimberly S. Kirkwood, Ryutaro Hirose, Ajay V. Maker, Adnan A. Alseidi, Mohamed A. Adam, Grace E. Kim, Andrew H. Ko, and Eric K. Nakakura have no conflicts of interest or funding to declare in relation to this work.

Figures

Fig. 1
Fig. 1
OS of patients who underwent neoadjuvant chemotherapy with and without radiation therapy. The median OS for the FOLFIRINOX groups was 41 months, whereas the median OS for the gemcitabine groups was not reached. OS overall survival
Fig. 2
Fig. 2
DFS of patients who underwent neoadjuvant chemotherapy with and without radiation therapy. The median DFS in the FOLFIRINOX groups was 38 months, whereas the median DFS for the gemcitabine groups was not reached. DFS disease-free survival
Fig. 3
Fig. 3
OS of patients who underwent FOLFIRINOX alone (no radiation therapy) stratified by resectability status. The median OS for patients with resectable, borderline resectable, and locally advanced disease was 37 months, 45 months, and 40 months, respectively. OS overall survival
Fig. 4
Fig. 4
DFS of patients who underwent FOLFIRINOX alone (no radiation therapy) stratified by resectability status. The median DFS for patients with resectable, borderline resectable, and locally advanced disease was 31 months, 41 months, and 30 months, respectively, and the relative hazard ratio was 1.1, 0.74, and 1.5 for resectable, borderline resectable, and locally advanced disease, respectively. DFS disease-free survival
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