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Modified FOLFIRINOX with or Without Stereotactic Body Radiation in Locally Advanced Unresectable Pancreatic Cancer
Changhoon Yoo1, Hyehyun Jeong2, Inkeun Park2
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. yooc@amc.seoul.kr.
Annals of Surgical Oncology
|May 7, 2026
Summary
Adding stereotactic body radiation therapy (SBRT) to modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) was feasible for locally advanced pancreatic cancer. While not improving median survival, it showed a trend toward better 1-year progression-free survival and local control.
Area of Science:
- Oncology
- Radiation Oncology
- Gastrointestinal Oncology
Background:
- Limited prospective data exist for stereotactic body radiation therapy (SBRT) combined with modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) in locally advanced unresectable pancreatic adenocarcinoma (PDAC).
- The SABER trial (NCT04986930) investigated the efficacy and safety of this combination therapy.
Purpose of the Study:
- To evaluate the feasibility and efficacy of adding SBRT to mFOLFIRINOX in patients with locally advanced unresectable PDAC.
- To compare 1-year progression-free survival (PFS) rates between patients receiving mFOLFIRINOX with or without SBRT.
Main Methods:
- An open-label, randomized, phase 2 study enrolled patients with locally advanced, unresectable PDAC suitable for SBRT.
- Participants were randomized to receive mFOLFIRINOX with or without SBRT (35 Gy in five fractions) within the first four cycles.
- The primary endpoint was the 1-year PFS rate.
Main Results:
- The study enrolled 37 of 92 planned patients and was terminated early due to slow accrual.
- Median PFS was 14.0 months with mFOLFIRINOX + SBRT versus 11.7 months with mFOLFIRINOX alone (HR 0.66; p=0.281).
- 1-year PFS rates were 66.7% versus 45.1%, respectively. Median overall survival (OS) was comparable (28.9 vs 28.1 months). Local progression rates were numerically lower with SBRT (11.1% vs 39.1%). Safety profiles were similar between groups.
Conclusions:
- SBRT combined with mFOLFIRINOX is feasible and safe for locally advanced unresectable PDAC.
- While not statistically improving median PFS or OS, the combination showed a trend towards improved 1-year PFS and local tumor control.
- Due to early trial closure and limited statistical power, these efficacy findings should be considered hypothesis-generating.
