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Published on: January 3, 2020
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.
Background:
Prospective data on stereotactic body radiation therapy (SBRT) combined with modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) in patients with locally advanced unresectable pancreatic adenocarcinoma (PDAC) are limited.
Patients And Methods:
The SABER trial was an open-label, randomized, phase 2 study. Patients with locally advanced, unresectable PDAC were eligible if they were suitable for SBRT with adherence to organ-at-risk constraints. Participants were randomized (1:1) to receive mFOLFIRINOX with or without SBRT. SBRT (35 Gy in five fractions) was administered within the first four cycles of mFOLFIRINOX. The primary endpoint was 1-year progression-free survival (PFS) rate.
Results:
Between September 2021 and January 2024, 37 out of a planned 92 patients were enrolled (18 in the mFOLFIRINOX+SBRT group; 19 in the mFOLFIRINOX group); the study was terminated early due to slow accrual. SBRT was delivered to 17 (94.4%) of 18 patients. After a median follow-up of 33.3 months (90% confidence interval [CI], 28.7-40.3), median PFS was 14.0 months with mFOLFIRINOX + SBRT and 11.7 months with mFOLFIRINOX alone (hazard ratio [HR] 0.66; 90% CI 0.35-1.25; p = 0.281); 1-year PFS was 66.7% versus 45.1%, respectively. Median OS was 28.9 versus 28.1 months (HR 0.80; 90% CI 0.38-1.68; p = 0.619), respectively. The rates of 1-year cumulative local and distant progression were 11.1% versus 39.1% (p = 0.096) and 22.2% versus 27.4% (p = 0.596), respectively. Safety profiles were comparable.
Conclusions:
Additional SBRT to mFOLFIRINOX was feasible without safety concerns. Although it did not improve median PFS or OS, it led to numerically improved 1-year PFS rates and local tumor control. Given premature trial closure and limited power, efficacy comparisons should be interpreted as hypothesis generating.
Trial Registration:
NCT04986930.
