In a single-institution phase II trial reported in JAMA Oncology, Murphy et al found that total neoadjuvant therapy with FOLFIRINOX (fluorouracil [5-FU], irinotecan, and oxaliplatin) and individualized chemoradiotherapy was associated with a high R0 resection rate and good outcomes in patients with borderline resectable pancreatic adenocarcinoma.
The study included 48 patients with newly diagnosed previously untreated localized pancreatic cancer considered to be borderline resectable. Patients had a median age of 62 years, and 27 were male. They were treated at Massachusetts General Hospital between August 2012 and August 2016.
Patients were to receive FOLFIRINOX for 8 cycles. After restaging, patients with resolution of vascular involvement received short-course chemoradiotherapy (5 Gy × 5 with protons) with capecitabine, and patients with persistent vascular involvement received long-course chemoradiotherapy with 5-FU or capecitabine.
R0 Resection and Survival Outcomes
Median follow-up was 18.0 months among the 30 surviving patients at the time of analysis. Among 43 patients with a planned 8 preoperative cycles of chemotherapy, 34 (79%) completed all cycles. Chemoradiotherapy was short-course in 27 patients (56%) and long-course in 17 patients (35%). R0 resection was achieved in 31 (65%) of all 48 eligible patients and in 97% of the 32 patients in whom resection was performed.
Among all 48 patients, median progression-free survival was 14.7 months, with a 2-year rate of 43%, and median overall survival was 37.7 months, with a 2-year rate of 56%. Among the 32 patients who underwent resection, median progression-free survival was 48.6 months, with a 2-year rate of 55%, and median overall survival was not reached, with a 2-year rate of 72%.
The investigators concluded, “Preoperative FOLFIRINOX followed by individualized chemoradiotherapy in borderline resectable pancreatic cancer results in high rates of R0 resection and prolonged median [progression-free survival] and median [overall survival]…. This study supports the design of the phase III Alliance trial for borderline pancreatic cancer.”
The study was funded by grants from the National Institutes of Health and National Cancer Institute.
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