Preoperative fluorouracil, irinotecan, plus oxaliplatin (FOFIRINOX) followed by chemoradiotherapy leads to high rates of margin-negative (R0) resection and improved survival outcomes among patients with borderline resectable pancreatic cancer, according to a study published in JAMA Oncology.1
In a single-arm phase 2 study (ClinicalTrials.gov Identifier: NCT01591733), researchers enrolled 50 previously untreated patients with newly diagnosed and borderline resectable pancreatic cancer. Patients were treated with 8 cycles of neoadjuvant FOLFIRINOX, and if there was no evidence of vascular involvement during restaging, patients received a short course of chemoradiotherapy; patients whose vascular involvement was not resolved received a longer course of chemoradiotherapy. Surgery was performed 1 to 3 weeks after the completion of radiotherapy. The median follow-up was 18 months.
Of the 50 patients, 48 were eligible were for the study. Thirty-four patients completed all 8 cycles of chemotherapy, and 27 and 17 patients received short-course and long-course chemoradiotherapy, respectively.
Among the 32 patients who underwent surgical resection, 31 (97%) had a R0 resection.
Among eligible patients, the median progression-free survival (PFS) was 14.7 months (95% CI, 10.5-not reached), and the 2-year PFS was 43%; median overall survival (OS) was 37.7 months (95% CI, 19.4-not reached), and the 2-year OS was 56%.
Among patients who underwent resection, median PFS was 48.6 months (95% CI, 14.4-not reached), and the median OS was not reached. The 2-year PFS and 2-year OS was 55% and 72%, respectively.
The authors concluded that “preoperative FOLFIRINOX followed by individualized chemoradiotherapy in borderline resectable pancreatic cancer results in high rates of R0 resection and prolonged median PFS and median OS, supporting ongoing phase 3 trials.”
- Murphy JE, Wo JY, Ryan DP, et al. Total neoadjuvant therapy with FOLFIRINOX followed by individualized chemoradiotherapy for borderline resectable pancreatic adenocarcinoma [published online May 3, 2018]. JAMA Oncol. doi: 10.1001/jamaoncol.2018.0329