Efficacy and feasibility of combining FOLFIRINOX and stereotactic radiotherapy for patients with LAPC (LAPC-1 Trial)

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Introduction: Patients with locally advanced pancreatic cancer (LAPC) rarely undergo resection with curative intent and controlling disease progression should be the goal of the treatment. We conducted a multicenter phase II trial (ClinicalTrials.gov Identifier: NCT02292745) to investigate the efficacy and feasibility of combining FOLFIRINOX and Stereotactic Radiotherapy (SBRT) for patients with LAPC (LAPC-1 trial). Methods: All eligible patients with biopsy-proven LAPC were included between January 2015 and June 2017. These patients underwent a staging laparoscopy to exclude occult metastasis and were treated with FOLFIRINOX (8 cycles) followed by SBRT (5 fractions/8 Gy) if there was no tumor progression on imaging. Primary outcome was overall survival (OS). Secondary outcomes were progression free survival (PFS), treatment-related toxicity, and resection rates. Results: In total, 53 patients were included in the study. The preliminary survival data showed a median OS of 18 months (95% CI 16-19) and median PFS of 12 months (95% CI 11-13). Thirty (60%) events of a grade 3 or 4 adverse event occurred during FOLFIRINOX. Thirty-nine (74%) patients had no tumor progression after the chemotherapy andreceived the full dose of SBRT. One (3%) patient had a grade 5 adverse event three months after SBRT, while no grade 3 or 4 adverse event occurred after SBRT. Seven (14%) patients underwent a resection, all being a radical resection. Conclusion: FOLFIRINOX combined with SBRT in patients with inoperable LAPC is feasible and effecitve. Forteen percent of the patients became operable and 6% had a complete response.