Locally advanced pancreatic cancer (LAPC) is often a mix of borderline and never-resectable tumors. Multimodality treatment might downstage these tumors to allow a potential radical resection, especially the borderline group. In this ongoing phase II study we examined the feasibility of FOLFIRINOX with or without CRT followed by surgery for both borderline and never-resectable tumors (NCT-01397019).
Patients in performance status 0-1, with initially non-resectable stage II/III pancreatic cancer were offered FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5FU 400 mg/m2+ 2400 mg/m2) every 14 days. Every 4th series the patients were evaluated and offered CRT (50.4 Gy/27F & capecitabine) if deemed potentially resectable. Resections were performed if deemed possible by the MDT.
Between August 2012 and present, 59 patients have been recruited with a median observation time of 17.4 months. Median age was 65(range 38-75) years, with 40%/60% stage II/III distribution. Median CA19-9 was 268(range 1-13,432). Three-hundred-sixty-two courses of FOLFIRINOX have been given, with a median of 6.0 per patient, with a median of 2 without dose modifications. Presently twenty-two patients have been treated with CRT. Six-teen patients have been resected, of which 8 received prior CRT. Median survival for all patients was 21.1 months (14-NR) with a 1-year survival of 74% (58-85). For patients not resected the median survival was 14.1 months (10-16) for resected the median survival has not yet been reached. The FOLFIRINOX was associated with adverse events similar to what is expected in metastatic patients.
FOLFIRINOX with or without CRT in patients with LAPC shows promising efficacy in patients with both borderline and never-resectable tumors. Unmodified FOLFIRINOX had acceptable toxicity, however dose reductions are often needed. CRT following initial FOLFIRINOX was feasible and without unexpected toxicity.
Clinical trial identification
Legal entity responsible for the study
Danish Pancreatic Cancer Group
All authors have declared no conflicts of interest.