Abstract
381 Background: Preoperative therapy in BRPC is intended to increase the likelihood of R0 resection although an optimal regimen is yet to be defined. Methods: Patients (pts) with BRPC (NCCNv.2.2010 guidelines) and ECOG PS 0-1 were enrolled in a single-institution, phase II trial (NCT01661088). Pts received FOLFIRINOX x 6, followed by IMRT (50 Gy in 25 fractions) concurrent with FDR-gemcitabine 1 g/m2 on days 1, 8, 22, 29. Two additional FDR-gemcitabine infusions completed pre-operative treatment. Pancreatic protocol CT scans (dual phase, 0.65 mm slices) were performed after 4 infusions of FOLFIRINOX, 3 weeks after IMRT, and at treatment completion. Pts without distant disease were offered surgical exploration. The primary objective was to determine R0 resection rate. Secondary objectives included progression free survival (PFS), overall survival (OS), response rate and safety. Results: A total of 25 pts (64% men) median age 60 years (range 47-77) were enrolled from 11/2011 through 01/2017. Twenty-one (84%) pts completed FOLFIRINOX and 19 (76%) all protocol therapy. Treatment-related grade 3-4 adverse events ( > 10%) included neutropenia (40%), nausea/vomiting (28%), diarrhea (16%) and fatigue (12%). One early death and 1 discontinuation due to toxicity occurred during FOLFIRINOX. Response to pre-op therapy included 11 PR, 9 SD, 3 PD and 2 NE. Of 25 treated pts, 18 (72%) had laparotomy and 13 (52%) underwent resection (all R0). The median PFS and OS were 18.1 (95% CI, 10.6 to 25.1) and 24.2 (95% CI, 12.6 to 40.0) months, respectively. The median OS for R0 resected pts was 37.1 (95% CI, 15.4 – not reached) months. Conclusions: Neoadjuvant therapy with FOLFIRINOX, followed by IMRT with concurrent FDR-gemcitabine in BRPC is feasible and tolerated. While R0 resection rate was not obviously improved, OS of the entire cohort and especially in R0 resected pts was favorable. Clinical trial information: NCT01661088.
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