Abstract
348 Background: Although there is a strong rationale for downstaging non-resectable pancreatic ductal adenocarcinoma (PDAC) for secondary resections by multi-agent chemotherapy, evidence from prospective randomized studies is missing. Methods: This prospective, randomized, open-label, phase II study aims to assess the activity, safety and feasibility of nab-paclitaxel/gemcitabine (nPG)- and FOLFIRINOX-based induction chemotherapy for patients (pts) with non-resectable PDAC. After two cycles of nPG pts are randomly allocated to receive either two additional cycles of nPG (arm A) or four cycles of FOLFIRINOX (arm B). Secondary resectability is assessed by exploratory laparotomy in all pts with at least stable disease (SD) after induction chemotherapy. The primary endpoint is to compare secondary complete macroscopic resection rates (R0/R1) in both arms. Results: We report the results of a planned interim (futility) analysis for efficacy data after at least 50 patients had completed induction chemotherapy and are evaluable for secondary surgical resection. Of pts who underwent randomization 42 pts were allocated to arm A and 44 pts to arm B, respectively. Disease control rate (DCR) after randomization was 93% in arm A and 89% in arm B. Explorative laparotomy was performed in 55% of randomized pts in arm A and 48% in arm B. Complete macroscopic resection (R0/R1) rate of randomized pts was 24% in arm A and 29% in arm B. For pts who received surgical exploration by laparotomy after completion of induction chemotherapy (n = 44) the complete macroscopic resection (R0/R1) rate was 43% in arm A and 62% in arm B. No new safety signals were identified thus far. Conclusions: nPG- and FOLFIRINOX-based induction chemotherapy approach revealed both effective and feasible in pts with LAPC supporting completion of patient recruitment in this trial. Interim results suggest promising secondary resection rates after multi-agent chemotherapy, especially when secondary resectability is assessed by surgical exploration. Clinical trial information: NCT02125136.
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