Phase 2 Trial of Neoadjuvant FOLFIRINOX and Intensity Modulated Radiation Therapy Concurrent With Fixed-Dose Rate-Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer.

Preoperative therapy in borderline resectable pancreatic cancer (BRPC) is intended to increase R0 resection rates. An optimal approach in BRPC is yet to be defined. Patients with BRPC, confirmed adenocarcinoma, performance status ≤1, and adequate organ function enrolled in a single-institution, phase 2 trial. Patients received FOLFIRINOX × 6 cycles, then radiation therapy (50 Gy in 25 fractions) concurrent with fixed-dose rate gemcitabine (1 g/m2 over 100 minutes) followed by 2 additional gemcitabine infusions. Computed tomography scans were performed at 2-month intervals during treatment. Patients without distant disease were offered surgical exploration. The primary objective was R0 resection rate with an alternate hypothesis of 55%. Secondary objectives included median progression-free survival (PFS), median overall survival (OS), response rate, and safety. The trial registration number is NCT01661088. Twenty-five patients with median age of 60 years (range, 47-77 years) enrolled from November 2011 through January 2017. Twenty-one (84%) completed FOLFIRINOX and 19 (76%) completed all protocol therapy. Treatment-related grade 3 to 4 toxicities included neutropenia (40%), nausea and vomiting (28%), diarrhea (16%), and fatigue (12%). Eighteen patients (72%) underwent laparotomy, 13 (52%) were resected (all R0). The median PFS and OS in 25 patients were 13.1 months (95% confidence interval [CI], 7.3-24.7) and 24.4 months (95% CI, 12.6-40.0), respectively. For resected patients, median PFS was 21.6 months (95% CI, 8.2-37.1) and OS was 37.1 months (95% CI, 15.4-not reached). Neoadjuvant therapy with FOLFIRINOX, followed by intensity modulated radiation therapy concurrent with fixed-dose-rate gemcitabine in BRPC is feasible and tolerated. Although the alternate hypothesis was not met, the OS of the resected cohort was favorable.

Tran NH ，Sahai V ，Griffith KA ，Nathan H ，Kaza R ，Cuneo KC ，Shi J ，Kim E ，Sonnenday CJ ，Cho CS ，Lawrence TS ，Zalupski MM ... -  《-》

Phase 2 trial of induction gemcitabine, oxaliplatin, and cetuximab followed by selective capecitabine-based chemoradiation in patients with borderline resectable or unresectable locally advanced pancreatic cancer.

Esnaola NF ，Chaudhary UB ，O'Brien P ，Garrett-Mayer E ，Camp ER ，Thomas MB ，Cole DJ ，Montero AJ ，Hoffman BJ ，Romagnuolo J ，Orwat KP ，Marshall DT ... -  《-》

Induction Chemotherapy Followed by Concurrent Full-dose Gemcitabine and Intensity-modulated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.

Badiyan SN ，Olsen JR ，Lee AY ，Yano M ，Menias CO ，Khwaja S ，Wang-Gillam A ，Strasberg SM ，Hawkins WG ，Linehan DC ，Myerson RJ ，Parikh PJ ... -  《-》

Total neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine for resectable and borderline resectable pancreatic cancer (PREOPANC-2 trial): study protocol for a nationwide multicenter randomized controlled t

Janssen QP ，van Dam JL ，Bonsing BA ，Bos H ，Bosscha KP ，Coene PPLO ，van Eijck CHJ ，de Hingh IHJT ，Karsten TM ，van der Kolk MB ，Patijn GA ，Liem MSL ，van Santvoort HC ，Loosveld OJL ，de Vos-Geelen J ，Zonderhuis BM ，Homs MYV ，van Tienhoven G ，Besselink MG ，Wilmink JW ，Groot Koerkamp B ，Dutch Pancreatic Cancer Group ... -  《BMC CANCER》

Neoadjuvant FOLFIRINOX for borderline resectable pancreas cancer: a new treatment paradigm?

Christians KK ，Tsai S ，Mahmoud A ，Ritch P ，Thomas JP ，Wiebe L ，Kelly T ，Erickson B ，Wang H ，Evans DB ，George B ... -  《-》