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  • Jul 30, 2018
    Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial

    The purpose of this single arm phase 2 trial was to determine R0 resection rate after a specified course of total neoadjuvant therapy. Investigators enrolled 48 patients with newly diagnosed and untreated borderline resectable pancreatic cancer. Patients received 8 cycles of FOLFIRINOX, after which restaging was performed. If they experienced resolution of vascular involvement, patients underwent hypofractionated radiotherapy (25Gy in 5fx with protons or 30Gy in 10 fx with photons) with concurrent chemotherapy. If persistent vascular involvement, patients underwent a long course radiotherapy 50.4Gy in 28 fractions. Intraoperative radiotherapy was allowed at the surgeon’s discretion. 81% completed all planned chemotherapy, 92% proceeded to chemoradiation, of which 89% underwent resection, showing the tolerability of the treatment regimen. R0 resection was achieved in 65% of patients undergoing surgery, an impressive rate compared to historical standards. The most common grade 3+ toxicity was diarrhea (10%), indicating a favorable toxicity profile of this treatment course. Median PFS and OS were 14.7 and 37.7 months, respectively. In conclusion, this trial demonstrated the tolerability and efficacy of a regimen of total neoadjuvant therapy for pancreatic cancer, and supports the design of the phase 3 Alliance trial for borderline resectable pancreatic cancer.

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    Journal & Date: JAMA Oncol. 2018;4(7):963-969
    Key Institution: Massachusetts General Hospital, Boston, MA
    Keywords: Pancreatic cancer, neoadjuvant therapy, chemoradiation, borderline resectable

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