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Primary systemic therapy in resectable pancreatic ductal adenocarcinoma using mFOLFIRINOX: A pilot study
Author(s) -
Marsh Robert,
Talamonti Mark S.,
Baker Marshall S.,
Posner Mitchell,
Roggin Kevin,
Matthews Jeffrey,
Catenacci Daniel,
Kozloff Mark,
Polite Blase,
Britto Michele,
Wang Chi,
Kindler Hedy
Publication year - 2018
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.24872
Subject(s) - medicine , clinical endpoint , tolerability , gemcitabine , folfirinox , oxaliplatin , surgery , irinotecan , toxicity , response evaluation criteria in solid tumors , chemotherapy , phases of clinical research , cancer , adverse effect , randomized controlled trial , colorectal cancer
Background and Objectives Surgery followed by gemcitabine and/or a fluoropyrimidine is standard therapy for resectable PDAC. mFOLFIRINOX (oxaliplatin 85 mg/m 2 , irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 Day 1, 5‐FU 2400 mg/m 2 × 48 h IV, peg‐filgrastim 6 mg SQ day 3, every 14 days) has substantial activity in metastatic PDAC. We wished to determine the tolerability/efficacy of peri‐operative mFOLFIRINOX in resectable PDAC. Methods Patients with resectable PDAC (ECOG PS 0/1) received four cycles of mFOLFIRINOX pre‐ and post‐surgery. The primary endpoint was completion of preoperative chemotherapy plus resection. Secondary endpoints included completion of all therapy, R0 resection, treatment related toxicity, PFS, and OS. Results Twenty‐one patients enrolled: median age 62 (47‐78); 20/21 (95%) completed four cycles of preoperative mFOLFIRINOX; response by RECIST was 1 CR, 3 PR, 16 SD; 17/21 (81%) completed resection, 16/21 (76%) R0; 14/21 (66%) completed four cycles of postoperative mFOLFIRINOX. Grade 3 and 4 toxicity occurred in 23% and 14% patients pre‐operatively, 26% and 6.0% post‐operatively. Nine patients are alive with median follow‐up of 27.7 (3.1‐47.1) months. Conclusions PST using mFOLFIRINOX in resectable PDAC is feasible and tolerable. R0 resection rate is high and survival promising, requiring longer follow‐up and larger studies for definitive assessment.