Swog S1505: Initial Surgical Outcome Results From A Randomized Clinical Trial Of Folfirinox Vs Gemcitabine/nab-paclitaxel For Perioperative Treatment Of Resectable Pancreatic Ductal Adenocarcinoma (pda)
Syed A Ahmad1, *Mai Duong2, *Davendra Sohal1, *Namita Gandhi3, *Muhammad Shaalan Beg4, *Andrea Wang-Gillam5, *James Lloyd Wade6, *Katherine A Guthrie7, Andrew M Lowy8, *Philip Agop Philip9, *Howard S Hochster10
1University of Cincinnati Medical Center, Cincinnati, OH;2SWOG Statistical Center, Fred Hutchinson Cancer Center, Seattle, WA;3Cleveland Clinic, Cleveland, OH;4The University of Texas Southwestern Medical Center, Dallas, TX;5Washington University School of Medicine, St Louis, MO;6Heartland Cancer Research Institute, Decatur, IL;7SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA;8UCSD Moores Cancer Center, San Diego, CA;9Karmanos Cancer Institute, Detroit, MI;10Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
OBJECTIVE(S): The optimal neoadjuvant therapy for resectable PDA and the impact on surgical outcomes remains unclear.
METHODS: . S1505 was a randomized phase II study of peri-operative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel (Arm 2). Measured parameters included resection rates, margin positivity, pathologic response, and toxicity.
RESULTS: 147 patients were randomized between 2015 and 2018. Of these, 30% (n=44) were deemed ineligible by central review. Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n=10), progression (n=9), or other (n=7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) of 73 required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The Grade 3-5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 61 (83%) started and 48 (66%) completed postoperative therapy.
CONCLUSIONS: This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA. We have demonstrated: 1) PDA resectability evaluation remains challenging, based on enrollment of ineligible patients; 2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; 3) Completion of adjuvant therapy in the perioperative format is difficult; 4) Major pathologic response rate of 33% is encouraging. Survival data mature in spring 2020. Funding: NIH/NCI/NCTN grants CA180888, CA180819, CA180820, CA180821, CA189830 and in part by the Celgene Corporation.
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