Survival Outcomes Associated with Clinical and Pathological Response following Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-paclitaxel Chemotherapy in Resected Pancreatic Cancer
Francis I. Macedo*1, Shishir Maithel*2, David Kooby2, Ryan Fields*3, William Hawkins3, Ugwuji Maduekwe*4, Hong J. Kim4, Syed Ahmad5, Sameer Patel*5, Daniel Abbott*6, Sharon Weber6, Charles R. Scoggins7, Robert CG Martin8, Alan S. Livingstone1, Dido Franceschi*1, Vikas Dudeja*1, Nipun B Merchant1
1University of Miami Health System, Miami, FL;2Emory University, Atlanta, GA;3Washington University, St Louis, MO;4UNC Chapel Hill, Chapel Hill, NC;5University of Cincinnati, Cinncinati, OH;6University of Wisconsin, Madison, WI;7University of Louisville, Loisville, KY;8University of Louisville, Louisville, KY
OBJECTIVE: Newer neoadjuvant chemotherapy(NAC) regimens have resulted in improved clinical and pathological responses in pancreatic cancer(PC), however the effects of these responses on survival outcomes remain unknown.
METHODS: Patients receiving NAC with FOLFIRINOX(FLX) or gemcitabine/nab-paclitaxel(GNP) +/-radiation(NRT) followed by curative-intent pancreatectomy from January 2010 to December 2016 at 7 academic medical centers were analyzed. Primary outcome was overall survival (OS), local(L-RFS) and distant recurrence-free survival(D-RFS) associated with biochemical(CA 19-9) and pathological response (complete,pCR, near-complete,nCR or limited,LR) following NAC.
RESULTS: Of 360 included patients, 49.4% were borderline resectable and 78.9% had pancreatic head tumors. Vein resection was performed in 38.6% and 30-day mortality was 3.1%. R0 and pCR rates were 84.9% and 4.7%. Median OS and RFS were 26 and 18.1months. OS, L-RFS and D-RFS were superior in patients with marked biochemical response (CA 19-9 decrease >50%vs.<50%: OS-37.5 vs. 23.1months,p=0.026; L-RFS-not reached (NR) vs. 19months,p<0.001; D-RFS-33.6 vs. 21.3months,p=0.017) and pathological response (pCR vs.nCR vs.LR: OS-NR vs.53.6 vs.22.7months,p<0.001; L-RFS-NR vs. 57 vs. 28months,p=0.043; D-RFS-NR vs. 27 vs. 20.7months,p=0.015). There was no difference in L-RFS (57 vs. 46months,p=0.710), D-RFS (25.8 vs.33.6months,p=0.423) or OS (26.8 vs.26.7months,p=0.863) between FLX or GNP. Despite no OS benefit (24.1 vs. 26months), NRT was associated with decreased LN positivity (11.2%vs.40.3%,p<0.001). On multivariate analysis, pCR, nCR, CA19-9 response, N0 status and R0 resection were independent predictors for improved OS.
CONCLUSIONS: This large, multicenter study shows that improved biochemical, pathological and clinical responses to NAC with FLX or GNP, result in improved OS and decreased local and distant recurrence in PC.
* By Invitation
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