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Survival Outcomes Associated With Clinical and Pathological Response Following Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-Paclitaxel Chemotherapy in Resected Pancreatic Cancer

Macedo, Francis I. MD*; Ryon, Emily MD*; Maithel, Shishir K. MD; Lee, Rachel M. MD; Kooby, David A. MD; Fields, Ryan C. MD; Hawkins, William G. MD; Williams, Greg MD; Maduekwe, Ugwuji MD§; Kim, Hong J. MD§; Ahmad, Syed A. MD; Patel, Sameer H. MD; Abbott, Daniel E. MD||; Schwartz, Patrick MD||; Weber, Sharon M. MD||; Scoggins, Charles R. MD**; Martin, Robert C. G. MD**; Dudeja, Vikas MD*; Franceschi, Dido MD*; Livingstone, Alan S. MD*; Merchant, Nipun B. MD*,⊠

doi: 10.1097/SLA.0000000000003468

Objective: To compare the survival outcomes associated with clinical and pathological response in pancreatic ductal adenocarcinoma (PDAC) patients receiving neoadjuvant chemotherapy (NAC) with FOLFIRINOX (FLX) or gemcitabine/nab-paclitaxel (GNP) followed by curative-intent pancreatectomy.

Background: Newer multiagent NAC regimens have resulted in improved clinical and pathological responses in PDAC; however, the effects of these responses on survival outcomes remain unknown.

Methods: Clinicopathological and survival data of PDAC patients treated at 7 academic medical centers were analyzed. Primary outcomes were overall survival (OS), local recurrence-free survival (L-RFS), and metastasis-free survival (MFS) associated with biochemical (CA 19–9 decrease ≥50% vs <50%) and pathological response (complete, pCR; partial, pPR or limited, pLR) following NAC.

Results: Of 274 included patients, 46.4% were borderline resectable, 25.5% locally advanced, and 83.2% had pancreatic head/neck tumors. Vein resection was performed in 34.7% and 30-day mortality was 2.2%. R0 and pCR rates were 82.5% and 6%, respectively. Median, 3-year, and 5-year OS were 32 months, 46.3%, and 30.3%, respectively. OS, L-RFS, and MFS were superior in patients with marked biochemical response (CA 19–9 decrease ≥50% vs <50%; OS: 42.3 vs 24.3 months, P < 0.001; L-RFS-27.3 vs 14.1 months, P = 0.042; MFS-29.3 vs 13 months, P = 0.047) and pathological response [pCR vs pPR vs pLR: OS- not reached (NR) vs 40.3 vs 26.1 months, P < 0.001; L-RFS-NR vs 24.5 vs 21.4 months, P = 0.044; MFS-NR vs 23.7 vs 20.2 months, P = 0.017]. There was no difference in L-RFS, MFS, or OS between patients who received FLX or GNP.

Conclusion: This large, multicenter study shows that improved biochemical, pathological, and clinical responses associated with NAC FLX or GNP result in improved OS, L-RFS, and MFS in PDAC. NAC with FLX or GNP has similar survival outcomes.

*Division of Surgical Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL

Division of Surgical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA

Department of Surgery, Barnes-Jewish Hospital, Alvin J. Siteman Cancer Center, Washington University in St. Louis School of Medicine, St Louis, MO

§Division of Surgical Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC

Division of Surgical Oncology, University of Cincinnati School of Medicine, Cincinnati, OH

||Division of Surgical Oncology, Carbone Cancer Center, University of Wisconsin School of Medicine, Madison, WI

**Division of Surgical Oncology, James Graham Brown Cancer Center, University of Louisville School of Medicine, Louisville, KY.

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The authors declare no conflict of interest.

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