SSAT - Neoadjuvant FOLFIRINOX for Pancreatic Ductal Adenocarcinoma Is Associated With Improved Clinicopathologic Outcomes and Equivalent Morbidity and Mortality Following Pancreaticoduodenectomy.

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Neoadjuvant FOLFIRINOX for Pancreatic Ductal Adenocarcinoma Is Associated With Improved Clinicopathologic Outcomes and Equivalent Morbidity and Mortality Following Pancreaticoduodenectomy.
Brandon Chapman^*, Alessandro Paniccia, James McCullough, Douglas Overbey, Cheryl Meguid, Ana Gleisner, Csaba Gajdos, Richard D. Schulick, Martin McCarter, Barish H. Edil
Department of Surgery, University of Colorado School of Medicine, Denver, CO

Introduction: Pancreatic ductal adenocarcinoma (PDA) in 40% of resected patients presents with locally advanced or borderline disease. Data are limited on post-operative outcomes with neoadjuvant FOLFIRINOX chemotherapy. The purpose of this study is to compare outcomes following open pancreaticoduodenectomy (OPD) in patients receiving neoadjuvant FOLFIRNOX with those who received no neoadjuvant therapy.
Methods: We analyzed data from a prospectively collected single institutional database identifying patients that underwent open pancreaticoduodenectomy for PDA from June 2012 to September 2015. Patient demographics and clinical information including intraoperative, postoperative, and oncologic outcomes were queried from the medical record. A Wilcoxon rank-sum (Mann-Whitney) test and chi-square analysis were used for comparison where appropriate.
Results:
Among 53 patients undergoing OPD, 20 (37.7%) received neoadjuvant FOLFIRINOX and 33 (62.3%) received no neoadjuvant chemotherapy. Eleven (55.0%) of patients in the FOLFIRINOX group received neoadjuvant radiotherapy (p<0.001). There were no differences in age (p=0.127), male gender (p=0.329), BMI (p=0.119), ASA class (p=0.651), and tumor size (p=0.977) between the two groups. Median follow-up time was 292 days (1-817) in the FOLFIRINOX group and 267 days (7-645) days in those not receiving neoadjuvant therapy (p=0.446). Local recurrence rates (p=0.749), metastatic recurrence rates (p=0.965), and median survival time (p=0.203) were similar in the two groups. The total number of lymph nodes (p=0.748), number of patients with positive lymph nodes (p=0.061), and positive margin rates (p=0.169) were similar; however, patients in the FOLFIRINOX group had a reduced number of positive lymph nodes (p=0.027) and lymph node ratio (p=0.014). Additionally, patients who received FOLFIRINOX had lower rates of lymph-vascular invasion (p=0.018) and peri-neural invasion (p=0.048). Although more patients in the FOLFIRINOX required vein resection (p=0.024), there was no difference in estimated blood loss (0.244) and operative time (p=0.086). While there was no difference in Clavien-Dindo complications (p=0.876), 30-day mortality (p=0.715), and 30-day readmission (p=0.117), there was a trend towards a longer length of hospital stay (p=0.058) and reduced pancreatic fistula rates (0.094) in patients receiving FOLFIRINOX.
Conclusions: Administration of neoadjuvant FOLFIRINOX may improve clinicopathologic characteristics and has equivalent post-operative morbidity and mortality. However, longer follow up is needed to further evaluate recurrence rates and survival.
FOLFIRINOX (n=20) NO FOLFIRINOX (n=33) p-value
Age, years 64 (49-81) 67 (43-88) 0.127
Male gender 10 (50.0) 21 (63.6) 0.329
ASA Classification 3 (2-4) 3 (2-4) 0.651
T-stage 0.405
No residual PDA 1 (5.0) 0 (0)
T1 1 (5.0) 2 (6.1)
T2 2 (10.0) 1 (3.0)
T3 16 (80.0) 30 (90.9)
N-stage 0.094
N0 7 (35.0) 5 (15.2)
N1 13 (65.0) 28 (84.8)
Tumor size, cm 2.6 (0.2-5) 2.6 (0.4-5.5) 0.977
Number positive lymph nodes 1.5 (0-9) 5 (0-17) 0.027
Lymph node ratio 0.087 (0-0.5) 0.2 (0-0.714) 0.014
Lympho-vascular invasion 8 (40) 24 (72.7) 0.018
Peri-neural invasion 15 (75.0) 31 (93.9) 0.048
Positive margins 1 (5.0) 6 (18.2) 0.169
Vein resection 9 (45.0) 5 (15.2) 0.017
Estimated blood loss, mL 400 (150-1500) 500 (150-2000) 0.244
Operative time, minutes 394.5 (213-521) 373 (207-471) 0.086
Length of hospital stay, days 10 (6-22) 8 (6-29) 0.058
30-day readmission 5 (25.0) 3 (9.1) 0.117
Pancreatic fistula 0 (0) 5 (15.2) 0.067
Clavien-Dindo Complications 0.876
Grade 0 7 (35.0) 14 (42.4)
Grade 1 2 (10.0) 5 (15.2)
Grade 2 8 (40.0) 9 (27.3)
Grade 3 2 (10.0) 3 (9.1)
Grade 4 0 (0) 1 (3.0)

Table 1. Patient demographics, pathologic characteristics, and intra-operative, post-operative, and long-term outcomes in patients undergoing open pancreaticoduodenectomy. n (%). median (range).

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