TY - JOUR
T1 - Surgical complications in patients with (borderline) resectable pancreatic cancer after neoadjuvant therapy in the PREOPANC-2 randomized controlled trial
AU - Dekker, Esther N.
AU - Theijse, Rutger T.
AU - Dutch Pancreatic Cancer Group
AU - van Dam, Jacob L.
AU - Janssen, Quisette P.
AU - Stoop, Thomas F.
AU - Bonsing, Bert A.
AU - Bosscha, Koop P.
AU - Bouwense, Stefan A.W.
AU - Busch, Olivier R.
AU - Coene, Peter Paul L.O.
AU - van Eijck, Casper H.J.
AU - van her Harst, Erwin
AU - de Hingh, Ignace H.J.T.
AU - Karsten, Tom M.
AU - Kazemier, Geert
AU - van der Kolk, Marion B.
AU - Liem, Mike S.L.
AU - Mieog, J. D.Sven
AU - Nieuwenhuijs, Vincent B.
AU - Patijn, Gijs A.
AU - van Santvoort, Hjalmar C.
AU - Schreinemakers, Jennifer M.J.
AU - de Wilde, Roeland F.
AU - Wit, Fennie
AU - Zonderhuis, Babs M.
AU - Homs, Marjolein Y.V.
AU - van Tienhoven, Geertjan
AU - Wilmink, Johanna W.
AU - Besselink, Marc G.
AU - Groot Koerkamp, Bas
AU - Beerepoot, Laurens V.
AU - van Bekkum, Marlies L.
AU - Bos, Hendrik
AU - Hol, Lieke
AU - Bruynzeel, Anna M.E.
AU - Cirkel, Geert A.
AU - Willem B. de Groot, Jan
AU - Haberkorn, Brigitte C.M.
AU - Loosveld, Olaf J.L.
AU - Luyer, Misha D.P.
AU - Luelmo, Saskia A.C.
AU - Mekenkamp, Leonie J.M.
AU - Nuyttens, Joost J.M.E.
AU - Oever, D. ten
AU - Stommel, Martijn W.J.
AU - Streppel, Mirte M.
AU - ten Tije, Albert J.
AU - Versteijne, Eva
AU - Droogh, Daphne H.M.
AU - Verkolf, Eva M.M.
N1 - Publisher Copyright:
Copyright © 2025 The Author(s)
PY - 2025/8/12
Y1 - 2025/8/12
N2 - Objective: To compare the incidence of major surgical complications between patients with (borderline) resectable pancreatic cancer treated with neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy.Summary of Background Data: There are ongoing concerns regarding the possible adverse impact of neoadjuvant treatment on postoperative complication rates following pancreatectomy. Methods:This study was a predefined analysis within the investigator-initiated nationwide randomized controlled PREOPANC-2 trial. Patients with (borderline) resectable pancreatic cancer were randomized to receive neoadjuvant FOLFIRINOX (FFX group) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT group), both followed by surgery, and adjuvant gemcitabine only in the CRT group. Surgical complications including postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, postoperative interventions, and 90-day mortality were compared, with major complications defined as Clavien-Dindo grade ≥3.Results: Between June 5, 2018, and January 28, 2021, in total 375 patients were randomized, of whom 280 (74.7%) underwent pancreatic resection. A pancreatoduodenectomy was performed in 238 patients (85.0%), left pancreatectomy in 41 patients (14.6%), and total pancreatectomy in one patient (0.4%). The incidence of major surgical complications was similar between the FFX and CRT groups (26.8% versus 27.5%, p=0.884). No differences were observed in the risk of postoperative pancreatic fistula grade B/C (9.9% versus 4.4%, p=0.076), postpancreatectomy hemorrhage grade B/C (7.7% versus 3.6%, p=0.137), bile leakage grade B/C (2.5% versus 2.5%, p>0.999), and postoperative interventions (26.1% versus 26.8%, p=0.886). Surgical reoperation was performed in nine patients (6.3%) in the FFX group and eight patients (5.8%) in the CRT group (p=0.850). The postoperative 90-day mortality was 1.4% in the FFX group (2/142 patients) and 2.9% in the CRT group (4/138 patients) (p=0.442). Conclusions: In the PREOPANC-2 randomized trial, the risk of major surgical complications after pancreatic resection following neoadjuvant FOLFIRINOX or neoadjuvant gemcitabine-based chemoradiotherapy was similar with an overall low 90-day mortality.
AB - Objective: To compare the incidence of major surgical complications between patients with (borderline) resectable pancreatic cancer treated with neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy.Summary of Background Data: There are ongoing concerns regarding the possible adverse impact of neoadjuvant treatment on postoperative complication rates following pancreatectomy. Methods:This study was a predefined analysis within the investigator-initiated nationwide randomized controlled PREOPANC-2 trial. Patients with (borderline) resectable pancreatic cancer were randomized to receive neoadjuvant FOLFIRINOX (FFX group) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT group), both followed by surgery, and adjuvant gemcitabine only in the CRT group. Surgical complications including postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, postoperative interventions, and 90-day mortality were compared, with major complications defined as Clavien-Dindo grade ≥3.Results: Between June 5, 2018, and January 28, 2021, in total 375 patients were randomized, of whom 280 (74.7%) underwent pancreatic resection. A pancreatoduodenectomy was performed in 238 patients (85.0%), left pancreatectomy in 41 patients (14.6%), and total pancreatectomy in one patient (0.4%). The incidence of major surgical complications was similar between the FFX and CRT groups (26.8% versus 27.5%, p=0.884). No differences were observed in the risk of postoperative pancreatic fistula grade B/C (9.9% versus 4.4%, p=0.076), postpancreatectomy hemorrhage grade B/C (7.7% versus 3.6%, p=0.137), bile leakage grade B/C (2.5% versus 2.5%, p>0.999), and postoperative interventions (26.1% versus 26.8%, p=0.886). Surgical reoperation was performed in nine patients (6.3%) in the FFX group and eight patients (5.8%) in the CRT group (p=0.850). The postoperative 90-day mortality was 1.4% in the FFX group (2/142 patients) and 2.9% in the CRT group (4/138 patients) (p=0.442). Conclusions: In the PREOPANC-2 randomized trial, the risk of major surgical complications after pancreatic resection following neoadjuvant FOLFIRINOX or neoadjuvant gemcitabine-based chemoradiotherapy was similar with an overall low 90-day mortality.
UR - https://www.scopus.com/pages/publications/105013647456
U2 - 10.1097/SLA.0000000000006910
DO - 10.1097/SLA.0000000000006910
M3 - Article
C2 - 40792645
AN - SCOPUS:105013647456
SN - 0003-4932
JO - Annals of Surgery
JF - Annals of Surgery
ER -
SDG 3 Good Health and Well-being