Surgical Complications in Patients with (borderline) Resectable Pancreatic Cancer after Neoadjuvant Therapy in the PREOPANC-2 Randomized Controlled Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 375 participants or records.
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