Neoadjuvant FOLFIRINOX and gemcitabine-based chemoradiotherapy were comparably effective for pancreatic cancer.
Previously, PREOPANC (NCT05679583) demonstrated an OS benefit of neoadjuvant gemcitabine-based chemoradiotherapy compared with upfront surgery in participants with borderline resectable and resectable pancreatic cancer.1 Meanwhile, the FOLFIRINOX combination (leucovorin calcium [folinic acid], fluorouracil, irinotecan hydrochloride, and oxaliplatin) demonstrated survival benefits both in the metastatic and adjuvant settings.2,3 The current phase 3, randomized PREOPANC-2 trial (EudraCT 2017-002036-17) compared neoadjuvant gemcitabine-based chemoradiotherapy with neoadjuvant FOLFIRINOX in participants with (borderline) resectable pancreatic cancer. Dr. Bas Groot Koerkamp of Erasmus Medical Center, Rotterdam, the Netherlands, presented the first results.4
PREOPANC-2 enrolled 375 participants who were randomized 1:1 to 8 cycles of FOLFIRINOX followed by surgery without adjuvant treatment (FFX arm) or 3 cycles of neoadjuvant gemcitabine with hypofractionated radiotherapy followed by surgery and 4 cycles of adjuvant gemcitabine (CRT arm). The primary endpoint was OS.
More participants in the CRT arm completed neoadjuvant treatment (88% vs 62% in the FFX arm); however, 81% of participants in the FFX arm received ≥4 cycles FOLFIRINOX. The resection rate was similar in both arms (77% CRT vs 75% FFX). The rates for R0 resection and complete pathological response were equal in both arms. No difference was observed in OS between arms. Median OS was 21.9 months in the FFX arm versus 21.3 in the CRT arm. OS rates at 1 year were 75.7% and 69.6% respectively, and 35.6% and 32.6% respectively at 3 years.
Grade 3-4 adverse events rates were comparable in both arms (67% in FFX vs 60% in CRT); however, diarrhea was more prominent in the FFX arm (23% vs 0% in CRT).
“Neoadjuvant FOLFIRINOX and gemcitabine-based chemoradiotherapy are comparably effective for overall survival of patients with borderline resectable or resectable pancreatic cancer,” concluded Dr. Groot Koerkamp.
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