FOLFIRINOX equals gemcitabine-based chemoradiotherapy in neoadjuvant setting for pancreatic cancer

The treatment with neoadjuvant FOLFIRINOX versus gemcitabine-based chemoradiotherapy in patients with borderline resectable or resectable pancreatic cancer was comparably effective concerning overall survival (OS), R0 resection rate, and adverse events, results from the PREOPANC-2 trial showed.

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 treatment with FOLFIRINOX demonstrated survival benefits both in the metastatic and adjuvant settings [2,3]. The current phase 3, randomised PREOPANC-2 trial (EudraCT 2017-002036-17) compared neoadjuvant gemcitabine-based chemoradiotherapy with neoadjuvant FOLFIRINOX in participants with (borderline) resectable pancreatic cancer. Prof. Bas Groot Koerkamp (Erasmus Medical Centre, the Netherlands) presented the first results [4].

PREOPANC-2 enrolled 375 participants who were randomised 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% vs 75% in CRT vs FFX, respectively), as were the rates for R0 resection and pathological complete response. No significant difference was observed in OS between arms. The median OS was 21.9 months in the FFX arm versus 21.3 months in the CRT arm (HR 0.87; 95% CI 0.68–1.12; P=0.28). The 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% vs 60% in FFX vs CRT, respectively). Diarrhoea was more prominent in the FFX arm (23% vs 0% in CRT).

“Neoadjuvant FOLFIRINOX and gemcitabine-based chemoradiotherapy are comparably effective regarding overall survival of patients with borderline resectable or resectable pancreatic cancer,” concluded Prof. Groot Koerkamp.

1. 
   
   1. Versteijne E, et al. J Clin Oncol. 2022;40(11):1220–1230.
   2. Versteijne E, et al. J Clin Oncol. 2022;40(11):1220–1230.
   3. Conroy T, et al. N Engl J Med 2011;364:1817–1825.
   4. Groot Koerkamp B, et al. Neoadjuvant chemotherapy with FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy for borderline resectable and resectable pancreatic cancer (P75 REOPANC-2): A multicenter randomized controlled trial. Abstract LBA83, ESMO 2023, 20–24 October, Madrid, Spain.

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Posted on 19 December, 202319 December, 2023