Clinico-biological factors predicting the benefit of the LV5FU2 maintenance strategy as a first-line therapy in patients with metastatic pancreatic cancer
Authors: Boisteau Emeric , Dahan Laetitia , Williet Nicolas , Le Malicot Karine , Desramé Jérôme , Bouché Olivier , Petorin Caroline , Malka David , Rebischung Christine , Aparicio Thomas , Lecaille Cédric , Rinaldi Yves , Turpin Anthony , Bignon Anne-Laure , Bachet Jean-Baptiste , Lepage Côme , Granger Victoire , Legoux Jean-Louis , Deplanque Gaël , Baconnier Mathieu , Lecomte Thierry , Bonnet Isabelle , Seitz Jean-François , François Eric , Lièvre Astrid ,   For the PRODIGE 35 Investigator/Collaborators, Pigui Anna , Escande Anne , Pezet Denis , Duluc Muriel , Barriere Nicolas , Moullet Isabelle , Audemar Franck , Bourgeois Vincent , Vimal-Baguet Agnès , Norguet Emmanuelle , Lagasse Jean-Paul , Duchmann Jean-Christophe , Guillet Marielle , Berdah Stéphane , Sverdlin Robert , Taieb Julien , Corbinais Stéphane , Lledo Gérard , Bedenne Laurent , Hebbar Mohamed , Bouhier-Leporrier Karine , Ferte Charles , Staudacher Lionel , Evesque Ludovic , Remy Stéphane , Charlois Thierry , Lombard-Bohas Catherine , Zaanan Aziz , Cornila Corina , Hollebecque Antoine , Artru Pascal , Dupont Kazma Laure , Walter Thomas , Devaure Iris , Gigout Julie , Desauw  , Guilngar Anne , Locher Christophe , Ezenfis Joël , Belletier  , Boige Valérie , Cattan Stéphane , Coufon Caroline , Sibertin-Blanc Camille , Villing Anne-Laure , Burtin Pascal , Boulat  , Andrau Pierre , Meunier Jérôme , Foll Le , Ducreux Michel , Plastaras Laurianne , Breysacher Gilles , Bernard Philippe , Durand Aurelie , Romano Olivier , Farneti Delphine , Simon Mireille , Talarmin Marie , Dupont Gossart Anne-Claire , Le Sourd Samuel , Hocine Fayçal , Sefrioui David , Le Roy Florence , Desgrippes Romain , Topolski Amalia , Mary Florence , Michel Pierre , Aparicio Thomas , Cavaglione Gérard , Baba-Hamed Nabil , Follana Philippe , Cumin Isabelle , Thomas Marques Laurence , Baize Nathalie , Arsenii Nicolae , Ceban Tatiana , Jouve Jean-Louis , Molin Yann , Pracht Marc 
Published: May 2024

Abstract

Introduction
Predictive markers of LV5FU2 maintenance benefit after first-line induction with FOLFIRINOX in patients with metastatic pancreatic cancer are necessary to select patients who will not be harmed by this strategy.

Patients and Methods
We focused on patients who received 12 cycles of FOLFIRINOX (arm A, N = 88) or 8 cycles of FOLFIRINOX followed by LV5FU2 maintenance in controlled patients (arm B, N = 91) from the PRODIGE-35 trial. Prognostic factors and predictors of efficiency were identified by using Cox regression. Median progression-free survival (PFS), overall survival (OS), and time to deterioration of quality of life (TTD-QoL) were evaluated.

Results
Poor independent prognostic factors were primary tumor in place, age &lt;65 years and the presence of liver metastases for PFS, a baseline neutrophil/lymphocyte ratio (NLR) ≥5 and CA19.9 ≥500 UI/L for OS, independent of the treatment arm. Patients with one metastatic site had a longer PFS in arm A, whereas patients with ≥2 metastatic sites had a longer PFS in arm B. We also identified predictors of OS and TTD-QoL in arm B but these differences were not statistically significant.

Conclusion
Except for patients with one metastatic site who benefited more from 12 cycles of FOLFIRINOX, a maintenance strategy with LV5FU2 should be widely offered to mPC patients whose survival and QoL are preserved after 4 months of FOLFIRINOX. (ClinicalTrials.gov: NCT02352337).