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Clinical Trial
. 2024 Sep 6;29(9):e1149-e1158.
doi: 10.1093/oncolo/oyae079.

Clinico-biological factors predicting the benefit of the LV5FU2 maintenance strategy as a first-line therapy in patients with metastatic pancreatic cancer

Emeric Boisteau  1 , Laetitia Dahan  2 , Nicolas Williet  3 , Karine Le Malicot  4 , Jérôme Desramé  5 , Olivier Bouché  6 , Caroline Petorin  7 , David Malka  8 , Christine Rebischung  9 , Thomas Aparicio  10 , Cédric Lecaille  11 , Yves Rinaldi  12 , Anthony Turpin  13 , Anne-Laure Bignon  14 , Jean-Baptiste Bachet  15 , Côme Lepage  16 , Victoire Granger  17 , Jean-Louis Legoux  18 , Gaël Deplanque  19 , Mathieu Baconnier  20 , Thierry Lecomte  21 , Isabelle Bonnet  22 , Jean-François Seitz  2 , Eric François  23 , Astrid Lièvre  1 ; PRODIGE 35 Investigator/Collaborators
Collaborators, Affiliations
Clinical Trial

Clinico-biological factors predicting the benefit of the LV5FU2 maintenance strategy as a first-line therapy in patients with metastatic pancreatic cancer

Emeric Boisteau et al. Oncologist. .

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 <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).

Keywords: chemotherapy; maintenance; metastases; pancreatic neoplasm.

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Conflict of interest statement

Nicolas Williet reported financial relationships with Sanofi, Servier, and Ispen. Thomas Aparicio declared conferences for Roche, Ipsen, Amgen, Servier, Sanofi, and AstraZeneca; financial support to congress from Roche and Bayer; and advisory roles for Biogen and Servier. Yves Rinaldi reported financial relationships with Sanofi, Merck, Servier, Amgen, Roche and Bayer. Victoire Granger declared financial support for research from Sanofi-Genzyme, Roche, Servier, and Astellas; consultancy from Amgen, Lilly, Roche, Sanofi-Genzyme, Servier, and Pierre Fabre; and financial support for congresses from Amgen, Ipsen, Lilly, Roche, and Sanofi-Genzyme. Jean-Louis Legoux declared consulting and advisory fees from Novartis, research funding fees from Sanofi, Keocyt, Novartis, Pfizer, and honoraria from Ipsen, Merck-Serono. Thierry Lecomte declared consulting fees, lecture fees and travel accommodations from IPSEN; lecture fees from AstraZeneca. Emeric Boisteau, Laetitia Dahan, Karine Le Malicot, Jerome Desramé, Olivier Bouché, Caroline Petorin, David Malka, Christine Rebischung, Cédric Lecaille, Anthony Turpin, Anne-Laure Bignon, Jean-Baptiste Bachet, Côme Lepage, Gael Deplanque, Mathieu Baconnier, Isabelle Bonnet, Jean-François Seitz, Eric François, and Astrid Lièvre declared no potential conflicts of interest.

Figures

Figure 1.
Figure 1.
Forest plots of predictive factors of the benefit of maintenance therapy associated with progression-free survival. CI, confidence interval; HR, hazard ratio; NLR, neutrophil/lymphocytes ratio, PFS, progression-free survival.
Figure 2.
Figure 2.
Progression-free survival according to treatment arm in patients with (A) 1 metastatic site and (B) ≥2 metastatic sites. N = number.
Figure 3.
Figure 3.
Forest plots of predictive factors of the benefit of maintenance therapy associated with overall survival. CI, confidence interval; HR, hazard ratio; NLR, neutrophil/lymphocytes ratio; ECOG PS, Eastern Cooperative Oncology Group Performance Status; OS, overall survival.
See this image and copyright information in PMC

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