Therapeutic drug monitoring of neoadjuvant mFOLFIRINOX in resected pancreatic ductal adenocarcinoma

Background: Despite a potentially curative treatment, the prognosis after upfront surgery and adjuvant chemotherapy for patients with resectable pancreatic ductal adenocarcinoma (PDAC) is poor. Modified FOLFIRINOX (mFOLFIRINOX) is a cornerstone in the systemic treatment of PDAC, including the neoadj...

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Autores: Vilalta-Lacarra, A. (Anna)|||/items/3e4f2cab-125a-4045-b6ab-320e7fd08b8c, Aldaz-Pastor, A. (Azucena)|||/items/4c5b635e-13a6-4fa6-b20d-dae786f6a09b, Sala-Elarre, P. (Pablo)|||/items/a91400e6-6375-4f58-a68e-9adf0eb4d678, Urrizola-Martínez, A. (Amaia)|||/items/ba23b021-eb8a-4c8b-9547-d86c87193da0, Chopitea-Ortega, A. (Ana)|||/items/4234674f-5287-4a3a-a66e-8b82d25afe53, Arbea-Moreno, L. (Leire)|||/items/076efa2b-de27-4a0c-a3e6-2e321ca22833, Rotellar-Sastre, F. (Fernando)|||/items/833cb788-f4b9-404d-a18b-ae1c84369b51, Pardo, F. (Fernando)|||/items/f4488eb3-3bf9-4dff-9d3f-402f36a1721e, Marti-Cruchaga, P. (Pablo)|||/items/97577c37-4c78-4a17-8b03-55eec0b40ff9, Zozaya-Larequi, G.N. (Gabriel Nicolás)|||/items/edce37f2-5ec6-40e5-996d-57a6e3ca7b0e, Subtil-Íñigo, J.C. (José Carlos)|||/items/df5600f0-7617-4bf8-be80-1fc8ca160b57, Rodríguez-Rodríguez, J. (Javier)|||/items/eb216e0c-3040-4db1-82a3-45514feafb00, Ponz-Sarvise, M. (Mariano)|||/items/2439c580-068e-431b-a20d-bdeab1b7c3ad
Formato: artículo
Fecha de publicación:2023
País:España
Recursos:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/67542
Acesso em linha:https://hdl.handle.net/10171/67542
Access Level:acceso abierto
Palavra-chave:CPT-11
Pharmacokinetics
5-Fluorouracil
Pancreatic ductal adenocarcinoma
Hepatología
Farmacia
Descrição
Resumo:Background: Despite a potentially curative treatment, the prognosis after upfront surgery and adjuvant chemotherapy for patients with resectable pancreatic ductal adenocarcinoma (PDAC) is poor. Modified FOLFIRINOX (mFOLFIRINOX) is a cornerstone in the systemic treatment of PDAC, including the neoadjuvant setting. Pharmacokinetic-guided (PKG) dosing has demonstrated beneficial effects in other tumors, but scarce data is available in pancreatic cancer. Methods: Forty-six patients with resected PDAC after mFOLFIRINOX neoadjuvant approach and included in an institutional protocol for anticancer drug monitoring were retrospectively analyzed. 5-Fluorouracil (5-FU) dosage was adjusted throughout neoadjuvant treatment according to pharmacokinetic parameters and Irinotecan (CPT-11) pharmacokinetic variables were retrospectively estimated. Results: By exploratory univariate analyses, a significantly longer progression-free survival was observed for patients with either 5-FU area under the curve (AUC) above 28 mcg$h/mL or CPT-11 AUC values below 10 mcg$h/mL. In the multivariate analyses adjusted by age, gender, performance status and resectability after stratification according to both pharmacokinetic parameters, the risk of progression was significantly reduced in patients with 5-FU AUC 28 mcg$h/mL [HR ¼ 0.251, 95% CI 0.096e0.656; p ¼ 0.005] and CPT-11 AUC <10 mcg$h/mL [HR ¼ 0.189, 95% CI 0.073e0.486, p ¼ 0.001]. Conclusions: Pharmacokinetically-guided dose adjustment of standard chemotherapy treatments might improve survival outcomes in patients with pancreatic ductal adenocarcinoma.