Therapeutic drug monitoring of neoadjuvant mFOLFIRINOX in resected pancreatic ductal adenocarcinoma.


Journal

Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]
ISSN: 1424-3911
Titre abrégé: Pancreatology
Pays: Switzerland
ID NLM: 100966936

Informations de publication

Date de publication:
Jun 2023
Historique:
received: 20 11 2022
revised: 20 02 2023
accepted: 06 03 2023
medline: 5 6 2023
pubmed: 12 5 2023
entrez: 11 5 2023
Statut: ppublish

Résumé

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. 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. 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 = 0.251, 95% CI 0.096-0.656; p = 0.005] and CPT-11 AUC <10 mcg·h/mL [HR = 0.189, 95% CI 0.073-0.486, p = 0.001]. Pharmacokinetically-guided dose adjustment of standard chemotherapy treatments might improve survival outcomes in patients with pancreatic ductal adenocarcinoma.

Sections du résumé

BACKGROUND 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 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 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 = 0.251, 95% CI 0.096-0.656; p = 0.005] and CPT-11 AUC <10 mcg·h/mL [HR = 0.189, 95% CI 0.073-0.486, p = 0.001].
CONCLUSIONS CONCLUSIONS
Pharmacokinetically-guided dose adjustment of standard chemotherapy treatments might improve survival outcomes in patients with pancreatic ductal adenocarcinoma.

Identifiants

pubmed: 37169668
pii: S1424-3903(23)00065-0
doi: 10.1016/j.pan.2023.03.001
pii:
doi:

Substances chimiques

Irinotecan 7673326042
Oxaliplatin 04ZR38536J
Leucovorin Q573I9DVLP
Fluorouracil U3P01618RT

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

411-419

Informations de copyright

Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.

Auteurs

Anna Vilalta-Lacarra (A)

Department of Medical Oncology, Clinica Universidad de Navarra, Pamplona, Spain.

Azucena Aldaz (A)

Pharmacy Service, Clinica Universidad de Navarra, Pamplona, Spain.

Pablo Sala-Elarre (P)

Department of Medical Oncology, Clinica Universidad de Navarra, Pamplona, Spain.

Amaia Urrizola (A)

Department of Medical Oncology, Clinica Universidad de Navarra, Pamplona, Spain.

Ana Chopitea (A)

Department of Medical Oncology, Clinica Universidad de Navarra, Pamplona, Spain.

Leire Arbea (L)

Department of Radiation Oncology, Clinica Universidad de Navarra, Pamplona, Spain.

Fernando Rotellar (F)

Hepatobiliary Surgery, Clinica Universidad de Navarra, Pamplona, Spain.

Fernando Pardo (F)

Hepatobiliary Surgery, Clinica Universidad de Navarra, Pamplona, Spain.

Pablo Martí-Cruchaga (P)

Hepatobiliary Surgery, Clinica Universidad de Navarra, Pamplona, Spain.

Gabriel Zozaya (G)

Hepatobiliary Surgery, Clinica Universidad de Navarra, Pamplona, Spain.

Jose Carlos Subtil (JC)

Department of Gastroenterology, Clinica Universidad de Navarra, Pamplona, Spain.

Javier Rodríguez-Rodríguez (J)

Department of Medical Oncology, Clinica Universidad de Navarra, Pamplona, Spain.

Mariano Ponz-Sarvise (M)

Department of Medical Oncology, Clinica Universidad de Navarra, Pamplona, Spain. Electronic address: mponz@unav.es.

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Classifications MeSH