Incidence of Venous Thromboembolism in Patients With Newly Diagnosed Pancreatic Cancer and Factors Associated With Outcomes.
Adult
Aged
Aged, 80 and over
Carcinoma, Pancreatic Ductal
/ complications
Female
Follow-Up Studies
France
/ epidemiology
Humans
Incidence
Male
Middle Aged
Neoplasm Staging
Pancreatic Neoplasms
/ complications
Progression-Free Survival
Prospective Studies
Risk Factors
Time Factors
Venous Thromboembolism
/ epidemiology
Blood Clot
Complication
Pancreatic Cancer
Prognostic Factor
Journal
Gastroenterology
ISSN: 1528-0012
Titre abrégé: Gastroenterology
Pays: United States
ID NLM: 0374630
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
13
07
2019
revised:
29
11
2019
accepted:
03
12
2019
pubmed:
18
12
2019
medline:
11
7
2020
entrez:
18
12
2019
Statut:
ppublish
Résumé
Pancreatic ductal adenocarcinoma (PDAC) is associated with the highest incidence of venous thromboembolism (VTE) of any cancer type. However, little is known about risk factors for VTE or its outcomes in patients with PDAC. We collected data from a prospective, observational study performed at multiple centers in France from May 2014 through November 2018 (the Base Clinico-Biologique de l'Adénocarcinome Pancréatique [BACAP] study) linked to a database of patients with a new diagnosis of PDAC of any stage. Data were collected from 731 patients at baseline and during clinical follow-up or in the event of symptoms. The primary endpoint was the onset of VTE during follow-up. The secondary endpoints were progression-free survival (PFS) and overall survival (OS) times. During a median follow-up of 19.3 months, 152 patients (20.79%) developed a VTE. The median time from PDAC diagnosis to the onset of VTE was 4.49 months. Cumulative incidence values of VTE were 8.07% (95% confidence interval [CI], 6.31-10.29) at 3 months and 19.21% (95% CI, 16.27-22.62) at 12 months. In multivariate analysis, PDAC primary tumor location (isthmus vs head: hazard ratio [HR], 2.06; 95% CI, 1.09-3.91; P = .027) and stage (locally advanced vs resectable or borderline: HR, 1.66; 95% CI, 1.10-2.51, P = .016; metastatic vs resectable or borderline: HR, 2.50; 95% CI, 1.64-3.79; P < .001) were independent risk factors for the onset of VTE. Patients who developed VTE during follow-up had shorter times of PFS (HR, 1.74; 95% CI, 1.19-2.54; P = .004) and OS (HR, 2.02; 95% CI, 1.57-2.60; P < .001). In an analysis of data from the BACAP study, we found that frequent and early onsets of VTE after diagnoses of PDAC are associated with significant decreases in times of PFS and OS. Studies are needed to determine whether primary prophylaxis of VTE in patients with PDAC will improve morbidity and mortality related to VTE. (ClinicalTrials.gov, Number: clinicaltrials.gov as number NCT02818829).
Sections du résumé
BACKGROUND & AIMS
Pancreatic ductal adenocarcinoma (PDAC) is associated with the highest incidence of venous thromboembolism (VTE) of any cancer type. However, little is known about risk factors for VTE or its outcomes in patients with PDAC.
METHODS
We collected data from a prospective, observational study performed at multiple centers in France from May 2014 through November 2018 (the Base Clinico-Biologique de l'Adénocarcinome Pancréatique [BACAP] study) linked to a database of patients with a new diagnosis of PDAC of any stage. Data were collected from 731 patients at baseline and during clinical follow-up or in the event of symptoms. The primary endpoint was the onset of VTE during follow-up. The secondary endpoints were progression-free survival (PFS) and overall survival (OS) times.
RESULTS
During a median follow-up of 19.3 months, 152 patients (20.79%) developed a VTE. The median time from PDAC diagnosis to the onset of VTE was 4.49 months. Cumulative incidence values of VTE were 8.07% (95% confidence interval [CI], 6.31-10.29) at 3 months and 19.21% (95% CI, 16.27-22.62) at 12 months. In multivariate analysis, PDAC primary tumor location (isthmus vs head: hazard ratio [HR], 2.06; 95% CI, 1.09-3.91; P = .027) and stage (locally advanced vs resectable or borderline: HR, 1.66; 95% CI, 1.10-2.51, P = .016; metastatic vs resectable or borderline: HR, 2.50; 95% CI, 1.64-3.79; P < .001) were independent risk factors for the onset of VTE. Patients who developed VTE during follow-up had shorter times of PFS (HR, 1.74; 95% CI, 1.19-2.54; P = .004) and OS (HR, 2.02; 95% CI, 1.57-2.60; P < .001).
CONCLUSION
In an analysis of data from the BACAP study, we found that frequent and early onsets of VTE after diagnoses of PDAC are associated with significant decreases in times of PFS and OS. Studies are needed to determine whether primary prophylaxis of VTE in patients with PDAC will improve morbidity and mortality related to VTE. (ClinicalTrials.gov, Number: clinicaltrials.gov as number NCT02818829).
Identifiants
pubmed: 31843588
pii: S0016-5085(19)41921-5
doi: 10.1053/j.gastro.2019.12.009
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02818829']
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1346-1358.e4Investigateurs
Barbara Bournet
(B)
Cindy Canivet
(C)
Louis Buscail
(L)
Nicolas Carrère
(N)
Fabrice Muscari
(F)
Bertrand Suc
(B)
Rosine Guimbaud
(R)
Corinne Couteau
(C)
Marion Deslandres
(M)
Pascale Rivera
(P)
Anne-Pascale Laurenty
(AP)
Nadim Fares
(N)
Karl Barange
(K)
Janick Selves
(J)
Anne Gomez-Brouchet
(A)
Bertrand Napoléon
(B)
Bertrand Pujol
(B)
Fabien Fumex
(F)
Jérôme Desrame
(J)
Christine Lefort
(C)
Vincent Lepilliez
(V)
Rodica Gincul
(R)
Pascal Artru
(P)
Léa Clavel
(L)
Anne-Isabelle Lemaistre
(AI)
Laurent Palazzo
(L)
Jérôme Cros
(J)
Sarah Tubiana
(S)
Nicolas Flori
(N)
Pierre Senesse
(P)
Pierre-Emmanuel Colombo
(PE)
Emmanuelle Samail-Scalzi
(E)
Fabienne Portales
(F)
Sophie Gourgou
(S)
Claire Honfo Ga
(CH)
Carine Plassot
(C)
Julien Fraisse
(J)
Frédéric Bibeau
(F)
Marc Ychou
(M)
Pierre Guibert
(P)
Christelle de la Fouchardière
(C)
Matthieu Sarabi
(M)
Patrice Peyrat
(P)
Séverine Tabone-Eglinger
(S)
Caroline Renard
(C)
Guillaume Piessen
(G)
Stéphanie Truant
(S)
Alain Saudemont
(A)
Guillaume Millet
(G)
Florence Renaud
(F)
Emmanuelle Leteurtre
(E)
Patrick Gele
(P)
Eric Assenat
(E)
Jean-Michel Fabre
(JM)
François-Régis Souche
(FR)
Marie Dupuy
(M)
Anne-Marie Gorce-Dupuy
(AM)
Jeanne Ramos
(J)
Jean-François Seitz
(JF)
Jean Hardwigsen
(J)
Emmanuelle Norguet-Monnereau
(E)
Philippe Grandval
(P)
Muriel Duluc
(M)
Dominique Figarella-Branger
(D)
Véronique Vendrely
(V)
Clément Subtil
(C)
Eric Terrebonne
(E)
Jean-Frédéric Blanc
(JF)
Etienne Buscail
(E)
Jean-Philippe Merlio
(JP)
Dominique Farge
(D)
Jean-Marc Gornet
(JM)
Daniela Geromin
(D)
Geoffroy Vanbiervliet
(G)
Anne-Claire Frin
(AC)
Delphine Ouvrier
(D)
Marie-Christine Saint-Paul
(MC)
Philippe Berthelémy
(P)
Chelbabi Fouad
(C)
Stéphane Garcia
(S)
Nathalie Lesavre
(N)
Mohamed Gasmi
(M)
Marc Barthet
(M)
Vanessa Cottet
(V)
Cyrille Delpierre
(C)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.