Corinne Frere1, Barbara Bournet2, Sophie Gourgou3, Julien Fraisse3, Cindy Canivet2, Jean M Connors4, Louis Buscail2, Dominique Farge5. 1. Sorbonne Université, INSERM UMRS_1166, Institute of Cardiometabolism and Nutrition, Paris, France; Assistance Publique Hôpitaux de Paris, Department of Haematology, Pitié-Salpêtrière Hospital, Paris, France. 2. University of Toulouse, Toulouse, France; CHU de Toulouse, Department of Gastroenterology and Pancreatology, Toulouse, France. 3. Université de Montpellier, Institut du Cancer de Montpellier-Unité de Biométrie, Montpellier, France. 4. Hematology Division, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. 5. Université de Paris, Institut Universitaire d'Hématologie, Paris, France; Assistance Publique Hôpitaux de Paris, Saint-Louis Hospital, Internal Medicine, Autoimmune and Vascular Disease Unit, Paris, France; Department of Medicine, McGill University, Montreal, Québec, Canada. Electronic address: dominique.farge-bancel@aphp.fr.
Abstract
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).
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).
Authors: Dominique Farge; Barbara Bournet; Thierry Conroy; Eric Vicaut; Janusz Rak; George Zogoulous; Jefferey Barkun; Mehdi Ouaissi; Louis Buscail; Corinne Frere Journal: Cancers (Basel) Date: 2020-03-06 Impact factor: 6.639
Authors: Eric Van Cutsem; Margaret A Tempero; Darren Sigal; Do-Youn Oh; Nicola Fazio; Teresa Macarulla; Erika Hitre; Pascal Hammel; Andrew E Hendifar; Susan E Bates; Chung-Pin Li; Sunil R Hingorani; Christelle de la Fouchardiere; Anup Kasi; Volker Heinemann; Anthony Maraveyas; Nathan Bahary; Laura Layos; Vaibhav Sahai; Lei Zheng; Jill Lacy; Joon Oh Park; Fabienne Portales; Paul Oberstein; Wilson Wu; Dimitrios Chondros; Andrea J Bullock Journal: J Clin Oncol Date: 2020-07-24 Impact factor: 50.717