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Observational Study
. 2025 Aug 4;30(8):oyae334.
doi: 10.1093/oncolo/oyae334.

Characterization of thrombosis risk in ambulatory patients with cancer: results of the observational, prospective, multicenter CARTAGO study

Javier Trujillo-Santos  1 , Ignacio García-Escobar  2 , Mercedes Salgado  3 , António Araújo  4 , Eva Martínez-de-Castro  5 , Raquel Molina  6 , Victoria E Castellón-Rubio  7 , Pere Domènech  8 , Enrique Gallardo  9 , Esteve Colomé  10 , Ferran Torres  11 , José-Carlos Benítez-Montañez  12 , Rut Porta  13 , Míriam Lobo-de-Mena  14 , Mariana Malheiro  15 , Carme Font  16 , Elena Brozos-Vázquez  17 , Fernando Garicano  18 , Víctor Sapena  11 , Ana-Lucia Costa  19 , Ana-Cristina Albuquerque  20 , Pablo Cerezuela  21 ; CARTAGO Study Group
Collaborators, Affiliations
Observational Study

Characterization of thrombosis risk in ambulatory patients with cancer: results of the observational, prospective, multicenter CARTAGO study

Javier Trujillo-Santos et al. Oncologist. .

Abstract

Background: Venous thromboembolism (VTE) is one of the leading causes of death in patients with cancer. Currently, there is a need to develop an easily applicable risk model that can identify patients who will benefit from receiving primary thromboprophylaxis to reduce the incidence of VTE.

Patients and methods: This was a non-interventional, multicenter, observational, prospective study carried out in 62 Oncology and Hematology services in Spain and Portugal between January 2018 and December 2019. The main objective of the CARTAGO study was to develop a predictive model within a competitive risk framework to assess the risk of VTE in patients with cancer undergoing chemotherapy, biological, or hormonal treatment.

Results: A total of 1596 patients were analyzed. VTE events occurred in 124 (8%) during the 6-month follow-up period (42% of deep vein thrombosis [DVT], 48% of pulmonary embolism [PE], and 10% of both DVT and PE). Four variables were selected for the multivariate predictive model to determine the risk of VTE (tumor type, D-dimer, compression of a vessel by the tumor, and leukocyte count). The 4 variables were associated with an increased risk of VTE (C-statistic, 0.646 [95%CI, 0.620-0.673]). The most significant variables in the internal validation with bootstrapping were the "very high risk" tumors (hazard ratio [HR] 2.032; 95%CI, 1.287-3.211).

Conclusion: The CARTAGO model predicts the VTE risk in patients with cancer receiving anticancer therapy in an outpatient setting. This model can easily aid in identifying ambulatory patients who would probably benefit from primary thromboprophylaxis.

Keywords: D-dimer; cancer; leukocytes; thromboprophylaxis; venous thromboembolism.

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Conflict of interest statement

Mercedes Salgado has received advisory/consultancy and speaker engagements from Amgen, AstraZeneca, Eisai, Eli Lilly and Company, GlaxoSmithKline, LEO Pharma, Merck Serono, Merck Sharp & Dohme, Pfizer, Roche, Rovi, Sanofi, Servier, and Techdow. António Araújo has received advisory/consultancy and speaker engagements from, Eli Lilly and Company, Janssen, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Eva Martinez-de-Castro has received advisory and consultancy honoraria from AstraZeneca, Bristol Myers Squibb, Nutricia, and Servier; speaker engagements from AstraZeneca, Bristol Myers Squibb, LEO Pharma, Merck, Roche, Rovi, Servier, and Sanofi; and travel and educational support from Merck, Roche, and Servier. Raquel Molina has received travel and educational support from Amgen, Bayer, LEO Pharma, Merck, Roche, Sanofi, and Servier. Enrique Gallardo has received advisory and consultancy honoraria from Advanced Accelerator Applications, Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly and Company, EUSA Pharma, Ipsen, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Rovi, Sanofi, and Techdow; speaker engagements from Advanced Accelerator Applications, Astellas, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Eisai, Eli Lilly and Company, EUSA Pharma, Ipsen, Janssen, LEO Pharma, Merck KGaA, Pfizer, Roche, Rovi, and Sanofi; travel and accommodations expenses from Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Ipsen, Janssen, Novartis, Pfizer, Pierre Fabre, Roche, and Sanofi; and grant support from Astellas, Bayer, Bristol-Myers Squibb, Ferrer, GlaxoSmithKline, Ipsen, Janssen, Pfizer, Roche, and Sanofi. Esteve Colomé works in LEO Pharma. Ferran Torres has received advisory and consultancy honoraria from Archivel Farma, Entera Health, LEO Pharma, and Universal Diagnostics; educational and training fees from Ferrer and Janssen; and Data Safety Monitoring Board fees from Archivel Farma, Argenx, Basilea Pharmaceutica, Cellaïon, and ROVI. Míriam Lobo-de-Mena has received travel and accommodations expenses from AstraZeneca, Ipsen, Novartis, PharmaMar, Roche, and Servier; and honoraria from LEO Pharma and Servier. Mariana Malheiro has received advisory/consultancy and speaker engagements from AstraZeneca, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Ipsen, Janssen, LEO Pharma, Merck KGaA, Merck Sharp & Dohme, and Pierre Fabre; and travel and educational support from Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, LEO Pharma, Merck KGaA, Merck Sharp & Dohme, and Pierre Fabre. Elena Brozos-Vázquez has received advisory and consultancy honoraria from Bayer, Pfizer, and Servier; travel and accommodations expenses from Amgen, Eli Lilly and Company, Daiichi Sankyo, LEO Pharma, Merck, Pfizer, Roche, Rovi, Sanofi, and Servier; and educational and training fees from Amgen, Bayer, Kyowa Kirin, LEO Pharma, Merck, Pierre Fabre, Rovi, Roche, and Sanofi. Victor Sapena has received advisory and consultancy honoraria from LEO Pharma. Pablo Cerezuela has received advisory/consultancy and speaker engagements from Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi and SunPharma. The other authors declare no potential conflict of interest with respect to the research, authorship and/or publication of this article.

Figures

Figure 1.
Figure 1.
Survival plot with the model-predicted (markers) and observed (step lines) cumulative incidence function stratified by tertiles of predicted risk groups.
Figure 2.
Figure 2.
CONSORT diagram of the population of the CARTAGO study. CONSORT: Consolidated Standard of Reporting Trials. Abbreviations: DVT, deep vein thrombosis; ECOG PS, Eastern Cooperative Oncology Group performance status; PE, pulmonary embolism; VTE, venous thromboembolism.
See this image and copyright information in PMC

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