Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2023 Dec;58(12):1261-1271.
doi: 10.1007/s00535-023-02033-3. Epub 2023 Sep 7.

Incidence and risk factors for venous thromboembolism in the Cancer-VTE Registry pancreatic cancer subcohort

Takuji Okusaka  1 , Akio Saiura  2 , Kazuaki Shimada  3 , Masafumi Ikeda  4 , Tatsuya Ioka  5 , Tetsuya Kimura  6 , Jun Hosokawa  6 , Atsushi Takita  7 , Mari S Oba  8   9
Affiliations
Observational Study

Incidence and risk factors for venous thromboembolism in the Cancer-VTE Registry pancreatic cancer subcohort

Takuji Okusaka et al. J Gastroenterol. 2023 Dec.

Abstract

Background: This substudy of the Cancer-VTE Registry estimated venous thromboembolism (VTE) incidence and risk factors in pancreatic cancer patients.

Methods: The Cancer-VTE Registry was an observational study that collected VTE data from patients with solid tumors across Japan. We measured baseline VTE prevalence, and at 1-year follow-up, the cumulative incidence of symptomatic and composite VTE (symptomatic VTE and incidental VTE requiring treatment), bleeding, cerebral infarction/transient ischemic attack (TIA)/systemic embolic event (SEE), and all-cause death.

Results: Of 1006 pancreatic cancer patients, 86 (8.5%) had VTE at baseline, and seven (0.7%) had symptomatic VTE. Significant risk factors of baseline VTE were Eastern Cooperative Oncology Group performance status (ECOG PS) of 1, body mass index (BMI) ≥ 25 kg/m2, history of VTE, D-dimer > 1.2 µg/mL, and hemoglobin < 10 g/dL. At 1-year follow-up, the cumulative incidence of events was higher for pancreatic cancer vs other cancers. Pancreatic cancer patients with VTE vs those without VTE had significantly higher incidences of bleeding, cerebral infarction/TIA/SEE, and all-cause death. No significant risk factors for composite VTE were identified.

Conclusions: The cumulative incidence of composite VTE during cancer treatment was higher in pancreatic cancer than in other cancer types. Some risk factors for VTE prevalence at cancer diagnosis were identified. Although VTE prevalence at cancer diagnosis did not predict the subsequent 1-year incidence of composite VTE, it was a significant predictor of other events such as all-cause death in pancreatic cancer patients.

Trial registration: UMIN Clinical Trials Registry; UMIN000024942.

Keywords: Incidence; Mortality; Pancreatic cancer; Risk factors; Venous thromboembolism.

PubMed Disclaimer

Conflict of interest statement

Takuji Okusaka received research grants from AstraZeneca K.K., Syneos Health Clinical K.K., and MSD K.K. Akio Saiura and Kazuaki Shimada have no conflicts of interest to disclose. Masafumi Ikeda received honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Incyte Biosciences Japan G.K., Novartis Pharma K.K., and Takeda Pharmaceutical Co., Ltd.; research grants from AstraZeneca K.K., Bayer Yakuhin, Ltd., Bristol-Myers Squibb K.K., Chiome Bioscience Inc., Chugai Pharmaceutical Co., Ltd., Delta-Fly Pharma, Inc., Eisai Co., Ltd., Eli Lilly Japan K.K., J Pharma Co., Ltd., Merck BioPharma Co., Ltd., Merus. N.V., MSD K.K., Nihon Servier Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Syneos Health Clinical K.K., and Invitae Japan K.K. Tatsuya Ioka received honoraria from Taiho Pharmaceutical Co., Ltd., and AstraZeneca K.K. Tetsuya Kimura, Jun Hosokawa, and Atsushi Takita are employees of Daiichi Sankyo Co., Ltd. Mari S Oba has no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
Cumulative incidence of events during the follow-up period (a) overall; (b) in patients with VTE at baseline screening; and (c) patients without VTE at baseline screening. The reference is the other five cancer types. “Other cancers” was a composite of cancers other than pancreatic cancer in the Cancer-VTE Registry (colorectal, lung, stomach, breast, and gynecologic cancer). p values in pancreatic cancer patients vs patients with the five other cancer types were calculated using Gray’s test for events other than all-cause death and the log-rank test for all-cause death. Error bars denote 95% CIs. CI confidence interval, HR hazard ratio, SEE systemic embolic event, TIA transient ischemic attack, VTE venous thromboembolism
Fig. 2
Fig. 2
Cumulative incidence of (a) symptomatic VTE; (b) composite VTE; (c) bleeding events; (d) cerebral infarction/TIA/SEE; (e) all-cause death events (time-to-event analysis) in patients with and without VTE at baseline. p values were calculated using Gray’s test (a–d) or log-rank test (e). Lightly shaded areas represent 95% CIs. CI confidence interval, HR hazard ratio, SEE systemic embolic event, TIA transient ischemic attack, VTE venous thromboembolism
See this image and copyright information in PMC

References

    1. Khorana AA, Francis CW, Culakova E, et al. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007;5:632–634. doi: 10.1111/j.1538-7836.2007.02374.x. - DOI - PubMed
    1. White RH, Keenan CR. Effects of race and ethnicity on the incidence of venous thromboembolism. Thromb Res. 2009;123(Suppl 4):S11–S17. doi: 10.1016/S0049-3848(09)70136-7. - DOI - PubMed
    1. The Japanese Circulation Society Joint Working Group. Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2017). https://www.j-circ.or.jp/cms/wp-content/uploads/2017/09/JCS2017_ito_h.pdf (in Japanese). Accessed 15 Feb 2023. - PubMed
    1. Nakamura M, Yamada N, Ito M. Current management of venous thromboembolism in Japan: current epidemiology and advances in anticoagulant therapy. J Cardiol. 2015;66:451–459. doi: 10.1016/j.jjcc.2015.03.012. - DOI - PubMed
    1. Cancer information service, National cancer center, Japan (Vital Statistics of Japan, Ministry of Health, Labour and Welfare). Cancer Statistics. https://ganjoho.jp/reg_stat/statistics/stat/cancer/10_pancreas.html (in Japanese). Accessed 20 Mar 2023.

Publication types