Incidence and risk factors for venous thromboembolism in gynecological cancer: the GOTIC-VTE trial.

Real-world data on venous thromboembolism (VTE) in Japanese patients with gynecological cancer are lacking. The GOTIC-VTE trial aimed to evaluate the frequency of VTE-associated events and risk factors at the time of cancer diagnosis and during 1-year follow-up. From July 2017 to February 2019, patients with endometrial, cervical, ovarian, tubal, or peritoneal cancer who underwent VTE screening within 2 months before registration, were enrolled. Of the 1008 patients enrolled, 881 were included in the analysis set, 51 (5.8%) had VTE at the time of cancer diagnosis (baseline), 7 (0.8%) had symptomatic VTE, and the majority had asymptomatic VTE (n = 44; 5.0%). Patients with ovarian, tubal, or peritoneal cancer had a higher incidence of VTE (13.7%) than those with other cancer types. During the 1-year follow-up, 0.9% (n = 8) of the patients had symptomatic VTE, 3.5% (n = 31) had composite VTE (symptomatic VTE and incidental VTE requiring treatment), 0.2% (n = 2) had bleeding events, and 4.3% (n = 38) had all-cause death, all of which were significantly higher in the VTE group at baseline. In the multivariate analysis, chemotherapy was an independent risk factor for composite VTE during the 1-year follow-up (hazard ratio 3.85, 95% confidence interval 1.39-13.63, p = 0.018). Among gynecological cancers, VTE incidence is particularly high in ovarian, tubal, or peritoneal cancer, and patients undergoing chemotherapy should be cautioned against VTE occurrence during treatment.The GOTIC-VTE trial Unique identifier, jRCTs031180124; Registration date, April 06, 2017.
Competing Interests: Declarations. Conflict of interest: Yoshifumi Takahashi received honoraria from Daiichi Sankyo. Hiroyuki Fujiwara received honoraria from Daiichi Sankyo, AstraZeneca, and Takeda Pharmaceuticals. Toyomi Satoh received honoraria from Daiichi Sankyo. Kouji Yamamoto received a research grant from Daiichi Sankyo. Keiich Fujiwara received honoraria from Daiichi Sankyo. The other authors have no conflict of interest. All authors had full access to all of the data in the study and had final responsibility for the decision to submit for publication. Ethical approval: This study was conducted in accordance with the principles of the Declaration of Helsinki. Approval of the research protocol by an Institutional Reviewer Board: Jichi Medical University Central Clinical Research Ethics Committee (Permission number: 20JMU001Mre). Consent to participate: All participants provided written informed consent at the time of the registration.
(© 2024. The Author(s).)