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A Phase II Study to Compare the Safety and Efficacy of Direct Oral Anticoagulants versus Subcutaneous Dalteparin for Cancer-Associated Venous Thromboembolism in Patients with Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY

1
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea
2
Division of Oncology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul 05505, Korea
3
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea
4
Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam 13620, Korea
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Department of Oncology, Haeundae Paik Hospital, Cancer Center, Inje University College of Medicine, Busan 47392, Korea
6
Division of Hematology and Oncology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon 35015, Korea
7
Division of Hematology-Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan 44033, Korea
*
Author to whom correspondence should be addressed.
These authors equally contributed to this work.
Academic Editor: Jesús García-Foncillas
Cancers 2022, 14(3), 559; https://doi.org/10.3390/cancers14030559
Received: 7 December 2021 / Revised: 14 January 2022 / Accepted: 20 January 2022 / Published: 22 January 2022
This prospective phase II trial evaluated the safety and efficacy of direct oral anticoagulants (DOACs) versus subcutaneous dalteparin for cancer-associated venous thromboembolism (CA-VTE) in patients with high-risk cancer types and currently active advanced cancers. The clinically relevant bleeding (CRB) as the primary endpoint and major bleeding (MB) more occurred in the DOAC group than in the dalteparin group, and the hazard ratio for CRB and MB was approximately three and four times more in the DOAC group than in the dalteparin group. Cancer involvement at the GI mucosa was also a significant risk factor for CRB. The extra caution is necessary when using DOAC therapy for CA-VTE in patients with advanced upper gastrointestinal (GI) tract, hepatobiliary, or pancreatic cancer.
Background: We evaluated the safety and efficacy of direct oral anticoagulants (DOACs) versus subcutaneous dalteparin for cancer-associated venous thromboembolism (CA-VTE) in patients with advanced upper gastrointestinal (GI) tract, hepatobiliary, or pancreatic cancer. Methods: This was a multicenter, randomized, open-label, phase II trial in five centers. Patients randomly received rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily)/apixaban (10 mg twice daily for the first 7 days, then 5 mg twice daily) or dalteparin (200 IU/kg once daily for the first month, then 150 IU/kg once daily). Randomization was stratified by the Eastern Cooperative Oncology Group Performance Status, primary cancer type, active chemotherapy, and participating centers. The primary endpoint was the rates of clinically relevant bleeding (CRB) in the full analysis set (FAS). Results: A total of 90 patients were randomly assigned to the DOAC (n = 44) and dalteparin groups (n = 46) in FAS. CRB and major bleeding (MB) rates were 34.1% and 13.0% (p = 0.018) and 18.2% and 4.3% (p = 0.047) for the DOAC and dalteparin groups, respectively. Time to CRB and MB was higher in the DOAC group than in the dalteparin group (hazard ratio [HR] 2.83; p = 0.031 and HR 4.32; p = 0.064). Cancer involvement at the GI mucosa was also a significant risk factor for CRB. Recurrent CA-VTE occurred in 2.3% and 2.2% of patients given DOAC and dalteparin, respectively (p = 1.000). Conclusion: DOAC therapy further increased the risk of bleeding compared with dalteparin in patients with active advanced upper GI tract, hepatobiliary, or pancreatic cancer, suggesting that extra caution should be taken when selecting anticoagulants for CA-VTE. View Full-Text
Keywords: dalteparin; rivaroxaban; apixaban; venous thromboembolism; gastrointestinal tract cancer; hepatobiliary cancer; pancreatic cancer dalteparin; rivaroxaban; apixaban; venous thromboembolism; gastrointestinal tract cancer; hepatobiliary cancer; pancreatic cancer
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MDPI and ACS Style

Kim, J.H.; Yoo, C.; Seo, S.; Jeong, J.H.; Ryoo, B.-Y.; Kim, K.-p.; Lee, J.B.; Lee, K.-W.; Kim, J.-W.; Kim, I.-H.; Kang, M.; Ryu, H.; Cheon, J.; Park, S.R. A Phase II Study to Compare the Safety and Efficacy of Direct Oral Anticoagulants versus Subcutaneous Dalteparin for Cancer-Associated Venous Thromboembolism in Patients with Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY. Cancers 2022, 14, 559. https://doi.org/10.3390/cancers14030559

AMA Style

Kim JH, Yoo C, Seo S, Jeong JH, Ryoo B-Y, Kim K-p, Lee JB, Lee K-W, Kim J-W, Kim I-H, Kang M, Ryu H, Cheon J, Park SR. A Phase II Study to Compare the Safety and Efficacy of Direct Oral Anticoagulants versus Subcutaneous Dalteparin for Cancer-Associated Venous Thromboembolism in Patients with Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY. Cancers. 2022; 14(3):559. https://doi.org/10.3390/cancers14030559

Chicago/Turabian Style

Kim, Jwa H., Changhoon Yoo, Seyoung Seo, Jae H. Jeong, Baek-Yeol Ryoo, Kyu-pyo Kim, Jung B. Lee, Keun-Wook Lee, Ji-Won Kim, Il-Hwan Kim, Myoungjoo Kang, Hyewon Ryu, Jaekyung Cheon, and Sook R. Park. 2022. "A Phase II Study to Compare the Safety and Efficacy of Direct Oral Anticoagulants versus Subcutaneous Dalteparin for Cancer-Associated Venous Thromboembolism in Patients with Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY" Cancers 14, no. 3: 559. https://doi.org/10.3390/cancers14030559

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