Robert D McBane1,2,3, Waldemar E Wysokinski1,2,3, Jennifer G Le-Rademacher4, Tyler Zemla4, Aneel Ashrani1,2, Alfonso Tafur5, Usha Perepu6, Daniel Anderson7, Krishna Gundabolu8, Charles Kuzma9, Juliana Perez Botero10, Roberto A Leon Ferre11, Stanislav Henkin12, Charles J Lenz1,3, Damon E Houghton1,2,3, Prakash Vishnu13, Charles L Loprinzi11. 1. Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota. 2. Hematology Division, Mayo Clinic, Rochester, Minnesota. 3. Cardiovascular Department, Mayo Clinic, Rochester, Minnesota. 4. Health Science Research Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota. 5. NorthShore Medical Group, Evanston, Illinois. 6. Medical Oncology, University of Iowa, Iowa City, Iowa. 7. Department of Hematology, Oncology and Transplantation, University of Minnesota, Regions Hospital, St Paul, Minnesota. 8. Department of Oncology and Hematology, University of Nebraska Medical Center, Omaha, Nebraska. 9. Department of Hematology and Oncology, First Health of the Carolinas, Pinehurst, North Carolina. 10. Froedtert Cancer Center, Milwaukee, Wisconsin. 11. Medical Oncology Department, Mayo Clinic, Rochester, Minnesota. 12. Department of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. 13. Department of Oncology and Hematology, Mayo Clinic, Jacksonville, Florida.
Abstract
BACKGROUND: Low-molecular-weight heparin is the guideline-endorsed treatment for cancer-associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, limited data support its use in cancer patients. OBJECTIVES: The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB). PATIENTS/ METHODS:Patients with cancer-associated VTE were randomly assigned to receive either apixaban 10 mg twice daily for seven days followed by 5 mg twice daily for six months or subcutaneous dalteparin (200 IU/kg for one month followed by 150 IU/kg once daily). RESULTS: Of 300 patients randomized, 287 were included in the primary analysis. Metastatic disease was present in 66% of subjects; 74% were receiving concurrent chemotherapy. Major bleeding occurred in 0% of 145 patients receiving apixaban, compared with 1.4% of 142 patients receiving dalteparin [P = .138; hazard ratio (HR) not estimable because of 0 bleeding event in apixaban group]. Recurrent VTE occurred in 0.7% of apixaban, compared to 6.3% of dalteparin patients [HR 0.099, 95% confidence interval [CI], 0.013-0.780, P = .0281). Major bleeding or CRNMB rates were 6% for both groups. CONCLUSIONS:Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.
RCT Entities:
BACKGROUND: Low-molecular-weight heparin is the guideline-endorsed treatment for cancer-associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, limited data support its use in cancerpatients. OBJECTIVES: The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB). PATIENTS/ METHODS:Patients with cancer-associated VTE were randomly assigned to receive either apixaban 10 mg twice daily for seven days followed by 5 mg twice daily for six months or subcutaneous dalteparin (200 IU/kg for one month followed by 150 IU/kg once daily). RESULTS: Of 300 patients randomized, 287 were included in the primary analysis. Metastatic disease was present in 66% of subjects; 74% were receiving concurrent chemotherapy. Major bleeding occurred in 0% of 145 patients receiving apixaban, compared with 1.4% of 142 patients receiving dalteparin [P = .138; hazard ratio (HR) not estimable because of 0 bleeding event in apixaban group]. Recurrent VTE occurred in 0.7% of apixaban, compared to 6.3% of dalteparin patients [HR 0.099, 95% confidence interval [CI], 0.013-0.780, P = .0281). Major bleeding or CRNMB rates were 6% for both groups. CONCLUSIONS: Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancerpatients.
Authors: A J Muñoz Martín; E Gallardo Díaz; I García Escobar; R Macías Montero; V Martínez-Marín; V Pachón Olmos; P Pérez Segura; T Quintanar Verdúguez; M Salgado Fernández Journal: Clin Transl Oncol Date: 2020-01-24 Impact factor: 3.405
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