Trine-Lise Hannevik1, Jorunn Brekke2, Tone Enden3, Hege Frøen4, Herish Garresori5, Eva Marie Jacobsen6, Petter Quist Paulsen7, Alina Carmen Porojnicu8, Anne Hansen Ree9, Dag Torfoss10, Elin Osvik Velle11, Hilde Skuterud Wik12, Waleed Ghanima13, Per Morten Sandset14, Anders Erik Astrup Dahm15. 1. Institute of Clinical Medicine, University of Oslo, P.O. BOX. 1171 Blindern, N-0318 Oslo, Norway; Department of Haematology, Akershus University Hospital, P.O. BOX 1000, N-1478 Lørenskog, Norway. Electronic address: t.l.hannevik@medisin.uio.no. 2. Department of Oncology, Haukeland University Hospital, P.O. BOX. 1400, N-5021 Bergen, Norway. Electronic address: jorunn.brekke@helse-bergen.no. 3. Department of Radiology, Oslo University Hospital, P.O. BOX. 4950 Nydalen, N-0424 Oslo, Norway. Electronic address: t.r.enden@medisin.uio.no. 4. Department of Medicine, Baerum Hospital, Vestre Viken Hospital Trust, P.O. BOX. 800, N-3004 Drammen, Norway. Electronic address: hegfro@vestreviken.no. 5. Department of Oncology, Stavanger University Hospital, P.O. BOX. 8100, N-4068 Stavanger, Norway. Electronic address: herish.garresori@sus.no. 6. Department of Haematology, Oslo University Hospital, P.O. BOX. 4950 Nydalen, N-0424 Oslo, Norway. Electronic address: uxemja@ous-hf.no. 7. Department of Hematology, St. Olav's University Hospital, P.O. BOX. 3250 Torgarden, N-7006 Trondheim, Norway. Electronic address: petter.quist.paulsen@stolav.no. 8. Department of Oncology, Drammen Hospital, Vestre Viken Hospital Trust, P.O.BOX. 800, N-3004 Drammen, Norway. Electronic address: alinacp@vestreviken.no. 9. Institute of Clinical Medicine, University of Oslo, P.O. BOX. 1171 Blindern, N-0318 Oslo, Norway; Department of Oncology, Akershus University Hospital, P.O. BOX. 1000, N-1478 Lørenskog, Norway. Electronic address: a.h.ree@medisin.uio.no. 10. Department of Oncology, Oslo University Hospital, P.O. BOX. 4950 Nydalen, N-0424 Oslo, Norway. Electronic address: dag.torfoss@ous-hf.no. 11. Department of Medicine, Volda Hospital, Møre and Romsdal Hospital Trust Volda, P.O. BOX 1600, N-6026 Ålesund, Norway. Electronic address: elin.velle@tussa.com. 12. Department of Haematology, Oslo University Hospital, P.O. BOX. 4950 Nydalen, N-0424 Oslo, Norway. Electronic address: hilde.skuterud@vikenfiber.no. 13. Institute of Clinical Medicine, University of Oslo, P.O. BOX. 1171 Blindern, N-0318 Oslo, Norway; Clinic of Internal Medicine, Østfold Hospital, P.O. BOX 300, N-1714 Grålum, Norway. 14. Institute of Clinical Medicine, University of Oslo, P.O. BOX. 1171 Blindern, N-0318 Oslo, Norway. Electronic address: p.m.sandset@medisin.uio.no. 15. Institute of Clinical Medicine, University of Oslo, P.O. BOX. 1171 Blindern, N-0318 Oslo, Norway; Department of Haematology, Akershus University Hospital, P.O. BOX 1000, N-1478 Lørenskog, Norway. Electronic address: a.e.a.dahm@medisin.uio.no.
Abstract
INTRODUCTION: The direct oral anti-coagulants (DOAC) edoxaban and rivaroxaban are suggested treatment alternatives for cancer-associated venous thromboembolism (VTE) together with low molecular-weight heparins. New studies indicate that the DOAC apixaban also is an option for cancer-associated VTE. The current study assessed recurrent VTE, arterial thrombosis, bleedings and adverse events in a cohort of apixaban treated cancer patients with VTE. MATERIALS AND METHODS: Single-arm, interventional study of apixaban as treatment of cancer-associated VTE. Inclusion criteria were cancer with objectively verified VTE. Patients received apixaban 10 mg bid for seven days, then 5 mg bid for six months. Primary efficacy and safety outcomes were recurrent VTE and bleeding respectively. This trial is registered with ClinicalTrials.gov identifier NCT02581176. RESULTS: We recruited 298 cancer patients with VTE. During six months treatment, recurrent VTE or death related to VTE occurred in 12 patients (4.0%, 95% confidence interval (CI) 2.1-6.9%). Major bleeding occurred in 16 patients (5.4%, 95% CI 2.8-7.9), most frequently gastrointestinal bleeding. There were no overrepresentation of major bleedings among patients with gastrointestinal cancer (7/126, 5.5%, 95% CI 2.3-11%). Twenty-six patients experienced one or more clinically relevant non-major bleedings (8.9%, 95% CI 5.5-12%). Twelve patients had arterial thrombosis (4.0%, 95% CI 2.1-6.9%), of which the majority were strokes in patients with pancreatic cancer. Death occurred in 35 patients (12%, 95% CI 8.3-16%). CONCLUSION: The frequency of recurrent VTE and major bleedings are in line with other studies on apixaban in cancer-associated VTE. Arterial thrombosis was a frequent serious adverse event.
INTRODUCTION: The direct oral anti-coagulants (DOAC) edoxaban and rivaroxaban are suggested treatment alternatives for cancer-associated venous thromboembolism (VTE) together with low molecular-weight heparins. New studies indicate that the DOAC apixaban also is an option for cancer-associated VTE. The current study assessed recurrent VTE, arterial thrombosis, bleedings and adverse events in a cohort of apixaban treated cancerpatients with VTE. MATERIALS AND METHODS: Single-arm, interventional study of apixaban as treatment of cancer-associated VTE. Inclusion criteria were cancer with objectively verified VTE. Patients received apixaban 10 mg bid for seven days, then 5 mg bid for six months. Primary efficacy and safety outcomes were recurrent VTE and bleeding respectively. This trial is registered with ClinicalTrials.gov identifier NCT02581176. RESULTS: We recruited 298 cancerpatients with VTE. During six months treatment, recurrent VTE or death related to VTE occurred in 12 patients (4.0%, 95% confidence interval (CI) 2.1-6.9%). Major bleeding occurred in 16 patients (5.4%, 95% CI 2.8-7.9), most frequently gastrointestinal bleeding. There were no overrepresentation of major bleedings among patients with gastrointestinal cancer (7/126, 5.5%, 95% CI 2.3-11%). Twenty-six patients experienced one or more clinically relevant non-major bleedings (8.9%, 95% CI 5.5-12%). Twelve patients had arterial thrombosis (4.0%, 95% CI 2.1-6.9%), of which the majority were strokes in patients with pancreatic cancer. Death occurred in 35 patients (12%, 95% CI 8.3-16%). CONCLUSION: The frequency of recurrent VTE and major bleedings are in line with other studies on apixaban in cancer-associated VTE. Arterial thrombosis was a frequent serious adverse event.