Impact of mild thrombocytopenia on bleeding and recurrent thrombosis in cancer Journal Article
| Authors: | Patell, R.; Hsu, C.; Shi, M.; Grosso, M. A.; Duggal, A.; Büller, H. R.; Raskob, G.; Zwicker, J. I. |
| Article Title: | Impact of mild thrombocytopenia on bleeding and recurrent thrombosis in cancer |
| Abstract: | Thrombocytopenia occurs frequently in patients with cancer-associated thrombosis (CAT), however prospective evaluation of clinical outcomes following randomization to anticoagulants is limited. The HOKUSAI VTE Cancer study was a randomized, open-label, non-inferiority, phase III trial comparing dalteparin with edoxaban in CAT patients. This post hoc analysis of Hokusai VTE Cancer Study was performed to compare outcomes in patients with platelet count ≤100×109/L at one or more specified time points (baseline, 1-month, or 3-month) versus those without thrombocytopenia. Cumulative incidences at 180 days were calculated with death as a competing risk. The primary outcome was major bleeding; secondary outcomes were clinically relevant non-major bleeding (CRNMB), recurrent thrombosis, and survival. The analysis included 1,045 patients with primarily solid tumor malignancies (89%), median age 65 years, and 52% male. The thrombocytopenia group comprised 9.6% (N=101) of the cohort and relative to the non-thrombocytopenia cohort (N=944), experienced significantly higher major bleeding (9.0% vs. 4.0%, sub-distribution hazard ratio [SHR] =2.4; P=0.02) and CRNMB (17.9% vs. 9.6%, SHR=2.0; P=0.01). Thrombocytopenia did not impact recurrent venous thromboembolic event (VTE) (9.8% vs. 7.4%, SHR=1.3; P=0.37) nor overall mortality (21.8% vs. 26.0%, HR=0.9; P=0.48). Major bleeding was higher in patients with thrombocytopenia and gastrointestinal malignancies receiving edoxaban versus dalteparin (16.8% vs. 0; P<0.01) but similar for patients with other malignancies (P=0.30). In patients with hematologic malignances and thrombocytopenia major bleeding was higher for patients receiving dalteparin compared to edoxaban (19.0% vs. 0; P<0.01). Mild thrombocytopenia was associated with a doubling in risk of major hemorrhage in patients receiving anticoagulation for CAT. Bleeding risk for edoxaban and dalteparin varied in gastrointestinal and hematologic malignances in patients with thrombocytopenia (clinicaltrails gov. Identifier: NCT02073682). ©2024 Ferrata Storti Foundation. |
| Keywords: | adult; controlled study; event free survival; aged; middle aged; major clinical study; clinical trial; mortality; drug dose reduction; solid tumor; pyridines; outcome assessment; cancer diagnosis; neoplasm; neoplasms; metastasis; bleeding; randomized controlled trial; thrombocytopenia; cohort analysis; recurrence; deep vein thrombosis; retrospective study; risk factor; lung embolism; thrombosis; anticoagulants; recurrent disease; anticoagulation; phase 3 clinical trial; epidemiology; drug therapy; thiazoles; creatinine clearance; platelet count; pyridine derivative; anticoagulant agent; dalteparin; gastrointestinal cancer; cumulative incidence; etiology; post hoc analysis; tumor thrombus; complication; hemorrhage; thiazole derivative; humans; human; male; female; article; edoxaban |
| Journal Title: | Haematologica |
| Volume: | 109 |
| Issue: | 6 |
| ISSN: | 0390-6078 |
| Publisher: | Ferrata Storti Foundation |
| Date Published: | 2024-06-01 |
| Start Page: | 1849 |
| End Page: | 1856 |
| Language: | English |
| DOI: | 10.3324/haematol.2023.284192 |
| PUBMED: | 37855029 |
| PROVIDER: | scopus |
| PMCID: | PMC11141682 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed and PDF -- MSK corresponding author is Jeffrey Zwicker -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work