Abstract 19936: Venous Thromboembolism Recurrence and Bleeding Risk Among Cancer Patients Using a Large Commercial Database

Objectives: To describe the role of anticoagulant use, active cancer and venous thromboembolism (VTE) type on bleeding risk and VTE recurrence among cancer patients diagnosed with VTE. Methods: A retrospective observational analysis of the Humedica database between 01JAN2008 and 31MARCH2014 was conducted including adult patients (aged >18 years) with ≥2 VTE diagnosis claims (ICD-9-CM codes) in an outpatient setting or with one VTE diagnosis in an inpatient setting who had continuous health plan enrollment 6 months pre-index date. Active cancer patients were differentiated from cancer patients based on diagnosis codes during the baseline period. The incidence rate (in person-years) was calculated for major bleeding and VTE recurrence. Time-to-major bleeding and time-to-VTE recurrence were estimated using Kaplan-Meier curves; a Cox regression was applied to adjust for baseline demographic and clinical characteristics. Results: A total of 72,224 cancer patients were identified, which included 8,222 active cancer patients. More than 70% of cancer patients were prescribed anticoagulants. The incidence rate of VTE recurrence (24.7 vs. 14.3 per 100 person-years) and major bleeding events (31.2 vs. 15.9 per 100 person-years) was higher among active cancer patients than all VTE cancer patients. The use of combination parenteral and oral anticoagulant treatment (hazard ratio [HR]=1.30, p<0.0001), active cancer (HR=1.10, p=0.0007) and having both pulmonary embolism (PE) and deep vein thrombosis (DVT) as prior diagnoses (HR=1.17, P<0.0001) were significantly associated with an increased risk of major bleeding. Clinical predictors of VTE recurrence included active cancer (HR=1.35, p<0.0001) and having both PE and DVT as prior diagnoses (HR=1.32, p<0.0001). Patients treated with anticoagulants (HR=0.71, p<0.0001) were at a lower risk of VTE recurrence. Discussion: Active cancer and having both PE and DVT as prior diagnoses were associated with increased VTE recurrence and bleeding risk. The bleeding risk was also highest among patients undergoing parenteral and oral anticoagulant therapy. However, anticoagulant treatment was shown to be associated with a lower risk of VTE recurrence.

Download Full-text

Clinical Impact and Course of Anticoagulant-Related Major Bleeding in Cancer Patients

Blood ◽

10.1182/blood.v128.22.2611.2611 ◽

2016 ◽

Vol 128 (22) ◽

pp. 2611-2611 ◽

Cited By ~ 1

Author(s):

Noémie Kraaijpoel ◽

Nick van Es ◽

Suzanne M Bleker ◽

Marjolein P Brekelmans ◽

Elise S Eerenberg ◽

...

Keyword(s):

Venous Thromboembolism ◽

Board Of Directors ◽

Cancer Patients ◽

Major Bleeding ◽

Clinical Presentation ◽

Clinical Course ◽

Vitamin K Antagonists ◽

Phase Iii ◽

Anticoagulant Treatment ◽

Advisory Committees

Abstract Background Venous thromboembolism (VTE), comprising deep vein thrombosis and pulmonary embolism, is a frequent complication in cancer patients. During anticoagulant treatment for VTE, the risk of major bleeding events (MBE) is 2- to 6-fold higher in cancer patients than in those without cancer. It is unknown whether the clinical presentation and course of anticoagulant-related MBE in cancer patients differ from patients without cancer. Methods Individual patient data from 4 randomized controlled phase III trials in which factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban) were compared with vitamin K antagonists for the treatment of VTE were used for the present analysis. The severity of the clinical presentation and clinical course of anticoagulant-related MBE were compared between patients with and without cancer. Using predefined criteria, the severity of the clinical presentation and course of MBE were classified into four categories by independent adjudicators, who were blinded to treatment allocation. Category 1 indicates a mild clinical presentation or course, while category 4 indicates a severe presentation or course (Table 1). A one-stage meta-analysis was used to estimate crude odds ratios (ORs) and ORs adjusted for age, sex, and type of anticoagulant treatment with 95% confidence intervals (CIs) for the effect of cancer on the severity of the clinical presentation and course. For this analysis categories 3 and 4 were combined. We also explored the cause and site of bleeding in these patients. Results The study group comprised 290 patients with MBE, of whom 50 (17%) had active cancer or were diagnosed with cancer during follow-up. The clinical presentation was judged to be severe (category 3 or 4) in 38% of patients with cancer and 44% of patients without cancer (adjusted OR 0.90, 95% CI 0.47-1.72). Clinical course was judged to be severe in 20% and 25% of patients with and without cancer, respectively (adjusted OR 0.75, 95% CI 0.35-1.61) (Table 2). The bleeding pattern varied significantly between the two groups (p=0.002); cancer patients more often had gastrointestinal (52% vs. 35%) and vaginal (14% vs. 6%) MBE, whereas intracranial (19% vs. 6% and retroperitoneal (5% vs. 0%) MBE occurred more often in patients without cancer (Table 3). MBE was related to the tumor site in 40% of cancer patients. Conclusion The findings of the present study indicate that the clinical presentation and course of anticoagulant-related MBE are not more severe in cancer patients than in patients without cancer, which is reassuring for physicians who treat cancer-associated VTE. Disclosures Eerenberg: Sanquin: Consultancy; CSL Behring: Consultancy; Baxter: Consultancy. Middeldorp:Aspen: Consultancy, Honoraria; Boehringer Ingelheim: Consultancy; Daiichi Sankyo: Consultancy, Honoraria; Bayer: Consultancy; Sanquin: Consultancy; GSK: Consultancy, Honoraria; BMS/Pfizer: Consultancy, Honoraria. Cohen:Takeda: Consultancy; Leo Pharma: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; Daiichi Sankyo: Consultancy, Honoraria, Speakers Bureau; Bayer: Consultancy, Honoraria, Speakers Bureau; Department of Health: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Honoraria, Speakers Bureau; Medscape: Speakers Bureau; UK Government Health Select Committee: Membership on an entity's Board of Directors or advisory committees; Boehringer Ingelheim: Consultancy, Speakers Bureau; Colation to Prevent Venous Thromboembolism: Other: Founder; NHS: Membership on an entity's Board of Directors or advisory committees; Johnson & Johnson: Consultancy, Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; Aspen: Consultancy, Speakers Bureau; ONO: Consultancy, Honoraria; XO1: Consultancy, Honoraria; Portola: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy; Lifeblood: Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria.

Download Full-text

Prevention and treatment of venous thromboembolism in cancer patients: project of clinical guidelines

Ukrainian Journal of Cardiology ◽

10.31928/1608-635x-2020.3.7588 ◽

2020 ◽

Vol 27 (3) ◽

pp. 75-88

Author(s):

S. M. Kozhukhov ◽

N. V. Dovganich ◽

I. I. Smolanka ◽

I. A. Kryachok ◽

O. F. Ligirda

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Cancer Progression ◽

Bleeding Risk ◽

Treatment Modalities ◽

Bleeding Events ◽

Related Factors ◽

Management Algorithm ◽

Cancer Associated Thrombosis ◽

Active Cancer

Cancer-associated thrombosis is an actual issue in the intersection of cardiology and oncology. Active cancer counts for approximately 20 % of the total number of cases of venous thromboembolism (VTE), and VTE is one of the leading cause of death in cancer patients, second only to cancer progression. VTE in cancer has some features that distinguish it from other VTE cases. The combination of cancer-related, treatment-related and patient-related factors increases their overall risk of VTE. The experts of the Cardio-Oncology working group have created a practical approach guideline for the management of VTE in cancer patients based on a multi-disciplinary strategy, ESMO, ASCO recommendations. This document has collected information on VTE, bleeding events and treatment modalities in cancer patients that may be beneficial for clinicians in determining strategies of anticoagulant therapies in these patients. Clinicians of various specialties using these recommendations will be able to determine the most appropriate VTE management algorithm, taking into account the bleeding risk, the type of cancer with its treatment, and drug interactions.

Download Full-text

Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis

Blood ◽

10.1182/blood-2002-01-0108 ◽

2002 ◽

Vol 100 (10) ◽

pp. 3484-3488 ◽

Cited By ~ 1049

Author(s):

Paolo Prandoni ◽

Anthonie W. A. Lensing ◽

Andrea Piccioli ◽

Enrico Bernardi ◽

Paolo Simioni ◽

...

Keyword(s):

Venous Thromboembolism ◽

Venous Thrombosis ◽

Cancer Patients ◽

Major Bleeding ◽

Cumulative Incidence ◽

Hazard Ratio ◽

Anticoagulant Treatment ◽

Thromboembolic Complications ◽

Patients With Cancer ◽

Recurrent Venous Thromboembolism

A small proportion of patients with deep vein thrombosis develop recurrent venous thromboembolic complications or bleeding during anticoagulant treatment. These complications may occur more frequently if these patients have concomitant cancer. This prospective follow-up study sought to determine whether in thrombosis patients those with cancer have a higher risk for recurrent venous thromboembolism or bleeding during anticoagulant treatment than those without cancer. Of the 842 included patients, 181 had known cancer at entry. The 12-month cumulative incidence of recurrent thromboembolism in cancer patients was 20.7% (95% CI, 15.6%-25.8%) versus 6.8% (95% CI, 3.9%- 9.7%) in patients without cancer, for a hazard ratio of 3.2 (95% CI, 1.9-5.4) The 12-month cumulative incidence of major bleeding was 12.4% (95% CI, 6.5%-18.2%) in patients with cancer and 4.9% (95% CI, 2.5%-7.4%) in patients without cancer, for a hazard ratio of 2.2 (95% CI, 1.2-4.1). Recurrence and bleeding were both related to cancer severity and occurred predominantly during the first month of anticoagulant therapy but could not be explained by sub- or overanticoagulation. Cancer patients with venous thrombosis are more likely to develop recurrent thromboembolic complications and major bleeding during anticoagulant treatment than those without malignancy. These risks correlate with the extent of cancer. Possibilities for improvement using the current paradigms of anticoagulation seem limited and new treatment strategies should be developed.

Download Full-text

Low Dose Apixaban As Secondary Prophylaxis for Venous Thromboembolism in Cancer Patients, 30 Months Follow-up

Blood ◽

10.1182/blood-2021-148105 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 3231-3231

Author(s):

Trine-Lise Hannevik ◽

Herish Garresori ◽

Jorunn Brekke ◽

Tone Ronnaug Enden ◽

Hege Froen ◽

...

Keyword(s):

Venous Thromboembolism ◽

Board Of Directors ◽

Cancer Patients ◽

Incidence Rate ◽

Major Bleeding ◽

Low Dose ◽

Advisory Committees ◽

Full Dose ◽

Kaplan Meier ◽

Recurrent Vte

Abstract Background: Apixaban is a treatment option for venous thromboembolism (VTE) in cancer patients. There are no data on the effect of low dose apixaban after 6 months treatment. We wanted to assess the efficacy and safety of apixaban 2.5 mg twice daily as prophylaxis for recurrent VTE after 6 months initial treatment with full-dose apixaban. Patients and methods: We included 298 patients with cancer and any type of VTE. All patients were treated with full dose apixaban for the first 6 months. After 6 months, all patients with active cancer continued with apixaban 2.5 mg twice daily and were followed for the next 30 months. The primary endpoint of efficacy was recurrent VTE, the primary safety endpoint was major bleedings. Clinically relevant non-major bleedings was a secondary endpoint. The endpoints are reported as incidence rates or fractions with 95% confidence intervals, and as Kaplan-Meier plots. Results: During the first 6 months of full-dose anticoagulation 12 of 298 patients had recurrent VTE (4.0%, 95% confidence interval 2.1-6.9), 16 experienced major bleeding (5.4%, 95% CI 2.8-7.9%), and 26 patients experienced one or more episodes of CRNMB (8.9%, 95% CI 5.5-12) as previously reported. 1 Of the 298 patients included, 196 continued with apixaban 2.5 mg twice daily after 6 months. During treatment from 6 to 36 months with low-dose apixaban 15 of 196 (7.6%, 95% CI: 4.4-12) patients had recurrent VTE, 7 (3.6%, CI: 1.5-7.2) patients experienced major bleeding and 16 (8.2%, 95% CI: 4.7-13) patients experienced CRNMB. The highest incidence rate of both recurrent VTE and major bleedings were seen during the first month of full-dose apixaban (Table 1). After the dose reduction of apixaban, the incidence rate of recurrent VTE increased slightly during 6 to 12 months while the incidence rate of major bleeding decreased during the same time-period. After 12 months the incidence rate of both recurrent VTE and major bleeding was low and remained low during the entire 30 months follow-up (Table 1 and Figure 1). The Kaplan-Meier plot of the composite endpoint of recurrent VTE or major bleeding did not change after dose-reduction. After about 9 months treatment (i.e. 3 months on low dose apixaban) the Kaplan-Meier curve of the composite endpoint flattened out. Conclusion: Dose reduction of apixaban to 2.5 mg twice daily after 6 months of full dose anticoagulation resulted in a small increase in recurrent VTE, but a marked decrease in major bleedings during the 6-12 months period. After approximately 9 months the frequency of recurrent VTE and major bleedings remained low compared with the first 6 months of full-dose treatment. Reducing the dose of apixaban to 2.5 mg twice daily after 6 months of full-dose treatment appears safe and effective. References 1. Hannevik TL, Brekke J, Enden T, et al: Thrombosis and bleedings in a cohort of cancer patients treated with apixaban for venous thromboembolism. Thromb Res, 2020 Figure 1 Figure 1. Disclosures Hannevik: Pfizer/Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees. Garresori: Pfizer: Honoraria; Amgen: Honoraria; Bayer: Honoraria. Froen: Bristol-Myers Squibb: Honoraria; Amgen: Membership on an entity's Board of Directors or advisory committees. Porojnicu: Bristol-Myers Squibb: Honoraria. Ghanima: Bayer, BMS/Pﬁzer: Research Funding; Amgen, Novartis, Pﬁzer, Bristol Myers Squibb, SOBI, Griffols, Sanoﬁ: Honoraria; Amgen, Novartis, Pﬁzer, Principia Biopharma Inc- a Sanoﬁ Company, Sanoﬁ, SOBI, Griffols, UCB, Argenx: Consultancy. Dahm: Pfizer: Honoraria; Novartis: Honoraria; Pfizer/Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees.

Download Full-text

Aspirin After Oral Anticoagulants for Prevention of Recurrence in Patients with Unprovoked Venous Thromboembolism. the Warfasa STUDY

Blood ◽

10.1182/blood.v118.21.543.543 ◽

2011 ◽

Vol 118 (21) ◽

pp. 543-543 ◽

Cited By ~ 3

Author(s):

Cecilia Becattini ◽

Giancarlo Agnelli ◽

Renzo Poggio ◽

Sabine Eichinger ◽

Eugenio Bucherini ◽

...

Keyword(s):

Venous Thromboembolism ◽

Major Bleeding ◽

Oral Anticoagulant ◽

Conflicts Of Interest ◽

Low Cost ◽

Oral Anticoagulants ◽

Hazard Ratio ◽

Anticoagulant Treatment ◽

Double Blind ◽

Oral Anticoagulant Treatment

Abstract Abstract 543 Background A recurrence occurs in 15–20% of patients with unprovoked venous thromboembolism (VTE) in the two years after the withdrawal of oral anticoagulant treatment. Extending anticoagulant treatment is effective but associated with increased bleeding risk. We assessed the efficacy and safety of aspirin for the prevention of VTE recurrence after a conventional course of oral anticoagulation. Methods Warfasa was an investigator-initiated double-blind randomized placebo-controlled event-driven study. Patients with a first-ever unprovoked VTE who had completed 6–12 months of oral anticoagulant treatment were randomized to receive aspirin, 100 mg daily, or placebo for at least two years. The primary efficacy outcome was objectively confirmed recurrent symptomatic VTE and VTE-related death. Clinically relevant (major and non-major) bleeding were the main safety outcome. All outcome events were blindly adjudicated by an independent committee. Results A VTE recurrence occurred in 27 of the 205 patients who received aspirin and 42 of the 197 patients who received placebo (6.3% versus 11.0% patient-years; hazard ratio, 0.57, 95% CI 0.35 to 0.93) during the study period (mean 24 months) (Figure A). While on study treatment, 22 and 38 patients who received aspirin or placebo, respectively had a recurrence (5.7% versus 10.7% patient-years; hazard ratio, 0.54, 95% CI 0.32 to 0.91) (mean on-treatment period 22 months) (Figure B). One patient in each treatment group had a major bleeding, with a similar incidence of clinically relevant non-major bleeding. Conclusions Aspirin reduces by about 40% the risk of recurrence in patients with unprovoked VTE without increasing bleeding, when given after a 6–12 month anticoagulant treatment. For its safety, practicality and low cost, aspirin is a valid alternative to oral anticoagulants in the extended treatment of VTE. Disclosures: No relevant conflicts of interest to declare.

Download Full-text

Patterns of VTE Treatment with Noac in Cancer Patients - Results of the Prospective Dresden Noac Registry (NCT01588119)

Blood ◽

10.1182/blood-2019-126535 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3667-3667

Author(s):

Sandra Marten ◽

Luise Tittl ◽

Christiane Naue ◽

Jan Beyer-Westendorf

Keyword(s):

Cancer Patients ◽

Incidence Rate ◽

Major Bleeding ◽

Research Funding ◽

Randomized Trials ◽

Gi Cancer ◽

Bayer Healthcare ◽

Term Data ◽

Active Cancer

Background: Until recently, patients with cancer associated thrombosis (CAT) were predominantly treated with low-molecular weight heparin (LMWH) but trial data and updated guidelines suggest that direct oral anticoagulants (DOAC) may represent feasible and convenient oral alternatives. However, most data supporting this relate to 6-12 months outcomes only and long-term data in this setting are scarce Aims: To evaluate the effectiveness and safety of CAT treatment with DOAC in daily care. Patients and methods: From the multicentric Dresden NOAC Registry, long-term outcomes of a subgroup of CAT patients (active or recent cancer, defined as cancer therapy within 5 years prior to thrombosis) receiving CAT therapy with DOAC were evaluated, based on prospectively collected data and centrally adjudicated outcome events. Results: Of the 1667 VTE patients enrolled in the registry until 30th June 2019, 186 patients (11.2%) were identified to have CAT (mean age 67.3 years; 61.3% male). At enrolment, cancer was reported as active in 97 (52.2) cases and recent in 89 (47.8) cases. Solid malignancies were diagnosed in 163 (87.6%) cases were, the remaining 23 (12.4%) cases were hematologic malignancies; table 1; figure 1). Of the 97 cases with active malignancies, 43.3% had metastatic disease. CAT treatment consisted of rivaroxaban in 80 (43.0%) patients, 66 (35.5%) received edoxaban and 40 (21.5%) apixaban. During follow-up (mean 27.8 months, range 0.5 - 88.6), 14 patients experienced recurrent VTE events (7.5 %; incidence rate 3.5/100 pt. years) of which 4 occurred during DOAC treatment and 10 after discontinuation or during prolonged (>3d) DOAC interruption (figure 2a). During DOAC exposure (within 3 days of last intake), major bleeding occurred in 15 patients (8.1%; incidence rate 5.9/100 pt. years; figure 2b) and presented as gastrointestinal (GI) bleeding in 7, intracranial bleeding in 3 and in other bleeding manifestations in 5 cases. For 34 patients with GI cancer, the incidence rate for major bleeding was 13.3/100 pt. years and all four major bleedings in this group presented as upper GI bleed. 40 patients died during FU (21.5%; incidence rate 9.4/100 pt. years). Causes of death included terminal malignant disease (n=22), infection (n=6), fatal bleeding (n=4), age related death (n=3), fatal cardiovascular event (n=3), and other reasons (n=2). Conclusions: Our results now contribute long-term data of DOAC treatment for CAT. Incidence rates of recurrent VTE and major bleeding were consistent with the results from recent randomized trials in CAT. Most VTE recurrences occurred after interruption or discontinuation of DOAC, which indicates the importance of continued therapy especially for patients with active cancer. On-treatment rates of major bleeding were comparable for patients with recent or active cancer, indicating a need for an individualized risk-benefit assessment, especially since patients with recent cancer were at lower risk for VTE recurrence. Our findings of higher major bleeding rates in patients with GI cancer (both active and recent) is in line with the observations in randomized trials and supports guidelines recommendations, cautioning against DOAC use in CAT patients at high risk for bleeding, such as GI cancer patients. Disclosures Marten: Daiichi Sankyo: Honoraria; Bayer HealthCare: Honoraria. Tittl:Daiichi Sankyo: Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Bayer HealthCare: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding.

Download Full-text

Bleeding Risk in Thrombocytopenic Cancer Patients with Venous Thromboembolism (VTE) Receiving Anticoagulation

Blood ◽

10.1182/blood.v120.21.3408.3408 ◽

2012 ◽

Vol 120 (21) ◽

pp. 3408-3408 ◽

Cited By ~ 3

Author(s):

Naresh Pemmaraju ◽

Michael H. Kroll ◽

Vahid Afshar-Kharghan ◽

Thein H Oo

Keyword(s):

Platelet Count ◽

Venous Thromboembolism ◽

Cancer Patients ◽

Major Bleeding ◽

Bleeding Event ◽

Bleeding Risk ◽

Platelet Counts ◽

End Point ◽

History Of ◽

The Impact

Abstract Abstract 3408 Introduction: Cancer-associated thromboses are commonly treated with anticoagulants, which sometimes cause bleeding. Cancer patients receiving chemotherapy develop thrombocytopenia and these patients are at an increased risk of bleeding. Because of concerns about bleeding risk when one combines anticoagulation and thrombocytopenia, the National Comprehensive Cancer Network considers a platelet count of less than 50,000/cmm as a contraindication to anticoagulation and the American Society of Clinical Oncology recommends anticoagulation in thrombocytopenic cancer patients with caution. This retrospective chart review aims to evaluate bleeding risks associated with anticoagulation in cancer patients with platelet counts of less than 50,000/cmm. Methods: From Jaunary 2008 to January 2011 chart reviews were made of 2,711 patients (18 years or older) with ICD9 diagnoses emcompassing venous thromboembolism and thrombocytopenia. The following cases were excluded from the study, (1) no anticoagulation, (2) platelet count above 50,000/cmm, (3) tumor thrombus, (4) asynchronous thrombosis and thrombocytopenia, (5) therapeutic embolization, (6) history of thrombotic events, (7) history of thrombocytopenia. The primary end point was bleeding and the secondary end point was recurrent thrombosis. Results: 53 patients were identified; male: female = 1.2 : 1.0, median age 58 (range 19 – 84), hematologic malignancies (including myelodysplasia): solid tumors = 1.8 : 1.0, median stage of cancer = 4.0, median baseline RIETE bleeding risk score = 2.5 (range 1.0 – 5.0), median platelet count at the start of anticoagulation = 33,000/cmm (range 18,000 – 49,000/cmm), median duration of anticoagulation = 83 days (range 4 – 740 days), DVT only = 35 cases, PE only = 13 cases, DVT + PE = 5 cases, unilateral DVT: bilateral DVT = 7 : 1, upper extremity DVT: lower extremity DVT = 1.3 : 1.0. 44 patients were treated with low molecular weight heparin (LMWH), 5 patients were treated with fondaparinux and 4 patients were treated with unfractionated heparin (UFH). 23 patients received anticoagulation for less than 3 months, including 11 patients who received it for < 14 days. 15 patients had ≥ 25% dose reductions of anticoagulants. Overall, 5/53 patients (9.4%) suffered bleeding while receiving anticoagulation. Using the WHO bleeding scale, there was 1 grade 5 bleeding event (cerebral hemorrhage in a patient with AML being treated with UFH infusion for cavernous sinus thrombosis); 1 grade 4 bleeding event (tracheostomy hemorrhage in a patient receiving therapeutic dose fondaparinux) and 3 grade 2 bleeding events (1 epistaxis while on therapeutic enoxaparin 1mg/kg/12 hours, 1 case of oozing from bone marrow biopsy site while on dalteparin 200 IU/kg/day and 1 episode of hematuria while on reduced dose enoxaparin 1mg/kg/day). Overall, there was a 1 recurrent thrombotic episode (1.8%), which occurred in a patient receiving dalteparin 100 IU/kg/day. Conclusion: We conclude that anticoagulation during periods of thrombocytopenia < 50,000/cmm is feasible and may be safe. Major bleeding risk (WHO grades 3, 4 and 5) was 2/53 (3.8%). This is comparable to the 6% major bleeding rate observed with 6 months of standard LMWH anticoagulation in cancer patients with platelet counts above 75,000/cmm, as reported in the CLOT trial (N Engl J Med 2003;349:146–53). Recurrence risk is 1/53 (1.8%). This is less than the 9% six month recurrence rate observed in those treated with LMWH in the CLOT trial. Our data also suggest that the impact of anticoagulation dose-reduction appears to be minor. Validation of our conclusions will require prospective studies, which also would provide a thrust towards optimizing the therapeutic index of anticoagulation therapy in thrombocytopenic cancer patients suffering from VTE. Disclosures: Kroll: Aplagon: Membership on an entity's Board of Directors or advisory committees; Optimer: Consultancy; Leo: Honoraria, Travel Expenses, Travel Expenses Other.

Download Full-text

Elevated white blood cell count and outcome in cancer patients with venous thromboembolism

Thrombosis and Haemostasis ◽

10.1160/th08-05-0339 ◽

2008 ◽

Vol 100 (05) ◽

pp. 905-911 ◽

Cited By ~ 29

Author(s):

Javier Trujillo-Santos ◽

Pierpaolo Micco ◽

Mariateresa Iannuzzo ◽

Ramón Lecumberri ◽

Ricardo Guijarro ◽

...

Keyword(s):

Venous Thromboembolism ◽

Blood Cell ◽

Cancer Patients ◽

White Blood Cell ◽

Major Bleeding ◽

Patients With Cancer ◽

Recurrent Vte ◽

Wbc Count ◽

Acute Venous Thromboembolism ◽

Active Cancer

SummaryA significant association between elevated white blood cell (WBC) count and mortality in patients with cancer has been reported,but the predictive value of elevatedWBC on mortality in cancer patients with acute venous thromboembolism (VTE) has not been explored. RIETE is an ongoing registry of consecutive patients with acute VTE. We compared the three-month outcome of cancer patients with acuteVTE according to theirWBC count at baseline. As of May 2007, 3805 patients with active cancer and acuteVTE had been enrolled in RIETE. Of them, 215 (5.7%) had low- (<4,000 cells/µl), 2,403 (63%) normal- (4,000–11,000 cells/µl), 1,187 (31%) elevated (>11,000 cells/µl) WBC count. During the study period 190 patients (5.0%) had recurrent VTE, 156 (4.1%) major bleeding, 889 (23%) died (399 of disseminated cancer, 113 of PE, 46 of bleeding. Patients with elevated WBC count at baseline had an increased incidence of recurrent VTE (odds ratio [OR]: 1.6; 95% confidence interval [CI]:1.2–2.2),major bleeding (OR:1.5;95% CI:1.1–2.1) or death (OR:2.7;95% CI:2.3–3.2).Most of the reported causes of death were significantly more frequent in patients with elevated BC count.Multivariate analysis confirmed that elevated WBC count was independently associated with an increased incidence of all three complications. In conclusion, cancer patients with acute VTE and elevated WBC count had an increased incidence of VTE recurrences,major bleeding or death. This worse outcome was consistent among all subgroups and persisted after multivariate adjustment.

Download Full-text