Effectiveness and safety of LMWH treatment in patients with cancer diagnosed with nonhigh-risk venous thromboembolism (VTE): Results of the Turkish observational study (TREBECA).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21656-e21656
Author(s):  
Ersin Ozaslan ◽  
Metin Ozkan ◽  
Irfan Cicin ◽  
Mustafa Benekli ◽  
Murat Kocer ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Observational Study ◽  
Cancer Patients ◽  
Normal Population ◽  
Treatment Protocol ◽  
Low Risk ◽  
Entire Study ◽  
Patients With Cancer ◽  
Primary Endpoints ◽  
Number Of Patients

e21656 Background: Venous thromboembolism (VTE) is one of the most important causes of death in cancer patients, with VTE risk being 4-7 times higher among these patients compared to normal population. TREBECA is an observational study on cancer outpatients with low risk VTE treated with LMWH. Methods: Patients were treated by medical oncologists in Turkey at 15 sites, where they were enrolled and followed-up for a period of 12 months. Each center used their own treatment protocol. Primary endpoints were efficacy and the time to a change inVTE status (dissolution of thrombosis). The doses of LMWHs have been calculated according to patients’ body weights based on the dosage scheme and administered subcutaneously once or twice daily. Results: Data for 250 patients who met the study inclusion criteria were examined and analyzed. Of the included patients; 239 patients (95.6%) completed their Day 15 visit, 176 (70.4%) completed their Month 3 visit, 130 (52.0%) completed their Month 6 visit, and 91 (36.4%) completed the entire study. The mean age of the patients was 60.2 ± 13.7, while 53.2% (n = 133) of the patients were women. Colorectal (21.2%), lung (16.8%) and breast (14.8%) cancers were the most common forms of cancer. One hundred thirty-three patients were treated with enoxaparin, 112 patients were treated with bemiparin and 5 patients were treated with tinzaparin. Bemiparin resulted thrombosis resolution in more patients than enoxaparin, during day 15, month 3 and month 6 visits (table 1; p < 0.05). Conclusions: The observation that bemiparin is more effective in resolution of thrombosis was noteworthy. Thrombosis could not be effectively treated within the first 15 days in a significant number of patients, but could effectively be treated in most patients by Month 3. We can conclude that a treatment of at least 3 months is appropriate for cancer patients, even among those who are at low risk for venous thromboembolism. [Table: see text]

scholarly journals Effectiveness and Safety of LMWH Treatment in Patients With Cancer Diagnosed With Non-High-Risk Venous Thromboembolism: Turkish Observational Study (TREBECA)

2018 ◽  
Vol 24 (6) ◽  
pp. 973-979 ◽  
Author(s):  
Ersin Ozaslan ◽  
Metin Ozkan ◽  
Irfan Cicin ◽  
Mustafa Benekli ◽  
Murat Kocer ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Protocol ◽  
Specific Treatment ◽  
Tolerability Profile ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Low Molecular Weight Heparins ◽  
Patients With Cancer ◽  
Medical Oncologists ◽  
Number Of Patients

We compared the efficacy and safety of low-molecular-weight heparins (LMWHs) in patients with cancer who are at low risk of venous thromboembolism (VTE). Patients were treated by medical oncologists in Turkey at 15 sites, where they were enrolled and followed up for a period of 12 months. Due to the study design, there was no specific treatment protocol for LMWH. Primary end points were efficacy and the time to change in VTE status. Of the included 250 patients, 239 (95.6%), 176 (70.4%), 130 (52.0%), and 91 (36.4%) completed their day 15, month 3, month 6, and month 12 visits, respectively. Number of patients treated with enoxaparin, bemiparin, and tinzaparin were 133, 112, and 5, respectively. Anticoagulant therapy provoked thrombus resolution in 1.2% and 12.7% of patients using enoxaparin and bemiparin, respectively ( P = .004). Thrombus resolution was observed in 81 more patients at month 3 visit. This ratio was 35 (40.2%) of 87 and 46 (54.1%) of 85 patients administered enoxaparin and bemiparin at the third visit, respectively ( P = .038). Thrombus resolution was observed in 21 more patients during month 6 visit. This ratio was 5 (7.7%) of 65 and 15 (23.4%) of 64 patients administered enoxaparin and bemiparin at the fourth visit, respectively ( P = .022). The LMWH was discontinued in only 2 patients due to gastrointestinal bleeding. This pioneering study shows bemiparin is more effective than enoxaparin in thrombosis resolution and has a similar tolerability profile.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

scholarly journals Adverse reactions of targeted therapy in cancer patients: a retrospective study of hospital medical data in China

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ruofei Du ◽  
Xin Wang ◽  
Lixia Ma ◽  
Leon M. Larcher ◽  
Han Tang ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Cancer Patients ◽  
Adverse Reactions ◽  
Cox Regression ◽  
Target Therapy ◽  
Skin Damage ◽  
Data Set ◽  
Patients With Cancer ◽  
Number Of Patients ◽  
Significant Difference

Abstract Background The adverse reactions (ADRs) of targeted therapy were closely associated with treatment response, clinical outcome, quality of life (QoL) of patients with cancer. However, few studies presented the correlation between ADRs of targeted therapy and treatment effects among cancer patients. This study was to explore the characteristics of ADRs with targeted therapy and the prognosis of cancer patients based on the clinical data. Methods A retrospective secondary data analysis was conducted within an ADR data set including 2703 patients with targeted therapy from three Henan medical centers of China between January 2018 and December 2019. The significance was evaluated with chi-square test between groups with or without ADRs. Univariate and multivariate logistic regression with backward stepwise method were applied to assess the difference of pathological characteristics in patients with cancer. Using the univariate Cox regression method, the actuarial probability of overall survival was performed to compare the clinical outcomes between these two groups. Results A total of 485 patients were enrolled in this study. Of all patients, 61.0% (n = 296) occurred ADRs including skin damage, fatigue, mucosal damage, hypertension and gastrointestinal discomfort as the top 5 complications during the target therapy. And 62.1% of ADRs were mild to moderate, more than half of the ADRs occurred within one month, 68.6% ADRs lasted more than one month. Older patients (P = 0.022) and patients with lower education level (P = 0.036), more than 2 comorbidities (P = 0.021), longer medication time (P = 0.022), drug combination (P = 0.033) and intravenous administration (P = 0.019) were more likely to have ADRs. Those with ADRs were more likely to stop taking (P = 0.000), change (P = 0.000), adjust (P = 0.000), or not take the medicine on time (P = 0.000). The number of patients with recurrence (P = 0.000) and metastasis (P = 0.006) were statistically significant difference between ADRs and non-ADRs group. And the patients were significantly poor prognosis in ADRs groups compared with non-ADRs group. Conclusion The high incidence of ADRs would affect the treatment and prognosis of patients with cancer. We should pay more attention to these ADRs and develop effective management strategies.

Accuracy of the CARG chemotherapy toxicity risk prediction tool in older Indian patients with cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24023-e24023
Author(s):  
Shreya Gattani ◽  
Vanita Noronha ◽  
Anant Ramaswamy ◽  
Renita Castelino ◽  
Vandhita Nair ◽  
...  
Keyword(s):  
High Risk ◽  
Cancer Patients ◽  
Risk Prediction ◽  
Risk Group ◽  
High Risk Group ◽  
Low Risk ◽  
Chemotherapy Toxicity ◽  
Patients With Cancer ◽  
Indian Patients ◽  
Grade 3

e24023 Background: Clinical judgement alone is inadequate in accurately predicting chemotherapy toxicity in older adult cancer patients. Hurria and colleagues developed and validated, the CARG score (range, 0–17) as a convenient and reliable tool for predicting chemotherapy toxicity in older cancer patients in America, however, its applicability in Indian patients is unknown. Methods: An observational retrospective and prospective study between 2018 and 2020 was conducted in the Department of Medical Oncology at Tata Memorial Hospital, Mumbai, India. The study was approved by the institutional ethics committee (IEC-III; Project No. 900596) and registered in the Clinical Trials Registry of India (CTRI/2020/04/024675). Written informed consent was obtained in the prospective part of the study. Patients aged ≥ 60 years and planned for systemic therapy were evaluated in the geriatric oncology clinic and their CARG score was calculated. Patients were stratified into low (0-4), intermediate (5-9) and high risk (10-17) based on the CARG scores. The CARG score was provided to the treating physicians, along with the results of the geriatric assessment. Chemotherapy-related toxicities were captured from the electronic medical record and graded as per the NCI CTCAE, version 4.0. Results: We assessed 130 patients, with a median age 69 years (IQR, 60 to 84); 72% patients were males. The common malignancies included gastrointestinal (52%) and lung (30%). Approximately 78% patients received polychemotherapy and 53% received full dose chemotherapy. Based on the CARG score, 28 (22%) patients belonged to low risk, 80 (61%) to intermediate risk and 22 (17%) to the high risk category. The AU-ROC of the CARG score in predicting grade 3-5 toxicities was 0.61 (95% CI, 0.51-0.71). The sensitivity and specificity of the CARG score in predicting grade 3-5 toxicities were 60.8% and 78.6%. Grade 3-5 toxicities occurred in 6/28 patients (21%) in the low risk group, compared to 62/102 patients (61%) in the intermediate /high risk group, p = 0.0002. There was also a significant difference in the time to development of grade 3-5 toxicities, which occurred at a median of 2.5 cycles (IQR, 1-3.8) in the intermediate /high risk group and at a median of 6 cycles (IQR, 3.5-8) in the low risk group, p = 0.0011. Conclusions: In older Indian patients with cancer, the CARG score reliably stratifies patients into low risk and intermediate/high risk categories, predicting both the occurrence and the time to occurrence of grade 3-5 toxicities from chemotherapy. The CARG score may aid the oncologist in estimating the risk-benefit ratio of chemotherapy. An important limitation was that we provided the CARG score to the treating oncologists prior to the start of chemotherapy, which may have resulted in alterations in the chemotherapy regimen and dose and may have impacted the CARG risk prediction model. Clinical trial information: CTRI/2020/04/024675.

scholarly journals Prevention of venous thromboembolism in cancer patients: current approaches and opportunities for improvement

2011 ◽  
pp. 191-204
Author(s):  
Alpesh N. Amin ◽  
Steven B. Deitelzweig
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Assessment Model ◽  
Major Surgery ◽  
Medical Illness ◽  
Patients With Cancer ◽  
Increased Risk ◽  
National Quality ◽  
American Society

Venous thromboembolism (VTE), a common complication in patients with cancer, is associated with increased risk of morbidity, mortality, and recurrent VTE. Risk factors for VTE in cancer patients include the type and stage of cancer, comorbidities, age, major surgery, and active chemotherapy. Evidence-based guidelines for thromboprophylaxis in cancer patients have been published: the National Comprehensive Cancer Network and American Society for Clinical Oncology guidelines recommend thromboprophylaxis for hospitalized cancer patients, while the American College of Chest Physician guidelines recommend thromboprophylaxis for surgical patients with cancer and bedridden cancer patients with an acute medical illness. Guidelines do not generally recommend routine thromboprophylaxis in ambulatory patients during chemotherapy, but there is evidence that some of these patients are at risk of VTE; some may be at higher risk while on active chemotherapy. Approaches are needed to identify those patients most likely to benefit from thromboprophylaxis, and, to this end, a risk assessment model has been developed and validated. Despite the benefits, many at-risk patients do not receive any thromboprophylaxis, or receive prophylaxis that is not compliant with guideline recommendations. Quality improvement initiatives have been developed by the Centers for Medicare and Medicaid Services, National Quality Forum, and Joint Commission to encourage closure of the gap between guideline recommendations and clinical practice for prevention, diagnosis, and treatment of VTE in hospitalized patients. Health-care institutions and providers need to take seriously the burden of VTE, improve prophylaxis rates in patients with cancer, and address the need for prophylaxis across the patient continuum.

scholarly journals Success of Online CME at Improving Knowledge and Confidence Around Guideline-Directed Management of Cancer-Associated Thrombosis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 13-13
Author(s):  
Caroline Padbury ◽  
Margaret Harris ◽  
Michael LaCouture ◽  
Jelena Spyropoulos
Keyword(s):  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Treatment Guidelines ◽  
Conflicts Of Interest ◽  
Oral Anticoagulants ◽  
Roundtable Discussion ◽  
Patients With Cancer ◽  
Cancer Associated Thrombosis ◽  
Post Assessment

Title:Success of Online CME at Improving Knowledge and Confidence Around Guideline-Directed Management of Cancer-Associated Thrombosis Study Objectives:Recent guidance statements recommend the use of direct oral anticoagulants (DOACs) as primary thromboprophylaxis in ambulatory patients with cancer who are starting chemotherapy and in patients with cancer and acute venous thromboembolism at low risk of bleeding and no drug-drug interactions.[Farge 2019; Key 2020] Yet, many clinicians lack knowledge and confidence with integrating DOACs into management strategies for patients with cancer in accordance to guideline recommendations.[Cushman 2015; Khorana 2016] We sought to determine if online continuing medical education (CME) could improve the knowledge and confidence of hematologists/oncologists regarding guideline-directed use of DOACs in the management of cancer-associated thrombosis. Methods:This CME intervention comprised of a 30-minute online video-based roundtable discussion among experts in the field of cancer-associated thrombosis management. Responses to 3 multiple-choice, knowledge questions and 1 self-efficacy, 5-point Likert scale confidence question were analyzed using a repeated pairs pre-/post-assessment study design. A chi-square test (P &lt;.05 is considered significant) assessed pre- to post-activity change . The activity launched December 23, 2019, and data were collected through February 24, 2020. Results:In total, 71 Hematologists/Oncologists were included in this study. Overall, there were knowledge and confidence improvements seen among all groups from pre- to post-assessment: 27% of hematologists/oncologists (P&lt;.01) improved at identifying guideline-directed therapy regarding recommended thromboprophylaxis in patients with cancer per guideline recommendations.27% of hematologists/oncologists (P&lt;.01) improved at selecting guideline-appropriate treatment options for cancer-associated thrombosis.44% of hematologists/oncologists had an increase in confidence in managing thrombosis in patients with cancer. Continued educational gaps: 25% of hematologists/oncologists failed to select guideline recommended DOAC therapy for thromboprophylaxis in cancer patients.45% of hematologists/oncologists failed to select guideline recommended DOAC therapy for treatment of thrombosis in cancer patients.66% of hematologists/oncologists still remain at only a rating of 1 to 3 on a scale of 1 to 5 in their confidence managing thrombosis in patients with cancer. Conclusion:This study demonstrates the success of online, CME-accredited, video-based roundtable discussion with experts in the field on significantly improving knowledge and confidence of hematologists/oncologists related to the guideline-recommended use of DOACs in the management of cancer-associated thrombosis. Continued gaps were also identified for future educational targets. Sources of support: Developed through an independent educational grant from Janssen in partnership with the University of Chicago. References: Cushman M, Creager MA. Improving awareness and outcomes related to venous thromboembolism. JAMA. 2015;314(18):1913-4. Farge D, Frere C, Connors JM, et al. 2019 International clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. The Lancet Oncology. 2019;20(10):e566-581. Key NS, Khorana AA, Kuderer NM, et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2020 Feb 10;38(5):496-520. Khorana AA, Yannicelli D, McCrae KR, et al. Evaluation of US prescription patterns: are treatment guidelines for cancer-associated venous thromboembolism being followed? Thromb Res. 2016 Sep;145:51-3. Disclosures No relevant conflicts of interest to declare.

scholarly journals Prevention of venous thromboembolism in cancer patients: current approaches and opportunities for improvement

2011 ◽  
Vol 5 (3) ◽  
pp. 191
Author(s):  
Alpesh N. Amin ◽  
Steven B. Deitelzweig
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Assessment Model ◽  
Major Surgery ◽  
Medical Illness ◽  
Patients With Cancer ◽  
Increased Risk ◽  
National Quality ◽  
American Society

Venous thromboembolism (VTE), a common complication in patients with cancer, is associated with increased risk of morbidity, mortality, and recurrent VTE. Risk factors for VTE in cancer patients include the type and stage of cancer, comorbidities, age, major surgery, and active chemotherapy. Evidence-based guidelines for thromboprophylaxis in cancer patients have been published: the National Comprehensive Cancer Network and American Society for Clinical Oncology guidelines recommend thromboprophylaxis for hospitalized cancer patients, while the American College of Chest Physician guidelines recommend thromboprophylaxis for surgical patients with cancer and bedridden cancer patients with an acute medical illness. Guidelines do not generally recommend routine thromboprophylaxis in ambulatory patients during chemotherapy, but there is evidence that some of these patients are at risk of VTE; some may be at higher risk while on active chemotherapy. Approaches are needed to identify those patients most likely to benefit from thromboprophylaxis, and, to this end, a risk assessment model has been developed and validated. Despite the benefits, many at-risk patients do not receive any thromboprophylaxis, or receive prophylaxis that is not compliant with guideline recommendations. Quality improvement initiatives have been developed by the Centers for Medicare and Medicaid Services, National Quality Forum, and Joint Commission to encourage closure of the gap between guideline recommendations and clinical practice for prevention, diagnosis, and treatment of VTE in hospitalized patients. Health-care institutions and providers need to take seriously the burden of VTE, improve prophylaxis rates in patients with cancer, and address the need for prophylaxis across the patient continuum.

scholarly journals Preventing Venous Thromboembolism in Ambulatory Patients with Cancer: A Narrative Review

Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 612 ◽  
Author(s):  
Anne Rossel ◽  
Helia Robert-Ebadi ◽  
Christophe Marti
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Absolute Risk ◽  
Narrative Review ◽  
Relative Reduction ◽  
Number Needed To Treat ◽  
Chemotherapeutic Regimen ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Risk Of Cancer

Venous thromboembolism (VTE) is frequent among patients with cancer. Ambulatory cancer patients starting chemotherapy have a 5% to 10% risk of cancer associated thrombosis (CAT) within the first year after cancer diagnosis. This risk may vary according to patient characteristics, cancer location, cancer stage, or the type of chemotherapeutic regimen. Landmark studies evaluating thrombophrophylaxis with low molecular weight heparin (LMWH) for ambulatory cancer patients have shown a relative reduction in the rate of symptomatic VTE of about one half. However, the absolute risk reduction is modest among unselected patients given a rather low risk of events resulting in a number needed to treat (NNT) of 40 to 50. Moreover, this modest benefit is mitigated by a trend towards an increased risk of bleeding, and the economic and patient burden due to daily injections of LMWH. For these reasons, routine thromboprophylaxis is not recommended by expert societies. Advances in VTE risk stratification among cancer patients, and growing evidence regarding efficacy and safety of direct oral anticoagulants (DOACs) for the treatment and prevention of CAT have led to reconsider the paradigms of this risk–benefit assessment. This narrative review aims to summarize the recent evidence provided by randomized trials comparing DOACs to placebo in ambulatory cancer patients and its impact on expert recommendations and clinical practice.

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