The Efficacy and Safety of Oral Anticoagulation in Patients with Cancer

Summary Objectives: To compare the complication rate (bleeding and thrombosis) of oral anticoagulation in a cohort of patients with cancer to a cohort without cancer Design: Prospective cohort study Setting: Outpatient anticoagulation clinic in a community hospital Patients: Consecutive patients enrolled in an anticoagulation clinic: 44 with cancer, 64 without cancer Interventions: Patients received prophylactic doses of Warfarin (target INR 2–3 in the majority of instances) and complication rates were assessed Measurements: Major bleeding (strictly defined), minor bleeding, recurrent thrombosis, proportion of time with therapeutic INR, frequency of clinic visits Results: The rates of major bleeding, minor bleeding, and recurrent thrombosis were not statistically significantly different in the two groups of patients. Therapeutic INR’s were more difficult to sustain in the cancer patients as compared to the non-cancer patients (43.3% vs 56.9%, p <0.0001). There was a non significant trend towards more frequent monitoring for the cancer patients compared with the noncancer patients (4.6 vs 3.5 visits per treatment month, p = 0.14) Conclusions: Oral anticoagulation is safe and effective in the patient with cancer. It is more difficult to sustain a therapeutic INR in the cancer patients and they may need more frequent monitoring to achieve a low complication rate

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Tinzaparin Safety in Patients With Cancer and Renal Impairment: A Systematic Review

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029620979592 ◽

2021 ◽

Vol 27 ◽

pp. 107602962097959

Author(s):

I. A. Vathiotis ◽

N. K. Syrigos ◽

E. P. Dimakakos

Keyword(s):

Systematic Review ◽

Molecular Weight ◽

Renal Impairment ◽

Creatinine Clearance ◽

Cancer Patients ◽

Major Bleeding ◽

Severe Renal Impairment ◽

Special Populations ◽

Low Molecular Weight ◽

Patients With Cancer

Low-molecular-weight heparins are approved for primary and secondary venous thromboembolism prevention. Tinzaparin is the low-molecular-weight heparin with the highest average molecular weight. The purpose of this systematic review is to provide an update regarding the safety profile of tinzaparin, prescribed either as a prophylactic or as a therapeutic regimen for venous thromboembolism in special populations, including cancer patients and patients with renal impairment. We identified prospective studies up to August 2020 reporting safety outcomes for cancer patients and patients with renal impairment on tinzaparin regimens. In patients with cancer major bleeding rates fluctuated between 0.8% and 7%. Patients on tinzaparin exhibited significantly lower rates of clinically relevant nonmajor bleeding events in comparison with those on vitamin K antagonists. Bioaccumulation of tinzaparin was not correlated with age, body weight or creatinine clearance. Periodic administration of either prophylactic or therapeutic doses of tinzaparin did not result in bioaccumulation, even in patients with severe renal impairment and creatinine clearance < 20 ml/min. Major bleeding rates for non-cancer patients with renal impairment on prophylactic tinzaparin regimens were 0%. Non-cancer patients with renal impairment on therapeutic tinzaparin regimens exhibited major bleeding in 0 to 3.4% of cases; major bleeding rates were higher for cancer patients with renal impairment on therapeutic tinzaparin regimens (4.3 to 10%). Tinzaparin can be used without dose adjustment in patients with severe renal impairment and creatinine clearance > 20 ml/min. Tinzaparin represents a safe choice for special populations at increased risk for thrombosis and bleeding.

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#49: Results of 10 Years of Peripherally Inserted Central Catheter Use and the Association with Infections in Pediatric Patients at a Tertiary Care Oncology Hospital

Journal of the Pediatric Infectious Diseases Society ◽

10.1093/jpids/piaa170.051 ◽

2021 ◽

Vol 10 (Supplement_1) ◽

pp. S16-S16

Author(s):

Jennia J Acebo ◽

María Costta ◽

Gisella Sánchez ◽

Erika Villanueva ◽

Erika Montalvo E ◽

...

Keyword(s):

Cancer Patients ◽

Complication Rate ◽

Best Practice ◽

Infectious Complication ◽

Pediatric Patients ◽

Tertiary Care ◽

Bloodstream Infections ◽

Complication Rates ◽

Peripheral Venous Access ◽

Pediatric Cancer Patients

Abstract Introduction Pediatric cancer patients merit the placement of central lines for the treatments they receive. Subcutaneous central ports (SCs) and peripherally inserted central catheters (PICCs) are the most frequently used lines. PICCs have gained popularity due to the ease of insertion, which can be invaluable in the pediatric oncology setting for administration of intravenous therapy, parenteral nutrition, and/or blood products. Since central-line-associated bloodstream infections increase the morbidity and mortality of cancer patients, as well as increase the cost generated by their treatment, active surveillance of these healthcare-associated infections is warranted. Methods This is a retrospective descriptive study of pediatric patients treated via PICCs at the Hospital SOLCA Núcleo Quito between 2009 and 2019. Results During the study period, 70 PICC lines were placed in 66 patients, totaling 1862 catheter-days. The majority of patients (75.7%) were diagnosed with leukemia or lymphoma. As of 2011, all PICCs were placed in the operating room by a surgeon. Ultrasound was used 39 times for the insertion of PICCs. Inadequate peripheral venous access was the most common indication (64.2%) for placement. Twenty-nine PICCs had complications, of which 13 were infectious complications and 16 were noninfectious. The most common infectious complication was PICC-related bloodstream infection (13), and the most frequent noninfectious complication was occlusion (10). The overall complication rate was 15.5 complications per 1000 catheter-days, and the overall infectious complication rate was 6.9 complications per 1000 catheter days. Annual complication rates fluctuated over the study period. The PICC line-associated infection rate per 1000 catheter-days was 13.1‰ in 2009, 12.4‰ in 2010, 5.0‰ in 2011, 7.9‰ in 2012, 0 in 2013, 13.4‰ in 2014, 4.8‰ in 2015, 16.2‰ in 2016, 8.2‰ in 2017, and 4.3‰ in 2018. Conclusion In general, complications related to PICC in pediatric patients at a tertiary care oncology hospital have fluctuated over the years. Our findings indicate the need for further efforts in staff education and training in the insertion, care, and maintenance of PICC lines. Best practice guidelines are also critical to reducing complications, especially occlusion and infection rates, to thereby improve patient outcomes.

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Venous Thromboembolism in Lymphoma: How Effectively Are We Treating Patients?.

Blood ◽

10.1182/blood.v110.11.1878.1878 ◽

2007 ◽

Vol 110 (11) ◽

pp. 1878-1878

Author(s):

Alaa A. Muslimani ◽

Timothy P. Spiro ◽

Asif A. Chaudhry ◽

Hamed A. Daw

Keyword(s):

Pulmonary Embolism ◽

Retrospective Study ◽

Therapeutic Range ◽

Major Bleeding ◽

Oral Anticoagulant ◽

Minor Bleeding ◽

Anticoagulant Treatment ◽

Recurrent Thrombosis ◽

Oral Anticoagulant Treatment ◽

Recurrent Vte

Abstract Introduction: Patients (pts) with solid tumors and venous thromboembolic episodes (VTE) have a high risk of complications (recurrent VTE/bleeding) during oral anticoagulant treatment. However, few data are available in pts with lymphoma. We conducted a retrospective study to determine the frequency of complications during oral anticoagulant treatment in lymphoma pts. Methods: Charts of histologically proven non-Hodgkin’s (NHL) and Hodgkin lymphoma (HL) pts at our institution from January 1998 through April 2007 were retrospectively reviewed. After excluding pts with thrombocytosis, solid tumors, hypercoagulability or previous treatment with anticoagulants, pts with their first acute symptomatic VTE were identified (49 NHL, 8 HL). 31 were males and 26 females, with an age range of 40–89 years. The first symptomatic VTE was defined as lymphoma associated if the VTE occurred within 3 months before or after the biopsy diagnosis of the lymphoma but before chemotherapy. These VTE were confirmed by contrast venography or doppler ultrasound for venous thrombosis (neck and upper-lower extremities) and chest computed tomography, ventilation/perfusion scan, or pulmonary angiography for pulmonary embolism. Major bleeding was defined as bleeding that required transfusion, caused a drop of hemoglobin > 2 g/dL, or occurred in critical sites. Minor bleeding was defined as any overt bleeding that required stopping the anticoagulant treatment but not fulfilling the definition of major bleeding. Results: All 57 pts were initially treated with high dose adjusted intravenous heparin or body weight adjusted low molecular weight heparin (LMWH). 46 pts were started on oral warfarin during the first 10 days of the initial treatment witch was continued for at least 3 months after discontinuing heparin. 11 pts received continuing LMWH and no warfarin. Recurrent VTE occurred in 14/46 pts on warfarin therapy. The international normalized ratio (INR) was within the therapeutic range (2.0–3.0) in 10/14 pts, and below the therapeutic INR (< 2.0) in 4/14 pts. Death was directly correlated to recurrent VTE (massive pulmonary embolism) in 2 pts in the warfarin treated group; a third death was caused by massive intracranial bleeding. Major bleeding was documented in 6/46 pts (4 pts had an INR within the therapeutic range, 2 had INR > 3), and minor bleeding in 9/46 pts. Recurrent VTE occurred in 1/11 pts treated with LMWH, major bleeding in 0/11 and minor bleeding in 3/11 pts with no deaths. Conclusions: Previous studies showed an overall incidence of 27.1% recurrent thrombosis and 5.4% major bleeding in pts with malignancy treated with oral anticoagulant for VTE. Our study showed 30.4% recurrent thrombosis and 13% major bleeding in pts with lymphoma. Most bleeding and thrombotic complications occurred with an INR within the therapeutic range (65%). The percentage of serious complications was very high during the use of warfarin (43.5%), and the death rate 6.5%, compared to 9% and 0% during the use of LMWH. A high failure rate of oral anticoagulant treatment in pts with lymphoma suggests the need for alternative treatment. Since the number of pts in this retrospective study is small, a prospective randomized, controlled study comparing warfarin with LMWH is indicated.

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Evaluation of Rivaroxaban and Dalteparin in Cancer Associated Thrombosis

Blood ◽

10.1182/blood.v126.23.432.432 ◽

2015 ◽

Vol 126 (23) ◽

pp. 432-432

Author(s):

Ateefa Chaudhury ◽

Asha Balakrishnan ◽

Christy Thai ◽

Bjorn Holmstrom ◽

Michael V. Jaglal

Keyword(s):

Cancer Patients ◽

Anticoagulant Therapy ◽

Major Bleeding ◽

Cancer Center ◽

Minor Bleeding ◽

Efficacy And Safety ◽

Recurrent Vte ◽

Chi Square Analysis ◽

Cancer Associated Thrombosis ◽

Active Cancer

Abstract Introduction: Venous thromboembolism (VTE) in the form of deep venous thrombosis (DVT) or pulmonary embolism (PE) is a complication of malignancy. Several studies have demonstrated the superiority of dalteparin (Fragmin®), a low molecular weight heparin (LMWH), in comparison to oral vitamin K antagonists in preventing VTE recurrence in the setting of active cancer. LMWH is the preferred treatment of cancer associated thrombosis. However, the cost of LMWH can be prohibitive and the need for daily subcutaneous injections can decrease patients' quality of life. While rivaroxaban (Xarelto®), a Factor Xa inhibitor, has been approved for the treatment and secondary prevention of DVT and PE, there is limited data regarding its use in cancer patients. The objective of our study is to determine the efficacy and safety of rivaroxaban compared to dalteparin in cancer associated thrombosis. Methods: This is a retrospective chart review of cancer patients greater than age 18 treated at H. Lee Moffitt Cancer Center between May 3, 2010 and June 30, 2015 on anticoagulation with rivaroxaban or dalteparin. Patients were excluded if the length of anticoagulant therapy was < 30 days, anticoagulant therapy was initiated > 6 months after VTE diagnosis, the indication for treatment was not DVT/PE, if patients had contraindications to either LMWH or rivaroxaban, or patients were not on treatment doses of therapy. Out of 459 patients identified, 226 patients (107 in the rivaroxaban group, and 119 in the dalteparin group) were eligible for analysis based on our exclusion criteria. Efficacy was determined by the incidence of recurrent VTE, such as recurrent DVT, new fatal or non-fatal PE within 30 days. The secondary endpoint of the study was to determine the safety of rivaroxaban compared to dalteparin in cancer patients for the treatment of VTE. Safety was determined by the incidence and severity of bleeding. Major bleeding was defined as clinically overt if it was associated with a fall in hemoglobin of 2 g/dL or more, required transfusions of ≥ 2 units of packed red blood cells, involved retroperitoneal, intracranial, or critical site bleeding, or if it contributed to death. Minor bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of anticoagulation treatment, or associated with any other discomfort such as pain or impairment of activities of daily life. Descriptive statistical analyses were utilized. Chi square analysis and t- test were performed to compare categorical and continuous variables. All data was analyzed using SPSS version 21.0 statistical software. Results: Rivaroxaban had a similar rate of DVT and PE failure with 1 event versus 2 with dalteparin (p = 0.625). The rivaroxaban group had 0 major and 8 minor bleeds compared to 3 major and 8 minor bleeds in the dalteparin group with p values of 0.09 and 0.86 respectively. Comorbidities and risk factors for thrombosis were similar in both groups as summarized in Table 1. Table. Rivaroxaban vs. Dalteparin: No Significant Differences in the Efficacy and Safety Profile in Cancer Associated Thrombosis RivaroxabanN = 107 DalteparinN =119 P value DVT Failure within 30 days 1 (0.93%) 2 (1.68%) 0.625 PE Failure within 30 days 1 (0.93%) 1 (0.84%) 0.94 Major Bleeding 0 (0 %) 3 (2.5%) 0.09 Minor Bleeding 8 (7.5%) 8 (6.7%) 0.864 Median Age (Yrs) 61 65 0.93 MaleFemale 58 (54.2%) 49 (45.8%) 60 (50.4%) 59 (49.6%) 0.596 Active Cancer 96 (86.5%) 111 (93.2%) 0.350 Surgery within 30 Days 14 (13.1%) 13 (10.9%) 0.684 Hypertension 58 (54.2%) 61 (51.3%) 0.69 Diabetes 14 (13.1%) 14 (11.8%) 0.84 Coronary Artery Disease 6 (5.61%) 11 (9.2%) 0.326 History of Previous DVT 12 (11.2%) 5 (4.2%) 0.074 BMI >30 39 (36.4%) 48 (40.3%) 0.585 Creatinine Clearance (Cr Cl) 30 - 50 Cr Cl 50 - 70 7 (6.5%) 100 (93.3%) 7 (5.9%) 112 (94.1%) 0.837 Conclusions: Our study evaluated the safety and efficacy of rivaroxaban compared to dalteparin in patients with predominantly active cancer treated at a large comprehensive cancer center and found rivaroxaban to be comparable to dalteparin in this cohort. There were no significant differences in regards to recurrent VTE or major/minor bleeding with patients on rivaroxaban or dalteparin in our cohort of patients. Large randomized trials evaluating the efficacy and safety of rivaroxaban in the oncology population are needed to further validate our findings. Disclosures No relevant conflicts of interest to declare.

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Safety of Anticoagulant Therapies for Treatment of Venous Thromboembolism in Patients with Cancer

Blood ◽

10.1182/blood.v128.22.1178.1178 ◽

2016 ◽

Vol 128 (22) ◽

pp. 1178-1178 ◽

Cited By ~ 2

Author(s):

Michael Streiff ◽

Dejan Milentijevic ◽

Keith McCrae ◽

Daniel Yannicelli ◽

Jonathan Fortier ◽

...

Keyword(s):

Cancer Patients ◽

Major Bleeding ◽

Research Funding ◽

Hazard Ratio ◽

Control Cohort ◽

Bleeding Events ◽

Employment Equity ◽

Patients With Cancer ◽

Equity Ownership ◽

Major Bleeding Events

Abstract Introduction: Anticoagulation is effective for the treatment of venous thromboembolism (VTE) in cancer patients, but it is also associated with an increased risk of bleeding. Previous clinical trials (e.g., CLOT and CATCH) of LMWH and warfarin for the treatment of VTE in cancer patients reported major bleeding in 3% to 6% of treated patients. The objective of this observational study was to compare the risk of major bleeding in cancer patients treated with anticoagulants for VTE in a real world setting. Methods: Medical and pharmacy claims from the Humana Database from 1/1/2013 to 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis, and with ≥1 dispensing of an anticoagulant within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban (other agents not included due to low utilization). Inverse probability of treatment weights based on propensity score were used to adjust for differences between treatment cohorts for the following comparisons: LMWH vs. rivaroxaban, LMWH vs. warfarin, and rivaroxaban vs. warfarin. Patients were followed up until the earliest event, either treatment non-persistence (gap > 60 days between the end of the days of supply of a dispensing and the start date of the next dispensing), or end of data availability. Major bleeding events were identified using validated criteria (Cunningham et al., 2011). Kaplan-Meier rates at 3 and 6 months and Cox proportional hazards models were used to compare the risk of bleeding between different treatment cohorts. To better understand the risk of major bleeding in cancer patients unrelated to anticoagulation, a cohort of patients with cancer who did not have VTE and did not receive an anticoagulant was added as a control cohort. Results: A total of 2,428 patients (LMWH: n=660; warfarin: n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced among treatment cohorts. Median duration of therapy with LMWH was shorter than rivaroxaban (1.0 vs. 3.0 months, p<.0001) and warfarin (1.0 vs. 3.5 months, p<.0001). Rates of major bleeding for LMWH and rivaroxaban were 8.3% and 8.2%, respectively at 6 months with a hazard ratio (HRs [95% CI]) of 1.03 (0.64-1.65; Figure 1A). In the comparison between LMWH and warfarin cohorts, major bleeding rates were 8.5% and 8.6%, respectively at 6 months with hazard ratio (HRs [95% CI]) of 1.04 (0.69-1.57; Figure 1B). The risk of major bleeding was also similar for rivaroxaban and warfarin cohorts, 9.0% and 8.7%, respectively at 6 months with a hazard ratio (HR [95% CI]) of 1.01 (0.71-1.43; Figure 1C). For the control cohort of cancer patients without VTE and not receiving anticoagulation median follow-up was 5.6 months. Rates of major bleeding events for the control cohort were 2.6% and 4.2 % at 3 and 6 months, respectively. Conclusion: This real world study of cancer patients treated for VTE found that the risk of major bleeding was similar for the 3 most widely prescribed anticoagulants in current clinical practice: LMWH, warfarin, and rivaroxaban. The observed rates of major bleeding were generally higher than what has been reported for LMWH and warfarin in the CLOT and CATCH trials. Patient characteristics such as older age (average age 73 years) could have contributed to the higher major bleeding rate seen in this study compared to the CLOT and CATCH trials, respectively. Figure 1 Rates of Major Bleeding Events LMWH vs. rivaroxaban cohorts Figure 1. Rates of Major Bleeding Events. / LMWH vs. rivaroxaban cohorts Figure 2 LMWH vs. warfarin cohorts Figure 2. LMWH vs. warfarin cohorts Figure 3 rivaroxaban vs. warfarin cohorts Figure 3. rivaroxaban vs. warfarin cohorts Disclosures Streiff: Portola: Research Funding; Janssen: Consultancy, Research Funding; Roche: Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Yannicelli:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Nelson:Janssen Scientific Affairs: Employment, Equity Ownership. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Roche: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding.

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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.

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Gynaecomastia correction: A review of our experience

Indian Journal of Plastic Surgery ◽

10.4103/0970-0358.129624 ◽

2014 ◽

Vol 47 (01) ◽

pp. 56-60 ◽

Cited By ~ 5

Author(s):

Arvind Mohan ◽

Muhammad Adil Abbas Khan ◽

Karthik Srinivasan ◽

Jeremy Roberts

Keyword(s):

Complication Rate ◽

Case Series ◽

Wound Dehiscence ◽

University Hospital ◽

Minor Bleeding ◽

Complication Rates ◽

Male Population ◽

Treatment Techniques ◽

High Satisfaction ◽

Superficial Wound

ABSTRACT Introduction: Gynaecomastia is a common problem in the male population with a reported prevalence of up to 36%. Various treatment techniques have been described but none have gained universal acceptance. We reviewed all gynaecomastia patients operated on by one consultant over a 7-year period to assess the morbidity and complication rates associated with the procedure. Materials and Methods: Clinical notes and outpatient records of all patients who underwent gynaecomastia correction at University Hospital North Staffordshire between 01/10/2001 to 01/10/2009 were retrospectively reviewed. A modified version of the Breast Evaluation Questionnaire was used to assess patients satisfaction with the procedure. Results: Twenty-nine patients and a total of 53 breasts were operated on during the study period. Patients underwent either liposuction alone (6 breasts - 11.3%), excision alone (37 breasts - 69.8%) or both excision and liposuction (10 breasts - 18.9%). Twelve operated breasts (22.6%) experienced some form of complication. Minor complications included seroma (2 patients), superficial wound dehiscence (2 patients) and minor bleeding not requiring theatre (3 patients). Two patients developed haematomas requiring evacuation in theatre. No cases of wound infection, major wound dehiscence or revision surgery were encountered. Twenty-six patients (89.7%) returned the patient satisfaction questionnaire. Patients scored an average 4.12 with regards comfort of their chest in different settings, 3.98 with regards chest appearance in different settings, and 4.22 with regards satisfaction levels for themselves and their partner/family. Overall complication rate was 22.6%. Grade III patients experienced the highest complication rate (35.7%), followed by grade II (22.7%) and grade I (17.6%). Overall complication rates among the excision only group was the highest (29.8%) followed by the liposuction only group (16.7%) and the liposuction and excision group (10.0%). There were high satisfaction rates amongst both patients and surgeon. Eleven patients (37.9%) had their outcome classified as ‘excellent’ by the operating surgeon, 16 patients (55.2%) as ‘good’, 1 (3.4%) as ‘satisfactory’ and 1(3.4%) as ‘poor’. Conclusion: Gynaecomastia is a complex condition which poses a significant challenge to the plastic surgeon. Despite the possible complications our case series demonstrates that outcomes of operative correction can be favourable and yield high levels of satisfaction from both patient and surgeon.

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Validation of the Ottawa Score in Cancer Patients with Venous Thromboembolism. the Predicare Cohort Study

Blood ◽

10.1182/blood-2019-129087 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 167-167 ◽

Cited By ~ 1

Author(s):

Guy Meyer ◽

Celine Chapelle ◽

Philippe Girard ◽

Florian Scotté ◽

Anne Lamblin ◽

...

Keyword(s):

Cohort Study ◽

Venous Thromboembolism ◽

Board Of Directors ◽

Cancer Patients ◽

Major Bleeding ◽

Research Funding ◽

Advisory Committees ◽

Patients With Cancer ◽

Recurrent Vte ◽

Support Research

Introduction Venous thromboembolism (VTE) is a difficult to treat condition in patients with cancer with a persisting risk of recurrent VTE during anticoagulant treatment with low-molecular weight heparin (LMWH). Recent data suggest that direct oral anticoagulants (DOACS) are associated with a lower risk of recurrence but a higher risk of bleeding in these patients. Predicting the risk of recurrent VTE with LMWH may help to select the best treatment option. We conducted a prospective multicenter observational cohort study in cancer patients with VTE treated with tinzaparin for 6 months in order to validate the Ottawa score (NCT03099031) and search for additional risk of recurrent VTE. The Ottawa score is composed of 5 variables, female sex (+1), lung cancer (+1), breast cancer (-1) cancer stage 1 (-2) and previous DVT (+1). A score ≤0 is associated with a low risk of recurrent VTE. Methods Adult cancer patients with recent diagnosis of documented symptomatic or incidental VTE (deep vein thrombosis (DVT) or pulmonary embolism (PE) treated with tinzaparin for 6 months were included in the study. The primary endpoint was the recurrence of symptomatic or asymptomatic VTE within the first 6 months of treatment with tinzaparin. Other endpoints were symptomatic recurrent VTE, major bleeding, heparin induced thrombocytopenia (HIT), all-cause mortality within 3 and 6 months. All events were adjudicated by a Central Adjudication Committee. Time-to-event outcomes were estimated by the Kalbfleisch and Prentice method to take into account the competing risk of death. Cumulative incidences were presented with corresponding 95% confidence interval (95% CI). To validate the Ottawa score, the area under the curve (AUC) and its 95% CI were calculated on receiver operating characteristic (ROC) curve analysis; the most discriminant cut-off was then determined by calculating the Youden index. Univariate and multivariate analyses were performed to identify additional predictive factors of recurrent VTE to those included in the Ottawa score using the Fine and Gray method and adjusted on factors included in the Ottawa score. Hazard ratio and their 95% CI were calculated. Results A total of 409 patients were included and analyzed on an intention-to-treat basis; the median age was 68 years and 51% of patients were males. 60.4% of patients had a PE (with or without DVT) .64% received chemotherapy at inclusion or in the month before inclusion. Lung (31.3%) and digestive track (18.3%) cancers were the most common cancer types and 67.0% had stage IV cancers. According to Ottawa score, 58% of patients were classified at high clinical probability of recurrence (score ≥ 1). During the 6 months treatment period, 23 patients had a recurrent VTE, yielding a cumulative incidence of 6.1% (95% CI 4.0-9.3) with a median time for recurrent VTE of 33 days. The recurrence rate of VTE was estimated to 7.8% (95% CI 4.9-12.5) for patients classified at high risk of recurrence according to the Ottawa score (score ≥ 1) compared to 3.8% (95%CI 1.6-8.9) for other patients (Ottawa score < 1). AUC of the Ottawa score was 0.60 (95% CI 0.55-0.65). In multivariable analysis, none of the potential risk factors for recurrent VTE was significantly associated with recurrent VTE at 6 months. During the 6 months treatment period, 15 patients had a major bleeding and 2 patients experienced a HIT. At 3 and 6 months, 104 and 144 patients had died yielding a cumulative incidence of 26.1%, (95% CI 21.8-30.4) and 37.8% (95% CI 32.8-42.9), respectively. The main cause of death was underlying cancer. Conclusion In this prospective cohort of patients with cancer receiving LMWH for VTE, the Ottawa score did not accurately predict recurrent VTE. No other clinical predictor of recurrent VTE was identified in this study. Disclosures Meyer: Bayer: Other: travel support; LEO pharma: Other: travel support, Research Funding; SANOFI: Other: travel support, Research Funding; BMS-Pfizer: Other: travel support, Research Funding; Boehringer Ingelheim: Research Funding. Girard:Leo Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: travel support. Scotté:LEO Pharma A/S: Honoraria, Research Funding, Speakers Bureau; Pfizer: Honoraria, Research Funding, Speakers Bureau; Tesaro: Honoraria, Research Funding, Speakers Bureau; Amgen: Honoraria, Research Funding, Speakers Bureau; BMS: Honoraria, Research Funding, Speakers Bureau; Roche: Honoraria, Research Funding, Speakers Bureau; MSD: Honoraria, Research Funding, Speakers Bureau; Pierre Fabre Oncology: Honoraria, Research Funding, Speakers Bureau. Lamblin:Leo Pharma: Employment. Laporte:Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Boston scientific: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Leo-Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Boehringer-Ingelheim: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees.

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Safe and Effective Use of Rivaroxaban for Treatment of Cancer-Associated Venous Thromboembolic Disease: A Quality Improvement Initiative

Blood ◽

10.1182/blood.v126.23.431.431 ◽

2015 ◽

Vol 126 (23) ◽

pp. 431-431 ◽

Cited By ~ 2

Author(s):

Simon Mantha ◽

Yimei Miao ◽

Debra Sarasohn ◽

Jonathan Kessler ◽

Rekha Parameswaran ◽

...

Keyword(s):

Lower Extremity ◽

Cancer Patients ◽

Major Bleeding ◽

Clinical Pathway ◽

Bleeding Risk ◽

Event Type ◽

Patients With Cancer ◽

Recurrent Vte ◽

Cancer Associated Thrombosis ◽

Low Rate

Abstract Background: Low-molecular weight heparin (LMWH) has been the standard of care for treatment of venous thromboembolism (VTE) in patients with cancer. LMWH injections are painful and costly. Rivaroxaban, an oral direct factor Xa inhibitor, was FDA approved in 2012 for treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT), but there has been a knowledge gap for its use in patients with cancer-associated thrombosis (CAT). Under a Quality Assurance Initiative (QAI), we established a Clinical Pathway to guide rivaroxaban use for CAT, and began to offer rivaroxaban as an alternative to enoxaparin, in January 2014, for patients who met appropriate clinical criteria. We are tracking all cancer patients with PE or symptomatic proximal DVT, whose full course of anticoagulation is with rivaroxaban (allowing up to 3 days of initial parenteral anticoagulation). We now report the characteristics of the first 200 patients, and an outcome analysis of our first 100 patients, who have been treated for at least 6 months or otherwise reached an endpoint. Materials and Methods: The Clinical Pathway guidelines will be available on request, pending publication. Patients were not treated with rivaroxaban if they had active gastrointestinal or genitourinary lesions, or had undergone gastric resection due to anticipated excess bleeding risk or reduced absorption. This excluded under 5% of patients. The Pathway provided dosing guidelines in the setting of thrombocytopenia, advanced age, transient renal, or hepatic dysfunction. Primary endpoints include new or recurrent PE, symptomatic proximal lower extremity DVT, major bleeding (ISTH definition), clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban, or death. Considering those outcomes as competing risks, the cumulative incidence of each event type was calculated using R 3.2.0 for Windows and package "Survival". Results: The characteristics of our first 200 patients are in Table 1. 70% of the patients had PE. Of the solid tumor patients, 65.6% had metastatic disease. The first 100 patients have completed at least 6 months of rivaroxaban anticoagulation or otherwise reached a primary endpoint. At 6 months, the cumulative incidence of death was 14.4% (95% CI=6.8-21.4%), new or recurrent VTE was 4.3% (95% CI=0.1-8.4%), major bleeding was 1.1% (95% CI=0-3.1%), and clinically relevant non-major bleeding leading to rivaroxaban discontinuation was 7.9% (95% CI=2.1-13.3%). Conclusions: In the analysis of the first 100 patients entered into our QAI program, the rates of major bleeding, and new or recurrent VTE compare favorably to two published studies of LMWH for treatment of cancer associated thrombosis. In the CLOT study (Lee et al, NEJM, 2003) and the Daltecan study (Francis et al, JTH, 2015), the 6-month rates of new or recurrent VTE were approximately 9%, and the rates of major bleeding were 6% and 9.5% respectively. Our final analysis awaits the completion of 6 months follow-up on 200 patients, to be completed in December 2015. But the rates of major bleeding and recurrent VTE at this point suggest safety and efficacy to be at least non-inferior to LMWH, with the advantage of reduced patient burden, and support the ongoing use of our Clinical Pathway. Our low rate of major bleeding likely is influenced by the exclusion of patients with active GI or GU lesions, who would be expected to have a high bleeding risk with an oral direct anticoagulant. However, we estimate this excluded less than 5% of cancer patients with VTE. Further, we anticipated reduced drug clearance in the elderly, and used a reduced dose for patients greater than 75 years of age. This appeared to be associated with no loss in efficacy, and helped maintain a low rate of major bleeding. A randomized trial is the optimal approach to establish non-inferiority or superiority of rivaroxaban to LMWH for cancer associated thrombosis. However, our QAI Clinical Pathway provides guidance and reassurance for rivaroxaban use until a randomized trial is conducted. Table. Baseline Characteristics of Patients Characteristic Number of Individuals Gender Male 82 Female 118 Event Type PE, with or without DVT 140 Proximal, Symptomatic Lower extremity DVT 60 Cancer Type Solid Tumor 186 Hematologic Malignancy 14 Cancer Stage (Of Solid Tumors) No Evidence of Disease (Post-Cancer Surgery) 11 (5.9%) 1 1 (0.5%) 2 4 (2.2%) 3 16 (8.6%) 4 122 (65.6%) Unknown 32 (17.2%) Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.

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Benefit and Risk of Primary Thromboprophylaxis in Ambulatory Patients with Advanced Pancreatic Cancer Receiving Chemotherapy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Blood ◽

10.1182/blood.v124.21.4266.4266 ◽

2014 ◽

Vol 124 (21) ◽

pp. 4266-4266

Author(s):

Nay Min Tun ◽

Elizabeth Guevara ◽

Thein H. Oo

Keyword(s):

Pancreatic Cancer ◽

Cancer Patients ◽

Major Bleeding ◽

Absolute Risk ◽

Meta Analysis ◽

Advanced Pancreatic Cancer ◽

Risk Difference ◽

Bleeding Events ◽

Patients With Cancer ◽

Ambulatory Patients

Abstract Background: Vascular thromboembolism (VTE) is the second leading cause of death in patients with cancer. Despite the fact that mortality is increased in cancer patients who developed VTE compared to those without VTE, empirical prophylaxis against VTE in ambulatory patients with cancer remains controversial. The risk of VTE is higher for certain types of cancer such as pancreatic and hematologic malignancies, in patients with advanced cancer, and in those who are undergoing chemotherapy or radiotherapy. We carried out a systematic review and meta-analysis of randomized controlled trials (RCT) to investigate the benefit and risk of primary thromboprophylaxis (PTP) with low-molecular weight heparins (LMWH) in ambulatory patients with advanced pancreatic cancer receiving chemotherapy. Methods: We undertook an extensive literature search using MEDLINE and EMBASE databases through July 13, 2014. References of the potential studies were also reviewed for any additional relevant studies. RCTs with reduction in symptomatic VTE as a primary endpoint were included. Mantel-Haenszel method was used to estimate the pooled event-based risk ratio (RR) as well as the pooled absolute risk difference (RD) with 95% confidence interval (CI). Fixed effects model was applied because there was homogeneity among the included studies (I2 = 0.00). Results: Two RCTs and a subgroup of another two RCTs, comprising a total of 738 patients with advanced pancreatic cancer, were eligible for analysis. Antithrombotics used in these trials were nadroparin (prophylactic dose), semuloparin (prophylactic dose), enoxaparin (semi-therapeutic dose), and dalteparin (therapeutic dose). The duration of PTP lasted from three to six months. The crude incidence of VTE was 5.51% and 15.12% in those receiving anticoagulants and in control patients, respectively, with a risk ratio of 0.36 (CI: 0.22 – 0.59, p < 0.0001). The absolute risk difference in VTE was 9.5% (CI: 5.3 – 13.8 %, p < 0.0001), with an estimate of the number needed to treat (NNT) of 10.5 to prevent one symptomatic VTE event. Major bleeding events were reported in 5.48% of patients on thromboprophylaxis compared to 7.94% in control patients according to an analysis of two RCTs. The pooled relative risk for major bleeding was statistically nonsignificant at 0.68 (CI: 0.33 – 1.39, p = 0.29). Conclusions: A previous meta-analysis reported that approximately 60 patients were required to be treated with LMWH to prevent one symptomatic VTE among unselected cancer patients receiving chemotherapy. Our meta-analysis revealed that thromboprophylaxis resulted in a significant reduction in symptomatic VTE events with NNT of 10.5 without an increase in major bleeding events, indicating that PTP with anticoagulants in advanced pancreatic cancer patients receiving chemotherapy may be beneficial. Further large randomized phase III studies are recommended to evaluate the effects of such targeted thromboprophylaxis on morbidity, mortality and the costs of care. Figure 1 Figure 1. Figure 2 Figure 2. Figure 3 Figure 3. Disclosures No relevant conflicts of interest to declare.

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