Implementation of a Standard Diet Regimen for Neutropenic High Risk Cancer Patients: Effects on Incidence of Infections, Foodborne Diseases, and Outcome

CONTEXT: Cancer patients are at unusually high risk for developing bloodstream infections (BSI), which are a major cause of in-hospital morbidity and mortality. OBJECTIVE: To describe the epidemiological characteristics and the etiology of BSI in cancer patients. DESIGN: Descriptive study. SETTING: Terciary Oncology Care Center. PARTICIPANTS: During a 24-month period all hospitalized patients with clinically significant BSI were evaluated in relation to several clinical and demographic factors. RESULTS: The study enrolled 435 episodes of BSI (349 patients). The majority of the episodes occurred among non-neutropenic patients (58.6%) and in those younger than 40 years (58.2%). There was a higher occurrence of unimicrobial infections (74.9%), nosocomial episodes (68.3%) and of those of undetermined origin (52.8%). Central venous catheters (CVC) were present in 63.2% of the episodes. Overall, the commonest isolates from blood in patients with hematology diseases and solid tumors were staphylococci (32% and 34.7%, respectively). There were 70 episodes of fungemia with a predominance of Candida albicans organisms (50.6%). Fungi were identified in 52.5% of persistent BSI and in 91.4% of patients with CVC. Gram-negative bacilli prompted the CVC removal in 45.5% of the episodes. Oxacillin resistance was detected in 26.3% of Staphylococcus aureus isolates and in 61.8% of coagulase-negative Staphylococcus. Vancomycin-resistant enterococci were not observed. Initial empirical antimicrobial therapy was considered appropriate in 60.5% of the cases. CONCLUSION: The identification of the microbiology profile of BSI and the recognition of possible risk factors in high-risk cancer patients may help in planning and conducting more effective infection control and preventive measures, and may also allow further analytical studies for reducing severe infectious complications in such groups of patients.

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Safety and Effectiveness of Apixaban, LMWH and Warfarin Among Venous Thromboembolism (VTE) Patients with Active Cancer: A Subgroup Analysis of VTE Risk Scale

Blood ◽

10.1182/blood-2019-126931 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 327-327

Author(s):

Alexander T Cohen ◽

Allison Keshishian ◽

Theodore Lee ◽

Gail Wygant ◽

Lisa Rosenblatt ◽

...

Keyword(s):

High Risk ◽

Board Of Directors ◽

Cancer Patients ◽

Lower Risk ◽

Cancer Type ◽

Advisory Committees ◽

Recurrent Vte ◽

High Risk Cancer ◽

Similar Risk ◽

Active Cancer

BACKGROUND: Cancer is an independent risk factor for venous thromboembolism (VTE) and the strongest predictor for all-cause and pulmonary embolism-related mortality. VTE risk is 4-7 times higher in cancer patients compared to non-cancer patients. Different cancer types are associated with different risk of VTE. Cancers of the brain, pancreas, stomach, liver, lungs, and kidneys-and hematologic malignancies-have the strongest association with the occurrence of VTE. The Khorana risk score based on the cancer type, blood counts, and body mass index is one of the VTE risk scales to predict the risk of thrombosis in cancer patients. This study evaluates the risk of major bleeding (MB), clinically relevant non-major (CRNM) bleeding, and recurrent VTE (non-fatal and fatal) among VTE patients with active cancer prescribed apixaban, low-molecular weight heparin (LMWH), or warfarin stratified by VTE risk. METHODS: A pooled study using four US commercial insurance claims databases identified VTE patients diagnosed with active cancer (defined as cancer diagnosis [any stage] or cancer treatment [chemotherapy, radiation, and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30 days following the first VTE event (01SEP2014-31MAR2018). Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. A subgroup analysis using a modified Khorana VTE risk scale (cancer type only) was conducted. Patients were classified as very high risk (stomach, brain, or pancreas), high risk (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma), or other (all remaining cancer types) depending on their cancer type. Cox proportional hazard models were used to evaluate the risk of MB, CRNM bleeding, and recurrent VTE. The statistical significance (P<0.10) of the interaction between treatment and different levels of VTE risk was evaluated. RESULTS: After applying the selection criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. Among all VTE cancer patients after IPTW, 15% of patients had very high-risk cancer and 40% patients had high-risk cancer. In the main analysis, apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin (Figure). When stratifying by the VTE risk scale, study findings were generally consistent with the primary analysis and across the different subgroups. No significant interactions were observed for MB or CRNM bleeding (Figure). Two significant interactions were evident for recurrent VTE: apixaban trended towards a lower risk of recurrent VTE compared to LMWH across all three subgroups, but the magnitude of the difference was larger in the other cancer group vs. very high risk and high risk cancer groups. For warfarin vs. LMWH, different trends in recurrent VTE risk were observed among patients with different VTE risk levels (Figure). CONCLUSION: Across subgroups of VTE cancer patients with different VTE risk levels, apixaban had a lower risk of recurrent VTE compared to warfarin and a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH consistent with the overall results. Warfarin patients had a similar risk of MB and CRNM bleeding compared to LMWH. Further studies are needed to evaluate the role of anticoagulants in high-risk subgroups of VTE cancer patients. Figure Disclosures Cohen: Aspen: Consultancy, Speakers Bureau; CSL Behring: Consultancy; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Guidepoint Global: Consultancy; TRN: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; Boston Scientific: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; AbbVie: Consultancy; GLG: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; Takeda: Consultancy; ACI Clinical: Consultancy. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.

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Health care costs associated with venous thromboembolism in select high-risk ambulatory solid tumor patients in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.6059 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 6059-6059

Author(s):

Alok A. Khorana ◽

Mehul Dalal ◽

Jay Lin ◽

Gregory Clayton Connolly

Keyword(s):

Venous Thromboembolism ◽

High Risk ◽

Cancer Patients ◽

Resource Utilization ◽

Healthcare Costs ◽

The United States ◽

Healthcare Resource Utilization ◽

Outpatient Prescription ◽

Clinical Consequences ◽

High Risk Cancer

6059 Background: Venous thromboembolism (VTE) is an increasingly common complication of cancer and its treatment, including chemotherapy. VTE has significant clinical consequences, including mortality. However, contemporary data on the healthcare costs of cancer-associated VTE are limited. We examined the real-world economic burden of VTE in ambulatory patients initiating chemotherapy for select common high-risk solid tumors. Methods: Healthcare claims data (2004-2009) from the IMS/PharMetrics Patient-Centric database were collected for propensity score-matched adult cancer (lung, colorectal, pancreas, stomach, bladder and ovary) patients with VTE (n=912) and without VTE (n=2,736) after initiating chemotherapy. Healthcare resource utilization (inpatient, outpatient medical, and outpatient prescription drug claims) and costs were compared between the two cohorts during 12 months’ follow-up after the index VTE event. Incremental costs of VTE were adjusted for demographic and clinical covariates. Results: Cancer patients with VTE had ~3-times as many all-cause hospitalizations (mean 1.38 vs. 0.55 per patient) and days in hospital (10.2 vs. 3.4 per patient), and more outpatient claims (331 vs. 206 per patient) than matched cancer patients without VTE (all P<0.0001). Cancer patients with VTE incurred significantly higher overall (all-cause) inpatient costs (mean $21,299 vs. $7,459 per patient), outpatient costs (mean $53,660 vs. $34,232 per patient) and total healthcare costs (mean $74,959 vs. $41,691 per patient) than cancer patients without VTE (all P<0.0001). Total VTE-related healthcare costs were (mean) $9,247 per VTE patient over 12 months. Adjusted incremental all-cause healthcare costs of VTE were (mean) $30,538 per patient across the selected tumors, ranging from $11,946 per patient for gastric cancer to $38,983 per patient for pancreatic cancer. Conclusions: VTE results in significant inpatient and outpatient resource utilization, and increased all-cause (in addition to VTE-related) healthcare costs. Measures to prevent outpatient cancer-associated VTE may reduce healthcare utilization and costs in high-risk cancer patients.

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Venous Thromboembolism (VTE) Prevention with Semuloparin in Cancer Patients Initiating Chemotherapy: Benefit-Risk Assessment by VTE Risk in SAVE-ONCO

Blood ◽

10.1182/blood.v118.21.206.206 ◽

2011 ◽

Vol 118 (21) ◽

pp. 206-206 ◽

Cited By ~ 32

Author(s):

Daniel George ◽

Giancarlo Agnelli ◽

William Fisher ◽

Ajay Kakkar ◽

Michael R Lassen ◽

...

Keyword(s):

Risk Assessment ◽

High Risk ◽

Board Of Directors ◽

Cancer Patients ◽

Research Funding ◽

P Value ◽

Advisory Committees ◽

Benefit Risk Assessment ◽

Bayer Healthcare ◽

High Risk Cancer

Abstract Abstract 206 Background: Cancer patients receiving chemotherapy are at increased risk for VTE. Recent oncology guidelines emphasize the need for randomized studies with VTE risk assessment in these patients (Streiff MB, et al. JNCCN. 2011;9:714–777). Semuloparin is a new ultra-low-molecular-weight heparin with high anti-factor Xa and minimal anti-factor IIa activities. The SAVE-ONCO study investigated semuloparin vs placebo for VTE prevention in cancer patients receiving chemotherapy. Methods: Patients with metastatic or locally advanced cancer of lung, pancreas, stomach, colon-rectum, bladder or ovary initiating a chemotherapy course, were randomized to once-daily subcutaneous semuloparin 20 mg or placebo until change of chemotherapy. The primary efficacy outcome was a composite of symptomatic deep-vein thrombosis, any non-fatal pulmonary embolism, or VTE-related death. The main safety outcome was clinically relevant bleeding (major and non major). Baseline VTE risk was assessed by a score specifically developed and validated in chemotherapy-treated cancer patients (Khorana AA, et al. Blood. 2008;111:4902–7). According to this predictive model a score of 2 was assigned to very high-risk cancer sites (pancreatic or gastric), a score of 1 was assigned to high-risk cancer sites (lung, ovarian, or bladder cancer) and 1 is added to the score for each of the following parameters: platelet count ≥350 × 109/L, hemoglobin <10 g/dL and/or use of erythropoietin-stimulating agents, leukocyte count >11 × 109/L, and body mass index ≥35 kg/m2. Results: Among the 3212 patients randomized, the majority had lung (36.6%) or colorectal (28.9%) cancer and approximately two-thirds had metastatic cancer. In total, 550 (17.4%) of patients enrolled were at high risk of VTE, 1998 (63.2%) were at moderate risk, and 614 (19.4%) were at low risk (VTE risk score of ≥ 3, 1–2, or 0 points, respectively). All risk groups were well balanced between the treatment groups. Median treatment duration was approximately 3.5 months. Overall, semuloparin significantly reduced VTE or VTE-related death by 64% (p<0.0001; Table) vs placebo. The treatment effect was consistent across various levels of VTE risk (interaction p-value=0.6048; Table). Clinically relevant bleeding occurred in 2.8% and 2.0% of the patients in the semuloparin and placebo groups, respectively (Table). The incidence of major bleeding was similar: 1.2% and 1.1% patients in the semuloparin and placebo groups, respectively (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.55–1.99). No increased incidence of clinically relevant bleeding was observed with semuloparin vs placebo across various levels of VTE risk (interaction p-value=0.9409; Table). Conclusions: In cancer patients receiving chemotherapy, thromboprophylaxis with semuloparin was consistently associated with a favorable benefit-risk profile across various levels of VTE risk, but greatest in moderate to high risk patients. Antithrombotic prophylaxis should be considered in patients with cancer receiving chemotherapy, particularly in those who are at moderate to high risk of VTE. Disclosures: George: Viamet: Consultancy, Research Funding; Sanofi: Consultancy, Speakers Bureau; Pfizer: Consultancy, Research Funding, Speakers Bureau; Novartis: Consultancy, Research Funding, Speakers Bureau; Medivation: Consultancy; Janssen: Consultancy, Research Funding, Speakers Bureau; Ipsen: Consultancy, Research Funding; Genentech/Roche: Consultancy, Speakers Bureau; Dendreon: Consultancy, Research Funding, Speakers Bureau; Bayer: Consultancy; Astellas: Consultancy; GSK: Research Funding, Speakers Bureau; BMS: Research Funding; Exelixis: Research Funding. Agnelli:GlaxoSmithKline: Honoraria; Boehringer Ingelheim: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; sanofi-aventis: Honoraria. Fisher:Boehringer Ingelheim: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; sanofi-aventis: Honoraria, Research Funding. Kakkar:Bayer HealthCare: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; sanofi-aventis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Boehringer-Ingelheim: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Meyers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Eisai: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; ARYx Therapeutics: Consultancy; Canyon: Consultancy; GlaxoSmithKline: Honoraria. Lassen:Astellas Pharma Europe: Consultancy; Bayer HealthCare AG: Consultancy; Bristol-Myers Squibb: Consultancy; Boehringer Ingelheim: Consultancy; GlaxoSmithKline: Consultancy; Merck Serono: Consultancy; Pfizer: Consultancy; Protola Pharma: Consultancy; sanofi-aventis: Consultancy. Mismetti:sanofi-aventis: served as a member of Steering Committees. Mouret:Bayer HealthCare: Consultancy, Honoraria; sanofi-aventis: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria. Lawson:Sanofi: Employment. Turpie:Astellas Pharma Europe: Consultancy; Bayer HealthCare AG: Consultancy; Portola Pharma: Consultancy; sanofi-aventis: Consultancy.

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