Evaluation of rivaroxaban use in patients with gynecologic malignancies at an academic medical center: A pilot study.

BACKGROUND: Patients with gynecologic malignancies are at an increased risk for venous thromboembolism. National guidelines recommend treatment of an acute venous thromboembolism with low molecular weight heparin for 5-10 days followed by long-term secondary prophylaxis with low molecular weight heparin for at least six months. Non-vitamin K oral anticoagulants are not currently recommended to be used in cancer patients for the management of venous thromboembolism because robust data on their efficacy and safety have yet to become available in cancer patients. The objectives of this study were to determine the proportion of gynecologic oncology patients with venous thromboembolism using rivaroxaban compared to warfarin or low molecular weight heparin as well as compare the safety and efficacy of these anticoagulants. METHODS: This study was a retrospective pilot analysis of adult patients with gynecologic malignancies who received either rivaroxaban, warfarin or low molecular weight heparin for treatment of venous thromboembolism at Augusta University Medical Center from 1 July 2013 to 30 June 2015. Statistical comparisons between the enoxaparin and rivaroxaban group were made using T-tests and Chi-square or Fisher's exact tests, where appropriate. RESULTS: Out of the 49 patients, 37% (18) patients were on rivaroxaban, 53% (26) on enoxaparin, and 10% (5) on warfarin. Only one patient (4%) in the enoxaparin group experienced a recurrent deep vein thrombosis while there were no cases of recurrent venous thromboembolism in the rivaroxaban and warfarin group. The incidence of major bleeding was 17% (n = 2), 20% (n = 1), and 8% (n = 2) in patients receiving rivaroxaban, enoxaparin, and warfarin, respectively. The rate of switching to a different anticoagulant than originally prescribed was 42% (n = 14) in the enoxaparin arm, and 5.5% (n = 1) in the rivaroxaban arm. CONCLUSION: A high proportion of our gynecologic oncology patients received rivaroxaban for the management of venous thromboembolism. The sample size of this pilot analysis was too small to draw any conclusions regarding efficacy and safety of rivaroxaban compared with enoxaparin and warfarin. High rate of rivaroxaban use in gynecologic oncology patients at our institution highlights the need for larger, well-designed randomized controlled trials to confirm the safety and efficacy of its use in this population.

Impact of fluoroquinolone prophylaxis on infectious-related outcomes after hematopoietic cell transplantation.

BACKGROUND: Patients immediately post-hematopoietic cell transplantation are at high risk for bacteremia. Judicious prophylactic antimicrobial utilization must balance anticipated benefits (reduction infections) versus risk (bacterial resistance, Clostridium difficile) . OBJECTIVE: To compare infectious outcomes (primary: incidence bacteremia; secondary: febrile neutropenia, C. difficile, susceptibility of bacteremia, time to discharge and 30-day mortality) between hematopoietic cell transplantation who received fluoroquinolone prophylaxis to those who did not. METHODS: A local institutional review board-approved retrospective study was conducted on all hematopoietic cell transplantation patients ( n = 171) comparing those who received fluoroquinolone prophylaxis ( n = 105) to those who did not ( n = 66). Data included infectious outcomes and mortality for the first 30 days post-hematopoietic cell transplantation. Chi-squared was performed for categorical variables (GraphPad Software Inc., 2015). Secondary analysis compared outcomes within autologous and allogeneic sub-groups. RESULTS: Bacteremia was significantly lower for the overall cohort receiving fluoroquinolone (median duration eight days) versus those without fluoroquinolone (15.2% vs. 31.8%; P < 0.01). No difference was seen in C. difficile infection ( P = 0.81) or 30-day mortality (2.9% vs. 4.5%; P = 0.67). In the autologous sub-group ( n = 115), bacteremia was significantly lower in the fluoroquinolone cohort (8.5% vs. 27.3%; P = 0.0069), while no differences were seen in C. difficile infection ( P = 1) or 30-day mortality ( P = 1). In the allogeneic sub-group ( n = 56), there was no difference between those with and without fluoroquinolone in bacteremia (29.4% vs. 40.9%; P = 0.4) or C. difficile ( P = 0.72); however, there was a trend toward improved 30-day mortality (2.9% vs. 9.1%; P = 0.55). CONCLUSIONS: Fluoroquinolone prophylaxis reduces incidence of bacteremia in autologous hematopoietic cell transplantation without increasing C. difficile after hematopoietic cell transplantation.

Clinical Outcomes of Acid Suppressive Therapy Use in Hematology/Oncology Patients at an Academic Medical Center.

BACKGROUND: Acid suppressive therapy (AST)-namely, proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs)-is routinely prescribed to hospitalized patients for stress ulcer prophylaxis (SUP). OBJECTIVE: To identify the incidence of and indications for AST use in the hematology/oncology population as well as to identify the occurrence of the following PPI-associated adverse events: pneumonia and Clostridium difficile-associated diarrhea (CDAD). METHODS: A retrospective chart review was conducted on adult hematology/oncology patients admitted to any oncology service for ≥48 hours from October 1, 2014, to December 31, 2014. RESULTS: Of the 298 patients who met the inclusion criteria, 73% (n = 218) received an AST during admission. The most common indication for an AST was SUP (63%). The incidence of hospital-acquired pneumonia (HAP) was 10%, 0%, and 4% in patients who received a PPI, H2RA, and no AST, respectively (14/142 vs 0/70 vs 3/80; odds ratio [OR] for PPI vs no AST = 2.68; 95% CI = 0.75-9.63). The incidence of CDAD was 3%, 1.3%, and 1.2% in patients who received a PPI, H2RA, and no AST, respectively (4/142 vs 1/70 vs 1/80; OR for PPI vs H2RA = 1.92; 95% CI = 0.21-17.47). CONCLUSION: This is the first study to describe the incidence of and indications for AST use in the hospitalized hematology/oncology population. There was a high occurrence of AST use, particularly PPIs, in these patients at our institution. Additionally, there was a trend toward an increased risk of HAP and CDAD in patients who received AST during admission.

Clinical and Cost Comparison Evaluation of Inpatient Versus Outpatient Administration of EPOCH-Containing Regimens in Non-Hodgkin Lymphoma.

BACKGROUND: Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-containing regimens are frequently utilized in non-Hodgkin's lymphoma, however, the incidence of febrile neutropenia (FN) in patients receiving inpatient versus outpatient EPOCH has not been described. Additionally, no comparisons have been made regarding financial implications of EPOCH administration in either setting. This study's primary objective was to compare hospital admissions for FN in patients receiving inpatient or outpatient EPOCH. METHODS: A single-center, institutional review board-approved review was conducted for adults receiving EPOCH beginning January 2010. Clinical and financial data were collected through chart review and the institution's financial department. Descriptive statistics were utilized for analysis. RESULTS: A total of 25 patients received 86 cycles of an EPOCH-containing regimen (61 [70.9%] inpatient). Five (8.2%) inpatient cycles resulted in an admission for FN compared to 4 (16%) outpatient cycles. Prophylactic antifungal and antiviral agents were prescribed more often after inpatient cycles (>80%) compared to outpatient cycles (<50%). Overall, 27 (31.4%) of 86 cycles did not receive granulocyte colony-stimulating factor support. Outpatient EPOCH administration was associated with a cost savings of approximately US$141 116 for both chemotherapy costs and hospital day avoidance. CONCLUSION: EPOCH-containing regimens can be safely administered in the outpatient setting, which may result in cost savings for healthcare institutions.