Recurrence of malignancy-associated venous thromboembolism among patients treated with rivaroxaban compared to enoxaparin.

Purpose Although low-molecular-weight heparin (LMWH) remains the standard of care, factor Xa inhibitors such as rivaroxaban may serve as an alternative treatment for venous thromboembolism (VTE) in patients with active malignancy. The purpose of the analysis was to evaluate outcomes of VTE management in cancer patients treated with rivaroxaban compared to enoxaparin. Methods This single-center retrospective analysis was conducted on patients with malignancy-associated VTE initiated on treatment with either rivaroxaban or enoxaparin. The primary endpoint was the incidence of recurrent VTE. Secondary outcomes included a comparison in rates of bleeding, mean duration of treatment, and mean time to recurrence of VTE. Results A total of 45 patients were included in each group. The incidence of recurrent VTE was 8.9% in the rivaroxaban group versus 13.3% in the enoxaparin group ( p = 0.53). There were no statistically significant differences in the secondary outcomes with the exception of longer mean duration of treatment in the rivaroxaban group compared to the enoxaparin group (169 vs. 110 days, respectively; p = 0.04). Conclusions This study provides important preliminary information regarding the efficacy and safety of rivaroxaban for treatment of VTE in cancer patients. Although LMWH should remain the standard of care, these results provide initial reassurance that rivaroxaban serves as a viable alternative in the event that injectable anticoagulation is not an acceptable approach to VTE management.

Feasibility of extended dosing intervals of denosumab.

Purpose Denosumab is a crucial supportive care agent for patients with advanced cancers affecting the bone. Despite the importance of treatment, logistical and financial obstacles hinder the ability to maintain long-term adherence. This analysis was designed to provide preliminary data regarding the feasibility of extended denosumab dosing intervals. Methods This retrospective, case cohort study was conducted on patients receiving treatment with denosumab for malignancies with bone involvement. A total of 60 patients were identified for analysis and were divided into cohorts according to the average number of days between denosumab doses. The standard interval group was comprised of patients receiving treatment once every 27-30 days ( n = 29), whereas the deviated interval group was comprised of patients with an interval of 31-56 days between injections ( n = 31). The primary outcome was the percentage of patients developing a skeletal-related event. Secondary efficacy outcomes included rate of pathologic fracture, spinal cord compression, radiation therapy, surgery, and hypercalcemia. Results Patients in the deviated interval arm experienced significantly more skeletal-related events compared to the standard interval group (61% vs. 31%, respectively; p = 0.02). Secondary efficacy endpoints trended in favor of the standard therapy arm except for requirement for surgery (results were virtually equivalent) and hypercalcemia (no events in either group). Conclusions Non-adherence with the standard denosumab dosing schedule demonstrated an increased risk of experiencing a skeletal-related event. Preservation of denosumab dose density appears imperative to maintain efficacy and as such extending the dosing interval should be discouraged.

Effectiveness of exogenous albumin administration for the prevention of ifosfamide-induced encephalopathy.

STUDY OBJECTIVES: To assess the effectiveness of prophylactic albumin for the prevention of ifosfamide-induced encephalopathy (IIE), and to describe risk factors for IIE and investigate the predictive potential of a novel risk-stratification model for IIE. DESIGN: Retrospective analysis. SETTING: Single academic medical center. PATIENTS: Forty-one adults who received 93 chemotherapy cycles of regimens that included ifosfamide for the treatment of hematologic or solid tumor malignancy between November 2007 and November 2008. Patients were divided into two groups based on the use of albumin for IIE prophylaxis: albumin group (32 cycles) and no albumin group (61 cycles). MEASUREMENTS AND MAIN RESULTS: Overall occurrence of neurotoxicity during therapy served as the primary outcome measure. Proposed risk factors for IIE were assessed by conducting a subgroup analysis of patients who did and those who did not experience IIE. A novel risk-stratification model was developed in an attempt to predict patients at risk for IIE. The validity of the scheme was assessed by comparing the occurrence of IIE among high- and low-risk patients as identified by the model. Overall, among the 93 cycles, six cases of IIE (6.5%) were identified. The occurrence of IIE was more common in the albumin group compared with the no albumin group (15.6% [5/32] vs 1.6% [1/61], p=0.01). Baseline albumin level was significantly lower, and serum creatinine and aspartate and alanine aminotransferase concentrations were significantly higher among patients experiencing IIE. All cases of IIE occurred among patients identified as high risk according to the risk-stratification model (p=0.01). CONCLUSION: Prophylactic therapy with exogenous albumin is not an effective strategy for the prevention of IIE. The novel risk-stratification model appears to be an effective method for predicting patients with the greatest potential for developing this adverse effect.

Initial therapy in multiple myeloma: investigating the new treatment paradigm.

The development of three novel chemotherapeutic agents - thalidomide, lenalidomide, and bortezomib - has resulted in a fundamental shift in the management of multiple myeloma. Despite this tremendous advancement, the selection of initial treatment must still be made with a degree of uncertainty as a true standard therapy has yet to be established. Although challenging, the relative abundance of therapeutic options, when taken into consideration with unique patient characteristics, creates the potential for individualization of care.For patients eligible for autologous stem cell transplantation, various combinations of novel agents with dexamethasone or traditional chemotherapy have supplanted the previous standard regimen consisting of vincristine, doxorubicin, and dexamethasone. In elderly patients or others that are deemed ineligible for the transplant procedure, the addition of a novel agent to melphalan-prednisone has demonstrated significant improvements in response rates. Due to the immaturity of the available data, it is perhaps best to regard the era of novel agents with a degree of rational enthusiasm, as the ultimate impact on patient care remains undetermined. Although further research is clearly implicated, recent advancements have resulted in significant progress toward obtaining optimum outcomes in a historically challenging disease.