First-Line Therapies for VTE Treatment and Secondary Prophylaxis in Patients With Cancer: A New Direction.

OBJECTIVE: To review evidence behind anticoagulants in cancer-associated venous thromboembolism (VTE) with a focus on low-molecular-weight heparins (LMWH) and the role of direct oral anticoagulants (DOACs). DATA SOURCES: PubMed was searched using terms "venous thromboembolism," "cancer," and "anticoagulation." This search was restricted to clinical trials, meta-analyses, and subgroup analyses. Additional references were identified from reviewing literature citations. STUDY SELECTION: English-language prospective and retrospective studies assessing the efficacy and safety of LMWH and DOACs in patients with cancer. DATA ANALYSIS: Several trials were analyzed that compared anticoagulation therapies for prevention of recurrent VTE in patients with cancer. Many studies comparing LMWH and vitamin K antagonists (VKAs) found nonsignificant differences between therapies. A single study demonstrated that LMWHs are superior to VKAs. This evidence supporting LMWH for long-term VTE treatment in patients with cancer is based on comparison to VKA, but results are limited by methodological issues, and the benefit of LMWH may be driven by poor control. Subanalyses of DOAC trials suggest these are equally or more effective as VKA in cancer, but this conclusion is underpowered. CONCLUSION: DOACs have the potential to bypass many challenges with traditional therapy. After analyzing the evidence available, we conclude that after careful consideration of risks and benefits, use of DOACs for VTE treatment are a reasonable option in patients with cancer.

Evaluation of the use of non-formulary oncology medications restricted to outpatient use in hospitalized patients after implementation of a criteria-for-use algorithm.

OBJECTIVE: To decrease the number of orders and total hospital spend for inpatient use of antineoplastic drugs of interest, while evaluating each case for urgent or emergent need for administration. METHODOLOGY: This study is a multicenter, retrospective, cost-evaluation, cohort study performed in five Ascension Seton hospitals in the Austin, Texas area between 1 January 2013 and 31 December 2018. Patients were identified via a dispense analysis report for the antineoplastic drugs of interest. RESULTS: An overall reduction of 56% was seen in orders processed with a 62% decrease in annual hospital spending after implementation of the criteria-for-use algorithm. When results were evaluated without including rituximab orders, a reduction of 17% was seen in orders processed with a 21% decrease in annual hospital spending. DISCUSSION AND CONCLUSION: The decreases in our primary outcomes were primarily driven by a reduction in the use of one drug, rituximab. Overall, implementation of a criteria-for-use algorithm was effective in reducing both overall number of orders and hospital spending for restricted antineoplastic agents.

Nivolumab-induced vitiligo in a metastatic melanoma patient: A case report.

The programmed-death-1 inhibitors selectively block programmed-death-1 interaction with its receptor, which restores active T-cell response directed at tumor cells, inducing an anti-tumor effect. This nonspecific activation of the immune system can also lead to a wide spectrum of side effects. Nivolumab has been used effectively to prolong survival in patients with metastatic melanoma and is recommended as a category 1 agent for systemic therapy in metastatic or unresectable melanoma per the National Comprehensive Cancer Network guidelines. We present a case of a 64-year-old woman who began nivolumab therapy for metastatic melanoma. After six doses of nivolumab therapy, the patient experienced generalized hypopigmentation on her face, chest, back, arms, and lower extremities. Although vitiligo has been reported in as many as 10.7% of patients undergoing nivolumab therapy in some clinical trials, we believe this is the first case to describe the progression of nivolumab-induced vitiligo in a metastatic melanoma patient. This case provides significant insight into the onset, symptoms, development, and treatment options for patients experiencing vitiligo as a result of nivolumab therapy.

Clinical dilemmas and a review of strategies to manage drug shortages.

OBJECTIVE: The objectives of this article are to review the clinical implications of drug shortages highlighting patient safety, sedation, and oncology and introduce an expanded phase approach for the management of drug shortages. DATA SOURCES: Literature retrieval was accessed through a PubMed search of English-language sources from January 1990 through April 2012 using the medical subject heading pharmaceutical preparations/supply and distribution and the general search term drug shortages. STUDY SELECTION AND DATA EXTRACTION: All original prospective and retrospective studies, peer-reviewed guidelines, consensus statements, and review articles were evaluated for inclusion. Relevance was determined considering the therapeutic class, focus on drug shortages, and manuscript type. DATA SYNTHESIS: The increased number of drug shortages has created significant challenges for health care providers. Two particularly vulnerable populations are critically ill and oncology patients. A lack of therapeutic alternatives in critically ill patients may impact patient safety as well as treatment outcomes. Similarly, a chemotherapy agent in short supply may contribute to adverse outcomes in oncology patients. CONCLUSIONS: The mounting number of drug shortages has created a health care crisis, requiring changes in management strategies as well as clinical practice. The expanded phased approach outlined here provides a consistent, systematic approach for the management of drug shortages.