Implementation of a pharmacy-managed program for the transition of chemotherapy to the outpatient setting.

PURPOSE: Implementation of a pharmacy-managed program for the transition of chemotherapy to the outpatient setting is described. SUMMARY: The University of Arizona Cancer Center and Banner-University Medical Center Tucson are affiliated not-for-profit academic medical centers in Tucson, Arizona, whose facilities include a hospital and ambulatory care clinics that maintain 3 outpatient infusion centers. The cancer center pharmacy currently employs 25 pharmacists, with 4 clinical pharmacists serving both the inpatient and outpatient treatment sites. A multidisciplinary team of staff members was assembled to address the transition of chemotherapy from inpatient to outpatient that included physicians, ambulatory clinical oncology pharmacists, finance, social workers, pharmacy staff, nursing staff, and information technology. The program was initiated in May 2014, with a 2-year postimplementation evaluation of our transition of chemotherapy to the outpatient setting. Chemotherapy order sets were developed in our electronic medical record for transitioning rituximab to the outpatient setting for inpatient chemotherapy orders as well as transitioning leukemia, lymphoma, and solid tumor chemotherapy regimens to be administered in the outpatient setting. Eighteen rituximab-containing regimens and 14 chemotherapy protocols were switched to the outpatient setting, with numerous variants of these regimens also created for outpatient only administration. The realized savings for high-cost chemotherapy transitioned to the outpatient setting with rituximab and clofarabine was $1,902,890. Over 747 inpatient bed days were saved, with an approximated cost savings to the health system of $1,402,866, with a cumulative cost savings to our health system of $3,305,756. CONCLUSION: This model for transitioning chemotherapy from the hospital to the outpatient setting enhanced access to care, decreased bed utilization in the hospital, and improved clinical and financial metrics.

Managing Drug Interactions in Cancer Therapy: A Guide for the Advanced Practitioner.

Mrs. P is a 30-year-old woman who presented to our bone marrow transplant program with myelodysplastic syndrome (MDS). She received a haploidentical allogeneic stem cell transplant with a conditioning regimen consisting of busulfan and cyclophosphamide. This treatment was followed by post-transplant immunosuppression for graft-versus-host disease (GVHD) with cyclophosphamide, mycophenolate mofetil (MMF), and tacrolimus (see Table 1 for medication list). Tacrolimus levels were monitored twice a week with adjustment to a goal range of between 5 and 10 ng/mL. We initiated tacrolimus at a dose of 0.03 mg/kg by mouth twice daily (rounded to 2 mg by mouth twice daily). Drug interactions were assessed by the clinical pharmacist prior to admission, routinely with medication changes, and then upon discharge.

Integrating Biosimilars Into Oncology Practice: Implications for the Advanced Practitioner.

Biosimilar agents are biologic products that have been shown to be "highly similar" to an already approved reference biologic product. Their integration into clinical practice has the potential to significantly decrease costs for patients, health-care systems, and insurance companies. Through legislation, the US Food and Drug Administration (FDA) approved the Biologics Price Competition and Innovation (BCPI) Act in 2009. In 2010, it was signed into law, allowing for an abbreviated pathway for biosimilar approval. This law implemented a framework for development and regulation of biosimilars for manufacturers and provided guidance for the key submission components necessary to achieve final FDA approval. Many factors will influence how biosimilars are integrated into health-care systems and oncology clinics. As biosimilar utilization in the United States expands beyond supportive care, unique challenges will emerge. Patient and staff education will be at the forefront of the successful application of biosimilar agents in oncology, and advanced practitioners will be in a unique position to lead change. The goal of this article is to describe the chemical and clinical nature of biosimilars, review focus areas of interest for biosimilar development in oncology, discuss implementation strategies for biosimilars, and provide techniques for patient education on biosimilars.

Hypercalcemia of Malignancy.

CASE STUDY: A 60-year-old man initially presented with pain in the right upper quadrant in October 2010. A computed tomography (CT) scan of the abdomen pelvis completed at that time showed a mass at the junction of the body and tail of the pancreas and multiple large liver lesions. A CT-guided liver biopsy revealed low-grade neuroendocrine carcinoma. The patient was initially started on systemic treatment with sunitinib (Sutent) and octreotide. He developed intolerable side effects, including nausea and migraine. Therapy was discontinued in October 2011, when a CT scan revealed evidence of disease progression. At this point, he was transitioned to everolimus (Afinitor). He was treated with everolimus, with overall stable disease, until a magnetic resonance image (MRI) of the abdomen and pelvis showed enlarging hepatic metastases in April 2014. Everolimus was discontinued. The patient presented to the clinic to start third-line systemic therapy; he described the recent onset of disorientation at home, with difficulty in concentration and mild muscle weakness. He was found to be lethargic on the day of the visit. He was noted to have a 4-kg weight loss. Blood pressure was 82/45 mm Hg, with a heart rate of 115 beats/minute. Lab tests revealed a serum calcium level of 12.7 mg/dL (9.5 mg/dL prior). At that time, the serum albumin level was 2.4 mg/dL. The corrected calcium for albumin was 14 mg/dL. The patient was treated with intravenous (IV) hydration, and vital signs normalized post treatment. Labs revealed an improvement in serum calcium to 11.8 mg/dL (corrected = 13.1 mg/dL). Additional laboratory analysis revealed vitamin D, 25-hydroxy level of 40 ng/mL (reference range, 20-50 ng/mL), parathyroid hormone-related protein of 5.2 pmol/L (reference range, < 2.0 pmol/L), thyroid-stimulating hormone of 1.04 mIU/mL (reference range, 0.35-4.00 mIU/mL). An electrocardiogram revealed sinus tachycardia with a QT of 31.6 ms (QTc of 38.4 ms). The patient improved symptomatically and was sent home. The patient returned for repeat labs 1 week later, with worsening of previously described weakness and lethargy. The serum calcium level had increased to 13.2 mg/dL, with a serum albumin level of 2.8 mg/dL. Intravenous zoledronic acid (4 mg) was administered, and he was admitted for symptomatic hypercalcemia. He received continuous IV hydration with normal saline at 300 mL/hr and telemetry monitoring. Once hydrated, he was treated with IV furosemide. His serum calcium level rapidly improved to 10 mg/dL by day 2 of admission, and lethargy and weakness symptoms resolved. He was discharged from the hospital at that time. After discharge, the patient continued on third-line capecitabine-based systemic therapy, with excellent radiologic and tumor marker response to therapy and monthly zoledronic acid infusion. Serum calcium levels returned to within the normal range and stable, and he remained without relapse of hypercalcemia. After 2 months, zoledronic acid was discontinued, and the serum corrected calcium remained within normal limits.

Management strategies in pancreatic cancer.

PURPOSE: Current first-line and adjuvant chemotherapeutic strategies for management of patients with pancreatic cancer are reviewed. SUMMARY: Pancreatic adenocarcinoma is the 10th most prevalent cancer and the fourth most common cause of cancer deaths in the United States. More than 80% of patients with pancreatic cancer are diagnosed with locally advanced or metastatic disease and are not candidates for surgery; these patients often require multimodal treatment. The most widely used chemotherapy for such patients, as well as patients requiring adjuvant therapy after surgery, is gemcitabine or gemcitabine-based chemotherapy. All current chemotherapies for pancreatic cancer are associated with dose-limiting hematologic toxicity and other adverse effects that require ongoing monitoring and dosage adjustment to balance the benefits and risks of treatment. Pharmacists can play an important role in monitoring and providing drug information and guidance to patients and oncologists. Current investigational strategies include efforts to improve chemotherapy response rates and outcomes through modulation of cell signaling pathways and use of nanotechnology to improve drug delivery. CONCLUSION: Current management of pancreatic cancer is multifaceted, involving anticancer therapy, supportive care, and toxicity management. Standard systemic therapy with gemcitabine as a single agent or in combination with other cytotoxic agents provides modest benefits in terms of response and symptom control.

High-dose chemotherapy with hematopoietic stem cell transplantation for the treatment of primary central nervous system lymphoma.

Primary central nervous system lymphoma (PCNSL) is a rare B-cell lymphoid neoplasm for which current regimens utilizing standard-dose chemotherapy and/or radiation therapy lead to high relapse rates and/or unacceptable neurologic sequelae. High-dose chemotherapy followed by hematopoietic stem cell transplantation may overcome limitations of current treatment schemas. A search was performed of all English-language literature (1968 to June 2009) within the MEDLINE, EMBASE and Cochrane Library databases to identify relevant clinical trials using the terms stem cell transplantation, bone marrow transplantation, primary central nervous system lymphoma, and PCNSL. Bibliographies were reviewed to extract other relevant articles. Use of high-dose chemotherapy followed by hematopoietic stem cell transplantation for the treatment of PCNSL in a predominantly elderly population is feasible. Use of this treatment modality for newly diagnosed and recurrent or relapsed disease is burdened by a paucity of data guiding patient selection, optimal induction regimen, stem cell mobilization and conditioning chemotherapy. Data are also sparse and confounding regarding timing of initiation of this procedure relative to the natural history of the disease and timing of each chemotherapy regimen relative to each other. High-dose chemotherapy followed by hematopoietic stem cell transplantation remains an experimental procedure with insufficient data to guide clinicians. However, the data are encouraging and merit continued research to guide patient selection and treatment regimens which may produce optimal outcomes.