International Society of Oncology Pharmacy Practitioners (ISOPP) position statement: Role of the oncology pharmacy team in cancer care.

The Oncology Pharmacy Team (OPT), consisting of specialty-trained pharmacists and/or pharmacy technicians, is an integral component of the multidisciplinary healthcare team (MHT) involved with all aspects of cancer patient care. The OPT fosters quality patient care, safety, and local regulatory compliance. The International Society of Oncology Pharmacy Practitioners (ISOPP) developed this position statement to provide guidance on five key areas: 1) oncology pharmacy practice as a pharmacy specialty; 2) contributions to patient care; 3) oncology pharmacy practice management; 4) education and training; and 5) contributions to oncology research and quality initiatives to involve the OPT.

Pharmacogenomics with red cells: a model to study protein variants of drug transporter genes.

The PharmacoScan pharmacogenomics platform screens for variation in genes that affect drug absorption, distribution, metabolism, elimination, immune adverse reactions and targets. Among the 1,191 genes tested on the platform, 12 genes are expressed in the red cell membrane: ABCC1, ABCC4, ABCC5, ABCG2, CFTR, SLC16A1, SLC19A1, SLC29A1, ATP7A, CYP4F3, EPHX1 and FLOT1. These genes represent 5 ATP-binding cassette proteins, 3 solute carrier proteins, 1 ATP transport protein and 3 genes associated with drug metabolism and adverse drug reactions.

Safety and efficacy of low-dose sirolimus in the PIK3CA-related overgrowth spectrum.

Purpose: PIK3CA-related overgrowth spectrum (PROS) encompasses a range of debilitating conditions defined by asymmetric overgrowth caused by mosaic activating PIK3CA variants. PIK3CA encodes the p110α catalytic subunit of phosphatidylinositol-3-kinase (PI3K), a critical transducer of growth factor signaling. As mTOR mediates the growth-promoting actions of PI3K, we hypothesized that the mTOR inhibitor sirolimus would slow pathological overgrowth.

Pharmacogenomics Implementation at the National Institutes of Health Clinical Center.

The National Institutes of Health Clinical Center (NIH CC) is the largest hospital in the United States devoted entirely to clinical research, with a highly diverse spectrum of patients. Patient safety and clinical quality are major goals of the hospital, and therapy is often complicated by multiple cotherapies and comorbidities. To this end, we implemented a pharmacogenomics program in 2 phases.

Stability of tacrolimus solutions in polyolefin containers.

Purpose: Results of a study to determine the stability of tacrolimus solutions stored in polyolefin containers under various temperature conditions are reported.

Methods: Triplicate solutions of tacrolimus (0.001, 0.

Integrating pharmacogenetic information and clinical decision support into the electronic health record.

Pharmacogenetics (PG) examines gene variations for drug disposition, response, or toxicity. At the National Institutes of Health Clinical Center (NIH CC), a multidepartment Pharmacogenetics Testing Implementation Committee (PGTIC) was established to develop clinical decision support (CDS) algorithms for abacavir, carbamazepine, and allopurinol, medications for which human leukocyte antigen (HLA) variants predict severe hypersensitivity reactions. Providing PG CDS in the electronic health record (EHR) during order entry could prevent adverse drug events.

Stability of alemtuzumab solutions at room temperature.

Purpose: The 24-hour stability of alemtuzumab solutions prepared at concentrations not included in the product label and stored in glass or polyolefin containers at room temperature was evaluated.

Methods: Triplicate solutions of alemtuzumab (6.67, 40, and 120 μg/mL) in 0.

Improving adherence to research protocol drug exclusions using a clinical alerting system.

Objective: To develop a general method for using the alerting function of an electronic health record (EHR) system to warn prescribers when a drug order may be in conflict with the restrictions of a patient's research protocol.

Methods: We examined a sample of clinical research protocols at the National Institutes of Health (NIH) to identify the frequency with which drugs were excluded by protocols. We analyzed two protocols and modeled the exclusions they contained.

The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone.

Background: The standard of care for metastatic gastric cancer (MGC) is systemic chemotherapy which leads to a median survival of 6-15 months. Survival beyond 3 years is rare. For selected groups of patients with limited MGC, retrospective studies have shown improved overall survival following gastrectomy and metastasectomies including peritoneal stripping with continuous hyperthermic peritoneal perfusion (CHPP), liver resection, and pulmonary resection.

Sorafenib and sunitinib: novel targeted therapies for renal cell cancer.

Renal cell cancer (RCC) is a relatively uncommon malignancy, with 51,190 cases expected to be diagnosed in 2007. Localized disease is curable by surgery; however, locally advanced or metastatic disease is not curable in most cases and, until recently, had a limited response to drug treatment. Historically, biologic response modifiers or immunomodulating agents were tested in clinical trials based on observations that some cases of RCC can spontaneously regress.

Chemotherapy dose density in early-stage breast cancer and non-Hodgkin's lymphoma.

Delivering standard-dose chemotherapy on schedule is important for survival in early-stage breast cancer and non-Hodgkin's lymphoma. Trials of dose-escalated regimens, in which higher-than-standard doses of chemotherapy are used, have produced equivocal results. In contrast, dose-dense regimens, in which standard doses are given with shorter (usually 14-day) intervals between cycles, have been more efficacious than standard 21-day regimens in trials in both early-stage breast cancer and non-Hodgkin's lymphoma.