Utilization and toxicity patterns of 2-weekly (Q2W) versus 4-weekly (Q4W) nivolumab for treatment of adjuvant and metastatic melanoma at BC cancer.

Background: Nivolumab, an immune checkpoint inhibitor used to treat several malignancies, is associated with immune-related adverse events (IrAEs). Original dosing for melanoma was 3 mg/kg (maximum 240 mg) every 2 weeks (Q2W). Based on simulation studies depicting similar efficacy and toxicity to original dosing, extended interval dosing of 6 mg/kg (maximum 480 mg) every 4 weeks (Q4W) was introduced.

International society of oncology pharmacy practitioners (ISOPP) position statement: The role of oncology pharmacy practitioners in immunotherapy treatment with immune checkpoint inhibitors for malignant conditions.

Oncology pharmacists, pharmacy technicians and assistants are key members of the multidisciplinary health care team (MHT) caring for patients receiving immunotherapy with immune checkpoint inhibitors. The International Society of Oncology Pharmacy Practitioners (ISOPP) developed this position statement to provide guidance on the role of oncology pharmacy practitioners in caring for patients receiving immune checkpoint inhibitors.Four key recommendations were identified: 1) participation as an integrated, collaborative member of the MHT;2) provision of education and training for patients, students, residents, fellows and other members of the MHT;3) involvement in clinical governance to optimise the use of immune checkpoint inhibitors and4) involvement in research and development in the field of immunotherapy.

Real-world incidence of venetoclax toxicities in British Columbia.

Introduction: Venetoclax is used to treat relapsed/refractory chronic lymphocytic leukemia (r/r CLL). Tumour lysis syndrome (TLS) is a serious toxicity associated with venetoclax, and real-world studies suggest that the incidence may be higher than in clinical trials. The purpose of this study is to describe the incidence of venetoclax toxicities in British Columbia (BC).

Defining cytotoxic drugs - you know it when you see it?

Safe handling precautions are an important measure used to prevent occupational exposure to hazardous antineoplastic drugs. Historically, the terms 'antineoplastic', 'chemotherapy' and 'cytotoxic' are frequently conflated. However, many current antineoplastic drugs do not have cytotoxic mechanisms of actions, leading to confusion when developing safe handling policies.

International Society of Oncology Pharmacy Practitioners global position on the use of biosimilars in cancer treatment and supportive care.

With the development of innovative cancer treatments over recent decades, the cost of cancer care has risen exponentially, limiting patient access to patented originator biotherapeutics in many countries. The introduction of biosimilars to the market has created new opportunities as well the need for changes in practice within healthcare institutions. A ‘biosimilar’ is a biotherapeutic product which is highly similar in terms of quality, safety and efficacy to an already licensed originator product.

Concomitant use of capecitabine and proton pump inhibitors - Is it safe?

Background: Capecitabine is a commonly used oral chemotherapy agent. Recent data suggest that concurrent use of proton pump inhibitors may reduce the efficacy of capecitabine by decreasing its absorption through increased gastric pH. Since proton pump inhibitors are widely used, we evaluated the supportive evidence for the probability of occurrence and potential seriousness of this drug interaction.

Clinical considerations of hyaluronidase as an adjunct to subcutaneous rituximab injection.

Subcutaneous rituximab injectables are formulated with recombinant human hyaluronidase as an adjunct to facilitate the absorption of the large volume of rituximab. We review the clinical considerations regarding the potential for systemic hyaluronidase toxicity and increased systemic absorption of subcutaneous or topical drugs administered subsequent to rituximab.

Survival outcomes associated with different sunitinib dosing regimens in metastatic renal cell carcinoma.

Background: Standard dosing regimen of sunitinib for metastatic renal cell carcinoma consists of four weeks treatment followed by two weeks rest (intermittent dosing). Alternative regimens have been suggested, including continuous daily dosing (continuous dosing) and non-conventional dosing (non-conventional dosing: e.g.

Efficacy of nivolumab four-weekly dosing schedule based on body weight.

Nivolumab has received regulatory approval to be given by weight-based or flat dosing every two weeks or by flat dosing every four weeks. However, flat dosing would lead to unnecessarily high doses for patients with lower body weight, increasing the drug usage and probability of toxicity. We review the rationale of using a four-weekly hybrid dosing strategy using weight-based and flat-dosing regimens adopted by some jurisdictions.

Evaluation of the role of pharmacy technicians in reviewing the eligibility for Oncotype DX genomic test and the impact of the test on treatment plans in breast cancer patients.

Purpose/objectives: The Oncotype DX genomic test is a treatment decision-making tool. Test results are presented as recurrence scores which are used to help decide between adjuvant hormonal therapy (low recurrence score) or chemotherapy (high recurrence score). Since 2014, the Oncotype DX test has been funded at the cancer treatment centres in our province for patients with early breast cancer.

Efficacy of bevacizumab and temozolomide therapy in locally advanced, recurrent, and metastatic malignant solitary fibrous tumour: A population-based analysis.

Background: Patients with locally advanced, recurrent or metastatic solitary fibrous tumour are often treated with bevacizumab and temozolomide based on the clinical efficacy reported in a case series of 14 patients. Given the rarity of solitary fibrous tumour, large trials are not feasible. We report the efficacy of this regimen based on a population-based analysis.

Challenges of dispensing costly tablets with short shelf-life.

Afatinib, trametinib and regorafenib are three costly oral oncology drugs with a short shelf-life after the original container has been opened. Their short shelf-lives are due to degradation on exposure to moisture. Therefore, manufacturers recommend them to be dispensed in the original packaging with the desiccant.

Approach to initiating QT-prolonging oncology drugs in the ambulatory setting.

Since the introduction of regulatory drug approval guidance on the evaluation of QT interval prolongation, an increasing number of drug monographs has included cautions on the risk of QT prolongation. For example, QT prolongation is mentioned in the Canadian product monographs of 29 drugs commonly seen in oncology practice. This presents two major challenges.

Safe handling of monoclonal antibodies: Too large to be hazardous?

It has been argued that the larger molecular weight of hazardous monoclonal antibodies may prevent their dermal absorption via occupational exposure. However, this assertion does not seem to be supported by direct evidence. Although the larger molecular weight may render monoclonal antibodies less probable to achieve therapeutic systemic level through dermal absorption, the concern in occupational health is whether these drugs can possibly attain a detectable level through repeated dermal exposure.

A deliberative framework to identify the need for real-life evidence building of new cancer drugs after interim funding decision.

Background: With the rising cost of new oncology treatments, it is no longer sustainable to base initial drug funding decisions primarily on prospective clinical trials as their performance in real-life populations are often difficult to determine. In British Columbia, an approach in evidence building is to retrospectively analyse patient outcomes using observational research on an ad hoc basis.

Methods: The deliberative framework was constructed in three stages: framework design, framework validation and treatment programme characterization, and key informant interview.

Loperamide and cardiac events: Is high-dose use still safe for chemotherapy-induced diarrhea?

High-dose loperamide is often used for the acute management of chemotherapy-induced diarrhea, with a maximum daily dosing of up to 24 mg. Recently, the US Food and Drug Administration has issued a warning that loperamide can cause rare serious cardiac events, including QT prolongation, torsades de pointes, cardiac arrest and death. Most events were reported in patients taking very high doses for an extended period of time.

Clinical effectiveness of bevacizumab in patients with recurrent brain tumours: A population-based evaluation.

Background Bevacizumab is an antiangiogenic agent active in patients with recurrent malignant gliomas. However, evidence for its clinical efficacy is relatively limited so that bevacizumab is approved for this indication in Canada and the United States, but not in the European Union. We reviewed the effectiveness of bevacizumab in patients with recurrent brain tumour using a large population database.

Development of a systematic approach to pharmaceutical industry's patient assistance programs on accessing unfunded cancer drugs.

Background New oncology drugs usually become commercially available several months before the funding decisions are made by provincial public payers. Increasingly, patient assistance programs are being set up by pharmaceutical companies in order to facilitate access of their new cancer drugs before public funding decisions are finalized. We discovered that there is a need to keep this information up to date and available in a central repository, thus we have created a centralized patient assistance chart for use by all who require information on accessing unfunded drugs in our province.

Adherence with capecitabine: A population-based analysis based on prescription refill data.

Background Patient adherence is important with the increasing use of oral anticancer drugs. Recent studies reported different capecitabine adherence rates based on self-reporting and microelectronic monitoring of the medication bottle. Patient's awareness of being monitored may confound these results.

Rationalizing the use of auxiliary label for oral oncology drugs.

Objective The objective of this study is to develop a systematic approach to standardize the use of auxiliary labels for oral oncology drugs. Design The project was multi-phased: environmental scan of auxiliary labels used at six BC Cancer Agency centre pharmacies, develop guidelines to support auxiliary labels standardization, develop inclusion criteria for common warnings and standardize warnings based on guiding principles and evidence (Canadian Compendium of Pharmaceutical Specialties, BC Cancer Agency Cancer Drug Manual, British National Formulary, literature). Results Consistent auxiliary labels use was rare (7% of drugs).

Evidence-based practice in times of drug shortage.

Shortage of oncology drugs is a particularly complicated issue because there are usually limited therapeutic options. Moreover, oncology practice may employ medications for supportive indications which differ from their main usage. This means shortage of oncology drugs is not usually addressed by the major drug shortage guidelines.

Clinical efficacy of generic imatinib.

Background: Generic imatinib has recently been approved for chronic myeloid leukemia in Canada and the European Union (EU). There are anecdotal concerns of reduced efficacy related to generic vs. brand name imatinib.

Hazards in determining whether a drug is hazardous.

The US National Institute for Occupational Safety and Health list and evaluation criteria have provided an important foundation to help institutions identify and create a list of hazardous formulary drugs. However, further guiding principles were needed to make the adoption feasible at our organization. First, we developed separate directives for determining the inherent hazardous toxicity of a drug and for the requirements for safe handling based on dosage forms (exposure risks) of these drugs.