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Oncology Nurse Practice: Exemplars in Assuring Safety in Clinical Implementation of Treatment Innovations in Melanoma

Conference Correspondent  - Melanoma, Conference Correspondent, ONS 2017 - Immunotherapy

Immunotherapy is an incredibly exciting and vibrant pillar in cancer treatment. Studies have shown that immunotherapeutic agents enhance overall patient survival and induce highly durable tumor responses, resulting in a plateau in the tail of the survival curve. The safety profile is milder and more manageable than traditional chemotherapy or targeted therapy; however, these agents are associated with higher rates of immune-mediated adverse events.

Melanoma of the skin is the fifth most common cancer, representing 5.2% of all new cancer cases in the United States. Melanoma accounts for approximately 1% of all cases of skin cancer, but is responsible for most skin cancer deaths. In 2017, an estimated 87,110 new melanomas will occur, and 9730 people will die of melanoma. The risk for melanoma increases with age, and the average age of persons diagnosed with melanoma is 63 years.

The future of melanoma treatment is promising and full of potential, thanks to advancements in immunotherapy. Ipilimumab was the first FDA-approved immunotherapeutic agent for patients with metastatic melanoma. In a pivotal phase 3 clinical trial, ipilimumab, a cytotoxic T-lymphocyte associated protein-4 immune checkpoint inhibitor, resulted in significantly higher rates of recurrence-free survival, overall survival, and distant metastasis–free survival. Since then, the FDA has approved many other immunotherapies for melanoma treatment, including nivolumab, pembrolizumab, talimogene laherparepvec, aldesleukin, interferon alfa-2b, and peginterferon alfa-2b.

Intralesional injection of a modified herpes simplex virus type 1, talimogene laherparepvec, is a recent immunotherapeutic advancement in the treatment of certain types of melanoma. Safe administration of this intralesional injection induces both viral lysis and tumor-specific response. This immunotherapeutic agent poses the risk for herpetic infection in immune-vulnerable populations via accidental exposure. Similar to other cancer therapies, this agent will require a comprehensive plan for safe implementation in clinical practice.

A recent study was developed to produce evidence-based and consensus-driven biosafety procedures to ensure the safe storage, transport, distribution, and administration of talimogene laherparepvec, as well as postprocedural patient care at a National Cancer Institute–designated cancer center. Oncology nurses developed biosafety procedures, processes, and educational materials for patients, providers, and staff. A go/no-go analysis was performed to ensure the implementation plan was complete, communicated to stakeholders, and ready to implement. This information was saved on the intranet so it could be shared among providers and departments. It also allowed for version control, rapid revision, and redistribution of documents as evidence emerges or practice requirements change.

The first injection was given without incident. A post–go-live analysis revealed that modifications were needed—primarily storage timing and drug preparation—to improve efficiency in distribution and administration procedures. The implemented biosafety procedures reduced the risk for biohazard exposure to patients and clinical staff, and will be evaluated regularly to assure best clinical practice.

The development of comprehensive, best practice guidelines is essential for the safe and effective administration of new biohazardous agents approved for the treatment of melanoma. Oncology nurses are integral in safely translating groundbreaking immunotherapeutic agents into clinical practice.

Finnan A, et al. ONS Abstract 88.

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Last modified: May 5, 2017