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Enhancing Veteran Access to Cutting-Edge Treatments: Launching a T Cell Engager Therapy Administration Program
Background
The rise in the number of T-cell engager therapies highlights their importance in modern cancer treatment paradigms. Having recognized the need for, and complexities of, administering these innovative medications to our patients, our team assessed our institution’s capability to provide these therapies to our patients. We identified that our facility was wellequipped for implementation of T-cell engager therapy due to inpatient administration capabilities, an outpatient infusion center, on-hand supportive care medications (tocilizumab), and access to higher levels of care. Key players included medical oncologists, pharmacists, inpatient and infusion nurses, staff physicians, critical care practitioners, and care coordinators.
Clinical Practice Initiative
Barriers identified: education, toxicity concerns, formulary management, and logistics. To overcome these obstacles, comprehensive plans for procurement, hospital admission, monitoring, and training were developed as a facility-specific standard operating procedure (SOP). All available Tcell engager therapies were presented to the formulary committee and received local approval. Physician and pharmacist champions were registered for the associated risk evaluation and mitigation strategies (REMS) programs. Recorded webinars were done to provide education on REMS requirements, medication logistics, and adverse event management.
An admission plan was formulated to outline admission criteria, medication administration, and safety logistics. Order sets created by pharmacists, encompassed pre, post, and as needed medications for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. To facilitate safe discharge and meet REMS criteria, patients received wallet cards, dexamethasone and acetaminophen PRNs with detailed instructions for use, and direction for seeking emergency care with consideration of local tocilizumab availability.
Conclusions
Our SOP has enabled administration of six T-cell engager therapies for six diseases. The primary limitation for some of these agents is the need for inpatient monitoring at initiation, which may not be available at smaller centers. Facilities that lack these capabilities could utilize community care or partner with a neighboring Veterans Affairs medical center for initial administration, then transition back for continued treatment. Facilities that lack inpatient oncology nursing could administer the drug in the infusion center followed by admission for monitoring and toxicity management. Our implementation plan serves as a scalable model for improving veteran access to novel therapies.
Background
The rise in the number of T-cell engager therapies highlights their importance in modern cancer treatment paradigms. Having recognized the need for, and complexities of, administering these innovative medications to our patients, our team assessed our institution’s capability to provide these therapies to our patients. We identified that our facility was wellequipped for implementation of T-cell engager therapy due to inpatient administration capabilities, an outpatient infusion center, on-hand supportive care medications (tocilizumab), and access to higher levels of care. Key players included medical oncologists, pharmacists, inpatient and infusion nurses, staff physicians, critical care practitioners, and care coordinators.
Clinical Practice Initiative
Barriers identified: education, toxicity concerns, formulary management, and logistics. To overcome these obstacles, comprehensive plans for procurement, hospital admission, monitoring, and training were developed as a facility-specific standard operating procedure (SOP). All available Tcell engager therapies were presented to the formulary committee and received local approval. Physician and pharmacist champions were registered for the associated risk evaluation and mitigation strategies (REMS) programs. Recorded webinars were done to provide education on REMS requirements, medication logistics, and adverse event management.
An admission plan was formulated to outline admission criteria, medication administration, and safety logistics. Order sets created by pharmacists, encompassed pre, post, and as needed medications for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. To facilitate safe discharge and meet REMS criteria, patients received wallet cards, dexamethasone and acetaminophen PRNs with detailed instructions for use, and direction for seeking emergency care with consideration of local tocilizumab availability.
Conclusions
Our SOP has enabled administration of six T-cell engager therapies for six diseases. The primary limitation for some of these agents is the need for inpatient monitoring at initiation, which may not be available at smaller centers. Facilities that lack these capabilities could utilize community care or partner with a neighboring Veterans Affairs medical center for initial administration, then transition back for continued treatment. Facilities that lack inpatient oncology nursing could administer the drug in the infusion center followed by admission for monitoring and toxicity management. Our implementation plan serves as a scalable model for improving veteran access to novel therapies.
Background
The rise in the number of T-cell engager therapies highlights their importance in modern cancer treatment paradigms. Having recognized the need for, and complexities of, administering these innovative medications to our patients, our team assessed our institution’s capability to provide these therapies to our patients. We identified that our facility was wellequipped for implementation of T-cell engager therapy due to inpatient administration capabilities, an outpatient infusion center, on-hand supportive care medications (tocilizumab), and access to higher levels of care. Key players included medical oncologists, pharmacists, inpatient and infusion nurses, staff physicians, critical care practitioners, and care coordinators.
Clinical Practice Initiative
Barriers identified: education, toxicity concerns, formulary management, and logistics. To overcome these obstacles, comprehensive plans for procurement, hospital admission, monitoring, and training were developed as a facility-specific standard operating procedure (SOP). All available Tcell engager therapies were presented to the formulary committee and received local approval. Physician and pharmacist champions were registered for the associated risk evaluation and mitigation strategies (REMS) programs. Recorded webinars were done to provide education on REMS requirements, medication logistics, and adverse event management.
An admission plan was formulated to outline admission criteria, medication administration, and safety logistics. Order sets created by pharmacists, encompassed pre, post, and as needed medications for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. To facilitate safe discharge and meet REMS criteria, patients received wallet cards, dexamethasone and acetaminophen PRNs with detailed instructions for use, and direction for seeking emergency care with consideration of local tocilizumab availability.
Conclusions
Our SOP has enabled administration of six T-cell engager therapies for six diseases. The primary limitation for some of these agents is the need for inpatient monitoring at initiation, which may not be available at smaller centers. Facilities that lack these capabilities could utilize community care or partner with a neighboring Veterans Affairs medical center for initial administration, then transition back for continued treatment. Facilities that lack inpatient oncology nursing could administer the drug in the infusion center followed by admission for monitoring and toxicity management. Our implementation plan serves as a scalable model for improving veteran access to novel therapies.
Don’t Miss Those Blind Spots
Background
Choroidal malignant melanoma is a relatively rare condition, yet it remains the most common primary intraocular malignancy in adults, affecting approximately 5 individuals per million each year in the United States. Associated risk factors include fair skin, light-colored eyes, ocular melanocytosis, and BAP1 genetic mutations. While 13% of patients presenting with choroidal melanoma are asymptomatic, some symptoms can include photopsia, floaters, blurred vision, and progressive visual field loss.
Case Presentation
We present a case of choroidal melanoma in a 57-year-old male with a past medical history of hypertension, hyperlipidemia, major depressive disorder, and alcohol use disorder. This patient presented to the clinic following a detoxification admission, reporting one week of progressive vision loss in the left eye. Upon initial physical examination, the patient exhibited left superior quadrantanopia, with a visual acuity of 20/40 measured in the left eye. Initial imaging with CT head identified an intraocular hyperdensity within the left globe, raising concerns for potential retinal detachment. Urgent ophthalmologic evaluation revealed an afferent pupillary defect and a large choroidal lesion adjacent to the optic nerve head. Ultrasonography showed a low internal reflectivity mass (5.36 mm by 9.05 mm), and a subsequent dilated fundus examination confirmed a classic dome-shaped choroidal melanoma (11.5 mm by 16.5 mm). Gene expression profiling demonstrated a class 1b uveal melanoma with PRAME positivity and mutations in GNAQ and SF3B1. Comprehensive staging scans were negative for metastatic disease. The patient received four treatment sessions of proton beam therapy, which resulted in rapid improvements in his visual fields. For long-term management, he was scheduled for close ophthalmologic follow-up and regular imaging of the chest and abdomen every six months to monitor for recurrence.
Conclusions
This case highlights the challenges of diagnosing choroidal melanoma in the primary care setting and the importance of multidisciplinary involvement, multimodal imaging, and gene expression profiling in facilitating early diagnosis and treatment.
Background
Choroidal malignant melanoma is a relatively rare condition, yet it remains the most common primary intraocular malignancy in adults, affecting approximately 5 individuals per million each year in the United States. Associated risk factors include fair skin, light-colored eyes, ocular melanocytosis, and BAP1 genetic mutations. While 13% of patients presenting with choroidal melanoma are asymptomatic, some symptoms can include photopsia, floaters, blurred vision, and progressive visual field loss.
Case Presentation
We present a case of choroidal melanoma in a 57-year-old male with a past medical history of hypertension, hyperlipidemia, major depressive disorder, and alcohol use disorder. This patient presented to the clinic following a detoxification admission, reporting one week of progressive vision loss in the left eye. Upon initial physical examination, the patient exhibited left superior quadrantanopia, with a visual acuity of 20/40 measured in the left eye. Initial imaging with CT head identified an intraocular hyperdensity within the left globe, raising concerns for potential retinal detachment. Urgent ophthalmologic evaluation revealed an afferent pupillary defect and a large choroidal lesion adjacent to the optic nerve head. Ultrasonography showed a low internal reflectivity mass (5.36 mm by 9.05 mm), and a subsequent dilated fundus examination confirmed a classic dome-shaped choroidal melanoma (11.5 mm by 16.5 mm). Gene expression profiling demonstrated a class 1b uveal melanoma with PRAME positivity and mutations in GNAQ and SF3B1. Comprehensive staging scans were negative for metastatic disease. The patient received four treatment sessions of proton beam therapy, which resulted in rapid improvements in his visual fields. For long-term management, he was scheduled for close ophthalmologic follow-up and regular imaging of the chest and abdomen every six months to monitor for recurrence.
Conclusions
This case highlights the challenges of diagnosing choroidal melanoma in the primary care setting and the importance of multidisciplinary involvement, multimodal imaging, and gene expression profiling in facilitating early diagnosis and treatment.
Background
Choroidal malignant melanoma is a relatively rare condition, yet it remains the most common primary intraocular malignancy in adults, affecting approximately 5 individuals per million each year in the United States. Associated risk factors include fair skin, light-colored eyes, ocular melanocytosis, and BAP1 genetic mutations. While 13% of patients presenting with choroidal melanoma are asymptomatic, some symptoms can include photopsia, floaters, blurred vision, and progressive visual field loss.
Case Presentation
We present a case of choroidal melanoma in a 57-year-old male with a past medical history of hypertension, hyperlipidemia, major depressive disorder, and alcohol use disorder. This patient presented to the clinic following a detoxification admission, reporting one week of progressive vision loss in the left eye. Upon initial physical examination, the patient exhibited left superior quadrantanopia, with a visual acuity of 20/40 measured in the left eye. Initial imaging with CT head identified an intraocular hyperdensity within the left globe, raising concerns for potential retinal detachment. Urgent ophthalmologic evaluation revealed an afferent pupillary defect and a large choroidal lesion adjacent to the optic nerve head. Ultrasonography showed a low internal reflectivity mass (5.36 mm by 9.05 mm), and a subsequent dilated fundus examination confirmed a classic dome-shaped choroidal melanoma (11.5 mm by 16.5 mm). Gene expression profiling demonstrated a class 1b uveal melanoma with PRAME positivity and mutations in GNAQ and SF3B1. Comprehensive staging scans were negative for metastatic disease. The patient received four treatment sessions of proton beam therapy, which resulted in rapid improvements in his visual fields. For long-term management, he was scheduled for close ophthalmologic follow-up and regular imaging of the chest and abdomen every six months to monitor for recurrence.
Conclusions
This case highlights the challenges of diagnosing choroidal melanoma in the primary care setting and the importance of multidisciplinary involvement, multimodal imaging, and gene expression profiling in facilitating early diagnosis and treatment.