Brentuximab Vedotin: A Nursing Perspective on Best Practices and Management of Associated Adverse Events

Clifford, Kathleen; Copeland, Amanda; Knutzen, Gregory; Samuelson, Ellen; Grove, Laurie E.; Schiavo, Karen

doi:10.1188/18.cjon.e103-e114

Cited by 7 publications

(9 citation statements)

References 47 publications

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“…The MTD of PSMA ADC compares favorably with the recommended ADCETRIS® dose of 1.8 mg/kg every 3 weeks and with the MTD range of 1.0‐2.4 mg/kg every 3 weeks reported for polatuzumab vedotin, another MMAE‐based ADC . For PSMA ADC, reductions in neutrophil counts were generally transient and self‐resolving or responsive to treatment with granulocyte colony‐stimulating factors . Prior or ongoing peripheral neuropathy is prevalent in post‐docetaxel subjects.…”

Section: Discussionmentioning

confidence: 65%

“…45 For PSMA ADC, reductions in neutrophil counts were generally transient and self-resolving or responsive to treatment with granulocyte colonystimulating factors. 46 Prior or ongoing peripheral neuropathy is prevalent in post-docetaxel subjects. In this study, peripheral neuropathy was observed in a subset of subjects and was typically delayed in onset.…”

Section: Discussionmentioning

confidence: 99%

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Phase 1 study of PSMA ADC, an antibody‐drug conjugate targeting prostate‐specific membrane antigen, in chemotherapy‐refractory prostate cancer

et al. 2019

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Background: Prostate-specific membrane antigen (PSMA) is a well-characterized target that is overexpressed selectively on prostate cancer cells. PSMA antibodydrug conjugate (ADC) is a fully human IgG1 monoclonal antibody conjugated to the microtubule disrupting agent monomethyl auristatin E (MMAE), which is designed to specifically bind PSMA-positive cells, internalize, and then release its cytotoxic payload into the cells. PSMA ADC has demonstrated potent and selective antitumor activity in preclinical models of advanced prostate cancer. A Phase 1 study was conducted to assess the safety, pharmacokinetics, and preliminary antitumor effects of PSMA ADC in subjects with treatment-refractory prostate cancer. Methods:In this first-in-man dose-escalation study, PSMA ADC was administered by intravenous infusion every three weeks to subjects with progressive metastatic Present address: William C. Olson, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY 10591. Present address: Robert J. Israel, Salix Pharmaceuticals, 400 Somerset Corporate Blvd, Bridgewater, NJ 08807. † Deceased PETRYLAK ET AL. | 3 605castration-resistant prostate cancer (mCRPC) who were previously treated with docetaxel chemotherapy. The primary endpoint was to establish a maximum tolerated dose (MTD). The study also examined the pharmacokinetics of the study drug, total antibody, and free MMAE. Antitumor effects were assessed by measuring changes in serum prostate-specific antigen (PSA), circulating tumor cells (CTCs), and radiologic imaging.Results: Fifty-two subjects were administered doses ranging from 0.4 to 2.8 mg/kg. Subjects had a median of two prior chemotherapy regimens and prior treatment with abiraterone and/or enzalutamide. Neutropenia and peripheral neuropathy were identified as important first-cycle and late dose-limiting toxicities, respectively. The dose of 2.5 mg/kg was determined to be the MTD. Pharmacokinetics were approximately dose-proportional with minimal drug accumulation. Reductions in PSA and CTCs in subjects treated with doses of ≥1.8 mg/kg were durable and often concurrent. Conclusions:In an extensively pretreated mCRPC population, PSMA ADC demonstrated acceptable toxicity. Antitumor activity was observed over dose ranges up to and including 2.5 mg/kg. The observed anti-tumor activity supported further evaluation of this novel agent for the treatment of advanced metastatic prostate cancer. K E Y W O R D Santibody-drug conjugate, Prostate cancer, prostate-specific membrane antigen

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Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 99%

Phase 1 study of PSMA ADC, an antibody‐drug conjugate targeting prostate‐specific membrane antigen, in chemotherapy‐refractory prostate cancer

et al. 2019

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“…TNSn, which is calculated from five of the seven items in the TNSc, can be considered as a reliable, alternative, and objective clinical assessment where strength and reflex testing is removed. It can be useful if a more extended neurologic examination is not possible, as it can be done by a trained healthcare professional involved in the multidisciplinary approach of BVIN [ 103 , 104 , 109 , 110 ]. Very recently, the cut-off values for a relevant change defined as minimal clinical important difference (MCID) of TNS have been reported [ 104 ], supporting TNS implementation in clinical trials of patients treated with BV.…”

Section: Early Diagnosis and Management Of Bvinmentioning

confidence: 99%

“…Throughout treatment, patients should be monitored for signs and symptoms of neurotoxicity. By encouraging open communication and speaking with patients and caregivers about the possibility of BVIN onset and the benefits of early symptom reporting, BV adherence and effective management of PN may improve [ 103 , 109 ]. Having expertise relevant to BVIN management should form part of nurses or assistant physicians’ routine practice with patients with HL.…”

Section: Early Diagnosis and Management Of Bvinmentioning

confidence: 99%

“…A comprehensive assessment should with such healthcare professionals observing patients as they walk into the examination room in order to evaluate any abnormal gait or difficulty with balance. Similarly, it is important to see whether patients wear slip-on clothing or slip-on footwear, such as slippers or flip-flops, and observe patients as they button clothing, tie shoelaces, and pick up small objects (e.g., coins or paper clips) [ 109 , 110 ]. The clinical evaluation by the treating physician assistant or nurse practitioner should be followed by screening for related sensory impairments.…”

Section: Early Diagnosis and Management Of Bvinmentioning

confidence: 99%

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Brentuximab-Induced Peripheral Neurotoxicity: A Multidisciplinary Approach to Manage an Emerging Challenge in Hodgkin Lymphoma Therapy

Velasco

Domingo‐Domenech

Sureda

2021

Cancers

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Brentuximab vedotin (BV) is an anti-CD30 antibody–drug conjugate approved to treat classical Hodgkin lymphoma (HL). BV-induced peripheral neurotoxicity (BVIN) is one of the greatest concerns for haematologists treating HL for several reasons. First, BVIN is highly frequent. Most patients receiving BV will experience some degree of BVIN, resulting in the primary reason for dose modification or discontinuation of HL therapy. Second, BV produces sensory, motor, and/or autonomic peripheral nerve dysfunction, which can present as severe, disabling forms of BVIN—predominantly motor—in some patients. Third, although largely reversible, BVIN may persist months or years after treatment and thereby become a major issue in HL survivorship. BVIN may, therefore, negatively affect the quality of life and work-life of often young patients with HL, in whom long-term survival is expected. Currently, the only strategy for BVIN includes dose adjustments and treatment discontinuation; however, this could interfere with LH therapy efficacy. In this setting, early recognition and adequate management of BVIN are critical in improving clinical outcomes. Careful neurologic monitoring may allow accurate diagnoses and gradation of ongoing forms of BVIN presentation. This review analysed current, available data on epidemiology, pathophysiology, patient- and treatment-related risk factors, clinical and neurophysiologic phenotypes, and management in patients with HL. Furthermore, this review specifically addresses limitations posed by BVIN assessments in clinical practice and provides skills and tools to improve neurologic assessments in these patients. Integrating this neurotoxic drug in clinical practice requires a multidisciplinary approach to avoid or minimise neurotoxicity burden in survivors of HL.

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Expert consensus on the clinical application of antibody‐drug conjugates in the treatment of malignant tumors (2021 edition)

2022

Cancer Innovation

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Antibody‐drug conjugates (ADCs) are targeted biological agents composed of a cytotoxic drug linked to a monoclonal antibody through a linker. The monoclonal antibody targets tumor cells and transports small‐molecule cytotoxic drugs for specific delivery and minimal off‐target side effects. It is necessary for clinicians to understand the molecular characteristics and mechanisms of ADCs. Patients' survival mainly depends on the appropriate dose and course of treatment and also on proper management of adverse reactions. This consensus provides a systematic review of commercially available ADCs and further discusses the clinical application and management of ADCs.

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Brentuximab Vedotin: A Nursing Perspective on Best Practices and Management of Associated Adverse Events

Cited by 7 publications

References 47 publications

Phase 1 study of PSMA ADC, an antibody‐drug conjugate targeting prostate‐specific membrane antigen, in chemotherapy‐refractory prostate cancer

Phase 1 study of PSMA ADC, an antibody‐drug conjugate targeting prostate‐specific membrane antigen, in chemotherapy‐refractory prostate cancer

Brentuximab-Induced Peripheral Neurotoxicity: A Multidisciplinary Approach to Manage an Emerging Challenge in Hodgkin Lymphoma Therapy

Expert consensus on the clinical application of antibody‐drug conjugates in the treatment of malignant tumors (2021 edition)

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