Unmet needs and recommendations to improve meningioma care through patient, partner, and health care provider input: a mixed-method study.

BACKGROUND: It has been suggested that lack of ongoing registration of patient-centered outcomes has resulted in existing care trajectories that have not been optimized for sequelae experienced by meningioma patients. This study aimed to evaluate the structure of current meningioma care and identify issues and potential high-impact improvement initiatives. METHODS: Using the grounded theory approach, a thematic framework was constructed based on the Dutch Comprehensive Cancer Organisation survey about issues in meningioma care trajectories. This framework was used during 3 semistructured interviews and 2 focus groups with patient-partner dyads (n = 16 participants), and 2 focus groups with health care providers (n = 11 participants) to assess issues in current meningioma care trajectories and possible solutions, including barriers to and facilitators for implementation. RESULTS: Identified issues (n = 18 issues) were categorized into 3 themes: availability and provision of information, care and support, and screening for (neurocognitive) rehabilitation. A lack of information about the intervention and possible outcomes or complications, lack of support after treatment focusing on bodily and psychological functions, and reintegration into society were considered most important. Sixteen solutions were suggested, such as appointment of case managers (solution for 11/18 issues, 61%), assessment and treatment by physiatrists (22%), and routine use of patient-reported outcome measures for patient monitoring (17%). Barriers for these solutions were lack of budget, capacity, technology infrastructure, and qualified personnel with knowledge about issues experienced by meningioma patients. CONCLUSIONS: This study identified issues in current multidisciplinary meningioma care that are considered unmet needs by patients, partners, and health care providers and could guide innovation of care.

Enzyme linked immunosorbent assay for the quantification of nivolumab and pembrolizumab in human serum and cerebrospinal fluid.

Immunotherapy with monoclonal antibodies targeting the programmed-death-1 (PD-1) receptor has become standard of care for an increasing number of tumor types. Pharmacokinetic studies may help to optimize anti-PD-1 therapy. Therefore, accurate and sensitive determination of antibody concentrations is essential. Here we report an enzyme linked immunosorbent assay (ELISA) capable of measuring nivolumab and pembrolizumab concentrations in serum and cerebrospinal fluid (CSF) with high sensitivity and specificity. The assay was developed and validated based on the specific capture of nivolumab and pembrolizumab by immobilized PD-1, with subsequent enzymatic chemiluminescent detection by anti-IgG4 coupled with horse radish peroxidase (HRP). The lower limit of quantification for serum and CSF was 2 ng/mL for both anti-PD-1 agents. The ELISA method was validated and showed long term sample stability of >1 year. This method is reliable, relatively inexpensive and can be used in serum and CSF from pembrolizumab and nivolumab treated patients.

Leptomeningeal metastasis: a Response Assessment in Neuro-Oncology critical review of endpoints and response criteria of published randomized clinical trials.

PURPOSE: To date, response criteria and optimal methods for assessment of outcome have not been standardized in patients with leptomeningeal metastasis (LM). METHODS: A Response Assessment in Neuro-Oncology working group of experts in LM critically reviewed published literature regarding randomized clinical trials (RCTs) and trial design in patients with LM. RESULTS: A literature review determined that 6 RCTs regarding the treatment of LM have been published, all of which assessed the response to intra-CSF based chemotherapy. Amongst these RCTs, only a single trial attempted to determine whether intra-CSF chemotherapy was of benefit compared with systemic therapy. Otherwise, this pragmatic question has not been formally addressed in patients with solid cancers and LM. The methodology of the 6 RCTs varied widely with respect to pretreatment evaluation, type of treatment, and response to treatment. Additionally there was little uniformity in reporting of treatment-related toxicity. One RCT suggests no advantage of combined versus single-agent intra-CSF chemotherapy in patients with LM. No specific intra-CSF regimen has shown superior efficacy in the treatment of LM, with the exception of liposomal cytarabine in patients with lymphomatous meningitis. Problematic with all RCTs is the lack of standardization with respect to response criteria. There was considerable variation in definitions of response by clinical examination, neuroimaging, and CSF analysis. CONCLUSION: Based upon a review of published RCTs in LM, there exists a significant unmet need for guidelines for evaluating patients with LM in clinical practice as well as for response assessment in clinical trials.