Assessment In Neuro-Oncology Scale Research Articles

Translation and validation of the Neurological Assessment in Neuro-Oncology scale to Brazilian Portuguese.

The Neurological Assessment for Neuro-Oncology (NANO) scale was elaborated to assess neurologic function in integration with radiological criteria to evaluate neuro-oncological patients in clinical setting and enable the standardization of neurological assessment in clinical trials. The objective of this study is the translation to Brazilian Portuguese and transcultural adaptation of NANO scale in patients with the diagnosis of glioblastoma, brain metastasis and low-grade glioma. Patients with diagnosis of glioblastoma, brain metastasis, and low-grade glioma were prospectively evaluated between July 2019 and July 2021. The process of translating and cross-culturally adapting the NANO scale included: translation from English to Portuguese, synthesis and initial revision by an expert committee, back-translation from Portuguese to English, a second revision by the expert committee, and the application of the NANO scale. Regarding the reliability of the NANO scale, Cronbach's alpha was employed to measure the internal consistency of all scale items and assess the impact of item deletion. Additionally, Spearman's correlation test was used to evaluate the convergent validity between the NANO scale and Karnofsky Performance Scale (KPS). One hundred and seventy-four patients were evaluated. A statistically significant inverse relation (p < 0.001) between KPS and NANO scale was founded. The Cronbach's alpha values founded for NANO scale were 0.803 for glioblastoma, 0.643 for brain metastasis, and 0.482 for low grade glioma. The NANO scale Brazilian Portuguese version proves to be reproducible and valid to evaluate neuro-oncological patients with glioblastoma and brain metastasis, presenting a strong correlation with KPS scale. Further studies are warranted to assess the validity and reliability of the scale in patients diagnosed with low-grade glioma.

Abstract CT061: TRIDENT phase 3 study (EF-32): First-line Tumor Treating Fields (TTFields; 200 kHz) therapy concomitant with chemo-radiation, followed by maintenance TTFields/temozolomide in newly diagnosed glioblastoma

Abstract Background: Tumor Treating Fields (TTFields) therapy is a loco-regional, noninvasive treatment approved for newly diagnosed (nd)/recurrent (r) glioblastoma (GBM) and mesothelioma. Approval for ndGBM was based on the pivotal phase 3 EF-14 study where TTFields therapy/temozolomide (TMZ), administered in the adjuvant setting, significantly improved PFS and OS vs TMZ monotherapy. TTFields therapy-related adverse events (AEs) were mostly mild-to-moderate skin reactions, with no evidence of TTFields therapy-related systemic toxicity. Radiotherapy (RT) concomitant with TTFields therapy demonstrated an increased therapeutic effect in preclinical models. Supplementary evidence from two pilot phase 2 studies demonstrated that concomitant administration of TTFields therapy with standard of care RT/TMZ was feasible and well-tolerated. Here we present a phase 3 study examining the efficacy and safety of TTFields therapy concomitant with RT/TMZ in patients with ndGBM. Materials and Methods: TRIDENT (EF-32; NCT04471844) is a global, randomized, phase 3 study of patients ≥18 years of age (≥22 years in the US) with histologically confirmed ndGBM, ≥3 months life expectancy, ≥70 Karnofsky Performance Status, and adequate organ function. Patients will be stratified by the extent of resection and methylation status of the MGMT promoter. Approximately 950 patients will be assigned 1:1 to continuous TTFields therapy (200 kHz, ≥18 h/day) concomitant with RT/TMZ (experimental arm) or RT/TMZ alone (control arm). Patients will first receive 6 weeks of experimental or control therapy, TTFields therapy will then be added to the control group and all patients will receive 6 cycles of maintenance TMZ and continuous TTFields therapy. Once initiated, TTFields therapy use will continue until second disease progression (PFS2) or until 24 months (if clinically able) from the time of randomization. The primary endpoint is median OS; secondary endpoints include 1- and 2- year OS rates, PFS, 6- and 12-month PFS rates, and PFS2 (all per Response Assessment in Neuro-Oncology [RANO]), overall radiological response (per RANO), severity and frequency of AEs, quality of life (QoL; per European Organisation for Research and Treatment of Cancer QoL Questionnaires), neurological function (per Neurological Assessment in Neuro-Oncology scale), and tumor pathology post study treatments (when available). The ability of TTFields therapy to prolong OS in a dose-dependent manner is an exploratory endpoint. The primary endpoint is based on the hypothesis that TTFields therapy/RT/TMZ can significantly improve OS (vs RT/TMZ) and will be tested using a stratified log-rank test. The sample size is calculated for a hazard ratio of &amp;lt;0.8 with a 5% type I error. The study is expected to enroll patients at 150 sites and is currently open in nine countries. Citation Format: Wenyin Shi, Lawrence Kleinberg, Suriya A. Jeyapalan, Samuel A. Goldlust, Seema Nagpal, Leonardo Lustgarten, Stephanie E. Combs, David Roberge, Ryo Nishikawa, David Reardon, Rachel Grossman, Martin Glas. TRIDENT phase 3 study (EF-32): First-line Tumor Treating Fields (TTFields; 200 kHz) therapy concomitant with chemo-radiation, followed by maintenance TTFields/temozolomide in newly diagnosed glioblastoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT061.

The Effects of Administrated Dexamethasone on Neurologic Assessment in Neuro-oncology Scale in Patients with Intracranial Tumors

BACKGROUND: In intracranial tumors, glucocorticoids are the main therapy to treat peritumoral edema. Neurologic Assessment in Neuro-Oncology (NANO) score is an instrument that can assess neurological function objectively and practically in patients with intracranial tumors. AIM: This study aims to determine the effect of dexamethasone administration on the NANO score of intracranial tumor patients. METHODS: This study was a pre-experimental study with a pre and post-test design at the H. Adam Malik General Hospital in Medan from March to September 2020. The study population was intracranial tumor patients. The research subject were 37 subjects taken consecutively. Treated with dexamethasone injection, then examined the NANO score before and after receiving dexamethasone injection on days 1, 2, and 3. Statistical analysis with Friedman test. RESULTS: Based on the demographic characteristics of the research subjects, the mean age was 53.29 ± 8.5 years. Most of the research subjects were male (54.1%) while female (45.9%). Most types of intracranial tumors were secondary tumors (59.5%) while primary tumors (40.5%). The significant effect of dexamethasone on NANO score in patients with intracranial tumors (p &lt; 0.001). CONCLUSION: There is an effect of dexamethasone on the NANO score of patients with intracranial tumors.

Response Assessment in Neuro-Oncology Clinical Trials.

Development of novel therapies for CNS tumors requires reliable assessment of response and progression. This requirement has been particularly challenging in neuro-oncology for which contrast enhancement serves as an imperfect surrogate for tumor volume and is influenced by agents that affect vascular permeability, such as antiangiogenic therapies. In addition, most tumors have a nonenhancing component that can be difficult to accurately quantify. To improve the response assessment in neuro-oncology and to standardize the criteria that are used for different CNS tumors, the Response Assessment in Neuro-Oncology (RANO) working group was established. This multidisciplinary international working group consists of neuro-oncologists, medical oncologists, neuroradiologists, neurosurgeons, radiation oncologists, neuropsychologists, and experts in clinical outcomes assessments, working in collaboration with government and industry to enhance the interpretation of clinical trials. The RANO working group was originally created to update response criteria for high- and low-grade gliomas and to address such issues as pseudoresponse and nonenhancing tumor progression from antiangiogenic therapies, and pseudoprogression from radiochemotherapy. RANO has expanded to include working groups that are focused on other tumors, including brain metastases, leptomeningeal metastases, spine tumors, pediatric brain tumors, and meningiomas, as well as other clinical trial end points, such as clinical outcomes assessments, seizures, corticosteroid use, and positron emission tomography imaging. In an effort to standardize the measurement of neurologic function for clinical assessment, the Neurologic Assessment in Neuro-Oncology scale was drafted. Born out of a workshop conducted by the Jumpstarting Brain Tumor Drug Development Coalition and the US Food and Drug Administration, a standardized brain tumor imaging protocol now exists to reduce variability and improve reliability. Efforts by RANO have been widely accepted and are increasingly being used in neuro-oncology trials, although additional refinements will be needed.