Acceptable Response Research Articles

Flexible humidity sensor for smart agricultural applications

In order to meet the increasing food demand, sensors that measure the ambient temperature and humidity in greenhouses are needed for more efficient vegetable and fruit production. For this purpose, two different flexible and resistant textile-based humidity sensors that can measure the humidity at higher levels (80%, 90%, and 100% relative humidity (RH)) were designed and printed directly on the four different greenhouse fabrics using silver and carbon conductive inks. Depending on the humidity value in the environment, the sensor performance was tested based on sensor electrical resistance measurements with respect to repeated bending/cyclic tests, rubbing, ultraviolet (UV) exposure/ weatherability (against UV and raining) tests in order to simulate greenhouse conditions for smart agriculture. Despite applying 1024 bending cycles, up to 20 rubbing cycles, and 10 times UV and rain exposure to the humidity sensors at high RH, no significant change was detected in the resistance values of the humidity sensors. Moreover, some important features of the sensors such as hysteresis, repeatability, response time have been also examined. According to hysteresis test results, humidity sensors show acceptable dynamic response and response time of the sensors are 15.8, 17.3, 24.8, and 25 s at 100% RH for G2S, W1S, B2C, and W1C, respectively. Statistical analyses showed that the sensor designs and type of conductive inks had significant effects on the performance of the humidity sensors and the best sensor performance was obtained with the polypropylene coated fabric using design II and silver based conductive ink. The fabricated textile based flexible humidity sensors detect the change in RH levels from 80% RH to 100% RH and achieve good durability, and repeatability even after prolonged UV exposure and raining. Thus, the developed textile-based flexible humidity sensor might be useful for future smart agricultural applications.

Assessing the utility of ChatGPT as an artificial intelligence-based large language model for information to answer questions on myopia.

ChatGPT is an artificial intelligence language model, which uses natural language processing to simulate human conversation. It has seen a wide range of applications including healthcare education, research and clinical practice. This study evaluated the accuracy of ChatGPT in providing accurate and quality information to answer questions on myopia. A series of 11 questions (nine categories of general summary, cause, symptom, onset, prevention, complication, natural history, treatment and prognosis) were generated for this cross-sectional study. Each question was entered five times into fresh ChatGPT sessions (free from influence of prior questions). The responses were evaluated by a five-member team of optometry teaching and research staff. The evaluators individually rated the accuracy and quality of responses on a Likert scale, where a higher score indicated greater quality of information (1: very poor; 2: poor; 3: acceptable; 4: good; 5: very good). Median scores for each question were estimated and compared between evaluators. Agreement between the five evaluators and the reliability statistics of the questions were estimated. Of the 11 questions on myopia, ChatGPT provided good quality information (median scores: 4.0) for 10 questions and acceptable responses (median scores: 3.0) for one question. Out of 275 responses in total, 66 (24%) were rated very good, 134 (49%) were rated good, whereas 60 (22%) were rated acceptable, 10 (3.6%) were rated poor and 5 (1.8%) were rated very poor. Cronbach's α of 0.807 indicated good level of agreement between test items. Evaluators' ratings demonstrated 'slight agreement' (Fleiss's κ, 0.005) with a significant difference in scoring among the evaluators (Kruskal-Wallis test, p < 0.001). Overall, ChatGPT generated good quality information to answer questions on myopia. Although ChatGPT shows great potential in rapidly providing information on myopia, the presence of inaccurate responses demonstrates that further evaluation and awareness concerning its limitations are crucial to avoid potential misinterpretation.

Comparison of anti-spike IgG, anti-spike IgA levels and neutralizing antibody activity induced by CoronaVac and BNT162b2 vaccines in patients with inflammatory rheumatic diseases receiving immunosuppressive therapy

BackgroundThe importance of COVID-19 vaccination for patients on immunosuppressive (IS) medication has increased due to the high risk of severe disease or mortality. Different vaccines have varying efficacy rates against symptomatic COVID-19, ranging from 46.8% to 95%. The objective of this study was to examine the differences in anti-Spike IgG, anti-Spike IgA, and neutralizing antibody (NAb) activity between the inactive CoronaVac vaccine and the mRNA-based BNT162b2 vaccine in IS patients.MethodA total of 441 volunteers, including 104 IS patients, 263 healthy controls (HC), who received two doses of CoronaVac or BNT162b2, and 74 unvaccinated patients with a history of SARS-CoV-2 infection, were included in the study. Anti-spike IgG, IgA, and NAb activity were investigated.ResultsImmunogenicity with BNT162b2 was higher than with CoronaVac, but in IS groups, it was lower than HC (CoronaVac-IS: 79.3%, CoronaVac-HC: 96.5%, p < 0.001; BNT162b2-IS: 91.3%, BNT162b2-HC: 100%, p = 0.005). With CoronaVac, anti-Spike IgG levels were significantly lower than BNT162b2 (CoronaVac-IS: 234.5AU/mL, CoronaVac-HC: 457.85AU/mL; BNT162b2-IS: 5311.2AU/mL, BNT162b2-HC: 8842.8AU/mL). NAb activity in the BNT162b2 group was significantly higher. NAb and anti-Spike IgG levels were found to be correlated. Among the IS group, a significantly lower response to the vaccines was observed when using rituximab. IgA levels were found to be lower with CoronaVac.ConclusionsAlthough immunogenicity was lower in IS patients, an acceptable response was obtained with both vaccines, and significantly higher anti-Spike IgG, anti-Spike IgA, and NAb activity levels were obtained with BNT162b2.

Automated clinical knowledge graph generation framework for evidence based medicine

To practice the evidence-based medicine, clinicians are interested to find the most suitable research for the clinical decision making. The use of knowledge graphs (KGs) in evidence-based clinical decision support systems is becoming increasingly popular. However, existing KG construction frameworks are not fully automated and contextualized, thus unable to adapt to new domains and incorporate constantly changing information into their knowledge base, resulting in loss of relevance over time. Furthermore, existing KGs construction frameworks don't generate KG that provide relevant information within an acceptable response time for evidence-based practitioners because the organization of constructed subgraphs is neither topic-specific nor evidence-based PICO (Participants/Problem P, Intervention-I, Comparison C, Outcome O) query-friendly. By employing concept extraction, semantic enrichment, optimized clustering, and state of art Recurrent Neural Networks (RNNs) with BioBERT based encoded representation to categorize PICO elements and predict relationships between concepts using huge corpus of publicly available literature on COVID-19 and cerebral aneurysm, this paper proposes a topic specific, PICO enabled, and fully automated framework to curate information and create KG of different clinical domains. The evaluation shows that the proposed framework achieves significant improvement over baseline models and has 93 %, and 82 % accuracy on aneurysm and COVID data set respectively for PICO classification. Also, the relationship extraction module has an accuracy of 96 % with precision and recall being 92 %, and 90 % respectively.

On Construction of Precise Positioning System via IEEE 802.11ax

Wireless network stability is critical for organizations. Most companies rely on a solid internet connection for at least part of their day-to-day activities. It is essential to show the fast and high capacity of Wi-Fi. Wireless network management also significantly supplies the user with quality service and helps the system administrator manage and track the network infrastructure. The user must be able to stay connected. The Wi-Fi connection engine was applied in this paper using the Analysis and Locations Engine (ALE). ALE provides the information, including MAC address, location, floor information, and the building where the device belongs. From this data, we presented the web visualization of the Wi-Fi network monitoring system on the map using Cesium. Except for the common information about Wi-Fi users, this work presents the vertical position visualization in the buildings to provide more details about user usage. This work analyzes the user experience of using the proposed system, and latency is the appropriate metric to measure the user experience. The experiment results show that the optimized number of cluster partitions is four, and the latency is less than 1.3 seconds for 4 MB data. Therefore, the system provides a visualization platform with acceptable system response, and Internet managers would consider the proposed system as the management tool.

Ixekizumab Real-World Effectiveness at 24 Weeks in Patients with Psoriasis: Data from the United States Taltz Customer Support Program.

Ixekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24weeks. To describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Customer Support Program. This was a 24-week prospective, observational study of commercially insured diagnosis-confirmed adults with PsO. Surveys were completed at weeks 0 (baseline), 2, 4, 8, 12, and 24 and included the Patient Report of Extent of Psoriasis Involvement questionnaire to assess the extent of body surface area (BSA) affected by PsO, itch and pain numeric rating scales, Patient Global Assessment of Disease Severity (PatGA), and Dermatology Life Quality Index (DLQI). 523 patients were included in the analysis. Proportions of patients with ≤ 2% BSA involvement were 34.5%, 40.1%, 50.9%, and 79.9% at weeks 0, 2, 4, and 24, respectively; 54.8% and 75.1% achieved National Psoriasis Foundation preferred (BSA ≤ 1%) and acceptable (BSA ≤ 3% or ≥ 75% improvement) responses at week 12, respectively. Improvements of ≥ 4 points in itch and pain were seen by week 2 in 21.1% and 28.0% of patients, respectively, which increased to 63.1% and 64.8% at week 24. Proportions of patients with PatGA scores of 0 (clear) or 1 were 13.4%, 24.1%, 34.0%, and 69.6% at weeks 0, 2, 4, and 24, respectively; and proportions with DLQI total scores of 0 or 1 [no or minimal impact] were 8.4%, 17.6%, 27.3%, and 53.8% at weeks 0, 2, 4, and 24, respectively. Patient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2weeks after initiation and continued through week 24.

Enhancing human activity recognition using features reduction in IoT edge and Azure cloud

The Internet of Things (IoT), cloud computing, and machine learning opened an opportunity for new smart systems. These technologies have triggered huge traffic and delay by continuously transmitting telemetry data to the cloud. IoT edge choice made decision-making closer to the environment, which decreases traffic and speeds up response time. Human activity recognition (HAR) systems, among other IoT applications, require systems with quick response time; reduce costs using constrained traffic to the cloud while maintaining accurate prediction results. This study proposes an application of HAR for predicting activities using up to three smartphone accelerometers. Three models are developed, trained, and deployed to achieve the necessary accuracy at the IoT edge and in the cloud, with an acceptable response time. Since each coordinate value from the three accelerometers has different importance in activity category prediction, focusing on the data from the most related values can help minimize the amount of information transferred from the edge to the cloud. Six models were trained in the cloud; three were deployed and tested at the edge with different features by selecting the most important ones using Principal Component Analysis (PCA). Different experiments showed that traffic and processing time decreased significantly based on the time required to predict HAR categories with acceptable accuracy. Since there is significant latency between the edge and the cloud and within the cloud, sending samples for verification save bandwidth, and processing requests locally at the edge speed up predictions. Results illustrate that the time required to serve one request from the environment where smartphones generate traffic through the internet connection to the cloud took about 5.8 s on average, including transmission delays and the prediction process. During this time, the model at the edge can serve 150 requests with the same accuracy using nine features. In addition, the edge can serve 286 requests in 5.8 s with 94.8 % accuracy when choosing the top four features at the edge.

Validation of a French version of the Breakthrough Pain Assessment Tool in cancer patients: Factorial structure, reliability and responsiveness.

Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

To evaluate responsiveness and minimal important change (MIC) for the Persian versions of FABQ, TSK, and PCS.

Fear avoidance beliefs questionnaire (FABQ), Tampa scale of kinesiophobia (TSK), and pain catastrophizing scale (PCS) are tools widely used to measure fear-avoidance beliefs, fear of movement, and pain-related catastrophic thinking in people with chronic spinal disorders. To evaluate responsiveness and minimal important change (MIC) for the Persian version of FABQ, TSK, and PCS. One hundred people with chronic non-specific neck pain participated in an intervention program including routine physiotherapy plus pain neuroscience education. They fulfilled FABQ, TSK, and PCS questionnaires at baseline and 4-week follow-up. The 7-point global rating of change (GRC) as the external anchor was also completed in follow-up by patients. Responsiveness was evaluated using receiver operating characteristic (ROC) curve analysis and correlation analysis. According to GRC, patients were classified into two groups (improved vs. unimproved). The best cutoff or MIC was estimated via the ROC curve. Acceptable responsiveness obtained for FABQ, TSK, and PCS with the area under the curve ranging from 0.84 to 0.94 and spearman coefficient > 0.6. The MIC values reflecting improvement were 9.5, 10.5, and 12.5 points, respectively, for FABQ, TSK, and PCS. The results of this study demonstrated that the Persian version of FABQ, TSK, and PCS have sufficient responsiveness and good ability to measure meaningful clinical changes in people with patient CNNP. The MIC scores of the FABQ, TSK, and PCS can help clinicians and researchers to detect changes significant to the patient following a rehabilitation program.

Mitigation of undesirable volatile aroma compounds in kefir by freeze drying and vacuum evaporation.

Commercial kefir was recently found to be effective in curing recurrent Clostridioides difficile infection when consumed alongside antibiotic treatment. However, kefir products have limited acceptance among Western consumers due to their characteristic flavor and texture. Plain, unsweetened commercial kefir with 1% milkfat was subjected to vacuum evaporation and freeze-drying processes to assess the effect on volatile organic compound concentration, sensory quality, and microbial viability. Vacuum evaporation and freeze-drying both significantly decreased the concentration of 26 out of 27 volatiles in the kefir (p<0.05), by an average of 61%. Vacuum evaporation exhibited an apparent greater reduction than freeze-drying in the concentrations of the ketones and aldehydes, while freeze-drying showed a more noticeable reduction in the concentrations of the acids, alcohols, and esters. While lowering the concentration of volatiles did not significantly improve the average consumer acceptance of commercial kefir, both treatments showed differences in the range of acceptability responses. Both treatments also produced a small but significant reduction in the concentrations of Lactobacillus and Lactococcus species present.

How honey bees make fast and accurate decisions.

Honey bee ecology demands they make both rapid and accurate assessments of which flowers are most likely to offer them nectar or pollen. To understand the mechanisms of honey bee decision-making, we examined their speed and accuracy of both flower acceptance and rejection decisions. We used a controlled flight arena that varied both the likelihood of a stimulus offering reward and punishment and the quality of evidence for stimuli. We found that the sophistication of honey bee decision-making rivalled that reported for primates. Their decisions were sensitive to both the quality and reliability of evidence. Acceptance responses had higher accuracy than rejection responses and were more sensitive to changes in available evidence and reward likelihood. Fast acceptances were more likely to be correct than slower acceptances; a phenomenon also seen in primates and indicative that the evidence threshold for a decision changes dynamically with sampling time. To investigate the minimally sufficient circuitry required for these decision-making capacities, we developed a novel model of decision-making. Our model can be mapped to known pathways in the insect brain and is neurobiologically plausible. Our model proposes a system for robust autonomous decision-making with potential application in robotics.

Comparative spectroscopic study of Tb:Ce(Sal)3Phen complex inhibited PVA nanofibres for flexible moisture sensor

In the present work, we report a systematic study on optical alteration in Tb:Ce(Sal)3Phen, Tb(Sal)3Phen complexes, and TbCl3·6H2O inhibited in polyvinyl alcohol (PVA) polymeric nanofibres. We also report the feasibility of Tb:Ce(Sal)3Phen complex dispersed electrospun nanofibres for opto-humidity sensor. Structural, morphological, and spectroscopic properties of the synthesized nanofibres were systematically compared using Fourier transform infrared spectroscopy, scanning electron microscopy, and Photoluminescence analysis. Synthesized Tb(Sal)3Phen complex inhibited in nanofibres yields characteristic bright green photoluminescence of Tb3+ under UV excitations, which is at least two manifolds enhanced on the addition of Ce3+ ions in the same complex. The presence of Ce3+ ions, the salicylate ligand, and the Tb3+ ion help to expand the absorption range (290 nm–400 nm) and, subsequently, the photoluminescence in blue and green regions. Our analysis revealed the linear enhancement of photoluminescence intensity with the addition of Ce3+ ions. Upon exposing the flexible Tb:Ce(Sal)3Phen complex dispersed nanofibres mat in different humidity environments, photoluminescence intensity shows a linear variation. The prepared nanofibres film shows good reversibility, small hysteresis, cyclic stability, and acceptable response and recovery times i.e. 35 and 45 s. The humidity sensing mechanism was proposed on the basis of infrared absorption analysis of dry and humid nanofibres.

Investigating the Responsiveness of the Persian Version of the Core Outcome Measure Index Neck Questionnaire in People With Non-specific Chronic Neck Pain

Background and Objectives: This study aims to investigate the responsiveness of the Persian version of the core outcome measure index (COMI) neck questionnaire in patients with chronic non-specific neck pain. Methods: The participants included 104 subjects in the age range of 18 to 15 years with non-specific chronic neck pain who were undergoing physiotherapy intervention. The participants received and completed the Persian version of the COMI neck questionnaire before the first session of physiotherapy treatment. After completing the treatment sessions, the subjects were re-evaluated and completed the Persian version of the COMI neck questionnaire. In this study, to evaluate external responsiveness, in addition to completing the mentioned questionnaire, the participants received and completed the global rating of change questionnaire in the final session of the treatment. The internal responsiveness was evaluated by performing the paired t-test in addition to evaluating changes in the Persian version of COMI neck scores before and after treatment and calculating the effect size consisting of standard response mean and Cohen d. Meanwhile, the external responsiveness was calculated via the receiver operating characteristic curve and the correlation analysis. Results: The Persian version of the COMI neck questionnaire has acceptable external responsiveness. The standard response mean was large and the Cohen d was very large. Significant changes were observed between the scores of the COMI neck questionnaire before and after the treatment. In this study, the minimal clinically important difference was 1.82. Also, a good correlation was found between COMI neck and the global rating of change questionnaire. Conclusion: The Persian version of the COMI neck questionnaire has acceptable responsiveness. This questionnaire can be used to study the effects of physiotherapy intervention in patients with chronic non-specific neck pain.

Do you know the answers? Japanese and Hungarian preschoolers’ response tendencies to comprehensible and incomprehensible yes-no questions

We investigated Japanese and Hungarian children’s response tendencies to comprehensible and incomprehensible yes-no questions about objects. We found that 2-year-old children exhibited a strong and consistent yes bias to all questions, 3-year-old children tended to exhibit a yes bias to comprehensible questions, and children aged 5 and 6 exhibited a nay-saying bias to incomprehensible questions. Moreover, both Japanese and Hungarian children aged 5 and 6 demonstrated an instruction effect (i.e., responded with “I don’t know” when told this was an acceptable response). We discuss the possibility that older children exhibit a nay-saying bias or respond with “I don’t know” due to their developed meta-cognitive and meta-linguistic knowledge.

Robot versus human barista: Comparison of volatile compounds and consumers’ acceptance, sensory profile, and emotional response of brewed coffee

The increasing trend of integrating robots into the food industry has sparked debates regarding their potential influence on consumer attitudes toward food technology. This study investigated volatile compound profiles via gas chromatography–mass spectrometry (GC–MS), consumer acceptability, sensory profiling, and emotional responses of consumers toward coffee samples brewed by robot and human baristas. Moreover, the effect of the robot experience on food technology neophobia (FTN) was investigated. The principal component analysis of the volatile compound profiles revealed that the samples by the robot barista exhibited a higher degree of similarity compared to those prepared by the human barista. The range of relative standard deviations of volatile compounds from the robot barista brewed coffee was 1.4–83.1% and the variation was smaller than that of the human barista, which was 5.0–118.3%. Participants had a significant decrease in FTN scores after evaluating the robot-brewed coffee (p < 0.05), but there was no significant difference in FTN scores before and after evaluating the coffee brewed by the human barista (p > 0.05). Sensory evaluation studies revealed no significant differences in acceptability ratings and purchase intentions between the two groups (p > 0.05). However, emotional responses to the coffee samples significantly varied, with the robot-brewed coffee inducing more dynamic and positive emotions and the human-brewed coffee inducing more static and positive emotions (p < 0.05). Overall, this study provides valuable insights into consumer attitudes toward food robot service to humans and indicates that consumer’s experience with food robots may significantly reduce FTN (p < 0.001).

Fully Integrated Wearable Device for Continuous Sweat Lactate Monitoring in Sports.

The chemical digitalization of sweat using wearable sensing interfaces is an attractive alternative to traditional blood-based protocols in sports. Although sweat lactate has been claimed to be a relevant biomarker in sports, an analytically validated wearable system to prove that has not yet been developed. We present a fully integrated sweat lactate sensing system applicable to in situ perspiration analysis. The device can be conveniently worn in the skin to monitor real-time sweat lactate during sports, such as cycling and kayaking. The novelty of the system is threefold: advanced microfluidics design for sweat collection and analysis, an analytically validated lactate biosensor based on a rational design of an outer diffusion-limiting membrane, and an integrated circuit for signal processing with a custom smartphone application. The sensor covering the range expected for lactate in sweat (1-20 mM), with appropriate sensitivity (-12.5 ± 0.53 nA mM-1), shows an acceptable response time (<90 s), and the influence of changes in pH, temperature, and flow rate are neglectable. Also, the sensor is analytically suitable with regard to reversibility, resilience, and reproducibility. The sensing device is validated through a relatively high number of on-body tests performed with elite athletes cycling and kayaking in controlled environments. Correlation outcomes between sweat lactate and other physiological indicators typically accessible in sports laboratories (blood lactate, perceived exhaustion, heart rate, blood glucose, respiratory quotient) are also presented and discussed in relation to the sport performance monitoring capability of continuous sweat lactate.

Determinants of continuous intention to use retail apps: A hybrid PLS-ANN approach

ABSTRACT Although consumers’ intent to use retail applications (apps) over time is crucial to their success, academics have paid less attention to this factor. Using the attractiveness of alternatives as a moderator, this study aims to determine how users’ perceptions of app quality affect their propensity to use the app in the future through measures of performance confirmation and trust. The study analyzed the 435 acceptable responses using a hybrid approach incorporating partial least squares structural equation modeling and deep learning (artificial neural network). Results showed that utilitarian and hedonic performance confirmation and trust drive the use of retail apps. Service and information qualities validate trust and utilitarian and hedonic performance confirmation. System quality solely influences utilitarian performance confirmation. The attractiveness of alternatives adversely moderates utilitarian performance confirmation and continuation intention. The novel theoretical model integrating stimulus–organism–reaction model and information system success model reveals the relative importance of specific aspects, providing a better understanding of retail app users’ continuation intention.

Ethics of antibiotic allergy

Antibiotic allergies are commonly reported among patients, but most do not experience reactions on rechallenge with the same agents. These reported allergies complicate management of infections in patients labelled as...

PEPN1924, a phase 2 study of trastuzumab deruxtecan (DS-8201a, T-DXd) in adolescents and young adults with recurrent HER2+ osteosarcoma: A children’s oncology group pediatric early-phase clinical Trial Network study.

11527 Background: Overall survival for patients (pts) with recurrent, unresectable osteosarcoma (OS) remains poor, and event free survival (EFS) based on historical benchmarks has been used to determine efficacy of investigational agents. HER2, a transmembrane receptor with kinase activity involved in cell signaling through the RAS pathway, is expressed in OS. T-DXd is a HER2 targeting antibody linked to DXd with preclinical in vitro studies demonstrating activity in OS correlating with the presence of HER2 expression. We report results of a Phase 2 study of T-DXd in adolescents and young adults with HER2 positive relapsed, unresectable OS. Methods: Pts (12-39 yrs) with relapsed, unresectable OS were eligible for screening. The most recent available tissue sample was centrally evaluated for HER2 expression by immunohistochemistry. Pts with greater than 10% of OS cells with cytoplasmic or membranous HER2 expression of any intensity were eligible to receive T-DXd at 5.4mg/kg IV every 3 wks for up to 2 yrs. The proportion of pts with an EFS at 24 wks was the primary endpoint estimated using a 9+15 Simon’s optimal two-stage design assuming an unacceptable response rate of 12%, acceptable response rate of 40%, 5% type 1 error, and 90% power. Results: 50 pts were screened for HER2, and 41 samples met the membranous or cytoplasmic HER2 expression inclusion criteria. A single pt had an assay failure and 8 pts had tumor samples with less than 10% HER2+ cells. Nine eligible pts were enrolled (7 male) between April 15th and November 11th of 2021 and received T-DXd. 2 pts were &lt; 18 yrs old and the median age was 19.3 years. Seven pts received 2 cycles and had progressive disease (PD) at the first evaluation. A single pt withdrew consent before the first evaluation. The final pt was event free at wk 24, meeting the protocol specified criteria for a response. With a single pt having more than 24 wks of stable disease (SD) of the 9 planned in the first stage, this study did not meet criteria to progress to stage 2. The estimated response rate is 11.1% (1-sided 95% CI LB: 0.6%). The single responder with SD for 12 cycles had 15% HER2 positive OS cells and the remaining pts had 30-100% HER2 staining. A single cycle 1 DLT of thrombocytopenia (GR4) was observed. No unexpected or at least possibly or greater related AE’s were observed. Grade 3-4 at least possibly related AE’s occurred in 3 of 9 patients and included nausea, vomiting, tumor hemorrhage, cytopenias (n = 3), wound infection, and hypertension. Conclusions: T-DXd did not demonstrate sufficient response to expand enrollment to the planned second stage in pts with OS. None of the pts had significant HER2 membranous staining which may account for the limited efficacy. No new toxicities were observed. Further correlative studies including PK, anti-T-DXd analyses and circulating tumor DNA are ongoing. Clinical trial information: NCT04616560 .

The smart options of induction therapy for locally advanced betel-nuts related HNSCC in Taiwan.

e18080 Background: The treatment of HNSCC in Taiwan is still very challenging and might be related to betel-nuts use. Betel nut chewing might contribute to strong angiogenesis/invasion and treatment refractoriness. In western countries where HPV+ oropharyngeal cancer prevalence is high, induction TPF (TAX323/324) response rate in locally advanced HNSCC is around 70%; Erbitux and TP (Argiris in JCO2008) induction response rate is 86%. In the analysis from KGMH in Taiwan, induction chemotherapy response for locally advanced HNSCC was 55% in betel-nuts chewers compared with 75% in non-users ( p=0.038; From Su in World Journal of Surgical Oncology 2016). In further studies from Taiwan, Avastin-PF induction benefit (ORR 80%) was also prominent from NTUH (Huang in ESMO Asia2016); Erbitux-TPF induction response rate was 88% from VGH by Lu in Head &amp; Neck2019. Neoadjuvant biochemotherapy seemed to bring more benefits in betel-nuts related HNSCC. In the era of incorporating immunotherapy to neoadjuvant setting of HNSCC, triple therapy of bio-chemoimmunotherapy deserves more attention. Methods: From 2012 to 2022, 111 unresectable stage IVA &amp; IVB betal-nuts related HNSCC patients (OSCC 69, Hypopharynx 26, OPC 13) had ever received induction Bio-chemotherapy or triple therapy (Bio-chemoimmunotherapy) in Yun-lin Branch of National Taiwan University Hospital. We have reviewed basic characteristics, therapeutic regimens, induction response, and final outcomes of these patients. Results: See table. Conclusions: Induction TPF response in locally advanced betel-nuts related HNSCC in Taiwan was not so prominent. Flexible chemotherapy backbones, such as TP/DP-HDFL(weekly docetaxel or paclitaxel with cisplatin and 24-hr high dose 5-fluorouracil/leucovorin infusion), might produce acceptable response rates with less toxicity. Bio(EGFR or VEGFR-targeting)-chemotherapy or Bio-chemoimmunotherapy has brought encouraging induction response with favorable toxicity profiles to conversion surgery or definite CCRT. Further investigation and clinical trials will be urgently warranted. [Table: see text]