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BACKGROUND: The global BOLERO-2 trial established the efficacy and safety of combination everolimus (EVE) and exemestane (EXE) in the treatment of estrogen receptor positive (ER +), HER2-, advanced breast cancer (ABC). BOLERO-5 investigated this combination in a Chinese population (NCT03312738). METHODS: BOLERO-5 is a randomized, double-blind, multicenter, placebo controlled, phase II trial comparing EVE (10 mg/day) or placebo (PBO) in combination with EXE (25 mg/day). The primary endpoint was progression-free survival (PFS) per investigator assessment. Secondary endpoints included PFS per blinded independent review committee (BIRC), overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), pharmacokinetics, and safety. RESULTS: A total of 159 patients were randomized to EVE + EXE (n = 80) or PBO + EXE (n = 79). By investigator assessment, treatment with EVE + EXE prolonged median PFS by 5.4 months (HR 0.52; 90% CI 0.38, 0.71), from 2.0 months (PBO + EXE; 90% CI 1.9, 3.6) to 7.4 months (EVE + EXE; 90% CI 5.5, 9.0). Similar results were observed following assessment by BIRC, with median PFS prolonged by 4.3 months. Treatment with EVE + EXE was also associated with improvements in ORR and CBR. No new safety signals were identified in BOLERO-5, with the incidence of adverse events in Chinese patients consistent with the safety profile of both drugs. CONCLUSION: The efficacy and safety results of BOLERO-5 validate the findings from BOLERO-2, and further support the use of EVE + EXE in Chinese post-menopausal women with ER + , HER2- ABC. NCT03312738, registered 18 October 2017.
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PURPOSE: The highly aggressive undifferentiated sarcomatoid carcinoma (USC) subtype of pancreatic ductal adenocarcinoma (PDAC) remains poorly characterized because of its rarity. Previous case reports suggest that immune checkpoint inhibitors could be a promising treatment strategy, but the prevalence of established predictive biomarkers of response is largely unknown. The objective of this study was to leverage comprehensive genomic profiling of USC PDAC tumors to determine the prevalence of biomarkers associated with potential response to targeted therapies. METHODS: USC tumors (n = 20) underwent central pathology review by a board-certified gastrointestinal pathologist to confirm the diagnosis. These samples were compared with non-USC PDAC tumors (N = 5,562). Retrospective analysis of DNA and RNA next-generation sequencing data was performed. RESULTS: USC PDACs were more frequently PD-L1+ by immunohistochemistry than non-USC PDAC (63% v 16%, respectively, P < .001). Furthermore, USC PDAC had an increase in neutrophils (8.99% v 5.55%, P = .005) and dendritic cells (1.08% v 0.00%, q = 0.022) and an increased expression of PDCD1LG2 (4.6% v 1.3%, q = 0.001), PDCD1 (2.0% v 0.8%, q = 0.060), and HAVCR2 (45.9% v 21.7%, q = 0.107) than non-USC PDAC. Similar to non-USC PDAC, KRAS was the most commonly mutated gene (86% v 90%, respectively, P = 1). CONCLUSION: To our knowledge, this work represents the largest molecular analysis of USC tumors to date and showed an increased expression of immune checkpoint genes in USC tumors. These findings provide evidence for further investigation into immune checkpoint inhibitors in USC tumors.
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Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Humanos , Neoplasias Pancreáticas/genética , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/patología , Masculino , Femenino , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Carcinoma Ductal Pancreático/genética , Carcinoma Ductal Pancreático/tratamiento farmacológico , Carcinoma Ductal Pancreático/patología , Anciano de 80 o más Años , Biomarcadores de Tumor/genética , Biomarcadores de Tumor/análisisRESUMEN
A crucial part of sentiment classification is featuring extraction because it involves extracting valuable information from text data, which affects the model's performance. The goal of this paper is to help in selecting a suitable feature extraction method to enhance the performance of sentiment analysis tasks. In order to provide directions for future machine learning and feature extraction research, it is important to analyze and summarize feature extraction techniques methodically from a machine learning standpoint. There are several methods under consideration, including Bag-of-words (BOW), Word2Vector, N-gram, Term Frequency- Inverse Document Frequency (TF-IDF), Hashing Vectorizer (HV), and Global vector for word representation (GloVe). To prove the ability of each feature extractor, we applied it to the Twitter US airlines and Amazon musical instrument reviews datasets. Finally, we trained a random forest classifier using 70% of the training data and 30% of the testing data, enabling us to evaluate and compare the performance using different metrics. Based on our results, we find that the TD-IDF technique demonstrates superior performance, with an accuracy of 99% in the Amazon reviews dataset and 96% in the Twitter US airlines dataset. This study underscores the paramount significance of feature extraction in sentiment analysis, endowing pragmatic insights to elevate model performance and steer future research pursuits.
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Algoritmos , Análisis de Sentimientos , Humanos , Aprendizaje AutomáticoRESUMEN
CONTEXT.: Nodular gastric antral vascular ectasia (GAVE) is a reported phenotype of GAVE that has histologic features overlapping with gastric hyperplastic polyps (GHPs), with additional features often seen in flat mucosa of GAVE. OBJECTIVE.: To determine if nodular GAVE and GHPs are distinct lesions by evaluating the prevalence of features reported in nodular GAVE in GHPs with or without associated GAVE. DESIGN.: A review of all lesions diagnosed as GHPs between 2014 and 2017 was performed. Slides were analyzed for a number of features including established histologic features of GAVE without knowledge of clinical or endoscopic features. RESULTS.: A total of 90 polyps were analyzed including 18 from patients with GAVE (20%). GAVE polyps were larger than non-GAVE polyps (average size, 1.3 cm versus 0.68 cm; P < .001), with more common extensive ulceration and associated granulation tissue (61.11% [n = 11] versus 4.17% [n = 3]; P = .004), fibrin thrombi (50% [n = 9] versus 15% [n = 11]; P = .003), moderate to marked vascular ectasia (83% [n = 15] versus 35% [n = 11]; P = .001), and fibrohyalinosis (72% [n = 13] versus 28% [n = 20]; P = .001). All polyps showed foveolar hyperplasia and smooth muscle proliferation. There were no features that were exclusively found in GAVE or non-GAVE cases. CONCLUSIONS.: Nodular GAVE appears to represent GHPs arising in a background of GAVE, with superimposed features found in flat mucosa of GAVE stomachs. The presence of fibrin thrombi, marked vascular ectasia, fibrohyalinosis, and/or ulceration in a GHP is suggestive but not diagnostic of GAVE, and the absence of these features does not rule out GAVE.
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Ectasia Vascular Antral Gástrica , Pólipos , Neoplasias Gástricas , Humanos , Ectasia Vascular Antral Gástrica/diagnóstico , Ectasia Vascular Antral Gástrica/complicaciones , Ectasia Vascular Antral Gástrica/patología , Dilatación Patológica/complicaciones , Neoplasias Gástricas/patología , Pólipos/diagnóstico , Pólipos/patología , FibrinaRESUMEN
Aflatoxin B1 (AFB1) is a typical mycotoxin that signifacntly endangers public health and economy. In this study, we systematically studied the interaction of aptamers with AFB1 using circular dichroism, molecular dynamics, molecular docking, and fluorescence analysis. The truncated sequence aptamers were screened using molecular docking. We successfully obtained the AFB1 aptamer with higher affinity and its truncated form was enhanced by 5.2-fold compared to the initial AFB1 aptamer. In addition, for rapid detection of AFB1, we designed a fluorescent nano-adaptor sensing platform using RecJf exonuclease signal amplification strategy based on the optimal aptamer. The aptasensor showed satisfactory sensitivity towards AFB1 with a linear detection range of 1-400 ng/mL and a detection limit of 0.57 ng/mL. The aptasensor was successfully applied to the determination of AFB1 in soybean oil and corn oil with recoveries of 91.02 %-106.59 % and 87.39 %-110.61 %, respectively. The successful application of the AFB1 aptasensor, developed through bioinformatics truncation of the aptamer, provides a novel approach to creating a cost-effective, eco-friendly, and rapid aptamer sensing platform.
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Aptámeros de Nucleótidos , Técnicas Biosensibles , Aflatoxina B1/análisis , Simulación del Acoplamiento Molecular , Límite de Detección , Colorantes FluorescentesRESUMEN
Liposarcoma is the most common type of soft-tissue sarcoma and typically occurs in the extremities or retroperitoneum. Primary liposarcoma of the pancreas is exceedingly rare, with only 10 cases reported since 1979. We present a patient who was incidentally discovered to have a pancreatic mass on imaging, which was ultimately diagnosed as dedifferentiated pancreatic liposarcoma. We review the clinical and histologic features of pancreatic liposarcoma in this case and in the 10 previously reported cases to increase awareness and knowledge of this rare disease.
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Introduction: Several attempts have been made to enhance text-based sentiment analysis's performance. The classifiers and word embedding models have been among the most prominent attempts. This work aims to develop a hybrid deep learning approach that combines the advantages of transformer models and sequence models with the elimination of sequence models' shortcomings. Methods: In this paper, we present a hybrid model based on the transformer model and deep learning models to enhance sentiment classification process. Robustly optimized BERT (RoBERTa) was selected for the representative vectors of the input sentences and the Long Short-Term Memory (LSTM) model in conjunction with the Convolutional Neural Networks (CNN) model was used to improve the suggested model's ability to comprehend the semantics and context of each input sentence. We tested the proposed model with two datasets with different topics. The first dataset is a Twitter review of US airlines and the second is the IMDb movie reviews dataset. We propose using word embeddings in conjunction with the SMOTE technique to overcome the challenge of imbalanced classes of the Twitter dataset. Results: With an accuracy of 96.28% on the IMDb reviews dataset and 94.2% on the Twitter reviews dataset, the hybrid model that has been suggested outperforms the standard methods. Discussion: It is clear from these results that the proposed hybrid RoBERTa-(CNN+ LSTM) method is an effective model in sentiment classification.
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Background: The incidence and aftermath of the COVID-19 pandemic brought about a drastic change in health professional education around the world. Traditional classrooms made way for online classrooms in order to ensure that learning continued in a safe and secure environment. However, how well health professional students perceived and accepted these changes have not been fully gauged yet. Therefore, this study aims to evaluate the perception of health professional students about their new educational climate. Methods: A modified and validated Dundee Ready Education Environment Measure (DREEM) questionnaire was used to collect data regarding student perception of their educational environment. Results: The mean DREEM scores for three time periods were in the accepted positive range of 101 to 150 indicating that most of the students perceived the changes positively. The results indicated that most students preferred blended learning over online learning or face-to-face learning alone. Areas where students were unsatisfied with their learning environment that need improvement were identified by poor item-wise scores. Conclusion: Strategic remedial measures for these concerns need to be developed to improve the quality of education received by the students. However, the results of our study indicated that most of the students were able to adapt positively to the new education environment due to the change in the circumstances during COVID.
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COVID-19 , Estudiantes de Medicina , Humanos , Pandemias/prevención & control , COVID-19/epidemiología , Aprendizaje , PercepciónRESUMEN
There are immunohistochemistry (IHC) and immunofluorescence (IF) panels described in the literature and established by personal and institutional experiences that are in common use by pathologists in their daily practice. Stewardship is a difficult discussion because IHC utilization is influenced by many factors including the pathologist's experience, background, practice setting, personal bias, and medicolegal culture. We developed the methodology to audit the IHC/IF utilization in our academic subspecialty practice. We aim to share this methodology and to provide our data that can be used for consideration by other subspecialized academic practices. This analysis included a total of 63,157 specimens that were accessioned during 2022, representing 38,612 cases. The likelihood of ordering IHC/IF ranged from 1 % (in genitourinary pathology) to 59 % (in renal pathology). The average percentage of specimens with IHC/IF was 21 % for the entire practice. In cases where IHC/IF was ordered, the number of stained slides averaged 4.9 per specimen for the entire practice. The number of IHC/IF slides per specimen ranged from 1.9 (in gastrointestinal pathology) to 12.2 (in renal pathology). The highest number of antibodies ordered for a single specimen by subspecialty ranged from 11 (in cardiac pathology) to 63 (in dermatopathology). Renal pathology was the only subspecialty that had an average number of IHC/IF slides that was statistically significantly different from all other subspecialties. We described the various patterns of utilization by subspecialty and rationalized their subtle differences. We also analyzed the types of cases that exceeded the reimbursement limits set by the Centers for Medicare and Medicaid Services (CMS).
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Medicare , Patólogos , Anciano , Humanos , Estados Unidos , Inmunohistoquímica , Técnica del Anticuerpo FluorescenteRESUMEN
Aflatoxin B1 (AFB1) is one of the most contaminated fungal toxins worldwide and is prone to cause serious economic losses, food insecurity, and health hazards to humans. The rapid, on-site, and economical method for AFB1 detection is need of the day. In this study, an AFB1 aptamer (AFB1-Apt) sensing platform was established for the detection of AFB1. Fluorescent moiety (FAM)-modified aptamers were used for fluorescence response and quenching, based on the adsorption quenching function of single-walled carbon nanohorns (SWCNHs). Basically, in our constructed sensing platform, the AFB1 specifically binds to AFB1-Apt, making a stable complex. This complex with fluorophore resists to be adsorbed by SWCNHs, thus prevent SWCNHs from quenching of fluorscence, resulting in a fluorescence response. This designed sensing strategy was highly selective with a good linear response in the range of 10-100 ng/mL and a low detection limit of 4.1 ng/mL. The practicality of this sensing strategy was verified by using successful spiking experiments on real samples of soybean oil and comparison with the enzyme-linked immunosorbent assay (ELISA) method.
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Various molecular subclasses of hepatocellular carcinoma (HCC) exists, with many novel cooperating oncogenes and tumor suppressor genes involved in its tumorigenesis. The emerging importance of WNT signaling in HCC has been established. However, the intricate genetic mechanisms involved in this complex signaling pathway remains to be elucidated. Importantly, while some cooperating genes have been identified, there are still many unknown genes associated with catenin beta 1 (CTNNB1)-induced HCC. Mutations in both oncogenes and tumor suppressor genes are required for HCC tumorigenesis. The emergence of the CRISPR/Cas9 system has allowed researchers now to target both alleles efficiently. In this novel study, the Sleeping Beauty transposon system was used as a gene delivery system in vivo to stably integrate an expression cassette that carry pools of gRNAs and overexpress a mutant version of CTNNB1 into the hepatocyte genome. We identified 206 candidate genes that drive HCC tumorigenesis in the context of WNT signaling activation and, neurofibromin 2 (NF2) gene, a known tumor suppressor gene with clinical relevance was validated in this proof-of-principle study.
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The safeguarding of online services and prevention of unauthorized access by hackers rely heavily on user authentication, which is considered a crucial aspect of security. Currently, multi-factor authentication is used by enterprises to enhance security by integrating multiple verification methods rather than relying on a single method of authentication, which is considered less secure. Keystroke dynamics is a behavioral characteristic used to evaluate an individual's typing patterns to verify their legitimacy. This technique is preferred because the acquisition of such data is a simple process that does not require any additional user effort or equipment during the authentication process. This study proposes an optimized convolutional neural network that is designed to extract improved features by utilizing data synthesization and quantile transformation to maximize results. Additionally, an ensemble learning technique is used as the main algorithm for the training and testing phases. A publicly available benchmark dataset from Carnegie Mellon University (CMU) was utilized to evaluate the proposed method, achieving an average accuracy of 99.95%, an average equal error rate (EER) of 0.65%, and an average area under the curve (AUC) of 99.99%, surpassing recent advancements made on the CMU dataset.
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Mycotoxin contamination in food products can easily cause serious health hazards and economic losses to human beings. How to accurately detect and effectively control mycotoxin contamination has become a global concern. Mycotoxins conventional detection techniques e.g; ELISA, HPLC, have limitations like, low sensitivity, high cost and time-consuming. Aptamer-based biosensing technology has the advantages of high sensitivity, high specificity, wide linear range, high feasibility, and non-destructiveness, which overcomes the shortcomings of conventional analysis techniques. This review summarizes the sequences of mycotoxin aptamers that have been reported so far. Based on the application of four classic POST-SELEX strategies, it also discusses the bioinformatics-assisted POST-SELEX technology in obtaining optimal aptamers. Furthermore, trends in the study of aptamer sequences and their binding mechanisms to targets is also discussed. The latest examples of aptasensor detection of mycotoxins are classified and summarized in detail. Newly developed dual-signal detection, dual-channel detection, multi-target detection and some types of single-signal detection combined with unique strategies or novel materials in recent years are focused. Finally, the challenges and prospects of aptamer sensors in the detection of mycotoxins are discussed. The development of aptamer biosensing technology provides a new approach with multiple advantages for on-site detection of mycotoxins. Although aptamer biosensing shows great development potential, still some challenges and difficulties are there in practical applications. Future research need high focus on the practical applications of aptasensors and the development of convenient and highly automated aptamers. This may lead to the transition of aptamer biosensing technology from laboratory to commercialization.
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Biología Computacional , Micotoxinas , Humanos , Cromatografía Líquida de Alta Presión , Ensayo de Inmunoadsorción EnzimáticaRESUMEN
Person re-identification (Re-ID) is a method for identifying the same individual via several non-interfering cameras. Person Re-ID has been felicitously applied to an assortment of computer vision applications. Due to the emergence of deep learning algorithms, person Re-ID techniques, which often involve the attention module, have gained remarkable success. Moreover, people's traits are mostly similar, which makes distinguishing between them complicated. This paper presents a novel approach for person Re-ID, by introducing a multi-part feature network, that combines the position attention module (PAM) and the efficient channel attention (ECA). The goal is to enhance the accuracy and robustness of person Re-ID methods through the use of attention mechanisms. The proposed multi-part feature network employs the PAM to extract robust and discriminative features by utilizing channel, spatial, and temporal context information. The PAM learns the spatial interdependencies of features and extracts a greater variety of contextual information from local elements, hence enhancing their capacity for representation. The ECA captures local cross-channel interaction and reduces the model's complexity, while maintaining accuracy. Inclusive experiments were executed on three publicly available person Re-ID datasets: Market-1501, DukeMTMC, and CUHK-03. The outcomes reveal that the suggested method outperforms existing state-of-the-art methods, and the rank-1 accuracy can achieve 95.93%, 89.77%, and 73.21% in trials on the public datasets Market-1501, DukeMTMC-reID, and CUHK03, respectively, and can reach 96.41%, 94.08%, and 91.21% after re-ranking. The proposed method demonstrates a high generalization capability and improves both quantitative and qualitative performance. Finally, the proposed multi-part feature network, with the combination of PAM and ECA, offers a promising solution for person Re-ID, by combining the benefits of temporal, spatial, and channel information. The results of this study evidence the effectiveness and potential of the suggested method for person Re-ID in computer vision applications.
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Aprendizaje Profundo , Humanos , Algoritmos , FenotipoRESUMEN
Blastomycosis is a fungal infection known to mimic many disease processes, including malignancy. A 70-year-old man presented with an enlarging neck mass and, incidentally found on preliminary imaging, a lung mass. The initial biopsy of the neck mass demonstrating cytologic atypia and mitotic figures was suggestive of malignancy. Whole body positron emission tomography (PET)/CT revealed hypermetabolic lesions in multiple sites, including the neck, lung, and soft tissue, raising concern for metastatic disease. Repeat sampling from multiple lesions, however, demonstrated granuloma. Microbiological studies were collected, and Blastomyces dermatitidis was isolated in culture. The diagnosis of disseminated blastomycosis was made, and the patient received antifungal therapy with good response. A high degree of suspicion for blastomycosis in endemic areas is required to ensure patients receive appropriate and timely treatment. Laryngoscope, 133:2237-2239, 2023.
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Blastomicosis , Neoplasias de Cabeza y Cuello , Masculino , Humanos , Anciano , Blastomicosis/diagnóstico , Blastomicosis/microbiología , Antifúngicos/uso terapéutico , Blastomyces , Neoplasias de Cabeza y Cuello/diagnóstico , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , CuelloRESUMEN
An 80-year-old man with a history of an orthotopic heart transplant was found to have a 25 × 40 mm centrally ulcerated mass at the hepatic flexure during evaluation of anemia. Owing to comorbidities, the patient was deemed to be a poor surgical candidate and was referred to the advanced endoscopy team to explore palliative and potentially curative options. We present a novel sequence of intervention involving full-thickness resection with subsequent morcellation clean-up to achieve complete endoscopic removal of a neoplastic lesion.
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Human precision-cut lung slices (hPCLS), considered a highly relevant ex vivo model of the lung, offer native architecture and cells of the lung tissue including respiratory parenchyma, small airways, and immune competent cells. However, the irregular availability of donor lungs has limited the accessibility of this system. As described here, thousands of hPCLS can be created from 1 lung, cryopreserved, and used "on demand" by applying slicing and cryopreservation methodology improvements. Fresh and cryopreserved (â¼7 and â¼34 weeks; F&C) hPCLS from 1 donor lung were cultured for up to 29 days and evaluated for biomass, viability, tissue integrity, and inflammatory markers in response to lipopolysaccharide (LPS; 5 µg/ml) and Triton X-100 (TX100; 0.1%) challenge (24 h) at days 1, 8, 15, 22, and 29 following culture initiation. The F&C hPCLS retained biomass, viability, and tissue integrity throughout the 29 days and demonstrated immune responsiveness with up to â¼30-fold LPS-induced cytokine increases. Histologically, more than 70% of normal cytomorphological features were preserved in all groups through day 29. Similar retention of tissue viability and immune responsiveness post cryopreservation (4-6 weeks) and culture (up to 14 days) was observed in hPCLS from additional 3 donor lungs. Banking cryopreserved hPCLS from various donors (and disease states) provides a critical element in researching human-derived pulmonary tissue. The retention of viability and functional responsiveness (≥4 weeks) allows evaluation of long-term, complex endpoints reflecting key events in Adverse Outcome Pathways and positions hPCLS as a valuable human-relevant model for use in regulatory applications.
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Sistema Inmunológico , Lipopolisacáridos , Humanos , Lipopolisacáridos/toxicidad , Criopreservación/métodos , Pulmón/patologíaRESUMEN
Purpose: To describe the cancer incidence burden and trends among adolescent and young adults (AYAs) in Alberta, Canada over a 35-year period. Methods: We obtained data from the Alberta Cancer Registry on all first primary cancers, excluding non-melanoma skin cancer, diagnosed at ages 15-39 years among residents in Alberta from 1983 to 2017. Cancers were classified by using Barr's AYA cancer classification system. Age-standardized incidence rates (ASIR) and the average annual percentage change (AAPC) in incidence rates were calculated. Statistically significant changes in the AAPC during the study period were assessed using Joinpoint regression. Results: Overall, 23,652 incident cases of AYA cancer were diagnosed in Alberta. Females accounted for â¼60% of the diagnoses. AYA cancer increased significantly over the study period overall (AAPC: 0.5%; 95%CI: 0.3%-0.7%), for each sex (AAPCmale: 0.7%; 95%CI: 0.4%-0.9%; AAPCfemale: 0.4%; 95%CI: 0.2%-0.6%), and among male and female 20-39 year-olds. Although statistically significant increases were observed in 11 out of 29 cancer sites for at least a portion of the study period, with significant AAPCs ranging from 0.8% (95%CI: 0.01%-1.5%) to 6.6% (95%CI: 4.6%-8.5%), the main driver was thyroid cancer (AAPC: 3.7%; 95%CI: 3.2%-4.2%). Statistically significant decreases were observed for six cancer sites, with AAPCs ranging from -6.4% (95%CI: -8.7% to -4.1%) to -1.1% (95%CI: -1.8% to -0.5%). Conclusions: There is a growing cancer burden among AYAs in Alberta, which is driven primarily by thyroid cancer and early-onset cancers in males. These results highlight the need for etiological studies and tertiary strategies to prevent and mitigate morbidity and mortality in the AYA population.
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Datos de Salud Recolectados Rutinariamente , Neoplasias de la Tiroides , Humanos , Masculino , Femenino , Adolescente , Adulto Joven , Adulto , Incidencia , Alberta/epidemiología , Sistema de RegistrosRESUMEN
PURPOSE: Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non-small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg fasted. In this subgroup analysis, we report outcomes in Asian patients of the ASCEND-8 trial. MATERIALS AND METHODS: Key efficacy endpoints were blinded independent review committee (BIRC)-assessed overall response rate (ORR) and duration of response (DOR) evaluated per Response Evaluation Criteria in Solid Tumors v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate; overall survival (OS). Safety was evaluated by frequency and severity of adverse events. RESULTS: At final data cutoff (6 March 2020), 198 treatment-naïve patients were included in efficacy analysis, of which 74 (37%) comprised the Asian subset; 450-mg fed (n=29), 600-mg fed (n=19), and 750-mg fasted (n=26). Baseline characteristics were mostly comparable across study arms. At baseline, more patients in 450-mg fed arm (44.8%) had brain metastases than in 750-mg fasted arm (26.9%). Per BIRC, patients in the 450-mg fed arm had a numerically higher ORR, 24-month DOR rate and 24-month PFS rate than the 750-mg fasted arm. The 36-month OS rate was 93.1% in 450-mg fed arm and 70.9% in 750-mg fasted arm. Any-grade GI toxicity occurred in 82.8% and 96.2% of patients in the 450-mg fed and 750-mg fasted arms, respectively. CONCLUSION: Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg fasted patients.