Cost-effectiveness analysis of amivantamab plus chemotherapy versus chemotherapy alone in NSCLC with EGFR Exon 20 insertions.

Objective: Amivantamab plus chemotherapy has been proved to be an efficient treatment strategy for non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertions. The aim of this study was to conduct the cost-effectiveness analysis of amivantamab-chemotherapy compared with chemotherapy alone in NSCLC harboring EGFR exon 20 insertion mutations. Methods: We constructed a Markov model based on the data derived from the PAPILLON trial. We evaluated the cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were used to evaluate the influence of different parameters on this model. Results: Compared with chemotherapy alone, amivantamab combined with chemotherapy treatment gained an incremental effectiveness of 0.473 QALYs and an incremental cost of $361,950.952, which resulted in an ICER of $765,224/QALY. The ICER was much higher than the willingness-to-pay threshold of 15,0000/QALY. One-way sensitivity analysis revealed that amivantamab cost was the leading influential factor in the model. Conclusions: Compared with chemotherapy alone, amivantamab plus chemotherapy is not a cost-effective first-line treatment choice for NSCLC patients with EGFR exon 20 insertions. The costly price of amivantamab is one of the major reasons for the high cost of this combined treatment strategy. Therefore, it is imperative to take into account the high cost of amivantamab in the subsequent clinical application and strive to attain a relative equilibrium between its significant clinical benefit and economic encumbrance.

Disparities in mortality risk after diagnosis of hematological malignancies in 185 countries: A global data analysis.

This study was to report proxy measures for mortality risk in patients with hematological malignancies across 185 countries globally and explore its association with their socioeconomic status and treatment. The incidence, mortality, and 5-year prevalence data were extracted from the GLOBOCAN database. The data regarding the human development index (HDI), gross national income (GNI), vulnerability index, and concordance with cancer Essential Medicines List (EML) were obtained from open-source reports. The ratio of mortality to 5-year-prevalence (MPR) and that of mortality to incidence (MIR) were calculated and age-standardized using Segi's world standard population. Finally, the possible associations were assessed using Pearson correlation analyses. In 2020, the global incidence, mortality, and 5-year prevalence of HMs were 1,278,362, 711,840, and 3,616,685, respectively. Global age-standardized MPR and MIR were 0.15 and 0.44, respectively; they varied significantly among 6 regions, 185 countries, 4 HM types, and 4 HDI groups worldwide. Older populations always had higher ratios. The correlation of MPRs and MIRs with HDI, GNI, and concordance with cancer EML was negative, whereas it was positive with the vulnerability index (lower was better). Increasing access to cancer drugs in resource-limited regions with a focus on vulnerable children may aid in reducing HM-related mortality risk.

Research interest in the usage of dupilumab for atopic dermatitis: a bibliometric analysis.

BACKGROUND: Recently, dupilumab has been used for the treatment of atopic dermatitis (AD), and growing interest in the subject has resulted in an increasing number of publications. OBJECTIVES: Our study aimed to evaluate the rapid progress, identify hot topics, and explore scientific advances and future trends in this field. MATERIALS & METHODS: The global distribution of publications was estimated with no time restrictions. Dupilumab as a treatment for AD was scanned in the Web of Science core collection using the topic terms "dupilumab" and "atopic Dermatitis". VOSviewer was applied for visualization of bibliometric analysis. Analysis of country and region distribution, impact of journal, authors, population, economic estimation among countries and regions, key words, as well as the top 20 cited articles were performed. RESULTS: In total, 910 publications were yielded from the Web of Science core collection database. Most studies were published in the USA (46.15%), Germany (17.91%), and France (14.07%); other countries included Denmark, the Netherlands, and Canada based on normalization of article numbers according to population and economic evaluation. Studies were most frequently reported in the British Journal of Dermatology and the Journal of the American Academy of Dermatology. Pirozzi, G. from France was the top-cited author. The most frequent key words were concepts in dermatology, allergy, and immunology. Remarkable landmark clinical trials were noted in the top 20 cited publications. CONCLUSION: The research of dupilumab for AD is rapidly developing. Countries in North America and Europe have remarkably contributed to researches of dupilumab as a treatment for AD. The bibliometric analysis also presents hallmark publications reporting scientific advances in therapy progress, which may provide a foundation for further research.

Assessment of delivered dose in prostate cancer patients treated with ultra-hypofractionated radiotherapy on 1.5-Tesla MR-Linac.

Objective: To quantitatively characterize the dosimetric effects of long on-couch time in prostate cancer patients treated with adaptive ultra-hypofractionated radiotherapy (UHF-RT) on 1.5-Tesla magnetic resonance (MR)-linac. Materials and methods: Seventeen patients consecutively treated with UHF-RT on a 1.5-T MR-linac were recruited. A 36.25 Gy dose in five fractions was delivered every other day with a boost of 40 Gy to the whole prostate. We collected data for the following stages: pre-MR, position verification-MR (PV-MR) in the Adapt-To-Shape (ATS) workflow, and 3D-MR during the beam-on phase (Bn-MR) and at the end of RT (post-MR). The target and organ-at-risk contours in the PV-MR, Bn-MR, and post-MR stages were projected from the pre-MR data by deformable image registration and manually adapted by the physician, followed by dose recalculation for the ATS plan. Results: Overall, 290 MR scans were collected (85 pre-MR, 85 PV-MR, 49 Bn-MR and 71 post-MR scans). With a median on-couch time of 49 minutes, the mean planning target volume (PTV)-V95% of all scans was 97.83 ± 0.13%. The corresponding mean clinical target volume (CTV)-V100% was 99.93 ± 0.30%, 99.32 ± 1.20%, 98.59 ± 1.84%, and 98.69 ± 1.85%. With excellent prostate-V100% dose coverage, the main reason for lower CTV-V100% was slight underdosing of seminal vesicles (SVs). The median V29 Gy change in the rectal wall was -1% (-20%-17%). The V29 Gy of the rectal wall increased by >15% was observed in one scan. A slight increase in the high dose of bladder wall was noted due to gradual bladder growth during the workflow. Conclusions: This 3D-MR-based dosimetry analysis demonstrated clinically acceptable estimated dose coverage of target volumes during the beam-on period with adaptive ATS workflow on 1.5-T MR-linac, albeit with a relatively long on-couch time. The 3-mm CTV-PTV margin was adequate for prostate irradiation but occasionally insufficient for SVs. More attention should be paid to restricting high-dose RT to the rectal wall when optimizing the ATS plan.

Clinical epidemiology and disease burden of bronchiolitis in hospitalized children in China: a national cross-sectional study.

BACKGROUND: Bronchiolitis is a common acute lower respiratory tract infection (ALRTI) and the most frequent cause of hospitalization of infants and young children with ALRTI. Respiratory syncytial virus is the main pathogen that leads to severe bronchiolitis. The disease burden is relatively high. To date, few descriptions of the clinical epidemiology and disease burden of children hospitalized for bronchiolitis are available. This study reports the general clinical epidemiological characteristics and disease burden of bronchiolitis in hospitalized children in China. METHODS: This study included the face sheet of discharge medical records collected from 27 tertiary children's hospitals from January 2016 to December 2020 that were aggregated into the FUTang Update medical REcords (FUTURE) database. The sociodemographic variables, length of stay (LOS) and disease burden of children with bronchiolitis were analyzed and compared using appropriate statistical tests. RESULTS: In total, 42,928 children aged 0-3 years were hospitalized due to bronchiolitis from January 2016 to December 2020, accounting for 1.5% of the total number of hospitalized children of the same age in the database during the period and 5.31% of the hospitalizations for ALRTI. The male to female ratio was 2.01:1. Meanwhile, more boys than girls were observed in different regions, age groups, years, and residences. The 1-2 year age group had the greatest number of hospitalizations for bronchiolitis, while the 29 days-6 months group had the largest proportion of the total inpatients and inpatients with ALRTI in the same age group. In terms of region, the hospitalization rate of bronchiolitis was the highest in East China. Overall, the number of hospitalizations from 2017 to 2020 showed a decreasing trend from that in 2016. Seasonally, the peak hospitalizations for bronchiolitis occurred in winter. Hospitalization rates in North China in autumn and winter were higher than those in South China, while hospitalization rates in South China were higher in spring and summer. Approximately, half of the patients with bronchiolitis had no complications. Among the complications, myocardial injury, abnormal liver function and diarrhea were more common. The median LOS was 6 days [interquartile range (IQR) = 5-8], and the median hospitalization cost was 758 United States dollars (IQR = 601.96-1029.53). CONCLUSIONS: Bronchiolitis is a common respiratory disease in infants and young children in China, and it accounts for a higher proportion of both total hospitalizations and hospitalizations due to ALRTI in children. Among them, children aged 29 days-2 years are the main hospitalized population, and the hospitalization rate of boys is significantly higher than that of girls. The peak season for bronchiolitis is winter. Bronchiolitis causes few complications and has a low mortality rate, but the burden of this disease is heavy.

Prevalence of anatomically specific infections with Chlamydia trachomatis among men who have sex with men in China: protocol for a nationwide cross-sectional study as part of Disease Burden Surveillance of Infections with Chlamydia (DBSIC).

INTRODUCTION: Chlamydia trachomatis (CT) causes the most prevalent bacterial sexually transmitted infection in the world, and men who have sex with men (MSM) are considered as a high-risk population for this infection. Data regarding the prevalence of CT infection in China are limited and fragmented. In this study, we aim to determine at the national level the anatomically specific CT prevalence and genotype distribution of CT strains among MSM, recruiting from the venues where MSM commonly seek sexual partners. METHODS AND ANALYSIS: The study will be a nationwide cross-sectional survey to estimate the prevalence of chlamydial infections among MSM who meet the inclusion criteria over a period of 6 months (May-October 2022). A total of 2429 participants will be recruited from the venues where MSM most often seek sex partners in 14 cities of the 7 geographical regions in China. A mobile phone app-based anonymous self-administered questionnaire will be used to collect sociodemographic and behavioural data, and specimens of urine, anorectal and pharyngeal swabs will be collected for identifying the infections of CT and Neisseria gonorrhoeae and genotypes of CT. The data will be analysed using the IBM SPSS program V.20 ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Ethics Committee of the Chinese Academy of Medical Sciences Institute of Dermatology and the National Center for STD Control on 9 October 2021 (approval number 2021-KY-037). The study is based on voluntary participation and a written informed consent process. The study results will be submitted for publication in peer-reviewed journals and reported in conferences. The relevant data will be made available to development of control programmes and used as health education materials to disseminate to the community. The dataset will be deposited in a public repository. TRIAL REGISTRATION NUMBER: ChiCTR2100052869.

Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer.

BACKGROUND: The phase 3 NCT00793962 trial demonstrated that postmastectomy hypofractionated radiation therapy (HFRT) was noninferior to conventional fractionated radiation therapy (CFRT) in patients with high-risk breast cancer. This study assessed the cost-effectiveness of postmastectomy HFRT vs CFRT based on the NCT00793962 trial. METHODS: A Markov model was adopted to synthesize the medical costs and health benefits of patients with high-risk breast cancer based on data from the NCT00793962 trial. Main outcomes were discounted lifetime costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). We employed a time-dependent horizon from Chinese, French and USA payer perspectives. Model robustness was evaluated with one-way and probabilistic sensitivity analyses. RESULTS: Patients receiving CFRT versus HFRT gained an incremental 0.0163 QALYs, 0.0118 QALYs and 0.0028 QALYs; meanwhile an incremental cost of $2351.92, $4978.34 and $8812.70 from Chinese, French and USA payer perspectives, respectively. Thus CFRT versus HFRT yielded an ICER of $144,281.47, $420,636.10 and $3,187,955.76 per QALY from Chinese, French and USA payer perspectives, respectively. HFRT could maintain a trend of >50% probabilities of cost-effectiveness below a willingness-to-pay (WTP) of $178,882.00 in China, while HFRT was dominant relative to CFRT, regardless of the WTP values in France and the USA. Sensitivity analyses indicated that the ICERs were most sensitive to the parameters of overall survival after radiotherapy. CONCLUSIONS: Postmastectomy HFRT could be used as a cost-effective substitute for CFRT in patients with high-risk breast cancer and should be considered in appropriately selected patients.

Safety and efficacy of preoperative chemoradiotherapy in fit older patients with intermediate or locally advanced rectal cancer evaluated by comprehensive geriatric assessment: A planned interim analysis of a multicenter, phase II trial.

BACKGROUND AND PURPOSE: Comprehensive geriatric assessment (CGA) is a diagnostic method to assess the physical and mental health status of older patients. The purpose of this study was to assess the safety and efficacy of preoperative concurrent chemoradiotherapy (preCRT) for intermediate or locally advanced rectal cancer in older people who were classified as "fit" by CGA. The interim analysis focusing on safety was reported here as the first part of this trial. METHODS AND MATERIALS: This is a single arm, multicenter, phase II trial. The eligible patients for this study were aged 70 years or above that fulfilled the standard of intermediate or locally advanced risk category, and met the standard of fit (SIOG1) evaluated by CGA. All patients received preCRT (50 Gy) with Raltitrexed (3 mg/m2 on d1 and d22). Qualitative and quantitative variables were described using descriptive statistics. The surgery adherence predicting was analyzed by multivariate logistic regression. RESULTS: Thirty-nine fit patients were enrolled. All patients except one finished radiotherapy without dose reduction. Thirty-two patients finished the prescribed Raltitrexed therapy as scheduled. A serious toxicity was observed in 12 patients (30.8%), and only six patients (15.4%) experienced non-hematological side effects. CONCLUSION: Overall, our results showed that preCRT was feasible and safe in older patients with rectal cancer who were evaluated as fit based on CGA, supporting the use of CGA to tailor oncological treatment and predict the tolerance of a specific therapy. Completing this trial as planned would provide further valuable insights.

Determination of Arsenic Species in Ophiocordyceps sinensis from Major Habitats in China by HPLC-ICP-MS and the Edible Hazard Assessment.

This study sought to determine the concentration and distribution of arsenic (As) species in Ophiocordyceps sinensis (O. sinensis), and to assess its edible hazard for long term consumption. The total arsenic concentrations, measured through inductively coupled plasma mass spectrometry (ICP-MS), ranged from 4.00 mg/kg to 5.25 mg/kg. As determined by HPLC-ICP-MS, the most concerning arsenic species­AsB, MMAV, DMAV, AsV, and AsШ­were either not detected (MMAV and DMAV) or were detected as minor As species (AsB: 1.4⁻2.9%; AsV: 1.3⁻3.2%, and AsШ: 4.1⁻6.0%). The major components were a cluster of unknown organic As (uAs) compounds with AsШ, which accounted for 91.7⁻94.0% of the As content. Based on the H2O2 test and the chromatography behavior, it can be inferred that, the uAs might not be toxic organic As. Estimated daily intake (EDI), hazard quotient (HQ), and cancer risk (CR) caused by the total As content; the sum of inorganic As (iAs) and uAs, namely i+uAs; and iAs exposure from long term O. sinensis consumption were calculated and evaluated through equations from the US Environmental Protection Agency and the uncertainties were analyzed by Monte-Carlo Simulation (MCS). EDItotal As and EDIi+uAs are approximately ten times more than EDIiAs; HQtotalAs and HQi+uAs > 1 while HQiAs < 1; and CRtotal As and CRi+uAs > 1 × 10−4 while CRiAs < 1 × 10−4. Thus, if the uAs is non-toxic, there is no particular risk to local consumers and the carcinogenic risk is acceptable for consumption of O. sinensis because the concentration of toxic iAs is very low.

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial.

OBJECTIVE: To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. METHODS: Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. RESULTS: Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months' intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. CONCLUSION: These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients.

Prenatal care in combination with maternal educational level has a synergetic effect on the risk of neonatal low birth weight: new findings in a retrospective cohort study in Kunshan City, China.

OBJECTIVES: To investigate the dose-response relationship and synergetic effect of the maternal educational level and two measures of prenatal care on neonatal low birth weight (LBW) risk. METHODS: Data were derived from the Perinatal Health Care Surveillance System (PHCSS) from January 2001 to September 2009 in Kunshan City, Jiangsu province, eastern China, which included data on 31412 women with a normal birth weight delivery and 640 women with a LBW delivery. Logistic modelling was performed to estimate the association including the joint effects with odds ratio (OR) and 95% confidence interval (CI) between the prenatal care measures and LBW risk after adjusting for the potential confounders. The dose-response relationship between the number of prenatal care visits and the risk of LBW was investigated by modeling the quantitative exposure with restricted cubic splines (RCS). RESULTS: There was a significant synergetic effect on the LBW risk between maternal educational attainment and the number of prenatal care visits (χ(2) = 4.98, P = 0.0257), whereas no significant maternal educational attainment interaction was found with the week of initiation of prenatal care after adjusting for relevant confounding factors (χ(2) = 2.04, P = 0.1530), and the LBW risk displayed a 'U-shape' curve tendency among the different number of prenatal care visits (P for nonlinearity = 0.0002) using RCS. In particular, the ORs were approaching the curve's bottom when the women had 9 or 10 prenatal care visits. Comparing with 5 prenatal care visits, the ORs and 95%CI of LBW risk for 7, 9, 11 and ≥ 13 visits were 0.92 (0.82-1.03), 0.50 (0.38-0.66), 0.62 (0.47-0.82), and 0.99 (0.61-1.60), respectively. CONCLUSIONS: Our findings suggest that appropriate prenatal care, in combination with a higher maternal educational level, can produce a protective interaction effect on LBW risk. Reasonable health resource assignment for different social statuses should be taken into account by policy-makers in developing countries.

[Inorganic N deposition in the Bayinbuluk alpine grassland of the central Tianshan mountains].

N deposition has increased significantly with economic development and intensive human activities in China and has affected natural ecosystems in remote areas. To evaluate the atmospheric N deposition of the Bayinbuluk alpine grassland of the central Tianshan Mountains, the dry and wet N depositions were monitored from May 2010 to December 2011. Fluxes of HNO3, NH3, NO2, particulate ammonium and nitrate (pNH4+ and pNO3-) averaged at 1.47, 0.68, 0.13, 0.23 and 0.25 kg N x hm(-2) x a(-1), respectively. Wet depositions of NH(4+)-N and NO(3-)-N were 2.47 and 1.59 kg N x hm(-2) x a(-1), respectively. Total atmospheric inorganic N deposition fluxes averaged at 6.82 kg N x hm(-2) x a(-1), and the wet and dry depositions were 4.06 and 2.76 kg N x hm(-2) x a(-1), respectively. Nitrogen deposition fluxes showed a significant seasonal change, with 72.1% of dry N deposition occurring in spring and summer, and 78.3% of wet N deposition concentrating in summer and autumn.

The effect of a structural intervention for syphilis control among 3597 female sex workers: a demonstration study in South China.

BACKGROUND: Syphilis has made a rapid resurgence in China, especially among high-risk groups including female sex workers (FSWs). METHODS: Two cities in each of 3 provinces in South China were chosen and allocated to intervention or control arms. The intervention consisted of enhancing community-based syphilis screening outreach intervention with comprehensive sexually transmitted infection services at designated clinics while the control maintained routine intervention activities. Generalized linear modeling was used to examine effect of the intervention on incident syphilis infection. RESULTS: A total of 8275 women were eligible, and 3597 women enrolled (n = 2011 in control arm, n = 1586 in intervention arm) in the study. The median follow-up duration was 375 days (interquartile range, 267­475). Syphilis incidence density in the intervention group was reduced by 70% (95% confidence interval, 53%­81%) compared with the incidence in the control arm. The syphilis prevention intervention benefits were robust among FSWs at low-tier venues, individuals with less than high school education, migrants, and women who did not report condom use during the last episode of sex. CONCLUSIONS: Integrated sexually transmitted infection and human immunodeficiency virus prevention strategies substantially reduce syphilis incidence among FSWs, especially among those at low-tier venues. This intervention suggests the need for scaling up comprehensive FSW programs in China.

Postmastectomy chest wall radiotherapy with single low-energy electron beam: An assessment of outcome and prognostic factors.

PURPOSE: This study aimed to evaluate the outcome of patients who had received postmastectomy chest wall radiotherapy using a single electron beam, and to identify the relevant factors that influenced prognosis. METHODS: The medical records of patients with breast cancer treated with postmastectomy radiotherapy from January 2000 to December 2004 were retrospectively analyzed (n = 328). Two hundred seventy-one (82.6%) patients were staged as (tumor-nodes-metastasis [TNM]) T3-4, any N, M0; or T1-2, N2-3, M0, and 57 (17.4%) patients were staged as T1-2, N1, M0. All patients received chest wall radiation with a 6-10 MeV electron beam. In addition, 327 patients (99.7%) received supraclavicular node radiation, 67 (20.4%) axillary radiation, and 35 (10.7%) internal mammary chain (IMC) radiation. Chemotherapy with anthracycline and taxane was given to 323 patients (98.5%). Of patients with positive hormone receptor, 183 (82.8%) received hormone therapy and 8 patients with negative and 3 patients with unknown hormone receptor received hormone therapy. Locoregional recurrence (LRR), distant metastasis (DM), and overall survival (OS) were calculated using the Kaplan-Meier method, and the differences assessed by log-rank test. RESULTS: The median follow-up time was 78 months (range, 5-123 months) for patients who remained alive. The 5-year LRR, DM, disease-free survival and OS rates were 5.9%, 26.2%, 72.5%, and 83.1%, respectively. LRR occurred in 1 or more sites in 21 patients. The 5-year recurrence rates in the chest wall, supraclavicular node, axilla, and internal mammary chain were 1.9%, 2.3%, 2.9%, and 0%, respectively. In multivariate analysis, hormone therapy was the only independent favorable prognostic factor for LRR (P = .017). LRR was significantly associated with DM and OS. The 5-year DM rate was 82.9% and 22.7% (P < .0001) and the 5-year OS rate was 52.8% and 84.7% (P < .0001) for patients with or without LRR. The treatment-related toxicity was low, with the incidence of symptomatic pneumonitis being 0.3%. CONCLUSIONS: Breast cancer patients can be treated with postmastectomy single electron beam radiotherapy with excellent local control and low toxicity.