Patients who complete neoadjuvant chemotherapy for breast cancer without a pathological complete response have a high risk of relapse. A randomized trial comparing capecitabine with no additional ...adjuvant therapy showed that capecitabine prolonged disease-free and overall survival.
Patients who have residual invasive breast cancer after the receipt of neoadjuvant chemotherapy have a high risk of relapse.
1
The rate of complete response as assessed on pathological testing (hereafter, pathological complete response) ranges from 13 to 22% among patients with human epidermal growth factor receptor 2 (HER2)–negative primary breast cancer.
1
Patients who do not have a pathological complete response after the receipt of neoadjuvant taxane and anthracycline chemotherapy have a 20 to 30% risk of relapse.
2
Patients with HER2-negative cancer who receive neoadjuvant chemotherapy often receive postoperative radiation therapy, whereas endocrine therapy is administered to patients with hormone-receptor–positive disease . . .
Abstract
Background
Coronavirus disease 2019 (COVID-19) has rapidly evolved to become a global pandemic, largely owing to the transmission of its causative virus through asymptomatic carriers. ...Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in asymptomatic people is an urgent priority for the prevention and containment of disease outbreaks in communities. However, few data are available in asymptomatic persons regarding the accuracy of polymerase chain reaction testing. In addition, although self-collected saliva samples have significant logistical advantages in mass screening, their utility as an alternative specimen in asymptomatic persons is yet to be determined.
Methods
We conducted a mass screening study to compare the utility of nucleic acid amplification, such as reverse-transcription polymerase chain reaction testing, using nasopharyngeal swab (NPS) and saliva samples from each individual in 2 cohorts of asymptomatic persons: the contact-tracing cohort and the airport quarantine cohort.
Results
In this mass screening study including 1924 individuals, the sensitivities of nucleic acid amplification testing with NPS and saliva specimens were 86% (90% credible interval, 77%–93%) and 92% (83%–97%), respectively, with specificities >99.9%. The true concordance probability between the NPS and saliva tests was estimated at 0.998 (90% credible interval, .996–.999) given the recent airport prevalence of 0.3%. In individuals testing positive, viral load was highly correlated between NPS and saliva specimens.
Conclusion
Both NPS and saliva specimens had high sensitivity and specificity. Self-collected saliva specimens are valuable for detecting SARS-CoV-2 in mass screening of asymptomatic persons.
Emerging evidences have shown the utility of saliva for the detection of SARS-CoV-2 by PCR as alternative to nasopharyngeal swab (NPS). However, conflicting results have been reported regarding viral ...loads between NPS and saliva. We conducted a study to compare the viral loads between NPS and saliva in 42 COVID-19 patients. Viral loads were estimated by the cycle threshold (Ct) values. SARS-CoV-2 was detected in 34 (81%) using NPS with median Ct value of 27.4, and 38 (90%) using saliva with median Ct value of 28.9 (P = 0.79). Kendall's W was 0.82, showing a high degree of agreement, indicating equivalent viral loads in NPS and saliva. After symptom onset, the Ct values of both NPS and saliva continued to increase over time, with no substantial difference. Self-collected saliva has a detection sensitivity comparable to that of NPS and is a useful diagnostic tool with mitigating uncomfortable process and the risk of aerosol transmission to healthcare workers.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Objectives
To assess the diagnostic value and contribution to BI-RADS categorisation of initial enhancement on ultra-fast DCE-MRI for differentiating malignant and benign breast lesions.
Methods
The ...institutional review board approved this study, and written informed consent was obtained from each participant. Both ultra-fast DCE-MRI for initial enhancement analysis and conventional MRI were performed on 200 subjects with a total of 215 lesions (147 malignant and 68 benign). BI-RADS categorisation of enhancing lesions was performed using the conventional MRI. Two initial enhancement measures, time to enhancement (TTE) and maximum slope (MS), were derived from the ultra-fast DCE-MRI. Diagnostic performance and the additional diagnostic value of adding TTE and MS to BI-RADS were evaluated.
Results
Both TTE and MS showed significant differences between malignant and benign breast lesions in masses (TTE,
p
<.001; MS,
p
= .006) and non-mass enhancement (NME) (TTE,
p
<.001; MS,
p
<.001). For masses, the AUC of TTE+MS combined with BI-RADS (0.864) was better than BI-RADS alone (0.823,
p
= .065). For NME, the AUC of TTE+MS combined with BI-RADS (0.923) was significantly larger than BI-RADS alone (0.865,
p
= .036), and diagnostic specificity improved by 40.9% (
p
= .005), without a significant decrease in the sensitivity (
p
= .083).
Conclusion
Initial enhancement analysis using ultra-fast DCE-MRI is especially useful for increasing the diagnostic performance of NME in breast MRI.
Key Points
• Ultra-fast dynamic MRI effectively differentiates benign from malignant breast lesions.
• Ultra-fast dynamic MRI contributes to BI-RADS categorisation in non-mass enhancement.
• Management of non-mass breast lesions becomes more appropriate.
Purpose
To evaluate factors related to myopia progression in children wearing either orthokeratology (OK) lenses or single-vision spectacles (SVS) for 2 years.
Study design
Pooled-analysis ...retrospective intervention study.
Methods
This study involved 105 school-aged children wearing SVS who participated in the multi-center Myovision Study and 89 school-aged children wearing one of 3 OK lens types Menicon Z Night (M, n = 27), αORTHO
®
-K (A, n = 32), and Emerald
™
(E, n = 30). In the OK-lens patients, last examination was performed at ≥ 3-weeks post lens-wear discontinuation. Of the subjects, 102 SVS-Group and 79 OK-Group (M: n = 24, A: n = 28, and E: n = 27) children completed all examinations. A relationship between refractive error (RE) change and 7 factors (correction methods, baseline age, baseline RE, baseline axial length, gender, right or left eye, and follow-up period) was derived by multiple regression modeling. Via those same methods, we investigated the relationship between RE change and 7 factors including 3 OK-lens corrections.
Results
Related influence factors were correction method (0.85 D myopia reduction in the OK Group,
P
< 0.001), baseline age (0.16 D myopia reduction in older-age patients,
P
< 0.001), and baseline RE (0.12 D myopia reduction per 1 D myopia,
P
= 0.01). No relationship was found between RE change and OK-lens type. No serious adverse events occurred.
Conclusion
Regardless of OK lens design, myopia progression in school-aged children was suppressed. The effect was examined not only via axial-length elongation but also RE change, and the myopia control effect by OK lenses was found to be 0.85 D over the 2-year period.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
The immune system exhibits circadian rhythms, and its response to viral infection is influenced by the circadian clock system. Previous studies have reported associations between the time of day of ...vaccination against COVID-19 and production of anti-SARS-CoV-2 antibody titer. We examined the effect of vaccination time of day on anti-SARS-CoV-2 antibody titer after the first dose of vaccination with the mRNA-1273 (Moderna) COVID-19 vaccine in an adult population. A total of 332 Japanese adults participated in the present study. All participants were not infected with SARS-CoV-2 and had already received the first dose of mRNA-1273 2 to 4 weeks prior to participating in the study. The participants were asked to provide basic demographic characteristics (age, sex, medical history, allergy, medication, and mean sleep duration), the number of days after the first dose of vaccination, and the time of day of vaccination. Blood was collected from the participants, and SARS-CoV-2 antibody titers were measured. Ordinary least square regression was used for assessing the relationship between basic demographic characteristics, number of days after vaccination, time of day of vaccination, and the log10-transformed normalized antibody titer. The least square mean of antibody titers was not associated with the vaccination time and sleep durations. The least square means of antibody titers was associated with age; the antibody titers decreased in people aged 50 to 59 years and 60 to 64 years. The present findings demonstrate that the vaccination time with mRNA-1273 was not associated with the SARS-CoV-2 antibody titer in an adult population, suggesting that these results do not support restricting vaccination to a particular time of day. The present findings may be useful in optimizing SARS-CoV-2 vaccination strategies.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
In some clinical situations, patients experience repeated events of the same type. Among these, cancer recurrences can result in terminal events such as death. Therefore, here we dynamically ...predicted the risks of repeated and terminal events given longitudinal histories observed before prediction time using dynamic pseudo-observations (DPOs) in a landmarking model.
The proposed DPOs were calculated using Aalen-Johansen estimator for the event processes described in the multi-state model. Furthermore, in the absence of a terminal event, a more convenient approach without matrix operation was described using the ordering of repeated events. Finally, generalized estimating equations were used to calculate probabilities of repeated and terminal events, which were treated as multinomial outcomes.
Simulation studies were conducted to assess bias and investigate the efficiency of the proposed DPOs in a finite sample. Little bias was detected in DPOs even under relatively heavy censoring, and the method was applied to data from patients with colorectal liver metastases.
The proposed method enabled intuitive interpretations of terminal event settings.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
There is growing data on T helper 2 (Th2) biomarker determinants in adult populations. However, the determinants and typical range of these biomarkers have not been well studied in general ...populations of children. Therefore, we assessed the determinants and typical range of three Th2 biomarkers, including blood eosinophils, FeNO, and serum total IgE in 9-11-year-old children in a prospective birth cohort.
We examined the pre- and postnatal factors associated with Th2 biomarkers using multivariable logistic regression analysis (n = 428) and extended the results to the original cohort (n = 17,009) using inverse probability weighting. We also measured typical Th2 biomarker distribution in all examined children and healthy participants without allergic diseases (n = 180).
At age 9–11, wheeze (odds ratio (OR) 7.63), rhinitis (OR 3.14), and eczema (OR 2.46) were significantly associated with increased blood eosinophils. All three allergic conditions were associated with FeNO and total serum IgE, but the ORs were smaller than those for blood eosinophils. Secondhand smoking was inversely associated with the blood eosinophils (OR, 0.38). Similar results were found in the original cohort. Male sex and prenatal factors (maternal smoking and parental history of allergies) were not independent predictors of high Th2 levels.
In addition to wheezing and rhinitis, eczema and secondhand smoke exposure are independent factors for Th2 biomarker interpretation in children. Furthermore, the typical values and cutoff values of blood eosinophils in adults may not be applicable to children.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The aim of this study was to examine the association of insulin resistance (evaluated by the short insulin tolerance test SITT) with parameters related to obesity and insulin resistance. We ...prospectively recruited controls and patients with type 2 diabetes mellitus (T2DM), subjected them to the SITT, and calculated the K indices of the intravenous insulin tolerance test (K.sub.ITT (iv)) and the subcutaneous insulin tolerance test (K.sub.ITT (sc)). We compared K.sub.ITT (iv) results between the volunteers and patients and examined its correlation with K.sub.ITT (sc). We also examined the association of K.sub.ITT (iv) with obesity, insulin resistance-related parameters, and the insulin dose required for glycemic control. A total of 24 participants (seven controls and 17 patients with T2DM) were studied. The mean K.sub.ITT (iv) was significantly lower in patients with T2DM than in the controls (2.5%±2.1% vs. 4.5%±1.8%). In all participants, K.sub.ITT (iv) was significantly correlated with the homeostasis model assessment for insulin resistance (HOMA-IR) values (r = -0.601, p<0.05) but not with K.sub.ITT (sc) (p = 0.62). K.sub.ITT (iv) was correlated positively with the serum adiponectin concentration, but negatively with the visceral fat area and serum concentrations of tumor necrosis factor-alpha and branched-chain amino acids. In patients with T2DM, K.sub.ITT (iv) and HOMA-IR values were significantly correlated with the total insulin dose required for glycemic control. Insulin resistance evaluated using K.sub.ITT (iv) was correlated with the HOMA-IR values, but not with the resistance evaluated using K.sub.ITT (sc). The degree of insulin resistance was associated with biomarkers, such as adiponectin, tumor necrosis factor-alpha, branched-chain amino acids, the visceral fat area, and the dose of insulin required for glycemic control.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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