Cumulative Incidence
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Author(s):  
Brandon S. Imber ◽  
Karen W. Chau ◽  
Jasme Lee ◽  
Jisun Lee ◽  
Dana L. Casey ◽  
...  

Radiotherapy plays an important role in managing highly radiosensitive, indolent non-Hodgkin lymphomas (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL). While the standard of care for localized iNHL remains 24Gy, de-escalation to very low dose radiotherapy (VLDRT) of 4Gy further reduces toxicities and treatment duration. Use of VLDRT outside of palliative indications remains controversial, however, we hypothesize that it may be sufficient for most lesions. We present the largest single institution VLDRT experience of adult patients with FL and MZL treated between 2005 and 2018 (n=299 lesions; 250 patients) utilizing modern principles including PET staging and involved site radiotherapy (ISRT). Outcomes include best clinical/radiographic response between 1.5-6 months post-VLDRT, and cumulative incidence of local progression (LP) with only death as competing risk. Post-VLDRT, the overall response rate was 90% for all treated sites with 68% achieving complete response (CR). With median follow-up of 2.4 years, the 2-year cumulative incidence of LP was 25% for the entire cohort and 9% after frontline VLDRT treatment for potentially curable, localized disease. Lesion size >6cm was associated with lower odds of attaining a CR and greater risk of LP. There was no suggestion of inferior outcomes for potentially curable lesions. Given the clinical versatility of VLDRT, we propose to implement a novel, incremental, adaptive ISRT strategy where patients will be treated initially with VLDRT, reserving full dose treatment for those who fail to attain a CR.


2021 ◽  
Author(s):  
Mars Stone ◽  
Eduard Grebe ◽  
Hasan Sulaeman ◽  
Clara Di Germanio ◽  
Honey Dave ◽  
...  

SARS-CoV-2 serosurveys can estimate cumulative incidence for monitoring epidemics but require characterization of employed serological assays performance to inform testing algorithm development and interpretation of results. We conducted a multi-laboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serological assays using blinded panels of 1,000 highly-characterized blood-donor specimens. Assays demonstrated a range of sensitivities (96%-63%), specificities (99%-96%) and precision (IIC 0.55-0.99). Durability of antibody detection in longitudinal samples was dependent on assay format and immunoglobulin target, with anti-spike, direct, or total Ig assays demonstrating more stable, or increasing reactivity over time than anti-nucleocapsid, indirect, or IgG assays. Assays with high sensitivity, specificity and durable antibody detection are ideal for serosurveillance. Less sensitive assays demonstrating waning reactivity are appropriate for other applications, including characterizing antibody responses after infection and vaccination, and detection of anamnestic boosting by reinfections and vaccine breakthrough infections. Assay performance must be evaluated in the context of the intended use.


2021 ◽  
Author(s):  
Saki Takahashi ◽  
Michael J Peluso ◽  
Jill Hakim ◽  
Keirstinne Turcios ◽  
Owen Janson ◽  
...  

Serosurveys are a key resource for measuring SARS-CoV-2 cumulative incidence. A growing body of evidence suggests that asymptomatic and mild infections (together making up over 95% of all infections) are associated with lower antibody titers than severe infections. Antibody levels also peak a few weeks after infection and decay gradually. We developed a statistical approach to produce adjusted estimates of seroprevalence from raw serosurvey results that account for these sources of spectrum bias. We incorporate data on antibody responses on multiple assays from a post-infection longitudinal cohort, along with epidemic time series to account for the timing of a serosurvey relative to how recently individuals may have been infected. We applied this method to produce adjusted seroprevalence estimates from five large-scale SARS-CoV-2 serosurveys across different settings and study designs. We identify substantial differences between reported and adjusted estimates of over two-fold in the results of some surveys, and provide a tool for practitioners to generate adjusted estimates with pre-set or custom parameter values. While unprecedented efforts have been launched to generate SARS-CoV-2 seroprevalence estimates over this past year, interpretation of results from these studies requires properly accounting for both population-level epidemiologic context and individual-level immune dynamics.


2021 ◽  
Author(s):  
Ruiping Zhai ◽  
Yingchen Lyu ◽  
Mengshan Ni ◽  
Fangfang Kong ◽  
Chengrun Du ◽  
...  

Abstract BackgroundThe aim of the study is to identify clinical and dosimetric factors that could predict the risk of hypothyroidism in nasopharyngeal carcinoma (NPC) patients following intensity-modulated radiotherapy (IMRT). MethodsA total of 404 non-metastatic NPC patients were included in our study. All patients were treated with IMRT. The thyroid function were performed for all patients before and after radiation at regular intervals. The time onset for developing hypothyroidism was defined as the time interval between the completion of RT and the first recorded abnormal thyroid hormone test. The cumulative incidence rates of hypothyroidism were estimated using Kaplan-Meier method. Univariate and multivariate Cox regression analyses were performed to detect the most promising factors that were associated with hypothyroidism. ResultsMedian follow up was 60.6 months. The 3-, 5- and 7- year cumulative incidence rate of hypothyroidism was 39.4%, 49.1% and 54.7%, respectively. The median time to primary hypothyroidism and central hypothyroidism were 15.4 months (range: 2.9-83.8 months) and 29.9 months (range: 19.8-93.6 months), respectively. Univariate and multivariate analyses revealed that younger age, female gender and small thyroid volume were the most important factors in predicting the risk of hypothyroidism. Dtmean (mean dose of thyroid), V30-V50 (percentage of thyroid volume receiving a certain dose level) and VS45-VS60 (the absolute volumes of thyroid spared from various dose levels) remained statistically significant in multivariate analyses. Cutoff points of 45 Gy (Dtmean), 80% (Vt40) and 5 cm3 (VS45Gy) were identified to classify patients as high-risk or low-risk group. ConclusionThyroid Vt40 predicted the risk of hypothyroidism after IMRT for NPC patients. We recommended plan optimization objectives to reduce thyroid V40 to 80%.Trial registration: retrospectively registered.


2021 ◽  
pp. JCO.20.02530
Author(s):  
Supriya Chopra ◽  
Sudeep Gupta ◽  
Sadhana Kannan ◽  
Tapas Dora ◽  
Reena Engineer ◽  
...  

PURPOSE Postoperative Adjuvant Radiation in Cervical Cancer (PARCER), a phase III randomized trial, compared late toxicity after image-guided intensity-modulated radiotherapy (IG-IMRT) with three-dimensional conformal radiation therapy (3D-CRT) in women with cervical cancer undergoing postoperative radiation. METHODS Patients were randomly assigned to receive either IG-IMRT or 3D-CRT after stratification for the type of hysterectomy and use of concurrent chemotherapy. The primary end point was 3-year grade ≥ 2 late GI toxicity assessed using Common Toxicity Criteria for Adverse Events v 3.0 and estimated using time-to-event, intention-to-treat analysis, with a study level type I error of 0.05 and a nominal α of .047 after accounting for one interim analysis. Secondary end points included acute toxicity, health-related quality of life, and pelvic relapse-free, disease-free, and overall survival. RESULTS Between 2011 and 2019, 300 patients were randomly assigned (IG-IMRT 151 and 3D-CRT 149). At a median follow-up of 46 (interquartile range 20-72) months, the 3-year cumulative incidence of grade ≥ 2 late GI toxicity in the IG-IMRT and 3D-CRT arms were 21.1% versus 42.4% (hazard ratio [HR] 0.46; 95% CI, 0.29 to 0.73; P < .001). The cumulative incidence of grade ≥ 2 any late toxicity was 28.1% versus 48.9% (HR 0.50; 95% CI, 0.33 to 0.76; P < .001), respectively. Patients reported reduced diarrhea ( P = .04), improved appetite ( P = .008), and lesser bowel symptoms ( P = .002) with IG-IMRT. However, no difference was observed in the time by treatment interaction. The 3-year pelvic relapse-free survival and disease-free survival in the IG-IMRT versus the 3D-CRT arm were 81.8% versus 84% (HR 1.17; 95% CI, 0.68 to 1.99; P = .55) and 76.9% versus 81.2% (HR 1.03; 95% CI, 0.62 to 1.71; P = .89), respectively. CONCLUSION IG-IMRT results in reduced toxicity with no difference in disease outcomes.


2021 ◽  
Author(s):  
Ali Aminian ◽  
Rickesha Wilson ◽  
Alexander Zajichek ◽  
Chao Tu ◽  
Kathy E. Wolski ◽  
...  

<p><b>Objective:</b> To determine which one of the two most common metabolic surgical procedures is associated with greater reduction in risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2DM) and obesity.</p> <p><b> </b></p> <p><b>Research Design and Methods:</b> A total of 13,490 patients including 1,362 Roux-en-Y gastric bypass (RYGB), 693 sleeve gastrectomy (SG), and 11,435 matched non-surgical patients with T2DM and obesity who received their care at the Cleveland Clinic (1998-2017) were analyzed with follow-up through December 2018. Multivariable Cox regression analysis estimated time to incident extended MACE, defined as first occurrence of coronary artery events, cerebrovascular events, heart failure, nephropathy, atrial fibrillation, and all-cause mortality. </p> <p><b> </b></p> <p><b>Results:</b> The cumulative incidence of the primary endpoint at 5 years was 13.7% [95%CI 11.4-15.9] in the RYGB groups and 24.7% [95%CI 19.0-30.0] in the SG group with an adjusted HR of 0.77 [95%CI 0.60 to 0.98], p=0.04. Of the 6 individual endpoints, RYGB was associated with a significantly lower cumulative incidence of nephropathy at 5 years compared with SG (2.8% vs 8.3%, respectively); HR 0.47 [95%CI 0.28-0.79], p=0.005. Furthermore, RYGB was associated with a greater reduction in body weight, glycated hemoglobin, and use of medications to treat diabetes and cardiovascular diseases. Five years after RYGB, patients required more upper endoscopy (45.8% vs 35.6%, p<0.001) and abdominal surgical procedures (10.8% vs 5.4%, p=0.001) compared with SG. </p> <p><b> </b></p> <p><b>Conclusion:</b> In patients with obesity and T2DM, RYGB may be associated with greater weight loss, better diabetes control, and lower risk of MACE and nephropathy compared with SG.</p>


2021 ◽  
Author(s):  
Ali Aminian ◽  
Rickesha Wilson ◽  
Alexander Zajichek ◽  
Chao Tu ◽  
Kathy E. Wolski ◽  
...  

<p><b>Objective:</b> To determine which one of the two most common metabolic surgical procedures is associated with greater reduction in risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2DM) and obesity.</p> <p><b> </b></p> <p><b>Research Design and Methods:</b> A total of 13,490 patients including 1,362 Roux-en-Y gastric bypass (RYGB), 693 sleeve gastrectomy (SG), and 11,435 matched non-surgical patients with T2DM and obesity who received their care at the Cleveland Clinic (1998-2017) were analyzed with follow-up through December 2018. Multivariable Cox regression analysis estimated time to incident extended MACE, defined as first occurrence of coronary artery events, cerebrovascular events, heart failure, nephropathy, atrial fibrillation, and all-cause mortality. </p> <p><b> </b></p> <p><b>Results:</b> The cumulative incidence of the primary endpoint at 5 years was 13.7% [95%CI 11.4-15.9] in the RYGB groups and 24.7% [95%CI 19.0-30.0] in the SG group with an adjusted HR of 0.77 [95%CI 0.60 to 0.98], p=0.04. Of the 6 individual endpoints, RYGB was associated with a significantly lower cumulative incidence of nephropathy at 5 years compared with SG (2.8% vs 8.3%, respectively); HR 0.47 [95%CI 0.28-0.79], p=0.005. Furthermore, RYGB was associated with a greater reduction in body weight, glycated hemoglobin, and use of medications to treat diabetes and cardiovascular diseases. Five years after RYGB, patients required more upper endoscopy (45.8% vs 35.6%, p<0.001) and abdominal surgical procedures (10.8% vs 5.4%, p=0.001) compared with SG. </p> <p><b> </b></p> <p><b>Conclusion:</b> In patients with obesity and T2DM, RYGB may be associated with greater weight loss, better diabetes control, and lower risk of MACE and nephropathy compared with SG.</p>


2021 ◽  
pp. archdischild-2021-322043
Author(s):  
Karoliina Videman ◽  
Lotta Hallamaa ◽  
Otto Heimonen ◽  
Charles Mangani ◽  
Mari Luntamo ◽  
...  

ObjectiveTo assess whether intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine (SP) and azithromycin (AZI) in a malaria-endemic area leads to sustained gains in linear growth and development in their offspring.DesignFollow-up study of a randomised trial.SettingMangochi District in rural southern Malawi.Participants1320 pregnant women and their offspring.InterventionsIPTp monthly with SP and twice with AZI (AZI-SP group), monthly with SP but no AZI (monthly SP), or twice with SP (control). No intervention was given to children.Main outcome measuresCognitive performance using Raven’s Coloured Progressive Matrices (CPM) at 13 years of age; mean height and height-for-age Z-score (HAZ), cumulative incidence and prevalence of stunting (HAZ <−2); weight, body mass index, mid-upper-arm circumference and head circumference.ResultsAt approximately 13 years of age, the mean CPM score was 14.3 (SD 3.8, range 6–29, maximum 36), with no differences between groups. Children in the AZI-SP group were on average 0.4 cm (95% CI −0.9 to 1.7, p=0.6) taller than those in the control group. For cumulative incidence of stunting, the HR in the AZI-SP group was 0.72 (95% CI 0.61 to 0.84, p<0.001) compared with the control and 0.76 (95% CI 0.65 to 0.90, p<0.001) compared with the monthly SP groups. There was no intergroup difference in stunting prevalence or anthropometric measurements.ConclusionsIn rural Malawi, maternal intensified infection control during pregnancy reduces offspring’s cumulative incidence of ever being stunted by 13 years of age. In this study, there was no evidence of a positive impact on cognitive performance.Trial registration numberNCT00131235.


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