Does qualitative radiologic assessment of tumor response measure up to traditional quantitative scoring methods?

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17034-17034
Author(s):  
R. Gottlieb ◽  
A. M. Litwin ◽  
T. L. Mashtare ◽  
G. Wilding ◽  
C. L. Raczyk ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Tumor Response ◽  
Proportional Hazards Model ◽  
Hepatic Metastases ◽  
Cox Proportional Hazards ◽  
Response To Therapy ◽  
Cox Proportional Hazards Model ◽  
World Health ◽  
Qualitative Assessment ◽  
Significant Difference

17034 Background: The Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) radiologic metrics are the standards for tumor response to therapy. However these methods are difficult to use and are limited in their prediction of clinical outcome. We hypothesize a simpler qualitative assessment of tumor response by CT is as reproducible and predictive of clinical outcome as the RECIST and WHO methods. Methods: This was a retrospective evaluation of 23 patients (11 males, 12 females, mean age 56.1 years, range 40–81 years) with biopsy proven metastatic colo-rectal carcinoma treated at our institution between 2002 and 2006 who did not have their primary tumor resected. Only patients with two consecutive CT examinations separated by at least three weeks were included. Two board certified radiologists, blinded to the other's reads, independently interpreted all CT examinations measuring up to five hepatic lesions on both CT examinations using RECIST and WHO criteria and qualitatively assessing all hepatic metastases, categorizing them as increased, decreased, or unchanged between scans. Clinical outcome, using time to progression of disease (TTP), was measured, utilizing a Cox proportional hazards model, to compare the predictive value of all three scoring systems for those patients starting first line chemotherapy (11 patients) at the time of our analysis. Results: Qualitative assessment resulted in agreement in 21/23 patients (91.3%, kappa = 0.78) classifying hepatic metastases as any increase (2 patients), any decrease (17 patients), or no change (2 patients) between scans compared with agreement in 20/23 patients (87.0%) for RECIST (kappa = 0.62) and WHO ( kappa = 0.67) methods placing patients into partial response (2 patients by RECIST and WHO), stable disease (17 patients by RECIST, 16 patients by WHO), and disease progression (1 patient by RECIST, 2 patients by WHO)categories by accepted criteria. No significant difference in prediction of TTP between methods was found. Conclusions: Our pilot data suggests our qualitative scoring system may be at least as reproducible and predictive of patient clinical outcome as the RECIST and WHO methods. No significant financial relationships to disclose.

Effect of chest-compression-only bystander cardiopulmonary resuscitation on the likelihood of initial shockable rhythm after out-of-hospital cardiac arrest: a propensity matching analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Funada ◽  
Y Goto ◽  
T Maeda ◽  
H Okada ◽  
M Takamura
Keyword(s):  
Cardiac Arrest ◽  
Chest Compression ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Shockable Rhythm ◽  
Significant Difference ◽  
Bystander Cardiopulmonary Resuscitation ◽  
Bystander Cpr

Abstract Background/Introduction Shockable rhythm after cardiac arrest is highly expected after early initiation of bystander cardiopulmonary resuscitation (CPR) owing to increased coronary perfusion. However, the relationship between bystander CPR and initial shockable rhythm in patients with out-of-hospital cardiac arrest (OHCA) remains unclear. We hypothesized that chest-compression-only CPR (CC-CPR) before emergency medical service (EMS) arrival has an equivalent effect on the likelihood of initial shockable rhythm to the standard CPR (chest compression plus rescue breathing [S-CPR]). Purpose We aimed to examine the rate of initial shockable rhythm and 1-month outcomes in patients who received bystander CPR after OHCA. Methods The study included 59,688 patients (age, ≥18 years) who received bystander CPR after an OHCA with a presumed cardiac origin witnessed by a layperson in a prospectively recorded Japanese nationwide Utstein-style database from 2013 to 2017. Patients who received public-access defibrillation before arrival of the EMS personnel were excluded. The patients were divided into CC-CPR (n=51,520) and S-CPR (n=8168) groups according to the type of bystander CPR received. The primary end point was initial shockable rhythm recorded by the EMS personnel just after arrival at the site. The secondary end point was the 1-month outcomes (survival and neurologically intact survival) after OHCA. In the statistical analyses, a Cox proportional hazards model was applied to reflect the different bystander CPR durations before/after propensity score (PS) matching. Results The crude rate of the initial shockable rhythm in the CC-CPR group (21.3%, 10,946/51,520) was significantly higher than that in the S-CPR group (17.6%, 1441/8168, p<0.0001) before PS matching. However, no significant difference in the rate of initial shockable rhythm was found between the 2 groups after PS matching (18.3% [1493/8168] vs 17.6% [1441/8168], p=0.30). In the Cox proportional hazards model, CC-CPR was more negatively associated with the initial shockable rhythm before PS matching (unadjusted hazards ratio [HR], 0.97; 95% confidence interval [CI], 0.94–0.99; p=0.012; adjusted HR, 0.92; 95% CI, 0.89–0.94; p<0.0001) than S-CPR. After PS matching, however, no significant difference was found between the 2 groups (adjusted HR of CC-CPR compared with S-CPR, 0.97; 95% CI, 0.94–1.00; p=0.09). No significant differences were found between C-CPR and S-CPR in the 1-month outcomes after PS matching as follows, respectively: survival, 8.5% and 10.1%; adjusted odds ratio, 0.89; 95% CI, 0.79–1.00; p=0.07; cerebral performance category 1 or 2, 5.5% and 6.9%; adjusted odds, 0.86; 95% CI, 0.74–1.00; p=0.052. Conclusions Compared with S-CPR, the CC-CPR before EMS arrival had an equivalent multivariable-adjusted association with the likelihood of initial shockable rhythm in the patients with OHCA due to presumed cardiac causes that was witnessed by a layperson. Funding Acknowledgement Type of funding source: None

scholarly journals Effect of PCSK9 E670G and R46L Polymorphisms on Major Adverse Cardio-Cerebrovascular Events in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

2021 ◽  
Author(s):  
Anwar Santoso ◽  
Yulianto Yulianto ◽  
Hendra Simarmata ◽  
Abhirama Nofandra Putra ◽  
Erlin Listiyaningsih
Keyword(s):  
Myocardial Infarction ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
St Segment Elevation ◽  
Coronary Syndrome ◽  
Segment Elevation Myocardial Infarction ◽  
Cerebrovascular Events ◽  
St Segment ◽  
Significant Difference

AbstractMajor adverse cardio-cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) are still high, although there have been advances in pharmacology and interventional procedures. Proprotein convertase subtilisin/Kexin type 9 (PCSK9) is a serine protease regulating lipid metabolism associated with inflammation in acute coronary syndrome. The MACCE is possibly related to polymorphisms in PCSK9. A prospective cohort observational study was designed to confirm the association between polymorphism of E670G and R46L in the PCSK9 gene with MACCE in STEMI. The Cox proportional hazards model and Spearman correlation were utilized in the study. The Genotyping of PCSK9 and ELISA was assayed.Sixty-five of 423 STEMI patients experienced MACCE in 6 months. The E670G polymorphism in PCSK9 was associated with MACCE (hazard ratio = 45.40; 95% confidence interval: 5.30–390.30; p = 0.00). There was a significant difference of PCSK9 plasma levels in patients with previous statin consumption (310 [220–1,220] pg/mL) versus those free of any statins (280 [190–1,520] pg/mL) (p = 0.001).E670G polymorphism of PCSK9 was associated with MACCE in STEMI within a 6-month follow-up. The plasma PCSK9 level was higher in statin users.

Polymorphisms in Inflammation Genes and Bladder Cancer: From Initiation to Recurrence, Progression, and Survival

2005 ◽  
Vol 23 (24) ◽  
pp. 5746-5756 ◽  
Author(s):  
Dan Leibovici ◽  
H. Barton Grossman ◽  
Colin P. Dinney ◽  
Randal E. Millikan ◽  
Seth Lerner ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Outcome ◽  
Proportional Hazards Model ◽  
Smoking Status ◽  
Recurrence Risk ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Peroxisome Proliferator ◽  
Necrosis Factor Alpha ◽  
Muscle Invasive

Purpose Since chronic inflammation contributes to tumorigenesis, we hypothesized that the risk and clinical outcome of bladder cancer (BC) might be modulated by genetic variations in inflammation genes. Methods Using the TaqMan method, we genotyped single nucleotide polymorphisms in interleukin (IL) -6 (−174 G→C), IL-8 (−251 T→A), tumor necrosis factor-alpha (TNF-α; −308 G→A), and peroxisome proliferator-activated receptor γ (PPARG; Pro12Ala), and determined their associations with BC initiation and clinical outcome. Results We found that the IL-6 variant genotype (C/C) was associated with an increased BC risk (OR, 1.77; 95% CI, 1.25 to 2.51). There were joint effects between the variant IL-6 genotypes and smoking status, and between the variant genotypes of IL-6 and other genes. To assess effect on recurrence, we grouped non-muscle-invasive BC patients according to intravesical Bacillus Calmette-Guerin (BCG) treatment status: no BCG, induction BCG (iBCG), and maintenance BCG (mBCG). In the Cox proportional hazards model, the variant IL-6 genotype was associated with an increased recurrence risk (hazard ratio [HR], 4.60; 95% CI, 1.24 to 17.09) in patients receiving mBCG. The variant PPARG genotype was associated with a reduced recurrence risk (HR, 0.41; 95% CI, 0.20 to 0.86) among untreated patients. In patients with non-muscle-invasive BC, the variant IL-6 genotype was associated with an increased progression risk (HR, 1.88; 95% CI, 0.80 to 4.11). In patients with invasive BC, variant IL-6 was associated with improved 5-year overall and disease-specific survival (HR, 0.43; 95% CI, 0.19 to 0.94 and HR, 0.39; 95% CI, 0.15 to 1.00, respectively). Conclusion Inflammation gene polymorphisms are associated with modified BC risk, treatment response, and survival.

Abstract 15567: Residual Cholesterol and Cardiovascular Events in Patients With Coronary Artery Disease Under Different Glucose Metabolism Status

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jian-jun Li ◽  
Yexuan Cao ◽  
Hui-Wen Zhang ◽  
Jing-Lu Jin ◽  
Yan Zhang ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Glucose Metabolism ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Significant Difference ◽  
Artery Disease

Introduction: The atherogenicity of residual cholesterol (RC) has been underlined by recent guidelines, which was linked to coronary artery disease (CAD), especially for patients with diabetes mellitus (DM). Hypothesis: This study aimed to examine the prognostic value of plasma RC, clinically presented as triglyceride-rich lipoprotein-cholesterol (TRL-C) or remnant-like lipoprotein particles-cholesterol (RLP-C), in CAD patients with different glucose metabolism status. Methods: Fasting plasma TRL-C and RLP-C levels were directly calculated or measured in 4331 patients with CAD. Patients were followed for incident MACEs for up to 8.6 years and categorized according to both glucose metabolism status [DM, pre-DM, normal glycaemia regulation (NGR)] and RC levels. Cox proportional hazards model was used to calculate hazard ratios (HRs) with 95% confidence intervals. Results: During a mean follow-up of 5.1 years, 541 (12.5%) MACEs occurred. The risk for MACEs was significantly higher in patients with elevated RC levels after adjustment for potential confounders. No significant difference in MACEs was observed between pre-DM and NGR groups (p>0.05). When stratified by status of glucose metabolism and RC levels, highest levels of RLP-C, calculated and measured TRL-C were significant and independent predictors of developing MACEs in pre-DM (HR: 2.10, 1.98, 1.92, respectively; all p<0.05) and DM (HR: 2.25, 2.00, 2.16, respectively; all p<0.05). Conclusions: In this large cohort study with long-term follow-up, data firstly demonstrated that higher RC levels were significantly associated with the worse prognosis in DM and pre-DM patients with CAD, suggesting RC might be a target for patients with impaired glucose metabolism.

scholarly journals Para-Aortic Nodal Radiation in the Definitive Management of Node-Positive Cervical Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Jason C. Sanders ◽  
Donald A. Muller ◽  
Sunil W. Dutta ◽  
Taylor J. Corriher ◽  
Kari L. Ring ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Chi Square ◽  
Node Positive ◽  
Significant Difference ◽  
Grade 3 ◽  
Severe Grade

ObjectivesTo investigate the safety and outcomes of elective para-aortic (PA) nodal irradiation utilizing modern treatment techniques for patients with node positive cervical cancer.MethodsPatients with pelvic lymph node positive cervical cancer who received radiation were included. All patients received radiation therapy (RT) to either a traditional pelvic field or an extended field to electively cover the PA nodes. Factors associated with survival were identified using a Cox proportional hazards model, and toxicities between groups were compared with a chi-square test.Results96 patients were identified with a mean follow up of 40 months. The incidence of acute grade ≥ 2 toxicity was 31% in the elective PA nodal RT group and 15% in the pelvic field group (Chi-square p = 0.067. There was no significant difference in rates of grade ≥ 3 acute or late toxicities between the two groups (p&gt;0.05). The KM estimated 5-year OS was not statistically different for those receiving elective PA nodal irradiation compared to a pelvic only field, 54% vs. 73% respectively (log-rank p = 0.11).ConclusionsElective PA nodal RT can safely be delivered utilizing modern planning techniques without a significant increase in severe (grade ≥ 3) acute or late toxicities, at the cost of a possible small increase in non-severe (grade 2) acute toxicities. In this series there was no survival benefit observed with the receipt of elective PA nodal RT, however, this benefit may have been obscured by the higher risk features of this population. While prospective randomized trials utilizing a risk adapted approach to elective PA nodal coverage are the only way to fully evaluate the benefit of elective PA nodal coverage, these trials are unlikely to be performed and instead we must rely on interpretation of results of risk adapted approaches like those used in ongoing clinical trials and retrospective data.

scholarly journals Associations between SARS-CoV-2 variants and risk of COVID-19 hospitalization among confirmed cases in Washington State: a retrospective cohort study

2021 ◽  
Author(s):  
Miguel I. Paredes ◽  
Stephanie Lunn ◽  
Michael Famulare ◽  
Lauren A. Frisbie ◽  
Ian Painter ◽  
...  
Keyword(s):  
Cohort Study ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Sentinel Surveillance ◽  
Cox Proportional Hazards Model ◽  
Ancestral Lineage ◽  
Significant Difference

Background: The COVID–19 pandemic is now dominated by variant lineages; the resulting impact on disease severity remains unclear. Using a retrospective cohort study, we assessed the risk of hospitalization following infection with nine variants of concern or interest (VOC/VOI). Methods: Our study includes individuals with positive SARS–CoV–2 RT PCR in the Washington Disease Reporting System and with available viral genome data, from December 1, 2020 to July 30, 2021. The main analysis was restricted to cases with specimens collected through sentinel surveillance. Using a Cox proportional hazards model with mixed effects, we estimated hazard ratios (HR) for the risk of hospitalization following infection with a VOC/VOI, adjusting for age, sex, and vaccination status. Findings: Of the 27,814 cases, 23,170 (83.3%) were sequenced through sentinel surveillance, of which 726 (3.1%) were hospitalized due to COVID–19. Higher hospitalization risk was found for infections with Gamma (HR 3.17, 95% CI 2.15–4.67), Beta (HR: 2.97, 95% CI 1.65–5.35), Delta (HR: 2.30, 95% CI 1.69–3.15), and Alpha (HR 1.59, 95% CI 1.26–1.99) compared to infections with an ancestral lineage. Following VOC infection, unvaccinated patients show a similar higher hospitalization risk, while vaccinated patients show no significant difference in risk, both when compared to unvaccinated, ancestral lineage cases. Interpretation: Infection with a VOC results in a higher hospitalization risk, with an active vaccination attenuating that risk. Our findings support promoting hospital preparedness, vaccination, and robust genomic surveillance.

Treatment of metastatic disease with immune checkpoint inhibitors nivolumab and pembrolizumab: Effect of performance status on clinical outcomes.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18689-e18689
Author(s):  
Leah Wells ◽  
Michael Cerniglia ◽  
Audrey C. Jost ◽  
Gregory Joseph Britt
Keyword(s):  
Disease Control ◽  
Proportional Hazards Model ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Time To Death ◽  
Significant Difference ◽  
Line Of Therapy

e18689 Background: While guidelines exist for appropriate use of chemotherapy in the metastatic setting based on performance status, such recommendations are less readily available for immune checkpoint inhibitors (ICIs). We sought to determine if there is a relationship between Eastern Cooperative Oncology Group (ECOG) performance status and outcomes on immunotherapy in patients treated for metastatic disease at our community-based oncology practice. Methods: 253 patients were identified as receiving nivolumab or pembrolizumab for stage IV malignancy at Cancer Centers of Colorado-SCL Health, between June 2018 and November 2020. Patients initiated on therapy after May 2020 were excluded from analysis, due to insufficient (less than 6 months) follow-up time. The remaining 183 patients were included in a retrospective cohort study comparing patients with ECOG 0, ECOG 1, and ECOG 2-4. Sex, age, type of cancer, and line of therapy were collected. Time on therapy was also calculated. Best response to therapy was determined (disease control or progressive disease). These baseline factors and outcomes were compared using ANOVA for numeric variables and chi-square tests of association for categorical variables. Time from initiation of ICI to death or hospice was also investigated and compared using a log-rank test. In addition, a multivariate Cox proportional hazards model was developed for the outcome, time to death/hospice, versus the predictors ECOG status, age, gender, and line of therapy. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated. Results: Of the 183 patients included in analysis, 31.7% had an ECOG of 0, 48.6% an ECOG of 1, and 19.7% an ECOG of 2-4. Non-small cell lung cancer and melanoma represented the majority of patients in each group. Gender and line of therapy did not differ between groups. There was a significant difference in age (p = 0.02) with mean age 62, 66, and 70 in ECOG 0,1, and 2-4, respectively. 54.6% of patients remained on therapy for at least 6 months (182 days), and there was no significant difference between groups in ability to complete 6 months of therapy (p = 0.32). For ECOG 0, 1, and 2-4, disease control was achieved in 67.2%, 59.6 %, and 41.7%, respectively (p = 0.048). Analysis of time to death/hospice with a log rank test and Kaplan Meier plot showed a significant difference between groups (p < 0.001). A multivariate Cox proportional hazards model revealed that patients with ECOG 0 had significantly longer time to death/hospice compared to patients in both other groups, after controlling for age, gender, and line of therapy (ECOG 1 vs. 0: HR 2.5, CI 1.27-4.9; ECOG 2-4 vs. 0: HR 2.83, CI 1.31-6.13). Conclusions: In this single institution retrospective study of patients receiving nivolumab or pembrolizumab for metastatic cancer, ECOG 0 was associated with disease control and increased time before death or transition to hospice.

Final overall survival and updated biomarker analysis results from the randomized phase III ICOGEN trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7559-7559 ◽  
Author(s):  
Yan Sun ◽  
Yuankai Shi ◽  
Li Zhang ◽  
Xiaoqing Liu ◽  
Caicun Zhou ◽  
...  
Keyword(s):  
Overall Survival ◽  
Egfr Mutation ◽  
Advanced Nsclc ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Significant Difference ◽  
Biomarker Analysis ◽  
Nsclc Patients

7559 Background: A total of 399 pretreated patients with advanced NSCLC were randomly assigned to receive gefitinib or icotinib in the phase III ICOGEN trial, the first head-to-head phase III trial of EGFR-TKIs. The results of the primary endpoint, PFS, have been reported previously. This report represents the final OS and biomarker analysis results. Methods: EGFR mutation was evaluated by using Scorpion ARMS (QIAGEN, n=152). Overall survival was analyzed by Cox proportional-hazards model analysis at 82% maturity. Results: Median OS was 13.3 months for icotinib and 13.9 months for gefitinib (hazard ratio [HR] = 0.90; 95% CI, 0.79 to 1.02; P = .109). The EGFR mutation rate was 43% in the icotinib group and 59% in the gefitinib group. Compared to wild type patients, patients with EGFR mutation had longer PFS (median, 6.2m vs. 2.3m; P=.00001) as well as OS (median, 20.5m vs. 7.7m; P=.00001). There were no significant differences in PFS or OS between the two treatment groups in EGFR mutation-positive subgroup (median PFS, 7.8m vs. 5.3m for icotinib and gefitinib, respectively, P =.3162; median OS, 20.9m vs. 20.2m for icotinib and gefitinib, respectively, P =.7611.) or in EGFR mutation-negative subgroup (median PFS, 2.3m vs. 2.2m for icotinib and gefitinib, respectively, P =.1531; median OS, 7.8m vs. 6.9m for icotinib and gefitinib, respectively, P =.7885.). Conclusions: There is no statistically significant difference between icotinib and gefitinib in PFS or OS when given to NSCLC patients. This suggests that icotinib can provide similar OS benefits to gefitinib in advanced NSCLC patients. Moreover, EGFR mutation status is the strongest predictor in identifying which patients are most likely to benefit from icotinib.

Denosumab and zoledronic acid treatment in patients with genitourinary cancers and bone metastases.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5079-5079 ◽  
Author(s):  
Luis Costa ◽  
Karim Fizazi ◽  
Fred Saad ◽  
Janet Elizabeth Brown ◽  
Roger Von Moos ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Bone Disease ◽  
Proportional Hazards Model ◽  
Transitional Cell ◽  
Cox Proportional Hazards ◽  
Metastatic Bone Disease ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Pivotal Phase ◽  
Significant Difference

5079 Background: Phase III trial results showed that denosumab is superior to zoledronic acid (ZA) in preventing skeletal-related events (SREs) in patients with cancer and metastatic bone disease (Lipton et al; 2012, Eur J Cancer). Genitourinary (GU) cancers are some of the most commonly diagnosed cancers worldwide. We now compare the efficacy and safety of denosumab (DMAb) or ZA in a subgroup analysis of patients with GU cancers enrolled in the pivotal phase III trials. Methods: Patients were randomized 1:1 to receive DMAb (120 mg, SC) or ZA (4 mg, IV, adjusted for renal function) every 4 weeks. Daily calcium and vitamin D supplements were strongly recommended. Time to 1st on-study SRE, using a Cox proportional hazards model, time to 1st and subsequent on-study SRE, using the Anderson-Gill model, and safety were evaluated for the GU subgroup in an ad hoc analysis. Results: 2,128 patients (1,052 DMAb; 1,076 ZA) had GU cancers (prostate = 1,901, renal = 155, bladder = 63, and transitional cell = 9). DMAb significantly delayed the time to 1st on-study SRE by 4.0 months compared with ZA (20.7 months vs 16.7 months) in patients with GU cancers (Table). DMAb also significantly delayed the time to 1st and subsequent on-study SRE. Time to disease progression and overall survival were similar between treatment groups. Adverse events (AEs) and serious AEs were reported by similar percentages of patients in both groups (AEs: 96.9% denosumab, 96.8% ZA; serious AEs: 62.8% denosumab, 60.2% ZA). 14.6% of DMAb pts and 15.9% of ZA pts had a renal AE. Hypocalcemia was reported for 12.9% of DMAb patients and 6.2% of ZA patients. There was no significant difference in the incidence of positively adjudicated osteonecrosis of the jaw between the DMAb (2.2%) and ZA (1.6%) groups (p=0.34). Conclusions: Among patients with GU cancers and metastatic bone disease, DMAb was superior to ZA in preventing SREs. Clinical trial information: NCT00330759 and NCT00321620. [Table: see text]

scholarly journals Assessment of preparation time and 1-year Invisalign aligner attachment survival using flowable and packable composites:

2021 ◽  
Author(s):  
Shuang Lin ◽  
Ling Huang ◽  
Jialing Li ◽  
Juan Wen ◽  
Li Mei ◽  
...  
Keyword(s):  
Survival Data ◽  
Tooth Extraction ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Secondary Outcome ◽  
Preparation Time ◽  
Cox Models ◽  
Significant Difference

ABSTRACT Objectives To compare preparation time and 1-year Invisalign aligner attachment survival between a flowable composite (FC) and a packable composite (PC). Materials and Methods Fifty-five participants (13 men and 42 women, mean age ± SD: 24.2 ± 5.9 years) were included in the study. Ipsilateral quadrants (ie, maxillary and mandibular right, or vice versa) of attachments were randomly assigned to the FC group (Filtek Z350XT Flowable Restorative) and the PC group (Filtek Z350XT Universal Restorative) by tossing a coin. The primary outcome was preparation time. The secondary outcome was time to the first damage of an attachment. Preparation times were compared using the paired t-test, and the survival data were analyzed by the Cox proportional hazards model with a shared frailty term, with α = .05. Results The preparation times were significantly shorter with the FC (6.22 ± 0.22 seconds per attachment) than with the PC (32.83 ± 2.16 seconds per attachment; P &lt; .001). The attachment damage rates were 14.79% for the FC and 9.70% for the PC. According to the Cox models, attachment damage was not significantly affected by the attachment material, sex, arch, tooth location, attachment type, presence of overbite, or occurrence of tooth extraction. Conclusions The use of a FC may save time as compared with the use of a PC. With regard to attachment survival, there was no significant difference between the two composites. None of the covariates of attachment materials (sex, arch, tooth location, attachment type, presence of overbite, oir occurrence of tooth extraction) affected attachment damage.

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