scholarly journals Blinded Independent Central Review (BICR) in New Therapeutic Lung Cancer Trials

Cancers ◽  
2021 ◽  
Vol 13 (18) ◽  
pp. 4533
Author(s):  
Hubert Beaumont ◽  
Antoine Iannessi ◽  
Yi Wang ◽  
Charles M. Voyton ◽  
Jennifer Cillario ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Progressive Disease ◽  
System Implementation ◽  
Time Points ◽  
Recist 1.1 ◽  
Reading Errors ◽  
Cancer Trials ◽  
Reading System ◽  
Time Point

Background: Double reads in blinded independent central reviews (BICRs) are recommended to control the quality of trials but they are prone to discordances. We analyzed inter-reader discordances in a pool of lung cancer trials using RECIST 1.1. Methods: We analyzed six lung cancer BICR trials that included 1833 patients (10,684 time points) involving 17 radiologists. We analyzed the rate of discrepancy of each trial at the time-point and patient levels as well as testing inter-trial differences. The analysis of adjudication made it possible to compute the readers’ endorsement rates, the root causes of adjudications, and the proportions of “errors” versus “medically justifiable differences”. Results: The trials had significantly different discrepancy rates both at the time-point (average = 34.3%) and patient (average = 59.2%) levels. When considering only discrepancies for progressive disease, homogeneous discrepancy rates were found with an average of 32.9%, while readers’ endorsement rates ranged between 27.7% and 77.8%. Major causes of adjudication were different per trial, with medically justifiable differences being the most common, triggering 74.2% of total adjudications. Conclusions: We provide baseline performances for monitoring reader performance in trials with double reads. Intelligent reading system implementation along with appropriate reader training and monitoring are solutions that could mitigate a large portion of the commonly encountered reading errors.

Circulating tumor cells monitored over time in lung cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 11025-11025 ◽  
Author(s):  
M. S. Luttgen ◽  
D. Marrinucci ◽  
D. Lazar ◽  
M. Malchiodi ◽  
P. Clark ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Assessment ◽  
Progressive Disease ◽  
Small Cell ◽  
Response To Therapy ◽  
Small Cell Lung ◽  
Cell Lung Carcinoma ◽  
Patient Status ◽  
Count Change ◽  
Time Point

11025 Background: Circulating tumor cell (CTC) detection and enumeration is a valuable tool for monitoring cancer patient status and outcome. While many current techniques employ immunomagnetic-enrichment based protocols focused on the importance of a particular CTC number as the indicator of patient status or outcome, we employ a cytometric, enrichment free approach using an immunofluorescent protocol to monitor CTC counts in patients with non-small cell lung cancer (NSCLC) over the course of treatment. Methods: Eligible patients had progressive stage IV NSCLC. The histological subtypes in the 42 cases for which the data was available included adenocarcinoma (22/42), squamous cell carcinoma (6/42), large cell undifferentiated carcinoma (3/42), and non-small cell lung carcinoma not further described, poorly differentiated, or with a mixed pattern (11/42). Blood samples were collected 3 wks, 3 mo, 6 mo, 9 mo, and 1 yr after the initial sample. CTCs were identified via immunofluorescence and cytometric analysis. Patient response to therapy was determined by RECIST every 3 months between time 0 and time 12 mo. Results: 80 of 109 patient samples have CTCs (73%) and all of the 52 patients tested have CTCs. 13 of 52 patients have CTC data for time 0 and 3 wks. Only 4 of these patients (30.8%) show a correlation linking CTC count change between time 0 and 3 wks and clinical assessment. 13 patients have CTC data for time 0 and 3 mo, 10 of whom show a correlation linking CTC count change between time 0 and 3 mo and clinical assessment. 7 of the 8 patients (87.5%) showing stable or partial response at 3 mo show a decrease in CTC count between time 0 and 3 mo. Five of the 6 patients (83.3%) clinically showing progressive disease at the 3 mo time point show an increase in CTC count between time 0 and 3 mo. The patients that do not show a correlation linking CTC count change between time 0 and 3 mo and clinical assessment at 3 mo show a correlation at the 6 mo time point. Conclusions: CTCs can be effectively enumerated in metastatic NSCLC patients, with the majority demonstrating CTCs in the setting of progressive disease. The change in CTC count at 3 mo, but not at 3 wks, correlates with radiographic response to chemotherapy. Further follow-up will determine the predictive value of CTC enumeration on survival. No significant financial relationships to disclose.

scholarly journals The impact of a dedicated physiotherapist clinic for children with dysfunctional breathing

2016 ◽  
Vol 2 (3) ◽  
pp. 00103-2015 ◽  
Author(s):  
Nicola J. Barker ◽  
Heather Elphick ◽  
Mark L. Everard
Keyword(s):  
Quality Of Life ◽  
Long Term Effects ◽  
Time Points ◽  
Significant Difference ◽  
Breathing Retraining ◽  
Dysfunctional Breathing ◽  
The Uk ◽  
The Impact ◽  
Time Point

Dysfunctional breathing is a significant cause of morbidity, adversely affecting an individual's quality of life. There is currently no data from paediatric centres on the impact of breathing retraining for dysfunctional breathing.Symptoms and quality of life were measured in 34 subjects referred sequentially for breathing retraining to the first dedicated paediatric dysfunctional breathing clinic in the UK. Data were obtained prior to the first intervention (time point 1), at discharge (time point 2) and by post 6 months later (time point 3).The mean (interquartile range) age of participants was 13.3 (9.1–16.3) years, with 52% female. Data were obtained at time points 2 and 3 in 23 and 13 subjects, respectively.Statistically significant improvements were observed in symptom scores, child quality of life and parental proxy quality of life between time points 1 and 2 (p<0.0001), while there was no significant difference in the data at time point 3 as compared with time point 2.This study suggests that physiotherapist-led breathing retraining offers significant benefit to young people with dysfunctional breathing which is maintained for at least 6 months after treatment is completed. Future studies will provide more information on the long-term effects of interventions for dysfunctional breathing.

scholarly journals PC3 - 219 Evaluation of delayed FDG-PET in differentiating progressive disease from post-treatment radiation effect in brain tumors

2016 ◽  
Vol 43 (S4) ◽  
pp. S23-S23
Author(s):  
R.A. Harrison ◽  
A. Masood ◽  
O. Mawlawi ◽  
D. Schellingerhout ◽  
B.A. Chasen ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Fdg Pet ◽  
Progressive Disease ◽  
Radiation Effect ◽  
Post Treatment ◽  
Delayed Imaging ◽  
Time Points ◽  
Delayed Time ◽  
Time Point

Traditional and advanced magnetic resonance imaging techniques are often unable to differentiate progressive central nervous system neoplasm from post-treatment radiation effect (PTRE). 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) with delayed imaging has been shown to increase the specificity of PET imaging for cerebral neoplasm in small studies. We sought to further evaluate the potential diagnostic benefits of delayed imaging at 5 hours versus standard imaging at 1 hour to differentiate progressive disease (PD) from PTRE in patients with primary or metastatic brain tumors treated with radiation therapy.Ten patients with primary (n=4) and metastatic (n=6) brain tumors were identified, with diagnostic confirmation of PD or PTRE provided by pathology or>3 month clinical and radiographic follow-up. Maximum standard uptake values (SUV) were calculated for suspicious areas of abnormal contrast enhancement (lesion) and compared to contralateral normal appearing brain (background) at both early and delayed time points. Seven patients were classified as having PD and 3 as having PTRE based pathology or clinical/radiographic follow up. The average lesion to background ratio (L/B) at the early time point (1.16+0.50) was significantly different than L/B for the later time point (1.72+1.10), p=0.030. The mean L/B for PD was 2.17+1.01 at the later time point compared to 0.65+0.06 for PTRE (p=0.010). For the earlier time point, L/B for PD was 1.40+0.42, compared to the L/B for PTRE which was 0.61+0.10 (p=0.003).L/B ratios at early and delayed time points successfully differentiated between patients with PD and PTRE, with significantly greater L/B ratios seen at delayed time points. These initial results are promising and further investigation is underway to evaluate the contribution of delayed imaging in differentiating PD from PTRE.

scholarly journals Quality of reporting on thoracic radiotherapy technique in prospective lung cancer trials

Medicine ◽  
2019 ◽  
Vol 98 (26) ◽  
pp. e16124 ◽  
Author(s):  
Yu Yang Soon ◽  
Desiree Chen ◽  
Teng Hwee Tan ◽  
Jeremy Chee Seong Tey
Keyword(s):  
Lung Cancer ◽  
Thoracic Radiotherapy ◽  
Quality Of Reporting ◽  
Cancer Trials

scholarly journals Longitudinal structural and perfusion MRI enhanced by machine learning outperforms standalone modalities and radiological expertise in high-grade glioma surveillance

2021 ◽  
Author(s):  
Loizos Siakallis ◽  
Carole H. Sudre ◽  
Paul Mulholland ◽  
Naomi Fersht ◽  
Jeremy Rees ◽  
...  
Keyword(s):  
Machine Learning ◽  
Progressive Disease ◽  
High Grade Glioma ◽  
Perfusion Mri ◽  
Svm Classifier ◽  
High Grade ◽  
Time Points ◽  
Group I ◽  
Sensitivity Specificity ◽  
Time Point

Abstract Purpose Surveillance of patients with high-grade glioma (HGG) and identification of disease progression remain a major challenge in neurooncology. This study aimed to develop a support vector machine (SVM) classifier, employing combined longitudinal structural and perfusion MRI studies, to classify between stable disease, pseudoprogression and progressive disease (3-class problem). Methods Study participants were separated into two groups: group I (total cohort: 64 patients) with a single DSC time point and group II (19 patients) with longitudinal DSC time points (2-3). We retrospectively analysed 269 structural MRI and 92 dynamic susceptibility contrast perfusion (DSC) MRI scans. The SVM classifier was trained using all available MRI studies for each group. Classification accuracy was assessed for different feature dataset and time point combinations and compared to radiologists’ classifications. Results SVM classification based on combined perfusion and structural features outperformed radiologists’ classification across all groups. For the identification of progressive disease, use of combined features and longitudinal DSC time points improved classification performance (lowest error rate 1.6%). Optimal performance was observed in group II (multiple time points) with SVM sensitivity/specificity/accuracy of 100/91.67/94.7% (first time point analysis) and 85.71/100/94.7% (longitudinal analysis), compared to 60/78/68% and 70/90/84.2% for the respective radiologist classifications. In group I (single time point), the SVM classifier also outperformed radiologists’ classifications with sensitivity/specificity/accuracy of 86.49/75.00/81.53% (SVM) compared to 75.7/68.9/73.84% (radiologists). Conclusion Our results indicate that utilisation of a machine learning (SVM) classifier based on analysis of longitudinal perfusion time points and combined structural and perfusion features significantly enhances classification outcome (p value= 0.0001).

PedsQL™ and EuroQol Most Responsive Measures To Change in Health-Related Quality of Life in Children with Hodgkin’s Disease.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1320-1320
Author(s):  
Robert J. Klaassen ◽  
Nicholas J. Barrowman ◽  
Ronald D. Barr ◽  
Murray Krahn ◽  
Joanna Hughes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hodgkin's Disease ◽  
Hodgkin’S Disease ◽  
Health Related Quality ◽  
Time Points ◽  
Related Quality ◽  
Health Related ◽  
Time Point

Abstract We evaluated four different health related quality of life measures to determine their ability to detect change over time. The four measures included the Health Utilities Index Mark 2 and 3 (HUI 2/3), the PedsQLTM 4.0 Generic Core and Cancer Module, the EuroQol and the Lansky Play - Performance Scale. Children with Hodgkin’s disease, their parents and the clinic nurse were all asked to complete the four measures at four time points: 2 weeks after the 1st course of chemotherapy, on the 3rd day of the 2nd course of chemotherapy, during the 3rd week of radiation and 1 year after diagnosis. At each follow up time point the respondents were asked to indicate whether the child’s HRQL had improved, stayed the same or became worse since the last measurement. 51 adolescents from 12 centres across Canada were enrolled in the study between May 1, 2002 and March 31, 2005. Two patients were excluded: one patient died shortly after the first time point, and the other patient failed to complete any of the questionnaires. The 49 patients included in the analysis had an average age of 14.7 years (8.9 - 17.9), with the two most common stages being IIA (39%) and IVA (18%). Complete data was available on 92% of patients at time 2, 89% at time 3 and 76% at time 4. Four of the 36 patients with complete follow up had relapsed (11%). The summary scores from the patients responses can be seen in the graph below. Figure Figure All measures showed a significant change between time 1 and time 4 (&lt;0.05). When the change in child scores was analysed between the time points using the child’s self-reported change in HRQL, the PedsQL and the EuroQol showed significant change at all time points. Change in Measures According to Reported Global Rating of Change by Patient Time Period HUI2 HUI3 PedsQL PedsQL cancer EuroQol Lansky Improved 1 to 2, n = 7 0.022 0.011 0.015 0.046 0.001 NS 2 to 3, n = 15 NS NS 0.028 0.039 0.017 NS 3 to 4, n = 20 NS NS 0.011 NS &lt;0.001 &lt;0.001 Same 1 to 2, n = 16 NS NS 0.033 NS NS NS 2 to 3, n = 9 NS NS 0.039 0.006 NS 0.028 3 to 4, n = 1 NS NS NS NS NS NS Worse 1 to 2, n = 6 NS NS NS NS 0.033 NS 2 to 3, n = 0 NS NS NS NS NS NS 3 to 4, n = 1 NS NS NS NS NS NS All of the measures were able to detect change in a diverse group of children with Hodgkin’s Disease. The PedsQL and the EuroQol appeared to be the most sensitive to change.

scholarly journals Thyroid-associated ophthalmopathy; quality of life follow-up of patients randomized to treatment with antithyroid drugs or radioiodine

2010 ◽  
Vol 163 (4) ◽  
pp. 651-657 ◽  
Author(s):  
Mirna Abraham-Nordling ◽  
Göran Wallin ◽  
Frank Träisk ◽  
Gertrud Berg ◽  
Jan Calissendorff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Multicenter Trial ◽  
Antithyroid Drugs ◽  
Time Points ◽  
Sf 36 ◽  
Thyroid Associated Ophthalmopathy ◽  
Design And Methods ◽  
Time Point

ObjectiveThe objective of this study was to investigate quality of life (QoL) in patients with Graves' disease treated with radioiodine or antithyroid drugs.Design and methodsThe design of the study consists of an open, prospective, randomized multicenter trial between radioiodine and medical treatment. A total of 308 patients were included in the study group: 145 patients in the medical group and 163 patients in the radioiodine group. QoL was measured with a 36-item Short Form Health Status Survey questionnaire (SF-36) at six time points during the 48-month study period.ResultsPatient who developed or got worse of thyroid-associated ophthalmopathy (TAO) at any time point during the 4-year study period (TAO group) had lower QoL when no respect was paid to the mode of treatment.TAO occurred in 75 patients who had radioiodine treatment at some time point during the study period as compared with TAO in 40 medically treated patients (P<0.0009).Comparisons between the group of patients who have had TAO versus the group without TAO, in relation to treatments and time, showed significantly decreased QoL scores for the TAO groups at several time points during the study.In patients without TAO, there were no differences in QoL related to mode of treatment.ConclusionsThe QoL in patients with Graves' ophthalmopathy was similar in radioiodine and medically treated patients, but patients who developed or had worsening of TAO had decreased QoL independent of mode of treatment. Furthermore, patients with TAO recovered physically within 1 year but it took twice as long for them to recover mentally.

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