Response Criteria

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STatistically Assigned Response Criteria in Solid Tumors (STARCIST)

STatistically Assigned Response Criteria in Solid Tumors (STARCIST)

FDG-PET is becoming increasingly important as a tool for assessing early treatment effects in clinical trials of novel oncology drugs [1]. To quantify FDG uptake in tumors, clinical trials often employ pre-defined visual scoring systems such as the Deauville criteria in lymph- oma [2], Cheson, 2014 #79 or semi-quantitatively using standardized uptake values (SUVs) [3]. SUVs derived from static FDG-PET scans are used as a practical way to estimate regional glucose metabolism, and imaging protocol guidelines have been proposed to standardize how such scans are performed (e.g. [4]). A key outcome metric is the change in SUV during the treatment course and, for a given patient, this change is typically defined by the relative change from baseline in SUVmax aver- aged across a set of target lesions. Metabolic response assessments are commonly based on the widely used EORTC criteria [5], which define a partial metabolic response (or metabolic progression) as a decrease (increase) in target lesion SUV of >25 % compared to pretreatment baseline, but newer assessment methods have also been proposed [6, 7]. In the present work, we propose a novel, statistically assigned, metabolic response criteria (termed STARCIST) for use with serial FDG-PET. Our method is based on the detailed noise distribution derived from of test-retest data and accounts for multiple target lesions in a rigorous statistical manner.
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Prospective comparison of various radiological response criteria and pathological response to preoperative chemotherapy and survival in operable high grade soft tissue sarcomas in the Japan Clinical Oncology Group study JCOG0304

Prospective comparison of various radiological response criteria and pathological response to preoperative chemotherapy and survival in operable high grade soft tissue sarcomas in the Japan Clinical Oncology Group study JCOG0304

Background: Soft tissue sarcomas (STS) are rare malignant tumors. The efficacy of preoperative chemotherapy for STS is evaluated using various tumor size-based radiological response criteria. However, it is still unclear which set of criteria would show the best association with pathological response and survival of the patients with STS. Methods: We compared radiological responses to preoperative chemotherapy for operable STS by the Response Evaluation Criteria in Solid Tumors (RECIST), modified RECIST, World Health Organization criteria, Japanese Orthopaedic Association criteria, and modified Choi criteria and analyzed the association with pathological response and survival using the data from the Japan Clinical Oncology Group (JCOG) study JCOG0304, a phase II clinical trial evaluating the efficacy of perioperative chemotherapy for STS in the extremities.
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The Disease Activity Score and the EULAR response criteria

The Disease Activity Score and the EULAR response criteria

The DAS is based on an external stan- dard of RA disease activity, and com- bines information from swollen joints, tender joints, the acute phase response and general health into one continuous measure of rheumatoid inflammation (Table I). Response criteria for RA cli- nical trials based on the core set vari- ables were developed by the European League against Rheumatism (EULAR) and the American College of Rheuma- tology (ACR) (5-8). The EULAR re- sponse criteria use the individual change in DAS and the level of DAS reached to classify trial participants as good, moderate or non-responders (7). Des- pite their different constructions, the EULAR response criteria and the ACR improvement criteria were found to be in reasonable agreement in the same set of clinical trials (9).
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Development of sodium fluoride PET response criteria for solid tumours (NAFCIST) in a clinical trial of radium-223 in osteosarcoma: from RECIST to PERCIST to NAFCIST

Development of sodium fluoride PET response criteria for solid tumours (NAFCIST) in a clinical trial of radium-223 in osteosarcoma: from RECIST to PERCIST to NAFCIST

On the basis of the preliminary data presented in the current study, we propose NAFCIST criteria (table 3). NAFCIST could supplant PET/CT functional response by adding metabolic response criteria for bone-forming disease. NAFCIST may represent a more accurate method of categorising osteosarcoma than RECIST, which mainly relies on unidimensional measurements of tumour lesions and the sum of diameters.

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ACR remission criteria and response criteria

ACR remission criteria and response criteria

As additional DMARDs have been added to the armamentarium of rheum- atologists over the last 60 years, the approach to the treatment of rheuma- toid arthritis has changed. Many clin- ical studies now are geared toward evaluating the concept of eradicating inflammation as a method to seek the elusive goal of sustained remission in RA. One of the first descriptions of remission in ‘RA’ was by Short et al in 1948, when he documented the natural progression of the disease. Since that time, various criteria have been devel- oped to define RA remission utilizing clinical, radiographic, and laboratory measures. The most stringent of criteria is the American College of Rheumatol- ogy Remission Criteria, developed in 1980, which consists of clinical symp- toms and signs of inflammation includ- ing fatigue, joint pain, morning stiff- ness, joint tenderness, joint swelling, and erythrocyte sedimentation rate (ESR). Several reports have compared ACR remission criteria to Disease Activity Score (DAS) values to identify equivalent DAS remission values, and these have been extrapolated to modi- fied versions of the DAS, the Simple Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI). The ACR remission criteria and the response measures were not designed for use as the target or goal for the clin- ical management of individual RA patients in routine clinical practice. Nevertheless, rheumatologists yearn for the eradication of inflammation in all RA patients, and attaining remission may be achievable in the future.
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Monitoring anti-PD-1-based immunotherapy in non-small cell lung cancer with FDG PET: introduction of iPERCIST

Monitoring anti-PD-1-based immunotherapy in non-small cell lung cancer with FDG PET: introduction of iPERCIST

Results: This was a retrospective analysis of 28 NSCLC patients treated with nivolumab, a programmed cell death 1 (PD-1) blocker. All patients underwent a PET scan before treatment (SCAN-1) and another scan 2 months later (SCAN-2). Disease progression was assessed by immune PET Response Criteria in Solid Tumors (iPERCIST), which was adapted from PERCIST; and the immune Response Evaluation Criteria in Solid Tumors (iRECIST). iPERCIST is a dual- time-point evaluation of “ unconfirmed progressive metabolic disease ” (UPMD) status at SCAN-2. UPMD at SCAN-2 was re-evaluated after 4 weeks with SCAN-3 to confirm PMD. Patients with complete/partial metabolic response (CMR or PMR) or stable metabolic disease (SMD) at SCAN-2 or -3 were considered responders. Patients with UPMD confirmed at SCAN-3 were considered non-responders. The Kaplan-Meier method was used to estimate survival. At SCAN-2, we found 9/28 cases of PMR, 4/28 cases of SMD, 2/28 cases of CMR, and 13/28 cases of UPMD. Four of the 13 UPMD patients were classified as responders at SCAN-3 (PMR n = 1, SMD n = 3). The remaining nine UPMD patients were classified as non-responders due to clinical degradation, and treatment was stopped. The median follow-up was 16.7 months [3.6 – 32.2]. Responders continued treatment for a mean of 10.7 months [3.8 – 26.3]. Overall survival was longer for responders than that for non-responders (19.9 vs. 3.6 months, log rank p = 0.0003). The 1-year survival rates were 94% for responders and 11% for non-responders. A comparison with iRECIST showed reclassification in 39% (11/28) of patients with relevant additional prognostic information.
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Placebo-Controlled Evaluation of Amphetamine Mixture—Dextroamphetamine Salts and Amphetamine Salts (Adderall): Efficacy Rate and Side Effects

Placebo-Controlled Evaluation of Amphetamine Mixture—Dextroamphetamine Salts and Amphetamine Salts (Adderall): Efficacy Rate and Side Effects

Measurements and Main Results. Efficacy rates were determined by comparing Adderall with placebo during the low-dose crossover sequence and also during the high-dose crossover sequence. The criteria that defined a positive response to Adderall relative to placebo (with each patient serving as their own control) included an indication of response by at least 1 of 2 parent measures of children’s behavior or at least 2 of 5 teacher measures of children’s behavior. The Adderall efficacy rate was determined based on parent criteria alone, teacher crite- ria alone, and by a more stringent definition of response that required concurrence between parent and teacher criteria. The Adderall response rate in this study ranged from 59% when requiring concurrence between parent and teacher observers, to 82% when based on parent criteria alone. Overall, 137 of 154 participants (89%) showed a positive response by either the parent or teacher response criteria.
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Electromechanical Dyssynchrony and Clinically
Silent Ventricular Dysfunction in Young Subjects with
Ventricular Pacing for Congenital and Early Acquired
Av Block

Electromechanical Dyssynchrony and Clinically Silent Ventricular Dysfunction in Young Subjects with Ventricular Pacing for Congenital and Early Acquired Av Block

Classic Pattern of Electromechanical Dyssynchrony This observational study demonstrates that identification of the classic pattern using strain analysis was associated with more significant cardiac dysfunction. In adults with native LBBB, the classic pattern criteria were based on longitudinal strain and designed to represent the consequences of a pathophysiological sequence in which electrical activation delays lead to electromechanical dyssynchrony, systolic dysfunction, and eventually heart failure (Figure 3) [14]. The classic pattern, found in subgroups of various populations with electromechanical dyssynchrony [11, 14, 15, 23- 27], was also identified in 38% of the current ventricular paced young patient cohort having normal cardiac anatomy. In subjects who require lifelong RVP, the classic pattern may help to identify a subgroup at increased risk for more severe dysfunction who may benefit from more frequent echo surveillance. Identification of the classic pattern may also more specifically identify those who will respond to an upgraded biventricular pacing system, but that was not systematically evaluated in this study.
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Unit 9 Progress Check FRQ ANS.pdf

Unit 9 Progress Check FRQ ANS.pdf

The response indicates that the change in entropy between ice, , and water vapor, , is greater because the entropy of water in the solid phase, with molecules bound in fixed positions within the solid, is less than the entropy of water in the liquid phase, with molecules able to move more freely and form a greater number of spatial configurations. Water in the gas phase, with molecules much more dispersed and even more free to move, has the highest entropy of the three phases. Therefore, process 1 (sublimation) involves a greater change in entropy than process 2 (evaporation from a liquid) does.
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Partially exhausted tumor-infiltrating lymphocytes predict response to combination immunotherapy

Partially exhausted tumor-infiltrating lymphocytes predict response to combination immunotherapy

while the presence of liver metastasis has been reported to inversely correlate with response to checkpoint inhibitors in melanoma, non–small cell lung cancer, and recently also in bladder cancer (13, 22). While no correlation with disease stage was observed (Figure 2, A and B), the presence of liver metastasis was associ- ated with reduced percentages of tumor-infiltrating peCTLs (Figure 2, C and D). Elevated LDH levels have been reported to correlate with reduced objective response rates (ORRs) to anti–PD-1 monotherapy (4, 11, 24, 25). Thus, we examined whether there was an association between LDH levels and both peCTL and Treg percentages. Neither of these T cell subsets was associated with elevated LDH (Figure 2, E and F).
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<p>A pooled analysis of transarterial radioembolization with yttrium-90 microspheres for the treatment of unresectable intrahepatic cholangiocarcinoma</p>

<p>A pooled analysis of transarterial radioembolization with yttrium-90 microspheres for the treatment of unresectable intrahepatic cholangiocarcinoma</p>

According to the inclusion and exclusion criteria, 16 eli- gible studies 11 – 26 were identi fi ed that reported the TARE with 90 Y microspheres for unresectable ICC (Figure 1). Five prospective and 11 retrospective studies were included. There were 472 patients included in this pooled analysis. Patient characteristics were presented in Table 1. Extrahepatic metastases were observed in a median of 48.7% (range: 8.7 – 57.9%). A median of 71.9% (range: 0.0 – 100.0%) patients received systemic chemotherapy before TARE with 90 Y microspheres, and a median of 12.3% (range: 7.1 – 28.0%) received postoperative chemotherapy.
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Semiautomated Volumetric Measurement on Postcontrast MR Imaging for Analysis of Recurrent and Residual Disease in Glioblastoma Multiforme

Semiautomated Volumetric Measurement on Postcontrast MR Imaging for Analysis of Recurrent and Residual Disease in Glioblastoma Multiforme

MATERIALS AND METHODS: This retrospective study included patients with native glioblastomas with MR imaging performed at 24 – 48 hours following resection and 2– 4 months postoperatively. 1D and 2D measurements were performed by 2 neuroradiologists with Certificates of Added Qualification. Volumetry was performed by using manual segmentation and computer-assisted volumetry, which combines region-based active contours and a level set approach. Tumor response was assessed by using established 1D, 2D, and volumetric standards. Manual and computer-assisted volumetry segmentation times were compared. Interobserver correlation was determined among 1D, 2D, and volumetric techniques.
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Unit8ProgressCheckFRQ_ANS.pdf

Unit8ProgressCheckFRQ_ANS.pdf

Select a point value to view scoring criteria, solutions, and/or examples and to score the response. If the student uses incorrect results in a later step, the point can be earned for the later step. Note: It is not possible to determine the (or ) in one step because a weak acid is reacting with a strong base, yielding a basic solution. However, it is possible to calculate by imagining that and react completely to form a solution of pure , which then hydrolyzes to form and . From the calculation of , and can be determined.

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Unit 4 FRQ Progress Check ANS.pdf

Unit 4 FRQ Progress Check ANS.pdf

Select a point value to view scoring criteria, solutions, and/or examples and to score the response.... 0 1.[r]

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Unit3ProgressCheckFRQ_ANS.pdf

Unit3ProgressCheckFRQ_ANS.pdf

Select a point value to view scoring criteria, solutions, and/or examples and to score the response.. 0 1.[r]

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Unit 2 FRQ Progress Check ANS.pdf

Unit 2 FRQ Progress Check ANS.pdf

1. For parts of the free-response question that require calculations, clearly show the method used and the steps involved in arriving at your answers. You must show your work to receive credit for your answer. Examples and equations may be included in your answers where appropriate.

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AP Classroom PG Unit 1 KEY.pdf

AP Classroom PG Unit 1 KEY.pdf

2. For parts of the free-response question that require calculations, clearly show the method used and the steps involved in arriving at your answers. You must show your work to receive credit for your answer. Examples and equations may be included in your answers where appropriate.

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All trans retinoic acid (ATRA) plus oxaliplatin plus 5 fluorouracil/leucovorin (FOLFOX) versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controll

All trans retinoic acid (ATRA) plus oxaliplatin plus 5 fluorouracil/leucovorin (FOLFOX) versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial

ratio of TARA + FOLFOX to placebo + FOLFOX and the associated two-sided 95.0% confidence interval will be computed using unadjusted and adjusted Cox pro- portional hazards modeling. Cox models will include treatment stratified by the aforementioned stratification factors, and an adjusted model, which will include a pre-defined list of covariates (described in the next para- graph) and the aforementioned stratification factors, all as covariates. The response rate (CR and PR) will be compared between the two treatments using the chi-square test or Fisher’s exact test. Repeated measures analysis of variance (ANOVA) (if applicable) will be used or the two-group t test/Wilcoxon signed rank test on the difference between the baseline score and the best score in each scale will be used to compare quality of life between the two treatments.
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Evaluation of Pupil Premium

Evaluation of Pupil Premium

As the survey found, schools’ practices for deciding how to target support were variable. The case studies show what appeared to be complex and, apparently, quite sophisticated, practices – and it may well be that schools found it difficult to capture all of their practices in response to the survey questions. The broad definitions of disadvantage used by schools meant that targeting was not simply a matter of identifying children who fell into particular categories. Instead, schools aligned their provision with the apparent needs of pupils in two ways. First, schools tended to take the view that certain kinds of needs were endemic in their populations and that provision to meet these needs should therefore be accessible to many. For instance, one secondary school (NWS1) put considerable emphasis on offering enrichment activities and ensuring that children from poorer families were able to access these, on the grounds that they were offered few activities of this kind in their homes and communities. Another, (ILS1) serving a predominantly minority ethnic and highly disadvantaged area, put a good deal of effort into working with parents and the local community, on the grounds both that many of its pupils’ problems stemmed from their home background and – more positively – that there were untapped resources in the community.
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Unit_7_Progress_Check_FRQ_ANS.pdf

Unit_7_Progress_Check_FRQ_ANS.pdf

Select a point value to view scoring criteria, solutions, and/or examples and to score the response.. 0 1 2.[r]

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