Low potency of fecal immunological surveillance testing soon after negative colonoscopy or resection of low-risk adenoma in average-risk patients

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Ryusaku Kusunoki ◽  
Hirofumi Fujishiro ◽  
Shinsuke Suemitsu ◽  
Masatoshi Kataoka ◽  
Aya Fujiwara ◽  
...  
2021 ◽  
pp. JCO.20.01372
Author(s):  
Amar Gajjar ◽  
Giles W. Robinson ◽  
Kyle S. Smith ◽  
Tong Lin ◽  
Thomas E. Merchant ◽  
...  

PURPOSE SJMB03 (ClinicalTrials.gov identifier: NCT00085202 ) was a phase III risk-adapted trial that aimed to determine the frequency and clinical significance of biological variants and genetic alterations in medulloblastoma. PATIENTS AND METHODS Patients 3-21 years old were stratified into average-risk and high-risk treatment groups based on metastatic status and extent of resection. Medulloblastomas were molecularly classified into subgroups (Wingless [WNT], Sonic Hedgehog [SHH], group 3, and group 4) and subtypes based on DNA methylation profiles and overlaid with gene mutations from next-generation sequencing. Coprimary study end points were (1) to assess the relationship between ERBB2 protein expression in tumors and progression-free survival (PFS), and (2) to estimate the frequency of mutations associated with WNT and SHH tumors. Clinical and molecular risk factors were evaluated, and the most robust were used to model new risk-classification categories. RESULTS Three hundred thirty eligible patients with medulloblastoma were enrolled. Five-year PFS was 83.2% (95% CI, 78.4 to 88.2) for average-risk patients (n = 227) and 58.7% (95% CI, 49.8 to 69.1) for high-risk patients (n = 103). No association was found between ERBB2 status and PFS in the overall cohort ( P = .74) or when patients were stratified by clinical risk ( P = .71). Mutations in CTNNB1 (96%), DDX3X (37%), and SMARCA4 (24%) were most common in WNT tumors and PTCH1 (38%), TP53 (21%), and DDX3X (19%) in SHH tumors. Methylome profiling classified 53 WNT (17.4%), 48 SHH (15.7%), 65 group 3 (21.3%), and 139 group 4 (45.6%) tumors. A comprehensive clinicomolecular risk factor analysis identified three low-risk groups (WNT, low-risk SHH, and low-risk combined groups 3 and 4) with excellent (5-year PFS > 90%) and two very high-risk groups (high-risk SHH and high-risk combined groups 3 and 4) with poor survival (5-year PFS < 60%). CONCLUSION These results establish a new risk stratification for future medulloblastoma trials.


2020 ◽  
Vol 29 (4) ◽  
pp. 1944-1955 ◽  
Author(s):  
Maria Schwarz ◽  
Elizabeth C. Ward ◽  
Petrea Cornwell ◽  
Anne Coccetti ◽  
Pamela D'Netto ◽  
...  

Purpose The purpose of this study was to examine (a) the agreement between allied health assistants (AHAs) and speech-language pathologists (SLPs) when completing dysphagia screening for low-risk referrals and at-risk patients under a delegation model and (b) the operational impact of this delegation model. Method All AHAs worked in the adult acute inpatient settings across three hospitals and completed training and competency evaluation prior to conducting independent screening. Screening (pass/fail) was based on results from pre-screening exclusionary questions in combination with a water swallow test and the Eating Assessment Tool. To examine the agreement of AHAs' decision making with SLPs, AHAs ( n = 7) and SLPs ( n = 8) conducted an independent, simultaneous dysphagia screening on 51 adult inpatients classified as low-risk/at-risk referrals. To examine operational impact, AHAs independently completed screening on 48 low-risk/at-risk patients, with subsequent clinical swallow evaluation conducted by an SLP with patients who failed screening. Results Exact agreement between AHAs and SLPs on overall pass/fail screening criteria for the first 51 patients was 100%. Exact agreement for the two tools was 100% for the Eating Assessment Tool and 96% for the water swallow test. In the operational impact phase ( n = 48), 58% of patients failed AHA screening, with only 10% false positives on subjective SLP assessment and nil identified false negatives. Conclusion AHAs demonstrated the ability to reliably conduct dysphagia screening on a cohort of low-risk patients, with a low rate of false negatives. Data support high level of agreement and positive operational impact of using trained AHAs to perform dysphagia screening in low-risk patients.


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