Practical Considerations for the Treatment of an Adrenal Metastasis With Stereotactic Body Radiation Therapy.

The purpose of this paper is to summarize 3 methods for treating adrenal metastases with stereotactic body radiation therapy. This article is not meant to provide consensus guidelines but rather to present 4 practical examples of treatment techniques using different treatment platforms from 3 institutions.

Alliance for clinical trials in Oncology (Alliance) trial A022101/NRG-GI009: a pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur).

BACKGROUND: For patients with liver-confined metastatic colorectal cancer (mCRC), local therapy of isolated metastases has been associated with long-term progression-free and overall survival (OS). However, for patients with more advanced mCRC, including those with extrahepatic disease, the efficacy of local therapy is less clear although increasingly being used in clinical practice. Prospective studies to clarify the role of metastatic-directed therapies in patients with mCRC are needed. METHODS: The Evaluating Radiation, Ablation, and Surgery (ERASur) A022101/NRG-GI009 trial is a randomized, National Cancer Institute-sponsored phase III study evaluating if the addition of metastatic-directed therapy to standard of care systemic therapy improves OS in patients with newly diagnosed limited mCRC. Eligible patients require a pathologic diagnosis of CRC, have BRAF wild-type and microsatellite stable disease, and have 4 or fewer sites of metastatic disease identified on baseline imaging. Liver-only metastatic disease is not permitted. All metastatic lesions must be amenable to total ablative therapy (TAT), which includes surgical resection, microwave ablation, and/or stereotactic ablative body radiotherapy (SABR) with SABR required for at least one lesion. Patients without overt disease progression after 16-26 weeks of first-line systemic therapy will be randomized 1:1 to continuation of systemic therapy with or without TAT. The trial activated through the Cancer Trials Support Unit on January 10, 2023. The primary endpoint is OS. Secondary endpoints include event-free survival, adverse events profile, and time to local recurrence with exploratory biomarker analyses. This study requires a total of 346 evaluable patients to provide 80% power with a one-sided alpha of 0.05 to detect an improvement in OS from a median of 26 months in the control arm to 37 months in the experimental arm with a hazard ratio of 0.7. The trial uses a group sequential design with two interim analyses for futility. DISCUSSION: The ERASur trial employs a pragmatic interventional design to test the efficacy and safety of adding multimodality TAT to standard of care systemic therapy in patients with limited mCRC. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05673148, registered December 21, 2022.

Consideration of Metastasis-Directed Therapy for Patients With Metastatic Colorectal Cancer: Expert Survey and Systematic Review.

BACKGROUND: A survey of medical oncologists (MOs), radiation oncologists (ROs), and surgical oncologists (SOs) who are experts in the management of patients with metastatic colorectal cancer (mCRC) was conducted to identify factors used to consider metastasis-directed therapy (MDT). MATERIALS AND METHODS: An online survey to assess clinical factors when weighing MDT in patients with mCRC was developed based on systematic review of the literature and integrated with clinical vignettes. Supporting evidence from the systematic review was included to aid in answering questions. RESULTS: Among 75 experts on mCRC invited, 47 (response rate 62.7%) chose to participate including 16 MOs, 16 ROs, and 15 SOs. Most experts would not consider MDT in patients with 3 lesions in both the liver and lung regardless of distribution or timing of metastatic disease diagnosis (6 vs. 36 months after definitive treatment). Similarly, for patients with retroperitoneal lymph node and lung and liver involvement, most experts would not offer MDT regardless of timing of metastatic disease diagnosis. In general, SOs were willing to consider MDT in patients with more advanced disease, ROs were more willing to offer treatment regardless of metastatic site location, and MOs were the least likely to consider MDT. CONCLUSIONS: Among experts caring for patients with mCRC, significant variation was noted among MOs, ROs, and SOs in the distribution and volume of metastatic disease for which MDT would be considered. This variability highlights differing opinions on management of these patients and underscores the need for well-designed prospective randomized trials to characterize the risks and potential benefits of MDT.

Flap Reconstruction Results in Longer Overall Treatment Time in Patients Treated with Surgery and Adjuvant Radiotherapy for Carcinoma of the Oral Cavity and Larynx.

OBJECTIVE: There is an inverse relationship between cancer cure and overall treatment time (OTT) in patients treated with surgical resection and radiotherapy (RT). METHODS: OTT was evaluated based on the reconstruction procedure in 420 patients with oral cavity and larynx cancers treated with surgery and RT between 1991 and 2020. RESULTS: With OTT >85 days, the difference between no versus yes flap reconstruction was ~20 percentage points and significant for all comparisons: primary closure (+/- skin graft), 49%, vs. rotation or free flap, 71% (P<0.0001); primary closure (+/- skin graft), 49%, versus free flap without bone, 66% (P=0.0358); and primary closure (+/- skin graft), 49%, versus free flap with bone, 82% (P<0.0001). CONCLUSIONS: The use of flap reconstructions results in substantial increases in OTT. Findings suggest a need to reevaluate current policies regarding the choice of reconstruction and starting RT sooner after surgery.

A phase II study of neoadjuvant liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in pancreatic adenocarcinoma.

For patients with localized pancreatic cancer with minimal vascular involvement, optimal survivability requires a multidisciplinary approach of surgical resection and systemic chemotherapy. FOLFIRINOX is a combination chemotherapy regimen that offers promising results in the perioperative and metastatic settings; however, it can cause significant adverse effects. Such toxicity can negatively impact some patients, resulting in chemotherapy discontinuation or surgical unsuitability. In an effort to reduce toxicities and optimize outcomes, this investigation explores the safety and feasibility of substituting liposomal irinotecan (nal-IRI) for nonliposomal irinotecan to improve tumor drug delivery and potentially reduce toxicity. This regimen, NALIRIFOX, has the potential to be both safer and more effective when administered in the preoperative setting.

For patients with pancreatic cancer with little to no cancer near the blood vessels, the best life expectancy usually requires surgery and chemotherapy. FOLFIRINOX is a chemotherapy medicine that offers promising results for both patients getting surgery and for patients with widespread disease. However, it can cause harmful side effects. The side effects can be so bad that the chemotherapy has to be stopped or that surgery is no longer possible. In order to reduce the harmful side effects and improve outcomes, this investigation looks into the safety and practicality of using a different version of one of the medicines. The different version hopes to improve drug delivery and reduce harmful side effects. This regimen, NALIRIFOX, can be safer and more effective in patients awaiting surgery. Clinical Trial Registration: UF-STO-PANC-004 (NCT03483038) (ClinicalTrials.gov).

National adoption of neoadjuvant chemotherapy: paradigm shift in the treatment of pancreatic cancer.

BACKGROUND: The historical standard of care in treating operable pancreatic cancer via upfront surgery has been challenged recently using a neoadjuvant approach. The aim of the study is to examine the national practice patterns in the management of pancreatic cancer with an emphasis on the trends of neoadjuvant systemic therapy use. METHODS: This is a cross-sectional time-series study using the National Cancer Database from 2006 to 2019. Patients who underwent resection for stage I-II pancreatic adenocarcinoma were selected. RESULTS: Overall, 25% of patients had neoadjuvant chemotherapy, 49% had surgery followed by adjuvant chemotherapy and 26% had surgery alone. The rate of neoadjuvant chemotherapy has increased from 11% in 2006 to 43% in 2019. There was a decrease in the rate of surgery followed by chemotherapy from 48% to 38%, and a decrease in the rate of surgery alone from 41% to 19%. The rate of radiation therapy use has decreased over time, as has the resection rate, while median overall survival has steadily improved over the years. CONCLUSIONS: In 2019, the rate of using neoadjuvant systemic therapy overtook the rate of surgery first followed by adjuvant systemic therapy, marking a pragmatic national shift in the clinical management of pancreatic cancer.

The room where it happens: addressing diversity, equity, and inclusion in National Clinical Trials Network clinical trial leadership.

Many multicenter randomized clinical trials in oncology are conducted through the National Clinical Trials Network (NCTN), an organization consisting of 5 cooperative groups. These groups are made up of multidisciplinary investigators who work collaboratively to conduct trials that test novel therapies and establish best practice for cancer care. Unfortunately, disparities in clinical trial leadership are evident. To examine the current state of diversity, equity, and inclusion across the NCTN, an independent NCTN Task Force for Diversity in Gastrointestinal Oncology was established in 2021, the efforts of which serve as the platform for this commentary. The task force sought to assess existing data on demographics and policies across NCTN groups. Differences in infrastructure and policies were identified across groups as well as a general lack of data regarding the composition of group membership and leadership. In the context of growing momentum around diversity, equity, and inclusion in cancer research, the National Cancer Institute established the Equity and Inclusion Program, which is working to establish benchmark data regarding diversity of representation within the NCTN groups. Pending these data, additional efforts are recommended to address diversity within the NCTN, including standardizing membership, leadership, and publication processes; ensuring diversity of representation across scientific and steering committees; and providing mentorship and training opportunities for women and individuals from underrepresented groups. Intentional and focused efforts are necessary to ensure diversity in clinical trial leadership and to encourage design of trials that are inclusive and representative of the broad population of patients with cancer in the United States.

Tumor volume as a predictor of survival in advanced laryngeal cancer treated with total laryngectomy.

BACKGROUND: Recent literature shows that tumor volume (TV) in T3 laryngeal squamous cell carcinoma (LSCC) is associated with response to radiation therapy. The aim of this study was to evaluate the effect of TV on survival outcomes in patients undergoing total laryngectomy (TL). METHODS: One hundred and seventeen patients with LSCC undergoing TL between 2013 and 2020 at the University of Florida were included. TV was measured using a previously validated method on preoperative-CT scans. Multivariable CoxPH models for overall survival (OS) and disease-specific survival (DSS), metastasis-free survival (MFS), and recurrence-free survival (RFS) were developed with TV. RESULTS: Mean age was 61.5 years and 81.2% were male. Higher TV was associated with decreased OS, MFS, DSS, and RFS with adjusted hazard ratios 1.02 (95%CI: 1.01, 1.03), 1.01, (95%CI: 1.00, 1.03), 1.03 (95%CI: 1.01, 1.06), and 1.02 (95%CI: 1.00, 1.03) respectively. TV >7.1 cc had worse prognoses. CONCLUSIONS: TV appears associated with decreased survival in LSCC treated with TL.

Does lymphovascular invasion predict survival in oral cancer? A population-based analysis.

OBJECTIVE: To evaluate lymphovascular invasion as an independent predictor for overall survival in patients with oral cavity squamous cell carcinoma. STUDY DESIGN: Retrospective cohort study. SETTING: Multi-center, population-based facilities reporting to the National Cancer Database registry. METHODS: The database was accessed to collect data on patients with oral cavity squamous cell carcinoma. A multivariate cox proportional hazards model was used to analyze the association between presence of lymphovascular invasion and overall survival. RESULTS: 16,992 patients met inclusion criteria. 3,457 patients had lymphovascular invasion. The mean follow-up was 32 ± 19 months. Lymphovascular invasion predicted reduced 2-year overall survival (relative hazard 1.29, 95% CI: 1.20, 1.38, p < 0.001) and 5-year overall survival (relative hazard 1.30, 95% CI: 1.23, 1.39, p < 0.001). LVI reduced overall survival in patients with squamous cell carcinoma of the oral tongue (HR: 1.27, 95% CI: 1.17, 1.39, p < 0.001), floor of mouth (HR: 1.33, 95% CI: 1.17, 1.52, p < 0.001) and buccal mucosa (HR: 1.44, 95% CI: 1.15, 1.81, p = 0.001). Patients with lymphovascular invasion treated with surgery plus post-operative radiotherapy had significantly improved survival compared to those who underwent surgery alone (relative hazard 1.79, 95% CI: 1.58, 2.03, p < 0.001), and patients treated with surgery + post-operative chemoradiotherapy had improved survival compared to those treated with surgery alone (relative hazard 2.0, 95% CI: 2.26, 1.79, p < 0.001). CONCLUSION: Lymphovascular invasion is an important independent risk factor for decreased overall survival in oral cavity squamous cell carcinoma involving the oral tongue, floor of mouth and buccal mucosa subsites.

Oligometastatic Colorectal Cancer: A Review of Definitions and Patient Selection for Local Therapies.

PURPOSE: Nearly one-third of patients diagnosed with colorectal cancer (CRC) will ultimately develop metastatic disease. While a small percentage of patients can be considered for curative resection, more patients have limited disease that can be considered for local therapy. Challenges remain in defining oligometastatic CRC as well as developing treatment strategies guided by high level evidence. METHODS: In this review, we present the challenges in defining oligometastatic CRC and summarize the current literature on treatment and outcomes of local therapy in patients with metastatic CRC. RESULTS: For patients with liver- and/or lung-confined CRC metastases, surgical resection is the standard of care given the potential for long-term progression-free and overall survival. For patients with liver- or lung-confined disease not amenable to surgical resection, non-surgical local therapies, such as thermal ablation, hepatic arterial infusion pump (HAIP), or stereotactic body radiation therapy (SBRT), should be considered. For patients with more advanced disease, such as lymph node or bony metastases, the role of metastasis-directed therapy is controversial. Emerging data suggests that SBRT to ablate all metastases can improve progression-free and overall survival. CONCLUSION: Multidisciplinary management is critical for patients with metastatic CRC due to the complexity of their cases and the nuanced patient, tumor, biological, and anatomical factors that must be weighed when considering local therapy. High-quality prospective randomized data in CRC are needed to further clarify the role of local ablative therapy in patients with unresectable oligometastatic CRC with ongoing studies including the RESOLUTE trial (ACTRN12621001198819) and the upcoming NCTN ERASur trial (NCT05673148).

Alliance for Clinical Trials in Oncology (Alliance) trial A022101/NRG-GI009: A pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur).

Background: For patients with liver-confined metastatic colorectal cancer (mCRC), local therapy of isolated metastases has been associated with long-term progression-free and overall survival (OS). However, for patients with more advanced mCRC, including those with extrahepatic disease, the efficacy of local therapy is less clear although increasingly being used in clinical practice. Prospective studies to clarify the role of metastatic-directed therapies in patients with mCRC are needed. Methods: The Evaluating Radiation, Ablation, and Surgery (ERASur) A022101/NRG-GI009 trial is a randomized, National Cancer Institute-sponsored phase III study evaluating if the addition of metastatic-directed therapy to standard of care systemic therapy improves OS in patients with newly diagnosed limited mCRC. Eligible patients require a pathologic diagnosis of CRC, have BRAF wild-type and microsatellite stable disease, and have 4 or fewer sites of metastatic disease identified on baseline imaging. Liver-only metastatic disease is not permitted. All metastatic lesions must be amenable to total ablative therapy (TAT), which includes surgical resection, microwave ablation, and/or stereotactic ablative body radiotherapy (SABR) with SABR required for at least one lesion. Patients without overt disease progression after 16-26 weeks of first-line systemic therapy will be randomized 1:1 to continuation of systemic therapy with or without TAT. The trial activated through the Cancer Trials Support Unit on January 10, 2023. The primary endpoint is OS. Secondary endpoints include event-free survival, adverse events profile, and time to local recurrence with exploratory biomarker analyses. This study requires a total of 346 evaluable patients to provide 80% power with a one-sided alpha of 0.05 to detect an improvement in OS from a median of 26 months in the control arm to 37 months in the experimental arm with a hazard ratio of 0.7. The trial uses a group sequential design with two interim analyses for futility. Discussion: The ERASur trial employs a pragmatic interventional design to test the efficacy and safety of adding multimodality TAT to standard of care systemic therapy in patients with limited mCRC.

Early-stage vocal cord cancer treated with hypofractionated radiotherapy to the larynx with or without concurrent chemotherapy.

BACKGROUND: We report outcomes among patients with T2 and select T3 glottic squamous cell carcinoma (SCC) treated with radiotherapy. METHODS: We reviewed T2 and T3 (only paraglottic space invasion) N0 M0 glottic SCC patients treated with curative-intent hypofractionated larynx radiotherapy, with or without concurrent systemic therapy. RESULTS: Of 71 patients, those who received concurrent chemotherapy (23/71; 32%) had worse prognostic factors, including impaired cord mobility (70% vs. 40%, p = 0.02) and larger median gross tumor volume (3.0 vs. 1.6 cm3 , p = 0.003). Over a median follow-up of 3.8 years, 2-year local control among patients with impaired cord mobility appeared higher for those who received chemotherapy (88% vs. 61%, p = 0.12), but the difference was not statistically significant. Acute and late toxicity rates were not higher among patients who received chemotherapy. CONCLUSIONS: The addition of concurrent platinum-based chemotherapy to hypofractionated larynx radiotherapy among patients with early-stage glottic SCC with impaired cord mobility appears safe and worthy of additional investigation.

Local Therapies in Advanced Colorectal Cancer.

Curative intent surgical resection of colorectal metastases to the liver and lungs in eligible patients results in improved disease control and prolonged overall survival with the potential for cure in a subset of patients. Additional ablative and local therapies for use in the liver, lungs, and other body sites have been developed with emerging data on the utility and toxicity of these treatments. Future studies should focus on identification of appropriate candidates for treatment and determining the optimal modality and timing of treatment accounting for both patient and disease factors.

Retromolar trigone squamous cell carcinoma: A population-based analysis of survival.

OBJECTIVES: To evaluate the difference in overall survival (OS) in patients with retromolar trigone squamous cell carcinoma (RMT SCC) treated with surgery alone versus surgery plus postoperative radiotherapy (PORT) versus surgery plus postoperative chemoradiotherapy (POCRT). MATERIALS AND METHODS: Retrospective cohort study of patients from 1,500 US facilities reporting to the National Cancer Database (NCDB) registry. Participants were adult patients treated with surgery as primary treatment modality for RMT SCC (n = 2,877). Exposures were primary definitive surgery versus surgery + PORT versus surgery + POCRT. Outcomes included OS after diagnosis and treatment of RMT SCC. A multivariate Cox proportional hazards model was constructed to compare survival between the three treatment modalities. Subgroup analysis was performed by T classification and overall staging. RESULTS: There were 1,415 (50%) patients treated with surgery alone, 870 (30%) patients treated with surgery + PORT, and 572 (20%) treated with surgery + POCRT. Treatment with surgery + PORT was associated with improved OS compared to surgery alone (relative hazard: 1.25, 95% CI: 1.01, 1.54, p = 0.042). Patients treated with surgery + POCRT also had improved OS compared with surgery alone (relative hazard: 1.89, 95% CI 1.45, 2.43, p < 0.001). Patients with T3/4 tumors had improved OS when treated with surgery + PORT (relative hazard 1.39, 95% CI: 1.05, 1.84, p = 0.022) or surgery + POCRT (relative hazard 2.27, 95% CI: 1.66, 3.15, p < 0.001). Patients with T1 or T2 disease had no significant difference in survival in both the surgery + PORT (p = 0.331) and surgery + POCRT treatment groups (p = 0.134). Therefore, there was no difference in OS for patients with stage I or II disease treated with surgery + PORT (p = 0.451), nor with surgery + POCRT (p = 0.853). CONCLUSION: Treatment with surgery + PORT +/- chemotherapy appears to be associated with significantly improved OS compared to surgery alone for advanced RMT SCCa.

Body composition measured by bioelectrical impedance analysis is a viable alternative to magnetic resonance imaging in children with nonalcoholic fatty liver disease.

OBJECTIVE: To determine the relationship between bioelectrical impedance analysis (BIA) and magnetic resonance imaging (MRI) obtained measures of body composition in children with nonalcoholic fatty liver disease (NAFLD). METHODS: Youth with obesity and NAFLD who had BIA and abdominal MRI testing were included. BIA measured skeletal muscle mass (SMM), appendicular lean mass (ALM), trunk muscle mass (TMM), and percent body fat. MRI measured total psoas muscle surface area (tPMSA) and fat compartments. Univariate analysis described the relationship between BIA- and MRI-derived measurements. Multivariable regression analyses built a model with body composition measured via MRI. RESULTS: 115 patients (82 (71%) male, 38 (33%) Hispanic, median age14 years) were included. There was a strong correlation between tPMSA and SMM, ALM, and TMM (correlation coefficients [CCs]: 0.701, 0.689, 0.708, respectively; all P < .001). Higher SMM, ALM, and TMM were associated with higher tPMSA. This association remained after controlling for age, sex, ethnicity, type 2 diabetes mellitus status, and body mass index z-score. Total fat mass by BIA and MRI-determined total, subcutaneous, and intraperitoneal fat area correlated significantly (CCs: 0.813, 0.808, 0.515, respectively; all P < .001). In univariate regression, higher total fat mass by BIA was associated with increased total fat area and increased fat in each of the four regions measured by MRI. After controlling for confounders, the association between total fat mass by BIA and total fat area by MRI persisted. CONCLUSIONS: BIA measures of muscle and fat mass correlate strongly with MRI measures of tPMSA and fat areas in children with obesity and NAFLD.

Human Papillomavirus-Negative Oropharyngeal Cancer Survival Outcomes Based on Primary Treatment: National Cancer Database Analysis.

OBJECTIVE: To compare survival outcomes between primary surgery and primary radiation therapy (RT) in patients with human papillomavirus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC). STUDY DESIGN: A retrospective observational cohort study. SETTING: National Cancer Database. METHODS: A National Cancer Database review was conducted of 2635 patients with HPV-negative OPSCC who underwent surgery or RT ± chemotherapy between 2010 and 2014. Univariate analysis was performed on all variables and entered into a multivariate model. The main outcome was overall survival (OS). RESULTS: A total of 2635 patients with HPV-negative OPSCC were organized into 4 groups based on cancer staging. In group 1 (T1-2 N0-1; n = 774), up-front surgery had significantly better 5-year OS (76.2%) than RT (56.8%; adjusted hazard ratio [aHR], 1.76; P = .009; 95% CI, 1.15-2.69) and chemoradiation therapy (CRT; 69.5%; aHR, 1.56; P = .019; 95% CI, 1.08-2.26). In group 2 (T3-4 N0-1; n = 327), no significant difference existed between surgery and CRT (5-year OS, 51.3% vs 52.4%; aHR, 0.96; P = .88; 95% CI, 0.54-1.69). In group 3a (T1-2 N2-3; n = 807), surgery with adjuvant treatment showed significantly better 5-year OS than CRT (78.6% vs 68.8%; aHR, 1.51; P = .027; 95% CI, 1.05-2.18). In group 3b (T3-4 N2-3; n = 737), surgery with adjuvant treatment was not statistically associated with better 5-year OS as compared with CRT (61.0% vs 43.7%; aHR, 1.53; P = .06; 95% CI, 0.98-2.39). CONCLUSION: Primary surgery may provide improved survival outcomes in many cases of HPV-negative OPSCCs. These data should be used in weighing treatment options and may serve as a basis to better delineate treatment algorithms for HPV-negative disease.

Impedance-based measures of muscle mass can be used to predict severity of hepatic steatosis in pediatric nonalcoholic fatty liver disease.

OBJECTIVES: The objective of this study was to investigate the association between measures of body composition based on bioelectrical impedance analysis (BIA) and histologic severity of liver disease in a pediatric cohort with nonalcoholic fatty liver disease (NAFLD). METHODS: This was a cross-sectional study of patients < 20 y old with histologically confirmed NAFLD followed in our Steatohepatitis Center from 2017 to 2019. Contemporaneous body-composition data were obtained using a multifrequency octopolar BIA device (InBody 370, InBody, Seoul, South Korea). BIA data collected were skeletal muscle mass, appendicular muscle mass, and percentage body fat. Skeletal and appendicular muscle mass were corrected for height (dividing by the square of height), generating their respective indices. Univariate linear and logistic regression, followed by multivariable logistic regression analyses, were used. RESULTS: Of the 79 children included (27% female, 73% male; 38% Hispanic; median age, 13 y; median body mass index Z-score, 2.43), the median NAFLD Activity Score was 4 (interquartile range, 3-5). In multivariable regression analyses, the skeletal muscle mass index was negatively associated with hepatic steatosis after controlling for confounders (odds ratio, 0.76; 95% confidence interval, 0.62-0.93). Similarly, the appendicular muscle mass index was negatively associated with severity of hepatic steatosis severity (odds ratio, 0.69; 95% confidence interval, 0.53-0.90). In contrast, percentage body fat was not associated with hepatic steatosis. NAFLD Activity Score, lobular inflammation, ballooning scores, and fibrosis stage were not associated with measures of body composition. CONCLUSIONS: There is an inverse association between BIA-based measures of muscle mass and severity of hepatic steatosis in children with NAFLD. BIA data could further inform clinical decision making in this context.

Development of Food Literacy Assessment Tool Targeting Adults With Low Income.

OBJECTIVE: Develop and test validity and reliability of the Food Literacy Assessment Tool (FLitT) in adults with low income. DESIGN: Face validity was tested using cognitive interviews, content validity using expert review, and internal consistency reliability and test-retest reliability based on 2 administrations of the survey. SETTING: Urban choice food pantry in Cincinnati, OH. PARTICIPANTS: There were 10 and 98 adults with low income for the cognitive interview and survey, respectively VARIABLES MEASURED: Knowledge, self-efficacy, and behavior required to plan and manage, select, prepare, and eat in relation to food. ANALYSIS: Cronbach α and Kuder-Richardson Formula 20 for internal consistency reliability and intraclass correlation coefficient (ICC) for test-retest reliability. RESULTS: Cognitive interviews and expert feedback suggested modifications to improve the clarity of FLitT and offer more response options. Testing shows acceptable internal consistency in self-efficacy (Cronbach α = 0.92) and behavior (Cronbach α = 0.90) but not in knowledge (Kuder-Richardson Formula 20 = 0.51). The FLitT shows acceptable test-retest reliability for knowledge (ICC = 0.84), self-efficacy (ICC = 0.70), and behavior (ICC = 0.93). CONCLUSIONS AND IMPLICATIONS: The FLitT was developed and tested for face and content validity and internal and test-retest reliability in adults with low income. Additional research is needed to conduct a second round of face validity and test construct validity using factor analysis with a larger size.