Pretreatment Weight Research Articles

6618 Risks for Cardiovascular Comorbidities Associated with Desiccated Thyroid Extract Administration

Abstract Disclosure: S.C. De La Torre: None. C. Godar: None. K. Flynn: None. A.A. Patel: None. D. Maxwell: None. M.K. Shakir: None. T.D. Hoang: None. Introduction: Levothyroxine (LT4), synthetic thyroid hormone (T4), is considered the standard of care for the management of hypothyroidism based on the current American Thyroid Association (ATA) guidelines. However, there is a small subset of patients demonstrating symptomatic improvement with desiccated thyroid extract (DTE), which is composed of desiccated porcine thyroid containing T4 and triiodothyronine (T3). Limited data or studies are available exploring long-term cardiovascular effects associated with DTE use. In this retrospective review, we aim to identify possible cardiovascular comorbidities associated with DTE use. Methods: The charts of 77 patients at a tertiary hospital center (64 females and 13 males) over the age of 18 who were prescribed DTE were reviewed. Data collected include duration of treatment, dose of treatment, pre-treatment and current weight, blood pressure (BP), TSH, free T4, and total T3 levels. New cardiovascular and other events following initiation of treatment (hypertension, coronary artery disease (CAD), myocardial infarction (MI), stroke, transient ischemic attack (TIA), atrial fibrillation, type 2 diabetes, fractures) were also obtained. Averages, medians, and totals of patient data were used for analysis. Results: Average patient age was 54 years, average duration of therapy was 77.5 months, and median DTE dose was 75 milligrams per day. Review of chart documentation from DTE initiation compared to current values identified a 2.5% increase in weight, 3.6% increase in systolic BP, 0.8% decrease in diastolic BP, 60.9% decrease in TSH, 5.2% decrease in free T4, and 14.4% increase in total T3. 19.5% patients (15 total, 80% of which were female) had recorded new cardiovascular events at any time following initiation of therapy. 15 patients developed HTN, 5 developed CAD, 2 developed atrial fibrillation, 5 developed type 2 diabetes, 5 new fractures, 0 MI, 0 stroke, and 0 TIA. Conclusion: These results demonstrate new cardiovascular events in our study population following the initiation of DTE, but it is unclear whether these events were directly associated with DTE use versus other factors based on our available data. Limitations of our study include small study size, uneven gender distribution, and data significance would be improved with comparison to a control group. Additional studies are needed to further evaluate long-term cardiovascular risk factors associated with DTE use. Presentation: 6/2/2024

6488 Factors associated with the response to SGLT2 inhibitors and GLP-1 Receptor Agonists in Veterans with Type 2 Diabetes

Abstract Disclosure: S. Hashmi: None. K. Samson: None. G. Arora: None. S. Azad: None. D. Awad: None. C.V. Desouza: None. Background: SGLT2 inhibitors and GLP1 agonists are recommended as first line pharmacological therapy (along with metformin) for type 2 DM, particularly in patients with CKD, CVD, or HF. Despite their effectiveness, there is limited evidence available to predict which patient subsets will respond favorably to SGLT2 inhibitors or GLP1 agonist. Purpose of study: To determine if baseline characteristics can predict response to therapy and to compare the differences in characteristics between SGLT2 inhibitor and GLP1 agonist groups. Methodology: Retrospective study of veterans ages 19-89 yr with T2DM initiated on treatment from Jan 1, 2015, to Dec 31, 2022, with either SGLT2 inhibitor or GLP 1 agonist for at least 6 months. The cohort comprised 866 patients, of which 544 individuals met the inclusion criteria (332 in the GLP-1 agonist group and 212 in the SGLT2 inhibitor group). Baseline characteristics assessed included age, sex, race, comorbidities, weight, BMI, HbA1c, eGFR, BP and lipids. Treatment response thresholds were defined as an HbA1c reduction of more than 0.5 percentage points and more than 3% of pretreatment weight loss, evaluated 6-12 months after initiating treatment. A complete response was defined as both treatment thresholds being met. Statistical analysis involved Chi-Square tests and independent samples t-test between variables of interest. Logistic regression was conducted with the dichotomous complete response outcome, for variables with bivariate p-values less than 0.10, in addition to variables preselected for inclusion based on the clinical relevance. Results: Three variables were statistically significant in the final logistic regression with complete response outcome. Patients on GLP1 had an increased adjusted odds of having a complete outcome (AOR: 2.45 (95% CI: 1.45, 4.15) relative to patients on SGLT2. In addition, older patients (AOR: 1.34 (95% CI: 1.02, 1.74)) and patients with a higher baseline HbA1c (AOR: 1.18 (95% CI: 1.02, 1.36)) had increased adjusted odds of having a complete response relative to patients 10 years younger and patients with an A1c 1 unit lower, respectively. 72.6% of patients on GLP1 agonists achieved the A1c response goal, in contrast to 48.6% on SGLT2 inhibitors (p < 0.001). Also, 47.6 % of individuals achieved weight loss goals on GLP1 agonist as compared to 41 % on SGLT2 inhibitor. A greater proportion of females (66.7%) achieved the A1c reduction goal compared to males (45.9%) on SGLT2 inhibitors (p = 0.04). Conclusion: Individuals receiving GLP-1 agonists had a twofold increased odds of achieving A1c reduction and weight loss goals after a 6-12 month treatment period compared to those prescribed SGLT2 inhibitors. Older patients and patients with higher baseline A1c levels had greater odds of reaching A1c and weight loss threshold whereas other baseline variables were not significantly associated with the outcome. Presentation: 6/3/2024

Impact of semaglutide and tirzepatide administration on weight in women with stage I-III breast cancer.

e24140 Background: Weight gain and obesity are significant problems for women receiving adjuvant therapy for breast cancer and obesity is associated with adverse breast cancer outcomes. In addition, obesity is associated with negative impact on overall physical and mental health. The GLP-1 agonists, semaglutide (S) and tirzepatide (T), are effective in achieving weight loss and have been associated with decreased incidence of diabetes, stroke and overall mortality in the non-diabetic as well as diabetic populations. There are limited data on the efficacy and safety of GLP1 agonists in women with breast cancer. Methods: We performed a retrospective analysis of the association of S and T use with weight loss in patients with stage I-III breast cancer diagnosed and treated at the Yale Cancer Center/Yale New Haven Health Network between 2017 and 2022. After institutional review board approval, a database including 7149 patients including 92,989 office visits was constructed. Maximal weight loss after S/T prescription as well as mean weight loss were calculated. S and T treated patient’s stage distribution and rates of recurrence were compared to untreated patients. For patients without metastatic disease, repeated measures regression analysis was utilized to evaluate changes in weight and BMI. Results: Of the 5430 evaluable patients with non-metastatic disease, 70 (1.3%) were prescribed S or T. Mean age was 58 (41-78). 74% received endocrine therapy. Mean pretreatment weight was 95.8 kg and BMI was 35.9 kg/m2. Mean weight loss for S/T treated patients was 3.03 kg (3.9-2.13, p < .0001) corresponding to reduction in BMI of 1.1 kg/m2 (0.7-1.5 p < .0001). We also calculated maximal weight loss after S/T prescription. Mean maximal weight loss was 8.89 kg (6.71-10.98 P < .0001) corresponding to a mean maximal reduction in BMI of 3.2 kg/m2 (2.3-4.2 P < .0001). Rates of local, locoregional, and distant breast cancer recurrence were 1.5%, 0%, 1.5% in the S/T treated patients and 1.3%, 4.7% and 3.3% in the untreated patients. None of these differences were statistically significant. Conclusions: In this retrospective analysis, GLP-1 agonist are associated with clinically meaningful weight loss in overweight and obese women with early breast cancer. Recurrence risk did not appear to be preliminarily impacted by treatment. Additional research is needed on long term safety as well as weight loss maintenance with these drugs in breast cancer survivors.

Semaglutide and Tirzepatide for the Management of Weight Recurrence After Sleeve Gastrectomy: A Retrospective Cohort Study.

Metabolic and bariatric surgery (MBS) is the most effective treatment for obesity and improvement of obesity-associated comorbidities. However, a proportion of these patients may suffer from weight recurrence and recurrence of obesity-associated comorbidities. A retrospective cohort study of patients who underwent SG between January 2008 and August 2022 and sought treatment for weight recurrence with semaglutide or tirzepetide from January 2022 onwards. A total of 115 patients were included, of which 70 had SG and treated for weight recurrence with semaglutide and 45 had SG and treated with tirzepatide. The mean age of patients was 38.8 (10.4) and 80.9% of patients were female. The mean pre-treatment weight and BMI was 94.0 (23.8) kg and 35.1 (6.0) kg/m2. Following treatment with semaglutide and tirzepatide, the mean post-treatment weight at 6months was 81.0 (19.0) kg from 90.1 (19.6) kg and 87.6 (28.3) kg from 100.2 (28.5) kg respectively, corresponding to a clinically significant mean weight loss from baseline to 6months of 10.3 (5.9)% (p < 0.05) and 15.5 (6.3)% (p < 0.05). Weight loss in tirzepatide patients was significantly greater than the semaglutide patients at 6months (p < 0.02). There were no reported severe adverse events to the treatment. Short-term outcomes show that semaglutide and tirzepatide can be an effective treatment for managing weight recurrence after SG. Studies with longer follow-up are needed to determine the durability, as weight regain after discontinuation of the medication is highly likely, and the high cost of these medications can limit their use.

Efficacy of a levothyroxine dosage regimen based on serum thyrotropin level, for primary hypothyroidism. An open label dose finding study.

There are no guidelines on individualized initial levothyroxine dosage in primary hypothyroidism. This prospective observational study was done to assess whether a predetermined dose of levothyroxine based on Thyroid Stimulating Hormone (TSH) levels would be able to make the patient euthyroid during a period of six weeks and to find other factors which influence the levothyroxine requirement. Newly diagnosed patients with primary hypothyroidism or those patients who were not on levothyroxine therapy were divided into TSH-based groups-Group 1, 5-9.99, Group 2, 10-29.99, Group 3, 30-99.99 and Group 4, >100 μIU/ml and treated with an initial levothyroxine dose of 25,50,75 and100 μg/day for next six weeks. Factors correlating with levothyroxine requirement were determined. Of the 171 patients who were included 142 completed the study, 34,46,28 and 34 patients were included in groups 1 to 4, respectively. Normalization of TSH with the above criteria was achieved in 111 (78.7%) out of 141 patients, and 91%, 67%, 75%, and 82% respectively in the 4 groups. Among adequately replaced patients pre-treatment TSH level (r = 0.81), T4 level (r = 0.61), and body weight (r = 0.19) correlated with the levothyroxine requirement. Based on these factors predicted initial dose (μg/day) was found to be 0.54 (Body Weight [Kg]) +0.47 (TSH [μIU/m]) - 1.4 (Total T4 [μg/dl]) +17.79 or 0.27 (Body Weight) +0.553 (TSH) +21. Serum thyrotropin-based categorization for initial levothyroxine dose leads to euthyroidism in nearly four of five patients with primary hypothyroidism. The dose required for adequate replacement of levothyroxine has correlation with pre-treatment serum TSH levels serum thyroxine levels and body weight.

Efficacy and safety of a proposed omalizumab biosimilar compared to the reference product in the management of uncontrolled moderate-to-severe allergic asthma: a multicenter, phase III, randomized, double-blind, equivalency clinical trial.

Allergic asthma has a considerable burden on the quality of life. A significant portion of moderate-to-severe allergic asthma patients need omalizumab, an anti-immunoglobulin-E monoclonal antibody, as an add-on therapy. In this phase III clinical trial P043 (Zerafil®, CinnaGen, Iran) efficacy, safety, and immunogenicity were compared with Xolair® (the originator omalizumab). The primary outcome was the rate of protocol-defined asthma exacerbations. Exacerbation rates, Asthma Control Test (ACT) results, spirometry measurements, immunogenicity, and safety were evaluated. Each subject received either medication with a dose ranging from 150 to 375 mg based on pre-treatment serum total IgE level (IU/mL) and body weight (kg) every two or four weeks for a duration of 28 weeks. Exacerbation rates were 0.150 (CI: 0.079-0.220) in the P043 group, and 0.190 (CI: 0.110-0.270) in the omalizumab group (per-protocol). The least squares mean differences of predicted Forced Expiratory Volume in the First second (FEV1) were -2.51% (CI: -7.17-2.15, P=0.29) and -3.87% (CI: -8.79-1.04, P=0.12), pre- and post-bronchodilator use. The mean ± SD of ACT scores at the screening and the last visit were 10.62 ± 2.93 and 20.93 ± 4.26 in P043 and 11.09 ± 2.75 and 20.46 ± 5.11 in the omalizumab group. A total of 288 adverse events were reported for the 256 enrolled participants. Among all, "dyspnea" and "headache" were the most reported ones. The overall incidence of adverse events (P=0.62) and serious adverse events (P=0.07) had no significant differences between the two groups. None of the samples were positive for anti-drug antibodies. P043 was equivalent to omalizumab in the management of asthma in reduction of exacerbations. There was no significant difference in other efficacy and safety parameters. www.clinicaltrials.gov (NCT05813470) and www.IRCT.ir (IRCT20150303021315N20).

Evaluation of weight alteration in patients undergoing orthodontic treatment in KIST dental hospital

Introduction: Fixed orthodontic treatment is the most favored treatment of choice of young individuals nowadays who are motivated by a desire to improve appearance.1 Fixed orthodontic treatment usually takes around 1½ to 3 years for its completion and during this duration many dietary restrictions and modifications are advised.2 The changes in dietary patterns might result in an increase or decrease in weight. This present study is conducted to assess the amount of weight loss in patients undergoing fixed orthodontic treatment. Methods: The height and weight of the study population was measured using stadiometer and digital weighing scale respectively. BMI of each individual was calculated. These measurements were taken three times in the duration of the study; first measurement collected pretreatment, second measurement in 1st follow up after starting of fixed orthodontic treatment and the third measurement will be collected in 2nd follow up i.e. after 2 months. The results were tabulated and analyzed with the Statistical Package for the Social Sciences software (SPSS). The mean changes between different parameters in three visits were compared. Results: When we compared the pretreatment weight and weight at 1st follow up statistically significant difference was observed. Similarly, the difference in pretreatment weight and weight at 3rd follow up was found statistically significant. The difference in pretreatment BMI and BMI at 2nd follow up was statistically not significant. Similarly the difference in pretreatment BMI and BMI at 3rd follow up was also statistically not significant. Conclusion: This study confirms the reduction in weight seen in patients undergoing fixed orthodontic treatment in the first month after initiation of treatment. If the nutritional demand and the intake can be monitored during the treatment, proper health can also be maintained for a long run along with the proper treatment outcome.

Impact of Pretreatment Weight Loss on Radiotherapy Utilization and Clinical Outcomes in Non-Small Cell Lung Cancer.

Cancer cachexia is a syndrome of unintentional weight loss resulting in progressive functional impairment. Knowledge of radiation therapy utilization in patients with cancer cachexia is limited. We evaluated the use of curative and palliative-intent radiation for the management of patients with non-small cell lung cancer (NSCLC) with cachexia to determine whether tumor-directed therapy affected cachexia-associated outcomes. Using an Institutional Tumor Registry, we evaluated all patients with stages of NSCLC treated at a tertiary care system from 2006 to 2013. We adopted the international consensus definition for cachexia, with staging designated by the registry and positron emission tomography. Radiotherapy delivery and intent were retrospectively assessed. In total, 1330 patients with NSCLC were analyzed. Curative-intent radiotherapy was utilized equally between patients with cachexia and non-cachexia with stages I to III NSCLC. Conversely, significantly more patients with stage IV disease and cachexia received palliative radiotherapy versus those without (74% vs 63%, P = 0.006). Cachexia-associated survival was unchanged irrespective of tumor-directed radiation therapy with curative or palliative intent. In fact, pretreatment cachexia was associated with reduced survival for patients with stage III NSCLC receiving curative-intent radiotherapy (median survival = 23.9 vs 15.0 mo, P = 0.009). Finally, multivariate analysis identified pretreatment cachexia as an independent variable associated with worsened survival (hazard ratio = 1.31, CI: 1.14,1.52). Patients with advanced NSCLC with cachexia received more palliative-intent radiation than those without weight loss. Tumor-directed therapy in either a curative or palliative approach failed to alter cachexia patient survival across all stages of the disease. These findings offer critical information on the appropriate utilization of radiation in the management of patients with NSCLC with cachexia.

Male sex and pretreatment weight loss are associated with poor outcome in patients with advanced non-small cell lung cancer treated with immunotherapy: a retrospective study

The influence of sex and body mass index (BMI) on the efficacy of immune checkpoint inhibitors (ICIs) in advanced non-small cell lung cancer (NSCLC) patients remains unclear. We conducted a retrospective study to evaluate the relationship between sex, BMI, pretreatment weight loss (PWL), and clinical outcomes in 399 stage IV NSCLC patients treated with ICIs using data abstracted from medical records. Multivariable Cox proportional hazards models were used to assess the impact on overall survival and progression-free survival. Females were significantly more likely to experience immune-related adverse events and had a significantly lower risk of death compared to males in our patient cohort. In stratified analyses, the latter was limited to those receiving first-line monotherapy. BMI was overall not significantly associated with outcome. However, underweight patients had a significantly higher risk of both progression and death compared to normal weight patients in the first-line monotherapy group. When stratified by sex, underweight males had a significantly higher risk of progression and death compared to normal weight males. This was not observed among females. Those with PWL had overall significantly worse outcomes compared to those without. In stratified analyses, PWL was associated with significantly worse OS in both females and males. Stratified by treatment, the worse outcome was limited to those receiving ICI monotherapy. In summary, utilizing real-world data, this study suggests that male sex, being underweight, and PWL negatively impact ICI efficacy in NSCLC patients. Therapeutic approaches to improve ICI outcomes in underweight patients and those with PWL should be investigated.

Effectiveness and tolerability of liraglutide for the management of weight regain following sleeve gastrectomy.

There is currently very little research evidence on the benefits and safety of liraglutide in the management of weight regain or inadequate weight loss following metabolic and bariatric surgery. This study aimed to determine the clinical effectiveness and tolerability of liraglutide as an adjunct therapy for managing weight regain and inadequate weight loss following sleeve gastrectomy (SG). This was a retrospective analysis of medical records conducted at a private clinic in Kuwait. Data of 57 post-SG patients were included in the analysis. The mean (±SD) pre-treatment weight was 96.12 (29.26) kg. Following a median liraglutide treatment duration of approximately 3months, the mean post-treatment weight was 90.19 (26.82) kg. This represents a statistically significant mean weight loss of 5.94 (6.31) kg (p<0.001), corresponding to a loss of 6.20% of pre-treatment weight. Patients aged 31-40years achieved a greater post-treatment weight loss of 7.63 (7.41) kg, a loss of 7.80%, relative to age groups after treatment (p=0.047). Patients who tolerated ≥2.4mg of liraglutide recorded a higher mean weight loss of 8.42 (7.63) kg, a loss of 8.10% (p=0.010). The use of liraglutide may be an effective adjunct treatment for weight optimization following SG. Maximizing the tolerable dose may yield greater weight reduction.

SP6.2 The Prognostic Impact of Pre-Treatment Cachexia in Patients Undergoing Resectional Surgery for Oesophagogastric Malignancy: A Systematic Review, Meta-Analysis &amp; Meta-Regression

Abstract Background Cancer cachexia is not purely an end-stage phenomenon and even influences the outcome of patients with potentially curative malignancies. This review aims to examine the effect of pre-treatment cachexia on survival in patients undergoing resection of an oesophagogastric malignancy. Methods A systematic literature search of MEDLINE, EMBASE and Cochrane Library databases was conducted, from January 2000 to May 2022, to identify studies reporting the influence of pre-treatment weight loss or cachexia on patients undergoing an oesophagogastric resection for cancer with curative intent. Meta-analyses of the primary (overall survival) and secondary (disease-free survival and postoperative mortality) outcomes were performed using random-effects modelling. Meta-regression was used to examine disease stage as a potential confounder. Results Ten non-randomised studies, comprising 7186 patients, were eligible for inclusion. The prevalence of pre-treatment cachexia was 35% (95% CI: 24-47%). Pooled adjusted hazard ratios found cachexia to be associated with decreased overall survival (HR 1.46, 95% CI: 1.31-1.60, p&amp;lt;0.001). Meta-analysis of proportions confirmed decreased overall survival at 1-, 3- and 5-years in weight-losing cohorts. Pre-treatment cachexia was not a predictor of disease-free survival and further data are required to establish its influence on postoperative mortality. The proportion of patients with T3/4 tumours was a significant moderator of between-study heterogeneity (p=0.018). Cachexia appeared to have a greater effect on overall survival in studies with a higher proportion of locally advanced tumours. Conclusions Pre-treatment cachexia adversely influences overall survival following resection of an oesophagogastric malignancy. Consideration of weight loss, during the shared decision-making process, may improve risk-stratification and facilitate targeted interventions.

Early Improved Functional Outcomes in Head and Neck Cancer Patients with Primary Tumor Detection.

We characterize functional outcomes in head and neck cancer of unknown primary (CUP) based on primary site identification. In this retrospective study, CUP cases were categorized as known primaries (KP) if a tumor was localized after diagnostic workup or persisting unknown primaries (UP). Age, sex, HPV status, diagnostic methods, and treatments regimens were collected. Pretreatment and short-term posttreatment (3-6 months after completion of treatment) weights, PHQ-9, Eating Assessment Tool (EAT-10), and Voice Handicap Index (VHI-10) scores were compared between UP and KP. Among 67 CUP patients, 35 (52.2%) had identified primaries (91.4% oropharyngeal and 8.6% nasopharyngeal). KP patients were younger (58 vs. 64, p = 0.04) and more likely to be HPV-positive (88.6% vs. 50%, p = 0.002). Overall detection rates were 16.7% for PET/CT, 34.7% for direct laryngoscopy, and 46.6% for transoral robotic oropharyngectomy. Diagnostic workup was not significantly different between groups. Patients with KP received smaller intermediate radiation dose volumes (436.5 vs. 278.9 cc, p = 0.03) and lower doses to the cricopharyngeal muscle (41.6 vs. 24.6 Gy, p = 0.03).Pretreatment weights, PHQ-9, EAT-10, and VHI-10 scores did not differ between groups. However, posttreatment, UP had greater relative weight loss (-14.1% vs. -7.6%, p = 0.032), higher EAT-10 scores (12.5 vs. 3, p = 0.004), and higher PHQ-9 scores (6 vs. 1.4, p = 0.017). Specifically, UP reported more stressful swallowing, difficulty swallowing solids and pills, and swallowing affecting public eating. KP patients experienced less weight loss, depression, and reduced swallowing dysfunction, highlighting an early functional benefit of primary tumor identification likely driven by reduced radiation treatment volumes. 4 Laryngoscope, 134:701-707, 2024.

Nutrition assessment reports in oncology clinical trials.

e24142 Background: Malnutrition is common in cancer and associated with greater treatment toxicity and poor clinical outcomes. Validated screening tools can identify individuals at risk; however, they are underutilized in clinical practice. It is also unclear how nutrition status is assessed and reported in oncology clinical trials. We analyzed nutrition assessment protocols in clinical trials published in major US oncology journals. Methods: Three researchers (YA, AA, VS) identified studies published in the Journal of Clinical Oncology, JAMA Oncology, and the New England Journal of Medicine under the “original reports”, “original articles”, or “’ research” categories, respectively (1/1/2022-12/31/2022). We selected studies that reported outcomes of systemic therapeutic interventions in any Phase clinical trial. This included chemotherapy, hormone therapy, and immunotherapy alone or combined with radiation therapy or surgical procedures. Systematic reviews, meta-analyses, commentaries, retrospective studies, and secondary analyses of pooled data from completed trials were excluded. Descriptive statistics summarized how malnutrition risk was assessed and nutrition data reported. Results: 521 articles were reviewed; 153 (29%) studies met eligibility criteria. Most were randomized trials (103/153, 67%) and Phase II or III (126/153, 82%). Malnutrition risk assessment was absent from all studies. Overall, 15/153 (10%) reported either baseline Body Mass Index or pre-treatment weight changes. These variables were included in the survival analysis of 5/15 studies. The primary cancer sites studied were breast (5/15), gynecologic (3/15), hematologic (3/15), multiple sites (2/15), prostate (1/15), and pancreatic (1/15). Conclusions: Most oncology clinical trials ignore and/or underreport nutrition status. Only 10% of the studies reported nutrition status data, and not all cancer sites were represented. There is a need to routinely assess nutrition status and (given the major prognostic value) investigate its potential uses for patient selection and stratification in clinical trials.

Eligibility of patients with esophageal and gastroesophageal cancer for biology-guided radiotherapy in a retrospective cohort.

e16100 Background: Biology-guided radiotherapy (BgRT) is a novel radiotherapy modality that uses real-time positron emission tomography (PET) to guide radiotherapy beamlets. The FDA recently cleared BgRT for clinical use for tumors in lung and bone using 18F FDG radiotracer. We sought to identify esophageal cancer (EC) and gastroesophageal junction cancer (GEJC) patients who may be BgRT candidates based on diagnostic FDG PET/CT imaging. Methods: Through IRB-approved extraction of patient medical record data from an institutional repository of prospectively maintained data, we verified a database of EC and GEJC patients diagnosed at a US tertiary care center between 01/01/2006 and 12/31/2013. When insufficient diagnostic clinical information was present, patients were excluded. Patient and tumor qualities were quantified and subjected to parameters of tumor diameter (≥2cm, &lt;5cm) and maximum standardized uptake value (≥6) to observe potential characteristics of a patient population eligible for this novel BgRT mechanism. Results: Thirty patients met tumor size and FDG uptake criteria for BgRT therapy out of an overall patient cohort of 90 patients. A significantly greater proportion of patients within the BgRT-eligible cohort presented with esophageal tumors (83.3%) compared to non-eligible patients (58.3%, P=0.0177). Otherwise, there was no significant variation of patient sex, race, tumor histology, tumor stage, comorbidity score, and pre-treatment weight loss between patients eligible and not eligible for BgRT therapy. Conclusions: After applying current boundaries of tumor size and radiotracer uptake for effective BgRT intervention, we observed broad applicability of the novel treatment modality across EC/ GEJC patients of varying characteristics and tumor qualities. The high eligibility of patients with tumors located within the esophagus supports further investigation of BgRT in their management. [Table: see text]

Clinical Features of Transient Growth Hormone Deficiency

Background: Most patients with idiopathic growth hormone deficiency (iGHD) in childhood have normal GH stimulation test results in adulthood. The present study aimed to investigate the characteristics and possible etiology of transient iGHD. Methods: Patients with childhood-onset iGHD who completed their GH treatment between March 2010 and March 2021 were retrospectively studied. Patients with a clear history of child abuse or constitutional delay of growth and puberty were excluded. Ten patients with a diagnosis of iGHD based on a decreased growth rate and growth hormone stimulation test findings at the time of onset were included. Retesting demonstrated that these patients had a normal GH level. Results: Five patients had insufficient weight gain (BMI SD score &lt; −1.0 at the start of treatment or a decrease in BMI SD score &gt; 1.0 from one year before treatment to the start of treatment). The other five patients had no remarkable clinical features. One patient had decreased height velocity at the same time as their sibling. Conclusion: Insufficient pre-treatment weight gain or a familial cluster of cases may be related to low GH peaks of GHST, leading to a diagnosis of transient GHD.

Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL)

IntroductionBehavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss...

OGC P38 Prognostic significance of weight loss in patients diagnosed with resectable oesophageal cancer

Abstract Background Weight loss is a common presenting symptom among oesophageal cancer patients. Although tumour volume-associated dysphagia can affect a patient's oral intake, other factors also contribute to weight loss. The aim of this study is to investigate and summarize the existing evidence in regards to the prognostic significance of weight loss in patients undergoing oesophagectomy. Methods The MEDLINE (via PubMed), Cochrane Library, and SCOPUS bibliographical databases were searched by two independent reviewers. Excessive weight loss was defined as more than a 10% decrease from a patient's baseline weight. Original clinical studies, published in English, comparing long term outcomes of resectable oesophageal cancer patients with pre-treatment weight loss of &amp;gt;10% versus 0–10% weight loss were deemed eligible for our study. The primary endpoint of our analysis was 3-year overall survival and disease-free survival. Results Fifteen studies with non-overlapping population reporting on 3271 (1241 reported excessive weight loss (&amp;gt;10%) and 1976 had 0–10% weight loss) patients, met our inclusion criteria. Early recurrence rates between the 2 groups could not be assessed as these were reported in only two of the fifteen studies. Our quantitative analysis demonstrated that patients with resectable oesophageal cancer with &amp;gt;10% weight loss on presentation were associated with significantly lower three-year disease-free and overall survival (OR: 0.80, 95% CI: 0.74 to 0.87, p &amp;lt; 0.01). Conclusions Excessive weight loss at diagnosis is a poor prognostic factor for patients undergoing surgical treatment for resectable oesophageal cancer. It is associated with decreased disease-free and overall survival.

Pretreatment and During-Treatment Weight Trajectories in Black and White Women

Black participants often lose less weight than White participants in response to behavioral weight-loss interventions. Many participants experience significant pretreatment weight fluctuations (between baseline measurement and treatment initiation), which have been associated with treatment outcomes. Pretreatment weight gain has been shown to be more prevalent among Black participants and may contribute to racial differences in treatment responses. The purpose of this study was to (1) examine the associations between pretreatment weight change and treatment outcomes and (2) examine racial differences in pretreatment weight change and weight loss among Black and White participants. Participants were Black and White women (n=153, 60% Black) enrolled in a 4-month weight loss program. Weight changes occurring during the pretreatment period (41 ± 14 days) were categorized as weight stable (±1.15% of baseline weight), weight gain (≥+1.15%), or weight loss (≤-1.15%). Recruitment and data collection occurred from 2011 to 2015; statistical analyses were performed in 2021. During the pretreatment period, most participants (56%) remained weight stable. Pretreatment weight trajectories did not differ by race (p=0.481). At 4-months, those who lost weight before treatment experienced 2.63% greater weight loss than those who were weight stable (p<0.005), whereas those who gained weight before treatment experienced 1.91% less weight loss (p<0.01). Pretreatment weight changes can impact weight outcomes after initial treatment, although no differences between Black and White participants were observed. Future studies should consider the influence of pretreatment weight change on long-term outcomes (e.g., weight loss maintenance) along with potential racial differences in these associations. This study is registered (retrospectively registered) at ClinicalTrials.gov (NCT02487121) on June 26, 2015.

Does Loosening the Inclusion Criteria of the CROSS Trial Impact Outcomes in the Curative-Intent Trimodality Treatment of Oesophageal and Gastroesophageal Cancer Patients?

AimTo determine the efficacy of preoperative chemoradiotherapy as per the CROSS protocol for oesophageal/gastroesophageal junction cancer (OEGEJC), when expanded to patients outside of the inclusion/exclusion criteria defined in the original clinical trial. Materials and methodsData were collected retrospectively on 229 OEGEJC patients referred for curative-intent preoperative chemoradiotherapy. Outcomes including pathological complete response (pCR), overall survival (OS), cancer-specific survival and recurrence-free survival (RFS) of patients who met CROSS inclusion criteria (MIC) versus those who failed to meet criteria (FMIC) were determined. ResultsIn total, 42.8% of patients MIC, whereas 57.2% FMIC; 16.6% of patients did not complete definitive surgery. The MIC cohort had higher rates of pCR, when compared with the FMIC cohort (33.3% versus 20.6%, P = 0.039). The MIC cohort had a better RFS, cancer-specific survival and OS compared with the FMIC cohort (P = 0.006, P = 0.004 and P = 0.009, respectively). Age >75 years and pretreatment weight loss >10% were not associated with a poorer RFS (P = 0.541 and 0.458, respectively). Compared with stage I–III patients, stage IVa was associated with a poorer RFS (hazard ratio (HR) = 2.158; 95% confidence interval (CI) = 1.339–3.480, P = 0.001). Tumours >8 cm in length or >5 cm in width had a trend towards worse RFS (HR = 2.060; 95% CI = 0.993–4.274, P = 0.052). ConclusionOur study showed that the robust requirements of the CROSS trial may limit treatment for patients with potentially curable OEGEJC and can be adapted to include patients with a good performance status who are older than 75 years or have >10% pretreatment weight loss. However, the inclusion of patients with celiac nodal metastases or tumours >8 cm in length or >5 cm in width may be associated with poor outcomes.

Clinical and laboratory parameters associated with rapid progression in advanced NSCLC patients treated with second or third-line single agent immune checkpoint inhibitors (ICIs).

e21087 Background: While laboratory parameters including PDL1 expression and NLR are associated with outcomes in patients with metastatic NSCLC treated with ICIs, these measures have not identified patients with rapid progression (RP) defined as progressive disease within 30 days. Clinical factors including patient age and weight loss have been associated with cancer outcomes in general. Identifying clinical correlates for NSCLC patients who experience RP on ICI therapy would be useful. Methods: The objective of this retrospective study was to evaluate relationships between pre-treatment cachexia and inflammation and RP in NSCLC patients who received 2nd- or 3rd- line single agent ICIs. Associations of age, race, gender, smoking status, and longitudinal changes in weight and NLR (from at least 6 weeks prior to treatment initiation) with RP were analyzed by univariate and multivariate statistical (Kaplan-Meier and related) methods. Results: 195 patients were included: 59% female, 18% Black, and 78% current or former smokers. 14% of patients had RP. Black race was associated with RP (HR = 2.32, p = 0.03). 191 patients had pretreatment weight available. 63% had weight loss prior to ICI, 25% with &gt; 5% loss. Any weight loss and weight loss &gt; 5% over the time period ≥6 weeks prior to treatment initiation were associated with RP (HR = 3.19 and 6.40, p = 0.03 and &lt; 0.01). 188 patients had pretreatment NLR values, 63% and 42% had NLRs &gt; 3.5 and &gt; 5, respectively. Pre-treatment NLR &gt; 5 and higher baseline NLR were associated with increased risk of RP (p = 0.03 and p &lt; 0.01). In multivariate analysis adjusted by age, smoking status and weight change, higher pre-treatment NLR is found to differentially increase RP risk for black patients (interaction HR = 1.27, p = 0.03). A model with these 5 variables provided 84.5% AUC of ROC curve (80% sensitivity, 75% sensitivity) for prognosticating RP. Conclusions: This retrospective study identified clinical variables including pre-treatment NLR &gt; 5, weight loss &gt; 0% &amp; &gt; 5%, black race, smoking status, and age that were associated with RP in previously treated advanced NSCLC patients receiving single agent ICIs. Though this requires validation with racially diverse data sets, these clinical parameters may be useful in identifying patients at high risk of RP on 2nd or 3rd line ICI therapy. Future directions include evaluating clinical characteristics and laboratory parameters in NSCLC patients treated with ICIs combined with chemotherapy and novel immunotherapy regimens, as well as single agent ICIs in the first line setting. If these clinical characteristics are associated with frequent RP in the setting of first line ICI treatment, it would be reasonable to consider novel immune strategies in this patient subset.