An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial.

BACKGROUND: Digital behavioral weight loss programs are scalable and effective, and they provide an opportunity to personalize intervention components. However, more research is needed to test the acceptability and efficacy of personalized digital behavioral weight loss interventions. OBJECTIVE: In a 6-month single-arm trial, we examined weight loss, acceptability, and secondary outcomes of a digital commercial weight loss program (WeightWatchers). This digital program included a personalized weight loss program based on sex, age, height, weight, and personal food preferences, as well as synchronous (eg, virtual workshops and individual weekly check-ins) and asynchronous (eg, mobile app and virtual group) elements. In addition to a personalized daily and weekly PersonalPoints target, the program provided users with personalized lists of ≥300 ZeroPoint foods, which are foods that do not need to be weighed, measured, or tracked. METHODS: We conducted a pre-post evaluation of this 6-month, digitally delivered, and personalized WeightWatchers weight management program on weight loss at 3 and 6 months in adults with overweight and obesity. The secondary outcomes included participation, satisfaction, fruit and vegetable intake, physical activity, sleep quality, hunger, food cravings, quality of life, self-compassion, well-being, and behavioral automaticity. RESULTS: Of the 153 participants, 107 (69.9%) were female, and 65 (42.5%) identified as being from a minoritized racial or ethnic group. Participants' mean age was 41.09 (SD 13.78) years, and their mean BMI was 31.8 (SD 5.0) kg/m2. Participants had an average weight change of -4.25% (SD 3.93%) from baseline to 3 months and -5.05% (SD 5.59%) from baseline to 6 months. At 6 months, the percentages of participants who experienced ≥3%, ≥5%, and ≥10% weight loss were 63.4% (97/153), 51% (78/153), and 14.4% (22/153), respectively. The mean percentage of weeks in which participants engaged in ≥1 aspects of the program was 87.53% (SD 23.40%) at 3 months and 77.67% (SD 28.69%) at 6 months. Retention was high (132/153, 86.3%), and more than two-thirds (94/140, 67.1%) of the participants reported that the program helped them lose weight. Significant improvements were observed in fruit and vegetable intake, physical activity, sleep quality, hunger, food cravings, quality of life, and well-being (all P values <.01). CONCLUSIONS: This personalized, digital, and scalable behavioral weight management program resulted in clinically significant weight loss in half (78/153, 51%) of the participants as well as improvements in behavioral and psychosocial outcomes. Future research should compare personalized digital weight loss programs with generic programs on weight loss, participation, and acceptability.

The Relationship Between How Participants Articulate Their Goals and Accomplishments and Weight Loss Outcomes: Secondary Analysis of a Pilot of a Web-Based Weight Loss Intervention.

BACKGROUND: In behavioral weight loss interventions, participants are asked to set weekly goals to support long-term habits that lead to weight loss. Although participants are asked to set and accomplish weekly goals, we do not know how often they do this and whether doing so is associated with weight loss. Web-based weight loss interventions allow for the analysis of participant engagement data, including how participants articulate their goals and accomplishments. OBJECTIVE: Using engagement data from a web-based weight loss intervention, we examined whether participants articulating their goals and accomplishments in measurable and repeating terms were associated with greater weight loss. METHODS: Adults with overweight or obesity received a 12-week Facebook-delivered weight loss intervention based on the Diabetes Prevention Program Lifestyle Intervention. Participants replied to conversation threads that queried about their goals and accomplishments. Two independent coders classified participants' posts that articulated goals or accomplishments as measurable or repeating. Crude and age-adjusted linear regression models were used to examine the relationship between the frequency of post type and percent weight loss. RESULTS: Participants (N=53; n=48, 91% female; n=48, 91% non-Hispanic White) were on average 46.2 (SD 10.5) years old with a mean BMI of 32.4 (SD 4.8) kg/m2. Over 12 weeks, participants shared a median of 4 (IQR 1-8) posts that reported goals and 10 (IQR 4-24) posts that reported accomplishments. Most participants shared ≥1 post with a goal (n=43, 81%) and ≥1 post with an accomplishment (n=47, 89%). Each post reporting a goal was associated with 0.2% greater weight loss (95% CI -0.3% to 0.0%). Sharing ≥1 post with a repeating goal was associated with an average of 2.2% greater weight loss (95% CI -3.9% to -0.4%). Each post with a repeating goal was associated with an average of 0.5% greater weight loss (95% CI -1.0% to 0.0%). Sharing ≥1 post with measurable and repeating goals was associated with an average of 1.9% greater weight loss (95% CI -3.7% to -0.2%). Sharing each post with an accomplishment was associated with an average of 0.1% greater weight loss (95% CI -0.1% to 0.0%). Every post with an accomplishment that was repeating was associated with an average of 0.2% greater weight loss (95% CI -0.3% to 0.0%). Sharing other types of goals and accomplishments was not associated with weight loss. CONCLUSIONS: In a web-based weight loss intervention, stating goals in repeating or both measurable and repeating terms was associated with greater weight loss, but simply stating them in measurable terms was not. For accomplishments, only those articulated in repeating terms were associated with greater weight loss. Posts about one-time goals and accomplishments represent an opportunity to encourage planning for future behaviors. Future research should examine if stating goals and accomplishments in repeating terms signals habit formation.

The Process of Responding to COVID-19 Misinformation in a Social Media Feed.

Misinformation can undermine public health recommendations. Our team evaluated a 9-week social media campaign promoting COVID-19 prevention to mothers (n = 303) of teen daughters in January-March 2021. We implemented an epidemiological model for monitoring, diagnosing, and responding quickly to misinformation from mothers. Overall, 54 comments out of 1617 total comments (3.3%) from 20 mothers (6.6% of sample) contained misinformation. Misinformation was presented in direct statements and indirectly as hypothetical questions, source derogation, and personal stories, and attributed to others. Misinformation occurred most (n = 40; 74%) in comments on vaccination posts. The community manager responded to 48 (89%) misinformation comments by acknowledging the comment and rebutting misinformation. No mothers who provided misinformation left the Facebook groups and a few commented again (n = 10) or reacted (n = 3) to responses. Only a small number of comments conveyed misinformation. Our quick-response epidemiological protocol appeared to prevent debate and dropout and exposed these mothers to credible information.

Promoting Social Distancing and COVID-19 Vaccine Intentions to Mothers: Randomized Comparison of Information Sources in Social Media Messages.

Background: Social media disseminated information and spread misinformation during the COVID-19 pandemic that affected prevention measures, including social distancing and vaccine acceptance. Objective: In this study, we aimed to test the effect of a series of social media posts promoting COVID-19 nonpharmaceutical interventions (NPIs) and vaccine intentions and compare effects among 3 common types of information sources: government agency, near-peer parents, and news media. Methods: A sample of mothers of teen daughters (N=303) recruited from a prior trial were enrolled in a 3 (information source) × 4 (assessment period) randomized factorial trial from January to March 2021 to evaluate the effects of information sources in a social media campaign addressing NPIs (ie, social distancing), COVID-19 vaccinations, media literacy, and mother-daughter communication about COVID-19. Mothers received 1 social media post per day in 3 randomly assigned Facebook private groups, Monday-Friday, covering all 4 topics each week, plus 1 additional post on a positive nonpandemic topic to promote engagement. Posts in the 3 groups had the same messages but differed by links to information from government agencies, near-peer parents, or news media in the post. Mothers reported on social distancing behavior and COVID-19 vaccine intentions for self and daughter, theoretic mediators, and covariates in baseline and 3-, 6-, and 9-week postrandomization assessments. Views, reactions, and comments related to each post were counted to measure engagement with the messages. Results: Nearly all mothers (n=298, 98.3%) remained in the Facebook private groups throughout the 9-week trial period, and follow-up rates were high (n=276, 91.1%, completed the 3-week posttest; n=273, 90.1%, completed the 6-week posttest; n=275, 90.8%, completed the 9-week posttest; and n=244, 80.5%, completed all assessments). In intent-to-treat analyses, social distancing behavior by mothers (b=-0.10, 95% CI -0.12 to -0.08, P<.001) and daughters (b=-0.10, 95% CI -0.18 to -0.03, P<.001) decreased over time but vaccine intentions increased (mothers: b=0.34, 95% CI 0.19-0.49, P<.001; daughters: b=0.17, 95% CI 0.04-0.29, P=.01). Decrease in social distancing by daughters was greater in the near-peer source group (b=-0.04, 95% CI -0.07 to 0.00, P=.03) and lesser in the government agency group (b=0.05, 95% CI 0.02-0.09, P=.003). The higher perceived credibility of the assigned information source increased social distancing (mothers: b=0.29, 95% CI 0.09-0.49, P<.01; daughters: b=0.31, 95% CI 0.11-0.51, P<.01) and vaccine intentions (mothers: b=4.18, 95% CI 1.83-6.53, P<.001; daughters: b=3.36, 95% CI 1.67-5.04, P<.001). Mothers' intentions to vaccinate self may have increased when they considered the near-peer source to be not credible (b=-0.50, 95% CI -0.99 to -0.01, P=.05). Conclusions: Decreasing case counts, relaxation of government restrictions, and vaccine distribution during the study may explain the decreased social distancing and increased vaccine intentions. When promoting COVID-19 prevention, campaign planners may be more effective when selecting information sources that audiences consider credible, as no source was more credible in general. Trial Registration: ClinicalTrials.gov NCT02835807; https://clinicaltrials.gov/ct2/show/NCT02835807.

Predicting Participant Engagement in a Social Media-Delivered Lifestyle Intervention Using Microlevel Conversational Data: Secondary Analysis of Data From a Pilot Randomized Controlled Trial.

BACKGROUND: Social media-delivered lifestyle interventions have shown promising outcomes, often generating modest but significant weight loss. Participant engagement appears to be an important predictor of weight loss outcomes; however, engagement generally declines over time and is highly variable both within and across studies. Research on factors that influence participant engagement remains scant in the context of social media-delivered lifestyle interventions. OBJECTIVE: This study aimed to identify predictors of participant engagement from the content generated during a social media-delivered lifestyle intervention, including characteristics of the posts, the conversation that followed the post, and participants' previous engagement patterns. METHODS: We performed secondary analyses using data from a pilot randomized trial that delivered 2 lifestyle interventions via Facebook. We analyzed 80 participants' engagement data over a 16-week intervention period and linked them to predictors, including characteristics of the posts, conversations that followed the post, and participants' previous engagement, using a mixed-effects model. We also performed machine learning-based classification to confirm the importance of the significant predictors previously identified and explore how well these measures can predict whether participants will engage with a specific post. RESULTS: The probability of participants' engagement with each post decreased by 0.28% each week (P<.001; 95% CI 0.16%-0.4%). The probability of participants engaging with posts generated by interventionists was 6.3% (P<.001; 95% CI 5.1%-7.5%) higher than posts generated by other participants. Participants also had a 6.5% (P<.001; 95% CI 4.9%-8.1%) and 6.1% (P<.001; 95% CI 4.1%-8.1%) higher probability of engaging with posts that directly mentioned weight and goals, respectively, than other types of posts. Participants were 44.8% (P<.001; 95% CI 42.8%-46.9%) and 46% (P<.001; 95% CI 44.1%-48.0%) more likely to engage with a post when they were replied to by other participants and by interventionists, respectively. A 1 SD decrease in the sentiment of the conversation on a specific post was associated with a 5.4% (P<.001; 95% CI 4.9%-5.9%) increase in the probability of participants' subsequent engagement with the post. Participants' engagement in previous posts was also a predictor of engagement in subsequent posts (P<.001; 95% CI 0.74%-0.79%). Moreover, using a machine learning approach, we confirmed the importance of the predictors previously identified and achieved an accuracy of 90.9% in terms of predicting participants' engagement using a balanced testing sample with 1600 observations. CONCLUSIONS: Findings revealed several predictors of engagement derived from the content generated by interventionists and other participants. Results have implications for increasing engagement in asynchronous, remotely delivered lifestyle interventions, which could improve outcomes. Our results also point to the potential of data science and natural language processing to analyze microlevel conversational data and identify factors influencing participant engagement. Future studies should validate these results in larger trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02656680; https://clinicaltrials.gov/ct2/show/NCT02656680.

A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial.

BACKGROUND: Behavioral weight loss programs typically enroll 12-40 people into groups that then suffer from declining engagement over time. Web-based patient communities, on the other hand, typically offer no limits on capacity and membership is fluid. This model may be useful for boosting engagement in behavioral weight loss interventions, which could lead to better outcomes. OBJECTIVE: In this study, we aimed to examine the feasibility and acceptability of continuously enrolling participants into a Facebook-delivered weight loss intervention for the first 8 of 16 weeks relative to the same intervention where no new participants were enrolled after randomization. METHODS: We conducted a randomized pilot trial to compare a Facebook weight loss group that used open enrollment with a group that used closed enrollment on feasibility and acceptability in adults with BMI 27-45 kg/m2. The feasibility outcomes included retention, engagement, and diet tracking adherence. We described the percentage loss of ≥5% weight in both groups as an exploratory outcome. We also explored the relationship between total volume of activity in the group and weight loss. The participants provided feedback via web-based surveys and focus groups. RESULTS: Randomized participants (68/80, 85% women) were on average, aged 40.2 (SD 11.2) years with a mean BMI of 34.4 (SD 4.98) kg/m2. We enrolled an additional 54 participants (50/54, 93% female) in the open enrollment condition between weeks 1 and 8, resulting in a total group size of 94. Retention was 88% and 98% under the open and closed conditions, respectively. Randomized participants across conditions did not differ in engagement (P=.72), or diet tracking adherence (P=.42). Participant feedback in both conditions revealed that sense of community was what they liked most about the program and not enough individualized feedback was what they liked the least. Weight loss of ≥5% was achieved by 30% (12/40) of the participants randomized to the open enrollment condition and 18% (7/40) of the participants in the closed enrollment condition. Exploratory analyses revealed that the open condition (median 385, IQR 228-536.5) had a greater volume of engagement than the closed condition (median 215, IQR 145.5-292; P=.007). Furthermore, an increase of 100 in the total volume of engagement in the Facebook group each week was associated with an additional 0.1% weekly weight loss among the randomized participants (P=.02), which was independent of time, individual participant engagement, and sociodemographic characteristics. CONCLUSIONS: Open enrollment was as feasible and acceptable as closed enrollment. A greater volume of engagement in the Facebook group was associated with weight loss, suggesting that larger groups that produce more engagement overall may be beneficial. Future research should examine the efficacy of the open enrollment approach for weight loss in a fully powered randomized trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02656680; https://clinicaltrials.gov/ct2/show/NCT02656680.

Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App.

BACKGROUND: Although calorie tracking is one of the strongest predictors of weight loss in behavioral weight loss interventions, low rates of adherence are common. OBJECTIVE: This study aims to examine the feasibility and acceptability of using the Slip Buddy app during a 12-week web-based weight loss program. METHODS: We conducted a randomized pilot trial to evaluate the feasibility and acceptability of using the Slip Buddy app compared with a popular commercial calorie tracking app during a counselor-led, web-based behavioral weight loss intervention. Adults who were overweight or obese were recruited on the web and randomized into a 12-week web-based weight loss intervention that included either the Slip Buddy app or a commercial calorie tracking app. Feasibility outcomes included retention, app use, usability, slips reported, and contextual factors reported at slips. Acceptability outcomes included ratings of how helpful, tedious, taxing, time consuming, and burdensome using the assigned app was. We described weight change from baseline to 12 weeks in both groups as an exploratory outcome. Participants using the Slip Buddy app provided feedback on how to improve it during the postintervention focus groups. RESULTS: A total of 75% (48/64) of the participants were female and, on average, 39.8 (SD 11.0) years old with a mean BMI of 34.2 (SD 4.9) kg/m2. Retention was high in both conditions, with 97% (31/32) retained in the Slip Buddy condition and 94% (30/32) retained in the calorie tracking condition. On average, participants used the Slip Buddy app on 53.8% (SD 31.3%) of days, which was not significantly different from those using the calorie tracking app (mean 57.5%, SD 28.4% of days), and participants who recorded slips (30/32, 94%) logged on average 17.9 (SD 14.4) slips in 12 weeks. The most common slips occurred during snack times (220/538, 40.9%). Slips most often occurred at home (297/538, 55.2%), while working (153/538, 28.4%), while socializing (130/538, 24.2%), or during screen time (123/538, 22.9%). The conditions did not differ in participants' ratings of how their assigned app was tedious, taxing, or time consuming (all values of P>.05), but the calorie tracking condition gave their app higher helpfulness and usability ratings (all values of P<.05). Technical issues were the most common type of negative feedback, whereas simplicity was the most common type of positive feedback. Weight losses of ≥5% of baseline weight were achieved by 31% (10/32) of Slip Buddy participants and 34% (11/32) of calorie tracking participants. CONCLUSIONS: Self-monitoring of dietary lapses and the contextual factors associated with them may be an alternative for people who do not prefer calorie tracking. Future research should examine patient characteristics associated with adherence to different forms of dietary self-monitoring. TRIAL REGISTRATION: ClinicalTrials.gov NCT02615171; https://clinicaltrials.gov/ct2/show/NCT02615171.

Inflammatory reaction to BioGlue™ masquerading as recurrence in patients with endometrial cancer: A report of two cases.

•BioGlue™, a glutaraldehyde-based vessel sealant, can cause a foreign body reaction.•Vessel sealants may be used for IVC repair during endometrial cancer staging.•Foreign body reaction to BioGlue™ may look like a cancer recurrence on imaging.•It is important to note prior use of vessel sealants in assessing paraaortic recurrence.

Blastic variant of plasma cell myeloma mimicking squamous cell carcinoma of the uterine cervix in a super-morbidly obese female.

•Plasmablastic plasma cell myelomas of the cervix can mimic the more common cervical squamous cell carcinoma.•It can be difficult to differentiate plasmablastic lymphoma of the cervix from cervical plasmablastic plasma cell myeloma.•The clinician must rely on clinical, laboratory, and radiologic findings to diagnose genital plasma cell myeloma.•Prompt diagnosis of this rare clinical condition can potentially allow timely treatment with systemic chemotherapy.

A comparison of perinephric fat surface area and Mayo Adhesive Probability score in predicting malignancy in T1 renal masses.

INTRODUCTION: Recent studies have proposed that nearby fat deposits may have metabolic influence on kidney cancer pathobiology. Both fat quantity and quality may play unique roles in this complex relationship. As such, we investigated whether perinephric fat surface area (PFA), a quantitative measure of fat, or Mayo Adhesive Probability (MAP) score, a qualitative measure, were predictive of malignant pathology or Fuhrman grade in small renal masses. METHODS: A total of 317 patients undergoing minimally invasive partial nephrectomy between 2010 and 2016 for renal masses were retrospectively reviewed. Preoperative abdominal CT and MRI scans were measured for PFA and MAP scores. Multiple binary logistic regression models were created to identify predictive factors of malignant disease and Fuhrman grade. RESULTS: A total of 253 patients had malignant masses, while 64 had benign masses. A total of 189 of the malignant masses were T1a, while 64 were designated T1b. A total of 221 patients with malignant masses had reported Fuhrman grades. Of these 211 patients, 143 (64.7%) had low-grade and 78 (35.3%) had high-grade disease. Mean PFA was 18.0 ± 13.3 cm2, while mean MAP score was 2.6 ± 1.2. Binary logistic regression analysis yielded three variables in the best-fit model for predictors of malignant pathology: MAP score (OR = 1.374, 95% CI: 1.007-1.873, P = 0.045), male sex (OR = 2.058, 95% CI: 1.004-4.218, P = 0.049), and BMI (OR = 1.064, 95% CI: 0.998-1.135, P = 0.059). Neither MAP nor PFA was predictive of Fuhrman grade. CONCLUSIONS: MAP score, a measure of perinephric fat quality, but not PFA, a qualitative measure of fat quantity, was predictive of malignant pathology, raising the question whether fat quality rather than quantity may be involved in the pathophysiology of RCC in a large and diverse patient population. Understanding the increasing burden of obesity, further studies are needed to elaborate on these findings and to discern the exact relationship between perinephric fat deposits and renal tumorigenesis.

Enterococcus hirae Bacteremia Associated with Acute Pancreatitis and Septic Shock.

Infection with Enterococcus hirae has rarely been reported in humans but is not uncommon in mammals and birds. We describe a case of Enterococcus hirae bacteremia associated with acute pancreatitis, acute cholecystitis, and septic shock responsive to antibiotic therapy and supportive critical care management. Unique aspects of this case of Enterococcus hirae bacteremia are its association with acute pancreatitis and its geographical origin. To our knowledge, this is the first report of Enterococcus hirae bacteremia occurring in a patient in the United States. Although human infection with this organism appears to be rare, all cases reported to date describe bacteremia associated with severe and life-threatening illness. Thus, physicians need to be cognizant of the clinical significance of this heretofore little recognized pathogen.

The visceral fat compartment is independently associated with changes in urine constituent excretion in a stone forming population.

The objective of this study was to identify the independent effect of visceral fat on urine constituent excretion in a stone forming population. Using a database of 382 kidney stone patients with available visceral fat quantification, we created multiple linear regression models predicting changes in urinary solutes based on visceral fat area and body mass-index, divided by gender. Chi-square tests were used to compare stone composition by body mass-index and visceral fat area. Visceral fat predicts increases in urinary creatinine, sodium, and volume in men, but only urinary phosphate in women. In women, total body mass-index does not appear to modify this effect, but in men it is more pronounced in overweight patients for creatinine and volume only. Elevated visceral fat is associated with increased probability of uric acid stone composition. Different fat compartments likely effect urine composition in different ways. This effect appears to be different in men and women. Understanding and quantifying the effects of different fat compartments is probably important to understanding the metabolism of urolithiasis.

Effects of visceral fat area and other metabolic parameters on stone composition in patients undergoing percutaneous nephrolithotomy.

PURPOSE: Obesity is a risk factor for metabolic syndrome and urolithiasis, particularly uric acid stones. As estimated by visceral fat area, visceral obesity is a more specific measure of the risk of metabolic syndrome than body mass index. We investigated the effects of visceral fat area and other metabolic factors on uric acid stone formation in patients treated with percutaneous nephrolithotomy. MATERIALS AND METHODS: We retrospectively reviewed the records of 269 patients who underwent percutaneous nephrolithotomy. Visceral fat area was measured in each patient on a CT axial slice at the umbilical level using the Aquarius iNtuition fat analysis tool. Analysis was performed to determine the effect of visceral fat area and other comorbidities on uric acid stone formation. RESULTS: Of the 269 patients analyzed there was no difference in baseline comorbidities between uric acid and nonuric acid stone formers. Patients with uric acid stones had a significantly higher mean visceral fat area (209.3 vs 161.9 cm², p = 0.001), and rates of hypertension (67.4% vs 47.3%) and coronary artery disease (14.3% vs 4.6%, each p = 0.011). On logistic regression analysis hypertension (OR 2.16, 95% CI 1.05-4.45, p = 0.04) and a high visceral fat area (OR 3.64, 95% CI 1.22-10.85, p = 0.02) were independent risk factors for uric acid stones. CONCLUSIONS: As a marker of visceral obesity, visceral fat area contributes to the risk of metabolic syndrome and urolithiasis. Uric acid stone formers showed a significantly higher hypertension rate and mean visceral fat area, which were independent risk factors for uric acid urolithiasis. Evaluating these characteristics in stone formers may facilitate a tailored metabolic assessment and treatment plan.

Targeting the local tumor microenvironment with vaccinia virus expressing B7.1 for the treatment of melanoma.

Immunotherapy for the treatment of metastatic melanoma remains a major clinical challenge. The melanoma microenvironment may lead to local T cell tolerance in part through downregulation of costimulatory molecules, such as B7.1 (CD80). We report the results from the first clinical trial, to our knowledge, using a recombinant vaccinia virus expressing B7.1 (rV-B7.1) for monthly intralesional vaccination of accessible melanoma lesions. A standard 2-dose-escalation phase I clinical trial was conducted with 12 patients. The approach was well tolerated with only low-grade fever, myalgias, and fatigue reported and 2 patients experiencing vitiligo. An objective partial response was observed in 1 patient and disease stabilization in 2 patients, 1 of whom is alive without disease 59 months following vaccination. All patients demonstrated an increase in postvaccination antibody and T cell responses against vaccinia virus. Systemic immunity was tested in HLA-A*0201 patients who demonstrated an increased frequency of gp100 and T cells specific to melanoma antigen recognized by T cells 1 (MART-1), also known as Melan-A, by ELISPOT assay following local rV-B7.1 vaccination. Local immunity was evaluated by quantitative real-time RT-PCR, which suggested that tumor regression was associated with increased expression of CD8 and IFN-gamma. The local delivery of vaccinia virus expressing B7.1 was well tolerated and represents an innovative strategy for altering the local tumor microenvironment in patients with melanoma.

Treatment of pediatric ocular melanoma with high-dose interleukin-2 and thalidomide.

Uveal melanoma is the most common primary ocular malignancy, although it is rare in children, and patients presenting with metastatic disease have a median survival of only 2 to 5 months. The tumor is generally unresponsive to systemic chemotherapy, but immunotherapy may be effective in selected patients. This report describes an 8-year-old girl with metastatic uveal melanoma treated with high-dose, bolus interleukin-2 (IL-2) and the antiangiogenic agent thalidomide. She tolerated treatment well and initially responded with stable disease in the liver and pancreas for 23 months. New pulmonary metastases developed and she was re-treated with high-dose IL-2, resulting in regression of her liver lesions and stable pulmonary disease for more than 18 months. These results suggest that IL-2 at high doses, and in combination with thalidomide, may be useful for uveal melanoma with tolerable side effects in children. Further study of this combination in children with immune-responsive tumors is warranted.