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Efficacious ventricular assist device (VAD) support in pediatric patients depends on successful antithrombotic management. The experience with antithrombotic management for the EXCOR Pediatric VAD Investigational Device Exemption (IDE) study is described. All 68 children in North America enrolled in the IDE study from May 9, 2007 to December 10, 2010 are included. The Edmonton Anticoagulation and Platelet Inhibition Protocol was provided for management guidance. Monitoring parameters, drug dosing, targeted serious adverse events, and pump changes were reviewed. Major bleeding occurred in 43% of all subjects with most events occurring within 14 days of implantation. Bleeding events were probably/definitely related in 24% to antithrombotic management. Neurologic events occurred in 28% of subjects and were probably/definitely related in 9% to antithrombotic therapy intensity. Most neurologic events occurred between 4 and 30 days postimplantation and sporadically thereafter. Pump change occurred in 56% of subjects. Use of an antithrombotic protocol for enrolled subjects was possible in this multicenter study. Incidence of significant bleeding and thromboembolic events was acceptable when balanced against life-saving benefits of VADs. Further studies are needed to optimize the antithrombotic management of this patient population.

Objective: To review and assess the ideal length of electrode in cochlear implant patients for hearing preservation. Methods: The English language literature was reviewed for studies including hearing preservation and speech understanding for electrodes of different lengths. Results: One prospective trial was found, and there were no studies that randomized patients into different length electrodes with an intent to preserve hearing. Eight studies total included multiple length electrodes and contained data regarding hearing preservation. Conclusions: Although there is some evidence that indicates that shorter electrodes may improve both short and long-term hearing preservation rates in cochlear implant patients, no study has directly compared implant length on hearing preservation in a similar patient population. A randomized trial of short and standard length electrodes for hearing preservation is warranted. In the interim, utilization of current electrodes measuring 20â25Â mm could seem to be a prudent approach when seeking to preserve residual hearing without unduly compromising cochlear coverage. Keywords: Electrode, Length, Hearing preservation, Cochlear implantation

BACKGROUND: Mechanically ventilated patients often need bronchodilators administered via a metered-dose inhaler (MDI). Unfortunately, there are no data examining the impact of shared canister delivery of MDI therapy in mechanically ventilated patients. METHODS: A prospective trial was conducted with subjects assigned to shared canister MDI therapy or single-patient canister MDI therapy. Outcomes assessed were occurrence of ventilator-associated pneumonia (VAP), hospital mortality, length of stay, ventilator-associated events, and MDI costs. RESULTS: Among 486 screened patients, 353 were included for analysis of which 201 (56.9%) received shared canister MDI therapy and 152 (43.1%) received single-patient canister therapy. VAP (7.0% vs 4.6%, P = .35), hospital mortality (21.9% vs 20.4%, P = .73), and ventilator days (median [interquartile range] 3.1 [0.9–7.5] d vs 2.7 [1.2–7.1] d, P = .62) were similar between the shared canister and single-patient canister groups. We did not observe clinically important differences for ventilator-associated events between study groups in our logistic regression analysis ( P = .07). There was a savings of $217/subject in the shared canister group due to the use of 299 fewer MDIs. CONCLUSIONS: Our study found that shared canister MDI therapy compared with single-patient MDI use was associated with a significant cost savings and similar rates of VAP, hospital mortality, and length of stay but a greater prevalence of ventilator-associated events. This finding suggests that shared canister delivery of MDIs may be a cost-effective practice in mechanically ventilated patients. Based on our findings, further studies examining the overall safety of shared canister use in mechanically ventilated patients seem warranted before recommending their routine use. (ClinicalTrials.gov registration [NCT01935388][1].) [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01935388&atom=%2Frespcare%2F61%2F10%2F1285.atom

Special blue fluorescent tubes are recommended by the American Academy of Pediatrics (AAP) as the most effective light source for lowering serum bilirubin. A high-intensity light-emitting diode ('super LED') could render intensive phototherapy more effective than the above conventional methods. This study compared the efficacy and safety of a high-intensity light-emitting diode bed vs conventional intensive phototherapy with triple fluorescent tube units as a rescue treatment for severe unconjugated neonatal hyperbilirubinaemia.This was a randomised, prospective trial. Two hundred jaundiced neonates ≥ 35 weeks gestation who met the criteria for intensive phototherapy as per AAP guidelines were randomly assigned to be treated either with triple fluorescent tube units (group 1, n = 100) or a super LED bed (group 2, n = 100). The outcome was the avoidance of exchange transfusion by successful control of hyperbilirubinaemia.Statistically significant higher success rates of intensive phototherapy were achieved among neonates treated with super LED (group 2) than in those treated conventionally (group 1) (87% vs 64%, P = 0.003). Significantly higher 'bilirubin decline' rates were reported in both haemolytic and non-haemolytic subgroups treated with the super LED bed compared with a similar sub-population in the conventionally treated group. Comparable numbers of neonates in both groups developed rebound jaundice (8% vs 10% of groups 1 and 2, respectively). Side-effects were mild in both groups, but higher rates of hyperthermia (12% vs 0%, P = 0.03), dehydration (8% vs 2%, P = 0.26) and skin rash (39% vs 1%, P = 0.002) were reported in the fluorescent tubes-treated group compared with the LED group.Super LED is a safe rescue treatment for severe neonatal hyperbilirubinaemia, and its implementation may reduce the need for exchange transfusion.

Despite evidence from prospective trials and meta-analyses supporting laparoscopic pyloromyotomy (LP) over open pyloromyotomy (OP), the open technique is still utilized by some surgeons on the premise that there is minimal clinical benefit to LP over OP. Although the potential cosmetic benefit of LP over OP is often cited in reports, it has never been objectively evaluated.After internal review board approval, the parents of patients from a previous prospective trial who had undergone LP (n = 9) and OP (n = 10) were contacted. After consent was obtained, the parents and patients were asked to complete a validated scar scoring questionnaire that was compared between groups. Standardized photos were taken of study subjects and controls with no abdominal procedures. Blinded volunteers were recruited to view the photos, identify if scars were present, and complete questions if a scar(s) was seen. Volunteers were also asked about the degree of satisfaction if their child had similar scars on a four-point scale from happy to unacceptable.Mean age was 7 years in both groups. Parental scar assessment scores were superior in the LP group in every category. Blinded volunteers detected abdominal scars significantly more often in the OP group (98%) vs. the LP group (28%; P .001). The volunteers detected a scar in 16% of the controls, comparable to the 28% detected in the LP group (P = .17). The degree of satisfaction estimate by volunteers was 1.78 for OP and 1.02 for LP and controls, generating a Cohen's d effect size of 5.1 standard deviation units comparing OP to either LP or controls (very large ≥1.3).Parents of children scored LP scars superior to OP scars. Surgical scars are almost always identifiable with OP while the surgical scars associated with LP approach invisibility to the observer, appearing similar to patients with no prior abdominal operation.

OBJECTIVE: To assess the association of cervical effacement with the rate of intrapartum cervical change among nulliparous women. METHODS: We conducted a secondary analysis of a prospective trial of intrapartum fetal pulse oximetry. For women who had vaginal deliveries, interval-censored regression was used to estimate the time to dilate at 1-cm intervals. For each given centimeter of progressive cervical dilation, women were divided into those who had achieved 100% cervical effacement and those who had not. The analysis was performed separately for women in spontaneous labor and those who were given oxytocin. RESULTS: A total of 3,902 women were included in this analysis, 1,466 (38%) who underwent labor induction, 1,948 (50%) who underwent labor augmentation (combined for the analysis), and 488 (13%) who labored spontaneously. For women in spontaneous labor, the time to dilate 1 cm was shorter for those who were 100% effaced starting at 4 cm of cervical dilation (P=.01 to

The utility of the focused assessment with sonography for trauma (FAST) examination in children is unknown.To determine if the FAST examination during initial evaluation of injured children improves clinical care.A randomized clinical trial (April 2012-May 2015) that involved 975 hemodynamically stable children and adolescents younger than 18 years treated for blunt torso trauma at the University of California, Davis Medical Center, a level I trauma center.Patients were randomly assigned to a standard trauma evaluation with the FAST examination by the treating ED physician or a standard trauma evaluation alone.Coprimary outcomes were rate of abdominal computed tomographic (CT) scans in the ED, missed intra-abdominal injuries, ED length of stay, and hospital charges.Among the 925 patients who were randomized (mean [SD] age, 9.7 [5.3] years; 575 males [62%]), all completed the study. A total of 50 patients (5.4%, 95% CI, 4.0% to 7.1%) were diagnosed with intra-abdominal injuries, including 40 (80%; 95% CI, 66% to 90%) who had intraperitoneal fluid found on an abdominal CT scan, and 9 patients (0.97%; 95% CI, 0.44% to 1.8%) underwent laparotomy. The proportion of patients with abdominal CT scans was 241 of 460 (52.4%) in the FAST group and 254 of 465 (54.6%) in the standard care-only group (difference, -2.2%; 95% CI, -8.7% to 4.2%). One case of missed intra-abdominal injury occurred in a patient in the FAST group and none in the control group (difference, 0.2%; 95% CI, -0.6% to 1.2%). The mean ED length of stay was 6.03 hours in the FAST group and 6.07 hours in the standard care-only group (difference, -0.04 hours; 95% CI, -0.47 to 0.40 hours). Median hospital charges were $46 415 in the FAST group and $47 759 in the standard care-only group (difference, -$1180; 95% CI, -$6651 to $4291).Among hemodynamically stable children treated in an ED following blunt torso trauma, the use of FAST compared with standard care only did not improve clinical care, including use of resources; ED length of stay; missed intra-abdominal injuries; or hospital charges. These findings do not support the routine use of FAST in this setting.clinicaltrials.gov Identifier: NCT01540318.

Aim:To observe and assess whether TKI can be de-escalated or discontinued without occurrence of molecular relapse in CML patients,who with continuous effective TKI over 5 years and maintain MR4.5(BCR-ABLIS≤0.0032%) at least 18 months. Methods: In this study,we conducted half standard TKI dose or discontinued treatment in patients with CML who were aged 18 years and older and duration effective TKI treatment at least 5 years,duration MR4.5 monitored by quantitative polymerase chain reaction(Q-PCR) in recent 18 months.Blood concentration and immune function were also monitored.Molecular relapse was defined as loss of MMR(BCR-ABLIS>0.1%), these patients restore the original dose at once. Results: 44 patients were enrolled between Jan 2016,and Jun 2019,35 in de-escalation group and 9 in discontinue group.In the de-escalation group,45.7% males,median age was 48(23-75) years,valid TKI therapy duration 84(60-204) months,and median sustained MR4.5 was 25(19-160) months.Follow-up 1 year,5(14.3%) of these 35 patients occurrence of molecular relapsed(3 before 6 months,one at month 8, one at month 9),all of them showed decreases in their BCR-ABL levels after reintroduction of original TKI dose.In the discontinue arm,55.6% males,the age ranged from 28 to 56,the median effective TKI treatment was 72(60-108) months and remained of MR4.5 was 36(18-72) months.Molecular recurrence-free events were 66.7% at 12 months,3 patients relapsed events occurred in discontinuous month 1,month 6 and month 12,respectively.All of them showed great reaction when treatment was restarted.Supervised patients blood concentration between standard treatment group and half-dose group,founded half-dose group was lower than standard group(1083.61±371.80ng/ml vs. 1622.28±771.36ng/ml ,P=0.000).The immune function of the relapse and non-relapse arm was observed,in relapsed group the proportion of CD3-/CD56+ cells was declined significantly(P=0.013). Conclusions: Treatment-free remission(TFR) has become the main therapeutic target for CML patients. With 85.7% TFR in 12 months follow-up after de-escalation TKI treatment ,our study demonstrates that de-escalated TKI would suitable for Chinese CML patients who with a sustained deep molecular response.The vivo insufficient of drug concentration and the damaged of NK cells may cause the recurrence events. Disclosures No relevant conflicts of interest to declare.

INTRODUCTION Achieving durable local control for larger brain metastases remains problematic. Resection (R) alone is typically insufficient. Even with the addition of stereotactic radiation the 12-month recurrence rate for larger lesions (i.e., >2.5–3 cm) is 20% or more in many series. To improve outcomes we designed and prospectively evaluated a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile (GammaTile, GT Medical Technologies, Tempe AZ). We combined maximum safe resection and collagen tile brachytherapy (CTBT) with the hypothesis that immediate radiation initiation and/or dose intensification could improve outcomes. MATERIALS/METHODS From 2013–2018 patients undergoing resection with either previously untreated or recurrent brain metastasis were enrolled on a single arm, multi-histology study (ClinicalTrials.gov, NCT#03088579). At resection completion the tumor bed was lined with collagen tiles imbedded with Cs-131, delivering 60–80 Gy at 5 mm depth. The device was designed to prevent direct source-to-brain contact and to maintain inter-source spacing after closure. No additional local therapy was given unless progression occurred. RESULTS 16 metastases (12 recurrent/4 previously untreated) in 11 patients were treated. Median diameter 3.1 cm, range 1.9–5.1. Histology was 7 breast, 6 lung, and 3 sarcoma. Median age 60 years; 7 females/4 males. Average time for implantation was 5 minutes. At median radiographic follow-up of 9.5 months (range 0.1–25.2) treatment site progression occurred 1/16 (6%) at 10.9 months. Median treatment site time-to-progression (TTP) has not been reached (95% CI, >10.9 months). Median overall survival (OS) 9.3 months. No surgical adverse events occurred. One patient (6.2%) experienced radiation brain changes and was treated medically. CONCLUSION R+CTBT demonstrated excellent safety and local control outcomes in this single-arm pre-commercial study. The device recently received FDA clearance for use in newly diagnosed and recurrent brain metastasis. Randomized clinical trials vs standard of care treatments are expected to open in 2020.

To evaluate the adherence to dietary guidelines (ADG) and the effectiveness of the nutritional intervention in terms of body weight change (BWC) in patients with early-stage breast cancer (EBC) undergoing treatment. This prospective study included EBC patients addressed to receive neoadjuvant or adjuvant therapy; eligible patients received a nutrition evidence-based tailored educational intervention by a skilled dietitian. Anthropometric and dietary assessments were performed. ADG was estimated through the validated Med-Diet 14-item questionnaire. Health-Related Quality of Life was analyzed with the EORTC QLQ-C30. Descriptive statistics was adopted. Associations between variables and groups according to nutritional variables were analyzed (Chi-square test). From 2016 to 2018, 204 patients were enrolled (median age 49 years). At baseline, 33.3% of patients were overweight and 22.5% were obese. Furthermore, 47.5% of patients gained ≥5% of their usual weight and 74.5% didn't perform physical activity. A significant correlation between baseline BMI and tension was observed (p These results suggest that tailored nutritional intervention for women undergoing treatment for EBC may help to improve their ADG and finally to weight control.

Background and purpose Customized mouth-opening-tongue-depressing-stents (MOTDs) may reduce toxicity in patients with head and neck cancers (HNC) receiving radiotherapy (RT). However, making MOTDs requires substantial resources, which limits their utilization. Previously, we described a workflow for fabricating customized 3D-printed MOTDs. This study reports the results of a prospective trial testing the non-inferiority of 3D-printed to standard and commercially-available (TruGuard) MOTDs as measured by patient reported outcomes (PROs). Materials and methods PROs were collected at 3 time points: (t1) simulation, (t2) prior to RT, (t3) between fractions 15–25 of RT. Study participants received a 3D-printed MOTDs (t1, t2, t3), a wax-pattern (t1), an acrylic-MOTDs (t2, t3) and an optional TruGuard (t1, t2, t3). Patients inserted the stents for 5–10 min and completed a PRO-questionnaire covering ease-of-insertion and removal, gagging, jaw-pain, roughness and stability. Inter-incisal opening and tongue-displacement were recorded. With 39 patients, we estimated 90% power to detect a non-inferiority margin of 2 at a significance level of 0.025. Matched pairs and t-test were used for statistics. Results 41 patients were evaluable. The 3D-printed MOTDs achieved a significantly better overall PRO score compared to the wax-stent (p = 0.0007) and standard-stent (p = 0.0002), but was not significantly different from the TruGuard (p = 0.41). There was no difference between 3D-printed and standard MOTDs in terms of inter-incisal opening (p = 0.4) and position reproducibility (p = 0.98). The average 3D-printed MOTDs turn-around time was 8 vs 48 h for the standard-stent. Conclusions 3D-printed stents demonstrated non-inferior PROs compared to TruGuard and standard-stents. Our 3D-printing process may expand utilization of MOTDs.

Background: There is little evidence on the use of intralesional triamcinolone (ILT) for managing fistulous tracts in hidradenitis suppurativa (HS). Objective: To assess the clinical and ultrasound response to ILT for single fistulous lesions in HS patients. Methods: A prospective open-label study was conducted to assess response to ILT (40 mg/mL) for fistulous tracts in HS. Consecutive patients (Hurley II stage exclusively) presenting to our department were recruited from August 2016 to August 2018. They received a single injection of ILT as the sole treatment. Lesions were assessed clinically and by ultrasound at baseline and 90 days. Results: Of the 53 included HS patients with fistulous tracts, 36 (67.9%) were women, 30 (56.6%) were smokers, and 36 (67.9%) were obese or overweight (body mass index ≥25). Median Sartorius score was 9.0 (IQR 9.0–36.0), and median duration of the lesion treated was 6 months (IQR 3.0–12.0). Fistulous tracts were injected with 0.5 mL triamcinolone 40 mg/mL. Seven patients were lost to follow-up. At 90 days, 20 (43.5%) lesions showed clinical and ultrasound resolution, 13 (28.3%) showed only clinical resolution while persisting on ultrasound, and 13 (28.3%) persisted both clinically and on ultrasound. Mean clinical size decreased from 17.0 to 5.1 mm (p < 0.0001), while mean length on ultrasound decreased from 16.0 to 8.6 mm (p < 0.0001). Limitations: Small sample size and no control group. Conclusions: Our study suggests that ILT is beneficial for small fistulous tracts in HS.

Aim Neuron-specific enolase (NSE) increases in response to brain injury and is recommended for outcome prediction in cardiac arrest patients. Our aim was to investigate whether NSE measured at different days after a cardiac arrest and its kinetics would improve the prognostic ability of two cardiac arrest specific risk scores. Methods Within this prospective observational study, we included consecutive adult patients after cardiac arrest. We calculated the Out-of-hospital cardiac arrest (OHCA) score and the Cardiac Arrest Hospital Prognosis (CAHP) score upon ICU admission and measured serum NSE upon admission and days 1, 2, 3, 5 and 7. We calculated logistic regression models to study associations of scores and NSE levels with neurological outcome defined by Cerebral Performance Category (CPC) scale and in-hospital death. Results From 336 included patients, 180 (54%) survived until hospital discharge, of which 150 (45%) had a good neurological outcome. NSE at day 3 showed the highest prognostic accuracy (discrimination) for neurological outcome (area under the curve (AUC) 0.89) and in-hospital mortality (AUC 0.88). These results were robust in reclassification statistics and across different subgroups. NSE kinetics with admission levels serving as a baseline did not further improve prognostication. NSE on day 3 significantly improved discrimination of both clinical risk scores (CAHP from AUC 0.81 to 0.91; OHCA from AUC 0.79 to 0.89). Conclusion NSE measured at day 3 significantly improves clinical risk scores for outcome prediction in cardiac arrest patients and may thus add to clinical decision making about escalation or withdrawal of therapy in this vulnerable patient population.

3556 Background: Molecular imaging of metabolic pathways critical for effector T cell response other than glucose could predict response to PD1 inhibitors. We have previously shown that high expression of tryptophan metabolic pathway enzymes in stage III/IV melanoma correlates with reduced abundance of tumor-infiltrating lymphocytes (TILs, ASCO 2019, e21014). Here we investigated C11-AMT, a PET tracer that images tryptophan metabolism, as a predictor of response to pembro in patients (pts) with PD1 inhibitor-naïve MM. Methods: In this trial (NCT03089606) pts must have had measurable MM by RECIST, have undergone IV contrast CT, FDG-PET, and C11-AMT PET scan (30-40 min dynamic imaging), plus a mandatory tumor biopsy prior to pembro treatment. Results: 21 pts (16 males; 15 stage IV; median age 61) had all 3 baseline scans and evaluable research biopsies. 13 pts were non-progressors (CR = 4, PR = 6, and SD = 3). At a median f/u of 13.7 mons (2.8-25.1+), 6 pts are dead from MM, 11 are alive without MM and 4 are alive with MM. 46 tumor lesions were assessed by all 3 scans. Of the pts with tumor lesion, C11-AMT PET SUVmax < 7 and skewness < +0.3 of the tumor lesion with the highest C11-AMT SUVmax was associated with non-progression by RECIST (SUVmax < 7/skewness < +0.3 in progressors vs. non-progressors; Fisher’s 2-tail test p= 0.055). The corresponding association between baseline FDG-PET (SUVmax < 14 and skewness < +0.3) with treatment response was insignificant ( p= 0.08). There was a weak (Spearman ρ= 0.33) but significant correlation ( p= 0.001) in SUVmax between FDG-PET and C11-AMT among the 46 tumors analyzed. There was no significant correlation between melanoma-specific expression of the tryptophan- (TPH1, TPH2, IDO1, TDO2, LAT1) and glucose-metabolizing enzymes (GLUT1, HK1, HK3) by immunohistochemistry. Response to pembro trends to associate with present TILs (Fisher’s p= 0.087). Conclusions: Baseline C11-AMT PET imaging using simple radiomics measures (highest metabolic activity, SUVmax, and tumor heterogeneity, skewness) may better predict clinical benefit from pembro in MM than FDG PET. Variability in C11-AMT’s SUVmax cannot be solely explained by FDG-PET’s SUVmax, suggesting that these two imaging modalities may provide complementary information about intratumoral metabolic dysregulation that may relate with pembro response. Texture analysis using LifeX v4.0 will be presented at the meeting. Clinical trial information: NCT03089606 .

e16136 Background: FOLFOXIRI had been recommended as induction treatment for patients with T4N+ rectal cancer in the latest NCCN guideline. However, no prospective study to support this recommendation in his population. Here, we tried to analyze the efficacy of FOLFOXIRI as induction chemotherapy in the subgroup of rectal cancer patients with T4N+ from a prospective trial. Methods: A phase II trial exploring the efficacy of mFOLFOXIRI as neoadjuvant chemotherapy in locally advanced rectal cancer had been conducted in our center recently. The subgroups of patients with clinical T4N+ rectal cancer were extracted for further analysis. All candidates were to receive 4 to 6 cycles of mFOLFOXIRI. MRI will be performed every two cycles to assess clinical responses. And then the patients would receive total mesorectal excision directly or proceed to chemoradiotherapy according to the result of restaging evaluation. Postoperative FOLFOX chemotherapy was recommended. The primary endpoint is the ratio of tumor downstaging to ypT0-2N0M0. Results: There were 27 patients with cT4N+. There were twenty male and 7 female, with the median age of 46 years old. MRF involved was observed in 14 patients. Neoadjuvant chemotherapy with mFOLFOXIRI was performed for at least 4 cycles. Six patients received radiotherapy before total mesorectal excision, including short-term radiation in 1 patient. R0 resection was achieved in all the patients (100%) and 24 (88.9%) of patients had received sphincter-saving operation. According to the pathologic result, all patients showed regression in the primary tumor (ypT0-3). The pCR rate was 22.2% (6/27) and the tumor downstaging (ypStage 0-I) rate was 29.6%. Another 13 (48.1%) patients showed downstaging to ypStage II. The main grade 3/4 adverse event was neutropenia (35.7%). With a median follow-up of 25 months, no local recurrence was observed. Only 3 patients developed distant metastasis. The 2-year survival rate for this group of population was 85.0%. Conclusions: mFOLFOXIRI showed high tumor downstaging rate in locally advanced rectal cancer. It could be reasonable to use mFOLFOXIRI as induction chemotherapy for cT4N+ rectal cancer patients. Clinical trial information: NCT02217020 . [Table: see text]

e21047 Background: The care of pts with locally-advanced NSCLC has continued to evolve. Dose escalation with conventional radiation and concurrent chemotherapy has failed to improve outcomes and is associated with low primary tumor control rates and high toxicity rates. We initiated a phase II study to evaluate full dose SBRT to the primary tumor followed by conventional chemoradiation to the involved lymph nodes followed by adjuvant immunotherapy in patients (pts) with unresectable locally-advanced NSCLC. Methods: Eligible pts included peripheral primary tumors ≤ 7cm or centrally based tumors that had at least 2 cm separation from involved nodal disease. Pts received SBRT to the primary tumor (50-54 Gy in 3-5 fractions) followed by standard radiation to 60 Gy in 30 fractions with concurrent chemotherapy (physician choice of carboplatin/paclitaxel or cisplatin/etoposide). Pts without disease progression after chemoradiation then received adjuvant durvalumab (PACIFIC trial). Planned analysis of early toxicity was performed given this is the first prospective trial to replace conventional fractionation and deliver full dose SBRT to the primary tumor in the locally advanced setting. Results: From May 2017 to January 2020, 35pts were enrolled. Median follow up is 7.9 months (range 0-27 months). Toxicity related to either SBRT or mediastinal radiation was lower than previous published prospective trials with a grade 2 radiation pneumonitis incidence of only 17%. There was no ≥grade 3 pneumonitis. Grade 3 esophagitis was observed in 1 pt (3%) with grade 2 esophagitis in 37%. No grade ≥3 toxicity has been attributed to SBRT with 26% of pts experiencing a grade 2 toxicity from SBRT. Overall incidence of grade ≥3 pulmonary toxicity attributed to any therapy was 9%. One pt died of neutropenic sepsis due to legionella while on therapy attributed to chemotherapy. No major cardiac events were reported to date. Conclusions: Full dose SBRT to the primary tumor followed by standard chemoradiation to the involved lymph nodes appears to have a favorable toxicity profile when compared with conventional dose escalation and to previously published experiences with SBRT boost following chemoradiation in the treatment of locally advanced NSCLC. Our trial continues to enroll with a target of 56 pts. Clinical trial information: NCT03141359 .

2067 Background: A patient’s understanding of surgery is often limited, especially in the setting of complex oncologic procedures. A recent review found that interventions such as the use of written materials, videos, and websites, improve patients’ knowledge of the procedure and their satisfaction with decision making. We sought to determine if a video-based approach in patients undergoing robotic endometrial cancer staging improves satisfaction with perioperative counseling. Secondary objectives were physician satisfaction, patient comprehension, and visit length. Methods: From 2018-2019, patients were randomized to standard physician education or multimedia-based education, which included watching two novel animated videos followed by focused physician counseling. Basic demographic information was collected. Patient satisfaction was assessed using the Client Satisfaction Questionnaire-8 (CSQ-8, a validated satisfaction survey, scored 8-32) and a global satisfaction score (10-point scale). Physician satisfaction was assessed using a global satisfaction score. Comprehension was assessed with a 9 question survey at 3 time points. Descriptive statistics were used to compare groups. Results: Of 76 patients randomized, the majority were Caucasian (68%), 50-70 years old (70%), and had at least some college education (75%). Most patients had undergone prior surgery (83%) and one fourth had a prior cancer diagnosis. Demographic variables and surgical history were similar between groups. The video patients reported higher satisfaction on the CSQ-8 (31.57 ± 1.02 vs 30.62 ± 2.09, p < 0.05) and global satisfaction score (9.95 ± 0.23 vs 9.74 ± 0.55, p < 0.05). There was no difference in comprehension scores between groups at either the initial or postoperative visit. At the time of surgery, comprehension scores were higher in the standard education group compared to the video group (p < 0.01). There was no difference in physician satisfaction between groups. Among the video group, there was improvement in physician satisfaction between the first and second half of patients enrolled (p < 0.05). There was no difference in visit length. Conclusions: While multimedia education improved patient satisfaction in the preoperative setting, this was not clinically significant. Provider satisfaction improved over time with the use of a video aid. Multimedia education may be implemented in perioperative counseling based on provider preference and consideration should be made for further study of satisfaction after the initial implementation period. Clinical trial information: NCT03899441.

12056 Background: Excess adiposity is linked to an increased risk of worse outcome among EBC pts. Pts undergoing EBC treatment are susceptible to change in nutrition status. However, implementation and assessment of the adherence to lifestyle interventions have been limited. This prospective trial aimed to evaluate the impact of an evidence-based nutrition intervention, according to the ADG, in terms of body composition changes in EBC pts. Methods: Entry criteria: EBC pts candidate to neoadjuvant/adjuvant therapy. At study entry, pts received a nutrition evidence-based tailored intervention. Dietary and anthropometric assessments were evaluated at baseline and after 12-months nutritional intervention. Waist circumference (WC) was assessed as a surrogate measure of fat distribution. ADG was estimated by Med-Diet 14-item questionnaire. Health-Related Quality of Life was analysed with EORTC QLQ-C30. Descriptive statistics was adopted. Associations between variables and groups according to nutritional variables were analysed (Chi-square test). Results: From February 2016 to December 2019, 243 pts were enrolled (median age 49 years): 27.6%/48.6% neoadjuvant/adjuvant treatment. At baseline, 38.3% of pts were overweight and 23.9% were obese. Notably, tumor size was significantly correlated with WC in the whole population (p = 0.003). Moreover, pts with central obesity were more likely to present HER2-negative tumors (57.4% vs. 42.5%, p = 0.03). Most pts reported relevant nutrition impact symptoms and symptoms affected QoL. Particularly, dyspepsia and constipation were more prevalent in overweight and obese pts (p < 0.0001 and p = 0.009, respectively), as well as in pts who gained ≥5% of weight (p = 0.04 and p = 0.02, respectively). At baseline, there was low ADG. After the 12-months intervention, ADG significantly increased (median Med-Diet score: 6 vs.12, p < 0.0001). A high ADG (defines as a Med-Diet score ≥10) significantly correlated with: 1) loss of weight ≥5% from the baseline weight (p = 0.003); 2) change in terms of BMI; 3) prevalence of central obesity. Conclusions: A tailored evidence-based nutritional intervention for EBC pts represents a tool to improve their ADG, weight management and, thus, to potentially influence the disease outcome. [Table: see text]

e17579 Background: To evaluate tumor heterogeneity and burden in nonmetastatic prostate cancer patients with an early PSA progression during castration by 68Ga-PSMA and 18F-FDG PET/CT. Methods: The trial prospectively included 37 patients who had an early PSA progression (≤2ng/ml) during castration, and high-risk (PSADT ≤10 months) nonmetastatic disease by conventional imaging. All patients underwent both 68Ga-PSMA and 18F-FDG PET/CT. Lesions were classified into PSMA-dominant lesions (PSMA+/FDG- and PSMA+/FDG+) and PSMA-/FDG+ lesions according to the tracer uptake status. The primary endpoint was the prevalence of PSMA-/FDG+ disease. Results: All patients were treated with RP (median duration of castration = 23 months). The median PSA at imaging was 0.57ng/ml. Overall, 114 lesions were detected in 29 of the 37 patients. A high prevalence (73%) of N+/M+ disease was observed. Of the 114 lesions, 81 were PSMA-dominant and 33 were PSMA-/FDG+. Per patient level, 9 men (24%, 95%CI: 10%-39%) showed at least one new PSMA-/FDG+ lesions. A short PSADT ( P= 0.009, OR = 8.000) were associated with PSMA-dominant disease, while a high Gleason grade group ( P= 0.022, OR = 13.091) with PSMA-/FDG+ disease. 19 patients (51%) with 51 lesions could be enrolled for oligometastases-directed therapy including 10 PSMA-/FDG+ lesions. Among different disease stages, PSMA-/FDG+ disease was rarely detected in the hormone-sensitive cohort, but frequently found in the castration-resistant cohort. Conclusions: Using 68Ga-PSMA and 18F-FDG PET, we observed a high prevalence of N+/M+ disease and a significant proportion of PSMA-/FDG+ disease in patients with an early PSA progression during castration. (ChiCTR 1900022634). Clinical trial information: 1900022634 . [Table: see text]

506 Background: The 70-gene signature MammaPrint has been shown to identify breast cancer patients for whom adjuvant chemotherapy (CT) could be safely omitted even in the presence of unfavorable standard clinical-pathological criteria. The MINDACT primary endpoint at 5 years median follow-up was met in 2016 (Cardoso et al, NEJM 2016) with a distant metastasis free survival (DMFS) rate at 5 years of 94.7% (95% CI: 92.5-96.2) in clinical high (C-High) / genomic low (G-Low) risk patients who received no CT. Longer follow-up is now available. Methods: 6693 patients were enrolled in the prospective phase III randomized MINDACT study (EORTC 10041/BIG3-04) between 2007-2011. We assessed the DMFS rate at 5 years in the primary test (PT) population of C-High / G-Low patients who were randomized to receive no CT (n = 644). As secondary analysis, we evaluated DMFS and overall survival (OS) in the intention to treat (ITT) population of the C-High / G-Low group randomized to CT vs no CT (n = 749 and 748 respectively). Comparisons between CT and no CT groups are low-powered. We used Kaplan-Meier estimates for time to event endpoints and hazard ratios (HR) with 95% CI from cox-regression models adjusted for stratification factors used for the randomization. Results: The median follow-up is 8.7 years, resulting in an updated 5-year DMFS rate for the PT population of C-High / G-Low patients with no CT of 95.1% (95% CI 93.1-96.6). The updated outcomes of the ITT population of C-High / G-Low patients are shown in the table. Further analyses will update the suggested age-dependent effect of CT omission for luminal breast cancer seen at 5 years in pre- versus post-menopausal women as in Tailor-X (Piccart et al, SABCS 2019). Conclusions: The primary DMFS endpoint at 5 years continues to be met in CT untreated C-High / G-Low risk women, confirming MINDACT as a positive de-escalation study. With longer follow-up and in line with the natural history of luminal breast cancer, more distant relapses do occur but the estimated gain of 2.6% for CT administration in C-High / G-Low patients remains small in light of CT harmful effects. The level IA evidence for the clinical utility of the 70-gene signature for adjuvant CT decision making is maintained. Clinical trial information: NCT00433589 . [Table: see text]

e18509 Background: The purpose of this study is to report on the feasibility and safety of Diffusing Alpha-emitters Radiation Therapy (DaRT), including interstitial implantation of a novel alpha-emitting brachytherapy source, to treat locally advanced and recurrent squamous cell carcinomas (SCC) of the skin and head and neck. Methods: This prospective, first-in-human Phase I multicenter study included 28 eligible patients with 31 lesions. The primary endpoint was the feasibility and safety of the DaRT treatment approach. The secondary endpoint was initial tumor response and local progression-free survival (PFS) outcomes. Eligibility criteria included biopsy-proven SCC of the skin and head neck with either recurrent or previously-treated disease with either surgery or prior external beam radiotherapy. Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events (Version 4.03). Tumor response was assessed at follow-up (30-45 days following treatment) using the Response Evaluation Criteria in Solid Tumors (Version 1.1). Results: Acute toxicity events included mostly erythema and swelling at the implantation site followed by pain and mild skin ulceration. Pain and Grade 2 skin ulcerations resolved in most patients within 3-5 weeks. Complete response (CR) to the Ra-224 DaRT treatment was observed in 22 lesions (22/28; 78.6%); seven lesions (6/28; 21.4%) manifested a partial response ( > 30% tumor reduction). Among the 22 lesions with a CR, 5 (22%) developed a subsequent local relapse at the site of DaRT implantation at a median of 4.9 months (range: 2.43-5.52 months). The one-year local PFS probability at the implanted site was 60% (95% Confidence Interval, CI: -28.61-81.35%) for complete responders. Overall survival (OS) at 12 months post-DaRT implantation was 75% (95% CI: 46.14-89.99%); among complete responders, OS was 93% (95% CI: 59.08-98.96%). Conclusions: Alpha-emitter brachytherapy using DaRT achieved significant tumor responses without Grade 3 or higher toxicities. Longer follow-up observations and larger studies are underway to validate these findings. Clinical trial information: NCT03015883 NCT03353077.

e16129 Background: The ypStage after neoadjuvant treatment was an important prognosis factor in locally advanced rectal cancer (LARC). pCR or ypStage 0 showed best prognosis, while ypStage II-III showed poor prognosis and further adjuvant chemotherapy with FOLFOX was recommended. Tumor regression grade (TRG) was another factor to evaluate the response to neoadjuvant treatment. Even in the same ypStage, the TRG could be different. Here, we tried to analyze the prognosis valve of TRG in the same ypStage after neoadjuvant treatment in LARC from a prospective trial (FOWARC study). Methods: Patients with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil plus radiotherapy followed by surgery and seven cycles of infusional fluorouracil as adjuvant treatment, the same treatment plus intravenous oxaliplatin 85 mg/m2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS). Survival analysis was performed on different ypStage and TRG (WHO classification) group. Results: In total, 495 patients were randomly assigned to different neoadjuvant treatment. 444 patients received surgery with a median follow-up of 45.2 months. The 3-year disease free survival (DFS) in ypStage 0, ypStage I, ypStage II and ypStage III was 95.8%, 89.2%, 71.7% and 55.1%, respectively (P < 0.0001). In TRG 0, 1, 2 and 3, the 3-year DFS was 93.3%, 83.2%, 68.4% and 63.6%, respectively (P < 0.0001). In ypStage I subgroup, TRG was not an independent prognosis factor, the 3-year DFS for TRG 1, 2 and 3 was 90.0%, 90.7% and 76.2%, respectively (P = 0.277). In ypStage II population, the 3-year DFS for TRG 1, 2 and 3 was 78.6%, 70.3% and 64.7%, respectively (P = 0.184). The ypStage III group showed great heterogeneity, the 3-year DFS for TRG 0-3 was 60.0%, 70.0%, 41.8% and 59.5%, respectively (P = 0.067). Conclusions: Both ypStage and TRG was strong prognosis factor for rectal cancer after neoadjuvant treatment. However, TRG was not an independent prognosis factor in the same ypStage after neoadjuvant treatment. Clinical trial information: NCT01211210 .

Federica Dall’Oglio,1 Gabriella Fabbrocini,2 Aurora Tedeschi,1 Marianna Donnarumma,2 Paolo Chiodini,3 Giuseppe Micali1 1Dermatology Clinic, University of Catania, Catania, Italy; 2Section of Dermatology, Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy; 3Medical Statistics Unit, University of Campania “Luigi Vanvitelli”, Naples, ItalyCorrespondence: Giuseppe MicaliDermatology Clinic, University of Catania, A.O.U. Policlinico -Vittorio Emanuele, via Santa Sofia, 78, Catania 95123, ItalyTel +39 095321705Fax +39 0953782425Email cldermct@gmail.comPurpose: Topical cosmetic agents if correctly prescribed and used may improve outcomes in acne therapy. The aim of this study was to assess the efficacy and tolerability of a new daily cosmetic regimen in the treatment of mild facial acne.Patients and methods: A multicenter, prospective, observational, clinical study was conducted on 91 adult patients with mild acne. Subjects were instructed to apply a fluid containing Licochalcone A/Salicylic acid/L-Carnitine in the morning and a cream with Licochalcone A/Hydroxy-Complex 10% at bedtime for 8 weeks. The efficacy was clinically evaluated by Global Acne Grading System (GAGS) score and by comedones/papules lesions count and by instrumental assessment (SebutapeTMand Reveal Photo Imager/VISIA-CR™ imaging) at baseline, at 4 and 8 weeks.Results: At 4 weeks a statistically significant reduction from baseline of GAGSwas observed. In addition, the mean total count of comedones and papules was significantly reduced by 41% and 45%, respectively, from baseline along with a significant reduction of mean sebum of 47%. At 8 weeks, a further statistically significant reduction from baseline of GAGS, total count of comedones and papules (64% and 71%, respectively), along with an additional sebum reduction of about 52% was also recorded.Conclusion: Our results suggest that the daily regimen based on Licochalcone A with Salicylic acid/L-Carnitine as fluid or with Hydroxy-Complex 10% as cream represent an interesting cosmetic approach for treating mild acne.Keywords: mild acne, topical cosmetic, licochalcone A, salicylic acid, hydroxyl-complex

Objectives: Up to 60% of women remove their levonorgestrel-releasing Intrauterine System (LNG-IUS) prematurely, mostly because of irregular bleeding disturbances up to six months after insertion. Assuming ongoing bleeding is due to atrophic bleeding of the endometrium, treatment with ooestrogen could be effective. No study in literature supports ooestrogen therapy for irregular bleeding in LNG-IUS users. Study design: A prospective cohort study was conducted in two hospitals to evaluate the effect of oral ooestradiol (started six months after LNG-IUS insertion) on irregular bleeding days. The participating women received 2mg ooestradiol daily for six weeks. We observed the discontinuation rate, the occurrence of adverse events and side effects due to ooestradiol. Women completed questionnaires at baseline and three months after start of the treatment. Results: Nineteen women were included. A median of 21 irregular bleeding days per month at baseline decreased to a median of five irregular bleeding days per month (p=0.003) after the use of ooestradiol for six weeks. Three out of nineteen women had their LNG-IUS removed at three months follow-up because of persistent irregular bleeding. No adverse events were reported, however, 68% of the participants reported side effects. Conclusion: In this study we observed a decrease in the number of irregular bleeding days in LNG-IUS users with ongoing irregular bleeding (>6 months after insertion), after administering oral ooestradiol for six weeks. We propose to conduct a larger prospective trial to evaluate ooestradiol as treatment option for irregular bleeding.

INTRODUCTION AND OBJECTIVE:Concern for discordance between endoscopic evaluation and final pathology drives current clinical management of patients deemed appropriate candidates for radical cystect...