Nivolumab and pembrolizumab can be safe and effective among patients with NSCLC and HIV. Larger studies will be needed to determine the overall safety and efficacy of immune checkpoint inhibitors among cancer patients with HIV.

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive tumor with high lethality. Even with surgery, radiotherapy, chemotherapy, and other locoregional or systemic therapies, the survival rates for PDAC are low and have not significantly changed in the past decades. The special characteristics of the PDAC’s microenvironment and its complex immune escape mechanism need to be considered when designing novel therapeutic approaches in this disease. PDAC is characterized by chronic inflammation with a high rate of tumor-associated macrophages and myeloid-derived suppressor cells and a low rate of natural killer and effector T cells. The pancreatic microenvironment is a fibrotic, microvascularized stroma that isolates the tumor from systemic vascularization. Immunotherapy, a novel approach that has demonstrated effectiveness in certain solid tumors, has failed to show any practice-changing results in pancreatic cancer, with the exception of PDACs with mismatch repair deficiency and high tumor mutational burden, which show prolonged survival rates with immunotherapy. Currently, numerous clinical trials are attempting to assess the efficacy of immunotherapeutic strategies in PDAC, including immune checkpoint inhibitors, cancer vaccines, and adoptive cell transfer, alone or in combination with other immunotherapeutic agents, chemoradiotherapy, and other targeted therapies. A deep understanding of the immune response will help in the development of new therapeutic strategies leading to improved clinical outcomes for patients with PDAC.

e16630 Background: Nivolumab, an anti-PD1 antibody, is FDA approved in patients (pts) with HCC. Anti-PD-1 promotes hyperstimulation of host immunity and is associated with a spectrum of toxicities known as immune-related adverse events (irAEs). In other malignancies, higher rates of irAEs are associated with improved cancer outcomes. This study shows correlation between irAEs and efficacy in pts with HCC treated with nivolumab. Methods: Demographic and toxicity data were collected retrospectively on all pts with HCC treated with nivolumab at a single institution from Jan 2012 – Sept 2019. Response was evaluated using RECISTv1.1. Adverse events were assessed according to CTCAEv5.0. Categorical variables were assessed by Fisher's exact test. Survival was estimated with the Kaplan-Meier method and compared using the log-rank test. Univariate and multivariate analyses were performed by the Cox-regression model. Results: 30 pts were treated; irAEs were detected in 16 (53%). There was no difference in baseline characteristics among those who did and did not experience irAEs (Table). The most frequent irAEs were elevated AST/ALT (n = 7; 44%), rash (n = 4; 25%), and hypothyroid (n = 4; 25%). 3 G3 (rash and transaminitis) and 1 G4 AE (pured red cell apalasia) were observed. Among all pts, overall response rate (RR) and disease control rate (DCR) were 13 and 50%, respectively. Median progression free survival (PFS) and overall survival (OS) were 27 and 56 weeks (w), respectively. The RR and DCR were higher among irAEs vs non-irAEs, although this did not reach statistical significance (RR 25 vs 0%; p = 0.05; DCR 62 vs 35%; p = 0.19). Median PFS and OS were longer in those with irAEs vs non-irAE; PFS 33 vs 16 w (HR: 0.26; CI 95%: 0.076-0.89; p = 0.028); (OS 69 vs 21 w HR: 0.18; CI 95%: 0.05-0.58; p = 0.002). On multivariate analysis, viral etiology was associated with prolonged PFS (p = 0.002) and MELD was associated with reduced OS (p = 0.004). Conclusions: Development of irAEs was associated with prolonged PFS and OS in pts with HCC treated with nivolumab. Further study is needed to determine whether type of irAE, onset time, or duration affect cancer outcomes. [Table: see text]

Background and objectives: Burn-out results from chronic workplace stress leading to emotional exhaustion, negativity, and decreased professional efficiency. In the healthcare system, this can have consequences like increased medical errors, absenteeism, substance abuse, depression, and suicide among health professionals, adversely affecting patient care. Various individual-directed measures like the mindfulness-based stress reduction program (MBSR), one of the most studied and widely adopted techniques, and physical activity, like aerobics or sports, have shown to be effective against burn-out. With this study, we intend to increase awareness regarding this public health issue among the residents and the faculty. Our aim is to define a successful intervention that can be incorporated as a yearly requirement for the completion of medical residency programs. Methodology: This study will be a phase III, multicentric, open-label, placebo (waiting list) controlled trial. Our sample size will be 720 residents sampled from 6 university hospitals from across the world, randomized into 3 parallel arms (1:1:1 ratio stratified according to site and specialty). Residents, diagnosed with burn-out based on baseline Maslach Burnout Inventory score (MBI) and having no prior physical or mental health issues, will be included. The first group will undergo the MBSR program for 8 weeks, the second group will undergo a supervised aerobics program for 8 weeks, and the third group will be put into a waiting list for any of the interventions. The primary outcome will be the change in MBI scores after the intervention. The secondary outcomes will be the change in MBI score 3 months after the intervention, and changes in measures like heart rate, blood pressure, glycated hemoglobin, cortisol levels, quality of sleep and quality of life after the intervention and 3 months later. We also plan to do a subgroup analysis to see the difference based on specialty and gender. Study impact:The residency training period is considered one of the most stressful phases in medical education. Higher rates of burn-out are noted in the residents, and this can negatively impact patient care and the progression of their careers. This trial will look at multiple interventions to combat burnout, recruiting residents of different specialties in different work environments across the world. We hope to remove the stigma surrounding burnout in the healthcare system. This study will show the short and long term benefits of these interventions and would help us recommend their inclusion in various residency programs.