Faculty Bibliography

Background Immunotherapy is emerging as the cornerstone for treatment of patients with advanced cancer, but significant toxicity (immune-related adverse events [irAEs]) associated with unbridled T cell activity remains a concern. Patients and methods A retrospective review of the electronic medical records of 290 patients with advanced cancer treated on an immunotherapy-based clinical trial in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center between February 2010 and September 2015 was performed. Clinical and laboratory parameters were collected to determine the incidence of irAEs, risk factors, and their association with treatment outcomes. Results Ninety eight of 290 patients (34%) experienced any grade irAEs. Among the 15 (5.2%) patients with grade ≥ 3 irAEs, the most common irAEs were dermatitis and enterocolitis. Although 80% of the patients with grade ≥ 3 irAEs required systemic corticosteroids, all the 15 patients recovered from the irAEs. On re-challenge, 4 of the 5 patients who had received systemic corticosteroids for irAE continued to respond. There were no irAE-related deaths. Importantly, patients with grade ≥ 3 irAEs had improved overall response rate (25 vs. 6%; p = 0.039) and longer median time to progression (30 weeks vs. 10 weeks; p = 0.0040) when compared to those without grade ≥ 3 irAEs. Conclusion Incidence of irAEs with immunotherapeutic agents indicates an active immune status, suggestive of potential clinical benefit to the patient. Further validation of this association in a large prospective study is warranted.

Background There are no longitudinal studies regarding thelong term cardiac health of children with cardiac manifestations of neonatal lupus (NL). This study was performed toevaluate risk factors for morbidity and provide evidence-basedguidance regarding the course of cardiac NL.Methods Echocardiograms throughout life were evaluated in240 individuals born with cardiac NL from the ResearchRegistry for Neonatal Lupus: 142 were available from ages 0 1 years, 174 from ages 1 17 years, and 65>17 years. A composite adverse outcome defined as qualitatively decreased leftventricular (LV) function or concurrent use of cardiac medications was assessed. Aortic dilation (root or ascendingaorta z-score >2.0) was also recorded. Analyses were performed to associate the composite adverse outcome and aorticdilation with maternal medications, pacing, and fetal diseasestatus, including a severity score based on mortality risk factors such as lower fetal heart rate and extranodal disease.Results The composite adverse outcome for cardiac dysfunctionwas identified in 21.1% of echos in children ages 0 1, 13.2% ages1 17% and 29.2% ages>17. In 89 children in which echos wereavailable at ages 0 1 and 1 17, 6/16 with dysfunction at ages 0 1were also affected at ages 1 17, while 10 reverted to normal.Among those without dysfunction at age 0 1, 8/90 developednew worsening of cardiac function during age 1 17. In 35 caseswith echos at ages 1 17 and >17, 3/3 cases with dysfunction atage 1 17 were also affected at >17, and 2/32 developed new dysfunction in adulthood. Cardiac dysfunction was significantly associated with number of years paced at all ages (p<0.001, 0.001,<0.001). A lower fetal ventricular heart rate at the first time ofheart block detection was associated with cardiac dysfunction age0 1 and >17 (p=0.048, 0.005 respectively) and lowest heart ratein utero associated with dysfunction at age <1 and 1 17(p<0.001, 0.015). Fetal extranodal cardiac disease was associatedwith dysfunction in ages1 17 and >17 (p=0.026, 0.023). Higherfetal severity score associated with postnatal dysfunction in ages0 1 and 1 17 groups (p=0.013, 0.001). Aortic dilation waspresent in 13.4% at ages 0 1% and 14.9% at ages 1 17, butat >17, dilation only occurred in 9.2%. There was no associationof postnatal cardiac dysfunction or aortic dilation with maternalmedication use, maternal rheumatic disease, fetal age at heartblock detection or gestational age of birth.Conclusions Cardiac dysfunction in the first year normalizesby later childhood in the majority of cases, possibly due tothe short term effects of cardiac pacing or resolution ofinflammation with the clearance of maternal autoantibodies.However, new onset dysfunction can occur after the first yearof life. Aortic dilation can continue for longer periods, butmay decrease in frequency with age. Nevertheless, cardiac dysfunction is present in roughly 30%, and in adulthood thereare associations with fetal extranodal disease and heart rate atdetection. Patients who develop morbidity in utero may havesubclinical damage or be more susceptible to future insultsthat manifest later in life, which can be exacerbated by prolonged pacing. Close monitoring and aggressive treatment ofearly extranodal disease in cardiac NL may have long termbenefit in preventing subsequent morbidity

Stent thrombosis is a potentially life threatening condition caused by several factors or a combination factors, such as resistance to platelet agents and type of anticoagulation used as well as stent types. We report a case of acute thrombosis and discuss potential areas of intervention with literature review.

BACKGROUND & AIMS: Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) is the standard of care for tissue sampling of solid lesions adjacent to the GI tract. Fine needle biopsy (FNB) may provide higher diagnostic yield with fewer needle passes. The aim of this study was to assess the difference in diagnostic yield between FNA and FNB. METHODS: This is a multicenter, prospective randomized clinical trial from six large tertiary care centers. Patients referred for tissue sampling of solid lesions were randomized to either FNA or FNB of the target lesion. Demographics, size, location, number of needle passes, and final diagnosis were recorded. RESULTS: After enrollment, 135 patients were randomized to FNA (49.3%) and 139 patients were randomized to FNB (50.7%).The following lesions were sampled: mass (n=210; 76.6%), lymph nodes (n=46, 16.8%), submucosal tumors (n=18, 6.6%). Final diagnosis was malignancy (n=192, 70.1%), reactive lymphadenopathy (n=30, 11.0%), and spindle cell tumors (n=24, 8.8%). FNA had a diagnostic yield of 91.1% compared to 88.5% for FNB (p=0.48). There was no difference between FNA and FNB when stratified by the presence of on-site cytopathology or by type of lesion sampled A median of 1 needle pass was needed to obtain a diagnostic sample for both needles. CONCLUSION: FNA and FNB obtained a similar diagnostic yield with a comparable number of needle passes. Based on these results, there is no significant difference in the performance of FNA compared to FNB in the cytological diagnosis of solid lesions adjacent to the GI tract. (ClincalTrials.gov identifier: NCT01698190).

Medication literacy is the ability of individuals to access and understand medication information and then use that information to act and take their medication in a safe and appropriate way. The purpose of this study was to explore medication literacy in a group of Somali older adults and their families using qualitative secondary analysis. We conducted an analytic expansion of an existing qualitative study that explored the home healthcare perceptions of Somali older adults and their families. Qualitative data collected from 14 Somali families about home healthcare were reviewed and analyzed for material related to medication literacy. Data analysis revealed a number of important findings related to medication literacy and resulted in the discovery of four themes: Medication literacy is needed among Somali older adults and their families, Using home healthcare (HHC) to improve medication literacy, Better communication is essential to improving medication literacy, and Medication literacy is an intersecting family and social issue. The results of this study indicate that HHC has a role to play in improving the health and medication literacy of these families. They also highlight the need to further explore what techniques, tools, and/or supports HHC professionals need to care for non-English speaking populations. Future research needs to address how to meet the needs of diverse and vulnerable patients like Somali older adults, and how best to prepare HHC providers to do this.

CONTEXT/BACKGROUND:Patients with advanced cancer often overestimate their time left to live. Those who have heightened awareness of their cognitive and physical deficits at the end of life may have a better prognostic understanding. OBJECTIVES/OBJECTIVE:We sought to investigate the extent to which patients' self-reports of physical well-being and cognitive function were associated with prognostic understanding. METHODS:Logistic regression analyzed data from Coping with Cancer II, a National Cancer Institute-funded study of patients with advanced cancer from nine U.S. cancer clinics. Patients with metastatic cancers who had an oncologist-estimated life expectancy of less than six months and did not have significant cognitive impairment were eligible (N = 300). Trained interviewers administered subsets of the McGill Quality of Life and the Functional Assessment of Cancer Therapy-Cognition, Version 2, to measure physical well-being and cognitive complaints. There were four dichotomous outcomes: acknowledgment of their terminal illness; understanding that their diagnosis was late or end stage; belief that life expectancy was months, not years; and prognostic understanding, which was defined as accurate responses to all three questions. Covariates included age and gender. RESULTS:Worse patient-reported physical well-being and cognitive function were independently associated with the patient's acknowledgment of his and/or her terminal illness (adjusted odds ratio 0.91; 95% CI = 0.82, 1.00; P = 0.047 and adjusted odds ratio 1.73; 95% CI = 1.17, 2.55; P = 0.006, respectively). CONCLUSION/CONCLUSIONS:Patients who reported worse cognitive function and physical well-being were more aware of their terminal illness than those with better cognitive function.