Regulatory approval of immune checkpoint inhibitors (ICIs) was based on results of large, randomized clinical trials, resulting in limited outcomes data in patient cohorts typically underrepresented in such trials. The objective of this study was to evaluate the efficacy and safety of ICIs in these unique patient cohorts. This is a multicenter, retrospective analysis of real-world data at six academic and community clinics in the United States from 1 January 2011 to 1 April 2018. Patients were included if they had received at least one cycle of ICI treatment. Unique patient cohorts included age > 75 years, non-White race, positive smoking history, ECOG performance status (PS) ≥ 2, BMI ≥ 30 kg/m², autoimmune diseases (AIDs), chronic viral infections (CVI), extensive prior lines of therapy (LOTs), or >three metastatic sites. Immune-related adverse events (irAEs), overall survival (OS), and time to treatment failure were evaluated in the entire cohort and in NSCLC patients treated with PD-(L)1 monotherapy. Outcomes and their association with unique patient cohorts were compared on univariate analysis and multivariate analysis to those without a particular characteristic in the entire NSCLC PD-(L)1 monotherapy cohorts. In total, 1453 patients were included: 56.5%—smokers, 30.4%—non-White, 22.8%—elderly, 20.8%—ECOG PS ≥ 2, 15.7%—history of AIDs, and 4.7%—history of CVI. The common ICIs were nivolumab (37.1%) and pembrolizumab (22.2%). Black patients, compared to White patients, experienced fewer irAEs (OR 0.54, p < 0.001). An ECOG PS of ≥2 (HR = 2.01, p < 0.001) and an increased number of previous LOTs were associated with poor OS (the median OS of 26.2 vs. 16.2 vs. 9.6 months for one vs. two vs. three prior LOTs, p < 0.001). The above results were confirmed in anti-PD-(L)1 monotherapy non-small cell lung cancer patients (n = 384). Overall, ICIs were safe and efficacious in these typically underrepresented patient cohorts. We noted ECOG PS ≥ 2 and an increased prior LOTs were associated with poor ICI efficacy, and Black patients, compared to White patients, experienced fewer irAEs.

Patients with high-risk multiple myeloma (hrMM) relapse after autologous stem cell transplantation (ASCT) with a median progression free survival (PFS) of 8-14 months without lenalidomide maintenance and 24-39 months with lenalidomide maintenance. We hypothesized that Pembro-Rd will prolong PFS post-ASCT in patients with hrMM compared to historical controls. This Phase II study enrolled hrMM patients with primary objective to assess the efficacy of the combination of Pembro-Rd for a total of 2 cycles and then an additional 2 cycles without dexamethasone. There were 12 evaluable subjects, as enrollment was stopped after an FDA hold. With a median follow-up of 50.7 months, the median PFS was 27.7 months. The PFS rates at years 1 and 2 are 90.9% and 63.6%, respectively. The most common adverse events were neutropenia (grade 1-3), cough, diarrhea and constipation, all grade 1 or 2. The PFS rate with fixed duration therapy was comparable to that seen with continuous dose lenalidomide, potentially offering a new post-ASCT therapeutic strategy.

The first coronavirus disease 2019 (COVID-19) patient in the state of New Jersey (NJ) was admitted on March 2, 2020. With the number of hospitalized patients increasing exponentially in the following days and no established treatment approaches, research was to play a significant role in this fight. To facilitate review of all COVID-19 research proposals in a large health care network in NJ, we established the COVID-19 Research Review Committee (RRC) and implemented a peer-review process prior to the Institutional Review Board submission. The RRC was tasked with processing, soliciting, reviewing, and prioritizing research proposals and was comprised of a multidisciplinary group of reviewers. Within a 9-week period, three network-wide requests for proposals were released with 238 proposals submitted and 93 approved, an approval rate of 39%. The establishment of the RRC helped ensure scientific merit, better utilization of resources, collaborations across disciplines and network hospitals, and compliance with applicable regulatory and ethical standard.

Background: In the United States, 88.3% of all 1,163,000 maids and housekeeping cleaners are female, and approximately half of them Latinas. Latinas are understudied and underrepresented in health research, particularly involving chemical exposure in cleaning practices, lack of job training, and inadequate access to personal protective equipment. The purpose of this study is twofold: 1) to examine the knowledge (via training experiences), attitudes and behaviors of a heterogeneous group of Latinas who clean occupationally and 2) to assess their cleaning practices at work and at home.Methods: This mixed-method study consisted of two phases: 1) three focus groups to explore knowledge (via training experiences), attitudes, and behaviors regarding cleaning practices (N = 15) and 2) a 43-question cross-sectional survey. Focus group audio recordings were analyzed using descriptive and in vivo coding and then coded inductively to explore thematic analysis. Statistical analysis of the survey evaluated means, frequency and percentage for each of the responses.Results: Participants (n = 9) were women (mean age = 48.78 and SD = 6.72) from South America (n = 5), Mexico (n = 1), El Salvador (n = 1) and Dominican Republic (n = 2). The mean length of time living in the US was 18.78 years and over half (55.6%) worked in the cleaning industry for 10 or more years.Findings from the three focus groups (n = 15) included that training in cleaning often occurred informally at a very young age at home. Participants reported cleaning in groups where tasks are rotated and/or shared. Most were the primary person cleaning at home, suggesting increased exposure. Gloves and masks were the most frequently used PPE, but use was not consistent. For participants who purchase their own products, driving factors included price, smell and efficacy. Some participants used products supplied or preferred by the employer.Conclusions: Latinas in cleaning occupations face a range of social and health barriers including lack of safety and health training, inadequate PPE and low literacy. To address these issues, the development of an intervention is warranted to provide training and resources for this critical population of essential workers.

Investigator-Initiated vs. Investigator-Sponsored Research: Definitions Matter