A phase 2, randomized, double-blind, placebo- controlled study of chemo-immunotherapy combination using motolimod with pegylated liposomal doxorubicin in recurrent or persistent ovarian cancer: a Gynecologic Oncology Group partners study.

A phase 2, randomized, placebo-controlled trial was conducted in women with recurrent epithelial ovarian carcinoma to evaluate the efficacy and safety of motolimod-a Toll-like receptor 8 (TLR8) agonist that stimulates robust innate immune responses-combined with pegylated liposomal doxorubicin (PLD), a chemotherapeutic that induces immunogenic cell death. Women with ovarian, fallopian tube, or primary peritoneal carcinoma were randomized 1 : 1 to receive PLD in combination with blinded motolimod or placebo. Randomization was stratified by platinum-free interval (≤6 versus >6-12 months) and Gynecologic Oncology Group (GOG) performance status (0 versus 1). Treatment cycles were repeated every 28 days until disease progression. The addition of motolimod to PLD did not significantly improve overall survival (OS; log rank one-sided P = 0.923, HR = 1.22) or progression-free survival (PFS; log rank one-sided P = 0.943, HR = 1.21). The combination was well tolerated, with no synergistic or unexpected serious toxicity. Most patients experienced adverse events of fatigue, anemia, nausea, decreased white blood cells, and constipation. In pre-specified subgroup analyses, motolimod-treated patients who experienced injection site reactions (ISR) had a lower risk of death compared with those who did not experience ISR. Additionally, pre-treatment in vitro responses of immune biomarkers to TLR8 stimulation predicted OS outcomes in patients receiving motolimod on study. Immune score (tumor infiltrating lymphocytes; TIL), TLR8 single-nucleotide polymorphisms, mutational status in BRCA and other DNA repair genes, and autoantibody biomarkers did not correlate with OS or PFS. The addition of motolimod to PLD did not improve clinical outcomes compared with placebo. However, subset analyses identified statistically significant differences in the OS of motolimod-treated patients on the basis of ISR and in vitro immune responses. Collectively, these data may provide important clues for identifying patients for treatment with immunomodulatory agents in novel combinations and/or delivery approaches. Clinicaltrials.gov, NCT 01666444

Critical Reflection About Socioeconomic Inequalities Among White Young Men From Poor and Working-Class Backgrounds

An intersectional approach to human development emphasizes the multiple social categories individuals occupy, some of which confer privilege (e.g., being White) and some of which confer marginalization (e.g., being poor). This approach is needed especially in critical consciousness scholarship, and particularly in regard to understanding whether and how it may manifest among youth who simultaneously experience privileges due to some aspects of their identities and marginalization due to other aspects of their identities. We explored critical reflection (CR) about socioeconomic inequalities through interviews with 31 White young men from low-income and working-class backgrounds who were attending trade colleges in Pennsylvania. Participants were asked about their understandings of the causes of poverty in the United States and potential solutions. Multiple rounds of qualitative analysis were conducted to understand the potential manifestation of CR in responses. Inductive across-case thematic analysis yielded 11 themes describing participants\u27 understandings of poverty. We then conducted case-based analyses to identify the specific attributions about poverty that each participant made (structural, fatalistic, and/or individual), the ways in which these attributions arose in responses, and how the pattern identified related to CR. Eight participants were identified as having some CR or the potential to develop CR, and their responses were explored for references to experiences that may have been related to CR as well as their membership in a privileged racial and gender group, and more marginalized socioeconomic group. Implications for examining and promoting CR in different groups of youth are discussed. © 2019 American Psychological Association

Development and Pilot Testing of a Bilingual Environmental Health Assessment Tool to Promote Asthma-Friendly Childcares

Background: Childhood marks the highest risk for allergic sensitization to asthma triggers. Hispanic/Latino children are at higher risk for hospitalization for asthma than non-Hispanic White children. Childcare providers lack knowledge about reducing asthma triggers. Objectives: The purpose of this paper is to describe a community-based participatory research (CBPR) initiative aimed at developing and pilot testing a bilingual walk-through assessment tool for asthma-friendly childcare environments. Methods: Ten Latina mothers of children with asthma living in the Pacific Northwest collaborated with research partners to develop and pilot test a Childcare Environmental Health (CEH) assessment walk-through survey. Results and Lessons Learned: The women innovated the survey with photography and structural examinations of stress and provision of basic needs. The survey tool identified environmental threats to asthma in all three childcares surveyed. Conclusions: Parents are well-positioned to build trust with childcare providers, assess asthma triggers, and recommend practical mitigation strategies. © 2018 Johns Hopkins University Press