ABSTRACT
Hypertension (HTN) is the strongest modifiable risk factor for CVD that is disproportionately higher in racial/ethnic groups, e.g., Native Hawaiians. Native Hawaiians have over a 50% prevalence of HTN (i.e., systolic blood pressure (SBP) of =130mmHg or diastolic blood pressure (DBP) of =80mmHg), placing them at higher risk for CVD. Behavioral/biological risk factors (e.g., BMI, diet, physical activity) are often the focus of epidemiological and intervention research;yet, socioeconomic factors, such as food insecurity, also affect blood pressure.The purpose of this study is to examine the association between food insecurity and SBP and DBP in Native Hawaiians communities, controlling for demographics and behavioral/biological risk factors.Participants in this 2020, cross-sectional study (N = 125) were from six, predominantly Native Hawaiian communities across Hawai'i. Demographic variables included age, sex, education, and race/ethnicity. Potential confounding variables were leisure-time physical activity, daily servings of processed meat, daily servings of red meat, daily servings of fruit and vegetables, resilience, BMI, use of HTN medication, and COVID-19 related mental health. To assess food insecurity participants were asked to indicate how often money for food runs out by the end of the month on a 5-point Likert scale, with higher scores indicating greater frequency. SBP and DBP were measured according to a standardized protocol. All confounding variables with a significant bivariate correlation with SBP or DBP were entered into the respective multiple regression model.Participants were predominantly female (73, 58.4%), had some college or were college graduates (73, 58.4%), a mean age of 39.2yrs (SD=9.9) and mean BMI of 31.6 (SD=8.7). Mean SBP and DBP were in the normotensive range, 122.9+/-17.5 and 79.5+/-11.9, respectively. Female sex (beta=-9.9, SE=2.6, p<0.001), daily servings of fruit and vegetables (beta=-2.35, SE=1.04, p=0.026), BMI (beta=0.76, SE=0.16, p<0.001), use of HTN medication (beta=14.01, SE=4.90, p=0.005), and food insecurity (beta=2.09, SE=0.95, p=0.030) were associated with SBP (R2=0.40, SE=14.05, p<0.001). Male sex, fewer daily servings of fruit and vegetables, greater BMI, use of HTN medication, and more food insecurity were significantly associated with higher DBP. Female sex (beta=-5.03, SE=1.90, p=0.009), BMI (beta=0.51, SE=0.12, p<0.001), and food insecurity (beta=1.36, SE=0.69, p=0.05) were associated with DBP (R2=0.31, SE=10.18, p<0.001). Male sex, greater BMI, and more food insecurity were significantly associated with higher DBP.After controlling for potential confounders, food insecurity retains a significant, independent association with both SBP and DBP such that a greater frequency of food insecurity was related to higher SBP and DBP. This provides additional evidence for the idea that food insecurity may directly impact CVD risk.
ABSTRACT
Background Taletrectinib is a potent, next-generation, CNS-active, ROS1 tyrosine kinase inhibitor (TKI) with selectivity over TRKB. In previous reports from TRUST-I, taletrectinib showed meaningful clinical efficacy and was well tolerated in pts with ROS1+ NSCLC (n = 109) regardless of crizotinib (CRZ) pretreatment status. We report updated efficacy and safety data with ~1.5 yr follow-up. Methods TRUST-I is a multicenter, open-label, single-arm study with two cohorts: ROS1 TKI-naive and CRZ-pretreated. Pts in both cohorts received taletrectinib 600 mg QD. Key study endpoints included IRC-confirmed ORR (cORR), DoR, disease control rate (DCR), PFS, and safety. A pooled analysis of ORR, PFS, and safety including pts from additional clinical trials was also conducted. Results In the 109 pts from TRUST-I (enrolled prior to Feb 2022) the median follow-up was 18.0 mo in TKI-naive (n = 67) and 16.9 mo in CRZ-pretreated pts (n = 42). cORR was 92.5% in TKI-naive and 52.6% in CRZ-pretreated pts (table). Median DoR (mDoR) and mPFS were not reached. Intracranial-ORR was 91.6%;ORR in pts with G2032R was 80.0%. In a pooled analysis with phase I studies, ORR was 89.5% and 50.0% for TKI-naive and CRZ-pretreated pts, respectively;mPFS was 33.2 mo and 9.8 mo. In 178 pts treated at 600 mg QD, treatment-emergent adverse events (TEAEs) were 92.7%;most (64.0%) were grade 1-2. The most common TEAEs were increased AST (60.7%), increased ALT (55.6%), and diarrhea (55.6%). Neurological TEAEs (dizziness, 18.5%;dysgeusia, 12.4%) and discontinuations due to TEAEs (3.4%) were low. Further updated results will be presented. [Formula presented] Conclusions With additional follow-up, taletrectinib continued to demonstrate meaningful efficacy outcomes including high response rates, prolonged PFS, robust intracranial activity, activity against G2032R, and tolerable safety with low incidence of neurological AEs. Clinical trial identification NCT04395677. Editorial acknowledgement Medical writing and editorial assistance were provided by Arpita Kulshrestha of Peloton Advantage, LLC, an OPEN Health company, and funded by AnHeart Therapeutics, Inc Legal entity responsible for the study AnHeart Therapeutics, Inc. Funding AnHeart Therapeutics, Inc. Disclosure S. He: Financial Interests, Personal, Other, Employment: AnHeart Therapeutics. T. Seto: Financial Interests, Institutional, Research Grant: AbbVie, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Kissei Pharmaceutical, MSD, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical;Financial Interests, Personal, Other, Employment: Precision Medicine Asia;Financial Interests, Personal, Speaker's Bureau, Honoraria for lectures: AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Daiichi Sankyo, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Mochida Pharmaceutical, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, Takeda Pharmaceutical, Towa Pharmaceutical. C. Zhou: Financial Interests, Personal, Other, Consulting fees: Innovent Biologics Qilu, Hengrui, TopAlliance Biosciences Inc;Financial Interests, Personal, Speaker's Bureau, Payment or honoraria: Eli Lilly China, Sanofi, BI, Roche, MSD, Qilu, Hengrui, Innovent Biologics, C-Stone LUYE Pharma, TopAlliance Biosciences Inc, Amoy Diagnositics, AnHeart. All other authors have declared no conflicts of interest.Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc.