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PURPOSE: Minoritized racial/ethnic groups are historically under-represented in cancer clinical trials, which may be exacerbated in recent trials on immune checkpoint inhibitors (ICIs). We examined the representation and reporting of the racial/ethnic composition of participants in clinical trials on ICIs. METHODS: We examined English full-text trials on ICIs published from 2007 to 2022. Information on trial characteristics and racial/ethnic composition of participants was extracted from published papers or ClinicalTrials.gov. Differences in participation by publication year, ICI agent, and cancer site were analyzed. Enrollment-incidence ratio (EIR) was calculated to compare the proportion of minoritized racial/ethnic group patients in US-based trials against age-adjusted cancer incidence data available for the US population. An EIR > 1 signified over-representation, whereas an EIR <1 signified under-representation. RESULTS: Of the 471 trials examined, racial composition was unreported in 146 (31%), whereas Hispanic/Latinx ethnicity was unreported in 278 (59%). Only 30 (6%) trials reported race/ethnicity-specific results. In US-only trials (n = 174), White patients were over-represented (EIR, 1.20 [95% CI, 1.17 to 1.22]), whereas Hispanic/Latinx patients were the most under-represented (EIR, 0.35 [95% CI, 0.24 to 0.48]), followed by Black/African American patients (EIR, 0.66 [95% CI, 0.54 to 0.79]). Subgroup analyses consistently indicated over-representation of White patients across publication years (EIR, 1.19-1.24), ICI classes (EIR, 1.16-1.23), and cancer sites (EIR, 1.11-1.31), whereas Hispanic/Latinx patients were consistently under-represented. An upward trend of trial representation and reporting was observed for all minoritized racial/ethnic groups over time (trend P values ≤.05). CONCLUSION: Disparities in the representation and reporting of minoritized racial/ethnic groups persist in recent trials on ICIs, necessitating collaborative efforts for improved diversity and equitable cancer treatment access.

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BACKGROUND: Vitamin D is critical to bone health by regulating intestinal absorption of calcium, whereas proinflammatory cytokines, including IL-1, IL-6, IL-12, and TNF-α, are known to increase bone resorption. We hypothesized that vitamin D and these cytokines at the time of breast cancer diagnosis were predictive for fragility fractures in women receiving aromatase inhibitors (AIs). METHODS: In a prospective cohort of 1,709 breast cancer patients treated with AIs, we measured the levels of 25-hydroxyvitamin D (25OHD), IL-1ß, IL-6, IL-12, and TNF-α from baseline blood samples. The associations of these biomarkers were analyzed with bone turnover markers (BALP and TRACP), bone regulatory markers (OPG and RANKL), bone mineral density (BMD) close to cancer diagnosis, and risk of fragility fractures during a median of 7.5 years of follow up. RESULTS: Compared to patients with vitamin D deficiency, patients with sufficient levels had higher bone turnover, lower BMD, and higher fracture risk; the latter became non-significant after controlling for covariates including BMD and no longer existed when patients taking vitamin D supplement or bisphosphonates or with history of fracture or osteoporosis were excluded. There was a non-significant trend of higher levels of IL-1ß and TNF-α associated with higher risk of fracture (highest vs. lowest tertile, IL-1ß: adjusted HR=1.37, 95% CI=0.94-1.99; TNF-α: adjusted HR=1.38, 95% CI=0.96-1.98). CONCLUSIONS: Our results do not support proinflammatory cytokines or vitamin D levels as predictors for risk of fragility fractures in women receiving AIs for breast cancer.

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Identifying women at high risk of osteoporotic fracture from aromatase inhibitor (AI) therapy for breast cancer is largely based on known risk factors for healthy postmenopausal women, which might not accurately reflect the risk in breast cancer patients post-AI therapy. To determine whether a polygenic score associated with fracture in healthy women is also significant in women treated with AIs for breast cancer, we used data from a prospective observational cohort of 2152 women diagnosed with hormonal receptor positive breast cancer treated with AIs as the initial endocrine therapy and examined a polygenic score of heel quantitative ultrasound speed of sound (gSOS) in relation to incident osteoporotic fracture after AI therapy during a median 6.1 years of follow up after AI initiation. In multivariable models, patients with the second and third highest tertiles (T) versus the lowest tertile of gSOS had significantly lower risk of fracture (T2: adjusted HR = 0.61, 95% CI: 0.46-0.80; T3: adjusted HR = 0.53, 95% CI: 0.40-0.70). The lower risk of fracture in patients with the highest tertile of gSOS remained significant after further adjustment for BMD at the hip (T3: adjusted HR = 0.62, 95% CI: 0.42-0.91). In conclusion, our analysis showed gSOS as a novel genetic predictor for fracture risk independent of BMD among breast cancer patients treated with AIs. Future studies are warranted to evaluate the performance of incorporating gSOS in prediction models for the risk of AI-related fracture in breast cancer patients.

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Previous studies suggest associations of metabolic syndromes with breast cancer prognosis, yet the evidence is mixed. In recent years, the maturation of genome-wide association study findings has led to the development of polygenic scores (PGS) for many common traits, making it feasible to use Mendelian randomization to examine associations between metabolic traits and breast cancer outcomes. In the Pathways Study of 3,902 patients and a median follow-up time of 10.5 years, we adapted a Mendelian randomization approach to calculate PGS for 55 metabolic traits and tested their associations with seven survival outcomes. Multivariable Cox proportional hazards models were used to derive HRs and 95% confidence intervals (CI) with adjustment for covariates. The highest tertile (T3) of PGS for cardiovascular disease was associated with shorter overall survival (HR = 1.34, 95% CI = 1.11-1.61) and second primary cancer-free survival (HR = 1.31, 95% CI = 1.12-1.53). PGS for hypertension (T3) was associated with shorter overall survival (HR = 1.20, 95% CI = 1.00-1.43), second primary cancer-free survival (HR = 1.24, 95% CI = 1.06-1.45), invasive disease-free survival (HR = 1.18, 95% CI = 1.01-1.38), and disease-free survival (HR = 1.21, 95% CI = 1.04-1.39). PGS for serum cystatin C levels (T3) was associated with longer disease-free survival (HR = 0.82, 95% CI = 0.71-0.95), breast event-free survival (HR = 0.74, 95% CI = 0.61-0.91), and breast cancer-specific survival (HR = 0.72, 95% CI = 0.54-0.95). The above associations were significant at a nominal P < 0.05 level but not after correcting for multiple testing (Bonferroni P < 0.0009). Our analyses revealed notable associations of PGS for cardiovascular disease, hypertension, and cystatin C levels with breast cancer survival outcomes. These findings implicate metabolic traits in breast cancer prognosis. Significance: To our knowledge, this is the largest study of PGS for metabolic traits with breast cancer prognosis. The findings revealed significant associations of PGS for cardiovascular disease, hypertension, and cystatin C levels with several breast cancer survival outcomes. These findings implicate an underappreciated role of metabolic traits in breast cancer prognosis that would warrant further exploration.

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PURPOSE: To determine whether use of alternative tobacco products (i.e., cigars, blunts, hookah, smokeless tobacco), alcohol, and marijuana differs among adolescents who currently use (1) electronic cigarettes (e-cigarettes); (2) cigarettes only; and (3) never smokers. METHODS: Analysis of a self-reported survey from four high schools in 2010-2011 (n = 3,102) with a subsample (n = 1,556) surveyed on alcohol and marijuana. Analyses were conducted with multinomial logistic regression models accounting for clustering by schools. RESULTS: The sample contained 2.4% (n = 76) e-cigarette users, 12.4% (n = 386) cigarette smokers, and 85.1% (n = 3,197) never smokers. E-cigarette users were more likely than cigarette-only smokers to report blunt (adjusted odds ratio, 1.81; 95% confidence interval, 1.21-2.71) and hookah use (adjusted odds ratio, 3.12; 95% confidence interval, 1.90-5.13), but not cigar, smokeless tobacco, alcohol, or marijuana use. CONCLUSIONS: E-cigarette users are more likely than cigarette smokers to use hookah and blunts.

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CT scans are becoming a more common method for detecting lung cancers at an earlier, potentially more curable, stage of disease. There is currently little data on attitudes and beliefs about screening for lung cancer. This paper presents the results of a 2011 survey of adult current and former smokers that queried about past use of CT scanning and reasons for having or not having the screening done. A random-digit dialed telephone survey was administered to a representative sample of 1290 US adults. Logistic regression analyses were used to examine the correlates of having the test while controlling for the covariates. A total of 13.4% (n = 45) of the sample had ever had a CT scan to detect lung cancer. Of current smokers, 14.6% had received a CT scan, as compared with 12.7% of former smokers. The oldest age group (55+) was significantly more likely to have received a CT scan than the younger age groups. 78.5% of current smokers and 81.4% of former smokers indicated willingness to get the test if advised to do so by their doctor. Among those who said they were not willing to get screened, lack of insurance coverage was cited by 33% of current smokers and 25% of former smokers. Additionally, 33% of current smokers were afraid to find out whether they had cancer. The main barrier to CT scanning for lung cancer is likely to be insurance coverage for the test, which would be a burden for those on limited and fixed incomes. Next steps should include further research into the effect of increased public education about the availability, risks, benefits and barriers to lung cancer screening.

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Electronic nicotine delivery systems (ENDS) have been gaining in popularity. The few prevalence studies in adults have found that most ENDS users are current or former smokers. The objectives of this study were to estimate the prevalence of ENDS usage in adolescents, and examine the correlates of use. Self-administered written surveys assessing tobacco use behaviors were conducted in multiple waves as part of a larger intervention study in two large suburban high schools. The prevalence of past-30 day ENDS use increased from 0.9% in February 2010 to 2.3% in June 2011 (p=0.009). Current cigarette smokers had increased odds of past-30 day ENDS use in all study waves. When adjusted for school, grade, sex, race and smoking status, students in October 2010 (Adjusted OR 2.12; 95% confidence interval (CI): 1.12-4.02) and June 2011 (Adjusted OR 2.51; 95% CI: 1.17-4.71) had increased odds past-30 day ENDS use compared to February 2010. The prevalence of ENDS use doubled in this sample of high school students, and current cigarette smoking is the strongest predictor of current use. Continued monitoring of ENDS is needed to determine whether it increases the likelihood of cigarette smoking initiation and maintenance in youth.

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