Citations

Background: Understanding personal and geographic factors associated with smoking is important to design and implement interventions focused on reducing cancer health disparities. Scant research has been published recently regarding factors associated with smoking history associations within rural communities. Purpose: To examine demographic factors and rural residence history for associations with smoking history. Methodology: In a cross-sectional study of cancer-related behaviors, 1,786 adults (mean age 47.9 ± 17.5 years; 53% female, 84% White) completed an online survey in 2020. We examined factors associated with smoking history (having smoked at least 100 cigarettes) using independent t-tests, chi-square tests, and logistic regression. Results: Of the participants, 36% had a rural residence history and 49% had a smoking history. A larger proportion of men than women (61% vs. 37%; p < .001), White than Black participants (50% vs. 39%; p = .001), and rural than nonrural residents (53% vs. 46%; p = .005) had a smoking history. Logistic regression analysis revealed that the young age group (18–30) was less likely ( p = .002), whereas the middle age group (31–50) was more likely ( p < .001) to have a smoking history than those older than 50 years. Rural residence was associated with a smoking history among women ( p < .001), but not among men ( p = .70) in this sample. Conclusions: Tobacco control efforts are needed to focus on middle-aged men in general and women with rural residence history. Implications: Nurse practitioners are uniquely positioned to directly contribute to future research with self-identified rural populations that could help inform future public health policy.

Introduction The Florida-California Cancer Research, Education, and Engagement (CaRE 2 ) Health Equity Center is a triad partnership committed to increasing institutional capacity for cancer disparity research, the diversity of the cancer workforce, and community empowerment. This article provides an overview of the structure, process innovations, and initial outcomes from the first 4 years of the CaRE 2 triad partnership. Methods CaRE 2 serves diverse populations in Florida and California using a “molecule to the community and back” model. We prioritize research on the complex intersection of biological, environmental, and social determinants health, working together with scientific and health disparities communities, sharing expertise across institutions, bidirectional training, and community outreach. Partnership progress and outcomes were assessed using mixed methods and four Program Steering Committee meetings. Results Research capacity was increased through development of a Living Repository of 81 cancer model systems from minority patients for novel cancer drug development. CaRE 2 funded 15 scientific projects resulting in 38 publications. Workforce diversity entailed supporting 94 cancer trainees (92 URM) and 34 ESIs (32 URM) who coauthored 313 CaRE 2 -related publications and received 48 grants. Community empowerment was promoted via outreaching to more than 3000 individuals, training 145 community cancer advocates (including 28 Community Scientist Advocates), and publishing 10 community reports. CaRE 2 members and trainees together have published 639 articles, received 61 grants, and 57 awards. Conclusion The CaRE 2 partnership has achieved its initial aims. Infrastructure for translational cancer research was expanded at one partner institution, and cancer disparities research was expanded at the two cancer centers.

Abstract Purpose: Smoking rates are higher in rural regions compared to urban regions. Given the mobility within the United States, rural norms around tobacco use may persist even after individuals move to urban areas. Little research is available regarding the difference in smoking history by demographics and rural residence history. The purpose of the study was to examine the influence of age, race, gender, and rural residence history on smoking history. Methods: In a cross-sectional study, we surveyed 1,786 adults using two sampling approaches: representative panels and a community-engaged sample. Participants were asked to complete the Florida Health and Ancestry Study (FHAS) survey through a link or by the phone with a research assistant. The smoking history question asked whether participants had smoked 100 cigarettes in their lifetime (yes/no). The rural residence question asked participants to indicate (yes/no) whether they have lived in a rural or farming community, or on a farm. We examined associations of smoking history with demographic variables using the Chi-square test and logistic regression including as predictors age group (young=18-30, middle age=31-50, old=51+ years), gender, race, and rural living by gender. Results: Participants were mostly White (16% Black, 84% White), female (47% male) and with a mean age around 50 years (mean 47.9±17.5 years, ranged 18 to 91). 36% of the sample reported a history of rural residence, and 51% reported that they had not smoked 100 cigarettes in their lifetime. A larger proportion of males (61%) smoked at least 100 cigarettes compared to females (37%) (p&lt;.001). A significantly larger proportion of White participants (50%) smoked at least 100 cigarettes in their lifetime than Black participants (39%) (p=.001). A larger proportion of participants who had lived in a rural place (53%) had smoked at least 100 cigarettes compared to those who had not lived in a rural place (46%) (p=.005). Difference in mean age for those with or without a history of smoking 100 cigarettes was not statistically significant in this sample (p=.12). Logistic regression analysis revealed that relative to the old age group, the young age group was less likely (p&lt;.001) and the middle age group was more likely (p=.002) to have smoked 100 cigarettes. Males (p&lt;.001) were more likely to have smoked 100 cigarettes than females. Rural residence was associated with smoking among females (p&lt;.001) but not among males (p=.70). Adjusting for other predictors, the association with race was not statistically significant in this sample (p=.06). Conclusion: Findings that the age group 18-30 years is more likely to have avoided becoming smokers is encouraging but must be analyzed more thoroughly relative to possible use of e-cigarettes and other tobacco products. To reduce individuals becoming smokers, we recommend increased cancer control efforts targeted to males in general and to females with a rural residence history. Additional research is planned to examine additional smoking variables and compare them to national data. Citation Format: Tyra Reed, Destiny Gordon, Brenda W. Dyal, Keesha Powell-Roach, Miriam O. Ezenwa, Versie Johnson-Mallard, Janice L. Krieger, Folakemi T. Odedina, Yingwei Yao, Diana J. Wilkie. Demographic factors and rural residence history associated with smoking history [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-012.

2551 Background: Protein kinase C iota (PKCi) is overexpressed in non-small cell lung (NSCLC), ovarian and pancreatic cancers and promotes tumorigenesis. The gold compound aurothiomalate (ATM) inhibits downstream activation of Rac1 by PKCi. We sought to determine the maximum tolerated dose (MTD) of ATM. Methods: We conducted a phase I dose escalation trial of ATM in patients with NSCLC, ovarian or pancreatic cancer. In the dose escalation cohort patients received ATM IM weekly for three cycles (cycle duration 4 weeks) at 25 mg, 50 mg or 75 mg in a 3+3 design. The dose was not escalated for individual patients. Up to 9 subjects were allowed to enroll in the expansion cohort at the MTD. Blood samples were analyzed for elemental gold levels. Patients were evaluated for response every eight weeks with computed tomography using modified response evaluation criteria in solid tumors. Results: Fifteen patients, all pretreated, enrolled in this study. There were ten patients with NSCLC, four with ovarian cancer and one with pancreatic cancer. Six patients were treated at the 25 mg dose, 6 patients at 50 mg, and 2 at 75 mg. There was 1 dose limiting toxicity (DLT) at 25 mg (hypokalemia), 1 DLT at 50 mg (urinary tract infection), and none at 75 mg. There were 3 grade 3 hematologic toxicities in the dose escalation cohort. The recommended MTD of ATM is 50 mg, and 1 subject was treated in the expansion cohort at 50 mg. Patients received treatment for a median of 2 cycles (range 1-3). The best response observed was stable disease in 2 subjects. There appeared to be a dose-related accumulation of steady-state plasma concentrations of gold with concentrations exceeding 20 µM after one month of therapy with 75 mg of ATM and after 2 months of therapy with 50 mg of ATM, consistent with linear pharmacokinetics. Conclusions: In summary, this phase I study was successful in identifying ATM 50 mg IM weekly as the MTD. In this heavily pre-treated group of patients in who we observed at best stable disease, it remains unclear whether future investigations that target PKCi should focus on single agent ATM, combination therapy with ATM, or other PKCi inhibitors that are currently in development. Clinical trial information: NCT00575393.

7605 Background: Overall survival (OS) can be partitioned into progression-free survival (PFS) and PPS. PPS helps to understand trial results, especially when PFS and OS data on trial treatment effects are discordant. At ASCO 2011, we reported that the magnitude of difference in the PFS estimates using different DP date methods was large enough to alter trial conclusions. Here, we investigate the impact of the DP date method on 1) PPS estimates, and 2) predictive utility of DP metrics on subsequent OS (SOS). Methods: Individual patient (pt) data from 14 trials were pooled. DP date was determined using: reported progression date (RPD) (method 1, M1), one day after last progression-free (PF) scan (M2), and midpoint between last PF scan and RPD (M3). PPS was estimated using the method of Kaplan-Meier for the 3 DP date methods. A flexible landmark analysis at 2, 4, and 6 months (mos) using Cox proportional hazards model was used to assess the impact of DP status (progression versus no-progression) on SOS (using M1, M2, or M3). Results: Among NSCLC (SCLC), 87% (91%) of pts reported DP. As expected, the PPS estimates were the lowest for RPD, highest for M2, and in-between for M3 (a direct consequence of the DP date method); with no difference by arm for the randomized trials. Regardless of the DP date method, patients who were progression-free had improved SOS (NSCLC: Hazard ratio, HR<=0.33; p < 0.0001; SCLC: HR<=0.48; p < 0.002) at each landmark time point, with comparable concordance index (SCLC: 0.57-0.65; NSCLC: 0.63-0.67), i.e., ability to discriminate patients with different SOS outcomes. Conclusions: While the DP date methods do not impact the predictive utility of the DP metrics, they significantly impact PPS estimates. The translation of a significant treatment effect on PFS to an effect on OS is influenced by PPS (longer PPS dilutes effect on OS). Standards for declaring DP date are thus critical to trial design and for trial go/no-go decisions. [Table: see text]

e13052 Background: The combination of GEM and CDDP has shown activity in a variety of cancers, including biliary tract/gallbladder. Preclinical testing shows a potential benefit to the addition of EV. Methods: Using a standard 3+3 design, the MTDs of GEM + EV (Cohort I) and GEM + CDDP + EV (Cohort II) were determined as shown in the table. The MTD was defined as the dose level below the lowest dose that induces a DLT in at least one-third of pts. At the MTD of Cohort II, 10 patients were enrolled with biliary tract/gallbladder cancer (Cohort III). A weekly CBC was obtained. Assessments occurred every 3 weeks and imaging for response at every other cycle. Results: In Cohort I (N=12), no DLT occurred at dose level 0, and in dose level 1, grade 3 thrombocytopenia was found in 2 of 6 pts. The MTD for Cohort I was determined to be dose level 0. Responses were seen in 3 pts: 2 CRs (primary peritoneal, pancreatic) and 1 PR (breast). In Cohort II (N=15) DLTs at dose level 0 were neutropenia and thrombocytopenia in 2 of 3 pts and at dose level -1, thrombocytopenia in 2 of 6 pts. At dose level -2, 1 of 6 pts experienced a DLT (grade 3 thrombocytopenia), establishing this dose level as the MTD. Responses were seen in 2 pts, both PRs (ampullary, pheochromocytoma). All 10 pts have been enrolled in Cohort III with 2 DLTs (neutropenia and thrombocytopenia). Stable disease seen in 5 of 7 evaluable pts. Conclusions: Gem + EV was well tolerated at dose level 0, though dose escalation was limited by thrombocytopenia. GEM + CDDP + EV had DLTs of neutropenia and thrombocytopenia leading to the MTD of dose level of -2. Cohort III is fully accrued and the 2 DLTs are hematologic. [Table: see text]

7555 Background: In a retrospective exploratory analysis of E4599, patients (pts) > 70 yo had a higher frequency of and more severe toxicities without apparent survival benefit from the addition of B to C+paclitaxel. We hypothesized that in this pt population, B will have better safety and efficacy profile when used in combination with C+P. Methods: Pts >/= 70 yo with previously untreated stage IIIB/IV (TNM 6th ed) nonsquamous NSCLC, ECOG PS 0-1, measurable disease and adequate organ function were eligible. C at AUC 6, P at 500 mg/m2 and B at 15 mg/kg were administered on day 1 of each 21-day cycle for up to 6 cycles followed by maintenance P+B in patients with CR, PR or SD. The primary endpoint was 6-month progression-free survival (PFS) rate. The treatment would be considered promising based on a single arm one-stage binomial design if 34 or more successes out of 55 patients were observed. This design had an exact significance level of 0.05 at 93% power to detect a true success rate of at least 70%. Polymorphisms in VEGFA, FPGS, GGH, SLC19A1 and TYMS in germline DNA were correlated with treatment outcome. Results: 58 eligible pts were enrolled; 29 males/29 females. Median age was 75. Median treatment cycles received was 6. Grade 3 or higher adverse events (AE) were reported in 49 (85%) pts. There were no treatment-related deaths. The most common grade 3/4 AEs(regardless of attribution) were hypertension (10%), fatigue (28%), dehydration (9%), neutropenia (43%) and thrombocytopenia (21%). There were 3 (5%) grade 3/4 hemorrhagic events. 8 (14%) had grade 4 neutropenia and 3 (5%) had grade 4 thrombocytopenia. Grade 3/4 ischemic/thromboembolic events occurred in 6 pts (10%). Thirty-four out of the first 54 (63%, 95% CI: 48.7-75.7%) evaluable pts met the primary endpoint (4 pts were lost to follow-up prior to 6 months). The confirmed ORR was 37.9% (95% CI: 25.5-51.6%). Median time to treatment failure was 4.8 months (95% CI: 3.9-6.4). Median PFS was 7.1 months (95% CI: 5.9-11.7), median OS was 13.7 months (95% CI: 9.4-15.7). Results of SNP analysis will be presented. Conclusions: C+P+B followed by maintenance P+B is an active and tolerable first-line regimen for elderly patients with good PS.