Baksh, Mizba

AbstractIntroductionHealth information technology (HIT) has the potential to improve healthcare delivery and engagement. Studying racial‐ethnic disparities in HIT engagement will help understand and overcome challenges to healthcare utilization.MethodsWe undertook a patient‐reported survey among patients with lymphoid malignancies at two campuses of Mayo Clinic, Florida to explore HIT‐related disparities. Variables between Whites and non‐Whites, and non‐Whites from the two campuses were compared.ResultsThe survey was completed by 1004 respondents, with 71% whites, 27% non‐Whites (race‐ethnicity not reported by 2%). Non‐Whites included 30% responders at the main campus and 64% at an inner‐city campus. Whites were significantly older and had higher education, while non‐Whites had lesser access to a computer. Only 51% of non‐Whites were registered to use electronic medical records (EMR) as compared to 72% Whites (p < 0.001) and significantly lesser number of non‐Whites even knew that EMR existed (81% vs. 92%, p < 0.001). Encouragingly, a higher number of non‐Whites wanted to engage in EMR. Non‐Whites from the main campus were older, more educated and had more access to a computer as compared to those from the inner‐city campus. Similar disparate factors were noted among minorities from the two campuses, suggesting impact of socioeconomic backgrounds on EMR usage among non‐Whites. Linguistic barriers were more striking among inner‐city campus non‐Whites.ConclusionsNon‐Whites continue to struggle with suboptimal utilization of the healthcare system and barriers related to integration in HIT, including disparities representing socioeconomic differences. Efforts need to be made at several levels to help racial‐ethnic minorities overcome awareness, access, and linguistic barriers to HIT utilization.

Introduction Contiguous non-mass enhancement (NME) often coexists with a solid tumor component on MRI, but it can be challenging to predict whether NME represents invasive breast cancer, ductal carcinoma in situ (DCIS), benign disease, or biopsy site reaction. The purpose of this study was to determine the association between the size/extent of NME and the presence of invasive cancer and/or DCIS on final pathology. Methods This was a single institution retrospective analysis of a prospectively maintained breast cancer registry (2010-2020). Female patients who underwent surgical resection were included if they had a diagnosis of invasive breast cancer (with or without DCIS) and had an MRI showing both a solid mass and contiguous NME. The size of NME on MRI was compared with the size of invasive cancer and/or DCIS on the final pathology. Results From a total of 3443 patients, 225 patients were included. 86.2% had invasive ductal carcinoma (IDC), and 12.0% had invasive lobular carcinoma 76.9% were ER+, 16.4% were HER2+, and 13.3% were triple negative breast cancer (TNBC). 18.7% received neoadjuvant chemotherapy (NCT) of whom 31% achieved a complete radiographic/pathologic response. Pearson correlation coefficients (r) between the size of NME and invasive cancer/DCIS showed a strong and positive correlation of MRI NME with DCIS on pathology in patients without NCT. Subgroup analysis showed the strongest correlations for NME and DCIS among non-white (r = .70) and HER2 + patients (r = .74) who did not receive NCT. Conclusions Strong correlations between NME and DCIS were found for HER2 + disease and non-white patients, but only modest correlations were found for other patient/disease characteristics. These correlations may impact decisions in surgical approach.

8022 Background: Bone marrow (BM) assessment of minimal residual disease (MRD) is being considered as a surrogate endpoint in clinical trials and is prognostic for survival in multiple myeloma (MM). Timing of BM assessment is variable across Chimeric Antigen Receptor T cell (CART) therapy trials and differs from standard of care practice. BM myeloma cell clearance can be detected by month 1 post CART, even before serum immunofixation becomes negative. BM is still hypocellular at month 1, thus prognostic value of MRD negative (MRDneg) at this timepoint is unclear. We examined impact of Day 30 MRD status in patients (pts) who received CART at Mayo Clinic. Methods: Medical records were reviewed retrospectively for MM pts who received CART between 8/2016 and 6/2021. PFS and OS were plotted by Kaplan-Meier method. Results: Sixty MM pts received CART and had BM biopsy at month 1. Median age was 62 yrs, 53% were male, and 78% were BM MRDneg by flow cytometry. Baseline demographics were similar between MRDneg and MRD+ (Table). Overall, 85% (40/47) who were month 1 BM MRDneg had i/u FLC<normal. Patients who achieved CR/sCR had higher rates of BM MRDneg (100% vs 61%, p<0.001) and i/u FLC< normal (89% vs 58%, p<0.001). At month 1, 24/60 (40%) pts had hypocellular BM. Serial BM samples at month 3 (n=35), 6 (n=28) and 12 (n=23) showed MRDneg rate of 93% (25/27), 56% (9/16) 58% (7/12), respectively.. Rate of hypocellularity was 54% (19/35), 32% (9/28) and 30% (7/23), respectively. Among the MRDneg/hypocellular pts at month 1, hypocellular BM was seen in 8/11 (73%) pts at month 3 and 2/4 (50%) pts at month 6 and 12. Compared to MRD+, pts who had BM MRDneg at months1 had longer PFS (Table). PFS was not statistically significantly different between pts who had BM MRDneg and were either hypocellular or not. MRDneg pts with i/u FLC<normal at months1 had better median PFS compared to those who did not. (MRD+:2.9 months (1.2-NR). MRDneg/FLC>normal: 4.9 months (2.3-NR). vs MRDneg/FLC<normal:17.9 months (11.8-NR), p<0.0001). Conclusions: Hypocellular BM is common in the 3 months post CART. Regardless of BM cellularity, BM MRDneg at month 1 correlates with deep response and prolonged PFS. Majority of BM MRDneg pts at month 1 also had FLC<normal. BM MRDneg status and FLC normalization were associated with longer survival. Our data support the continued evaluation of BM early post CART infusion as a prognostic tool. [Table: see text]

The management of cancer has always relied heavily on the imaging modalities used to detect and monitor it. While many of these modalities have been around for decades, the technology surrounding them is always improving, and much has been discovered in recent years about the nature of tumors because of this. There have been several areas that have aided those discoveries. The use of artificial intelligence has already helped immensely in the quality of images taken but has not yet been widely implemented in clinical settings. Molecular imaging has proven to be useful in diagnosing different types of cancers based on the specificity of the probes/contrast agents used. Intravital imaging has already uncovered new information regarding the heterogeneity of the tumor vasculature. These three areas have provided a lot of useful information for the diagnosis and treatment of cancer, but further research and development in human trials is necessary to allow these techniques to fully utilize the information obtained thus far.

Abstract Background: There is an urgent need to improve clinical trial (CT) enrollment of breast cancer (BC) patients (pts), especially from unrepresented minorities. In this regard, our study aims to better understand the characteristics and factors associated with CT enrollment to inform strategies to enhance CT accrual rates. Method: We included 1,308,767 female pts from the National Cancer Data Base diagnosed from 2010 to 2017 with known ER, PR, and HER2 status. Demographic, socioeconomic, Charlson-Deyo Score (CDS) and BC specific data were compared between CT versus non-CT enrolled pts for initial therapy. Comparisons were assessed by Chi-square test. Logistic regression was utilized to determine associations between characteristics and CT enrollment. Odds ratios (OR) and p-values are reported for each group. Results: A total of 1797 pts (0.14%) were enrolled in CT for initial BC therapy. Focusing on the CT group, majority of pts were non-Hispanic White (W;(78.2%), followed by non-Hispanic black (AA;12.2%); Hispanic (H; 5.6%); and non-Hispanic Asian (A; 4%). Most pts (29.3%) were in 50-59 age quartile. TNBC pts formed 22% of CT pts and non-TNBC were 78%. Most pts were from academic centers (54%), followed by comprehensive community cancer (CCC; 23.5%), community cancer (3.9%) and integrated network cancer (INC; 5.6%) programs. Most had private insurance (70%) versus government insurance (27%) and others (3%). Stage IV pts were only 10% of the CT group while most pts (41%) had Stage II BC. CDS of 0 was noted in 90% pts while 1.3% pts had CDS of 2 or more. Most CT pts traveled &lt; 50 miles from treatment center (88.5%), and only 1.2% CT pts traveled 200 or more miles. Most CT pts resided in areas with highest literacy rate (30%) while 15% were from areas with lowest literacy rate. In multivariable model, non-white pts were less likely than Whites to be enrolled in CT (OR 0.81, p&lt;0.05). The odds of CT enrollment in 40-49, 50-59 and 60-69 age quartiles were 3.5, 2.7 and 2.3 times respectively that of pts 70 years or older (p&lt;0.001). TNBC pts were 1.9 times more likely to be enrolled in CT than non-TNBC pts (p&lt;0.001). Academic center pts were 3 times more likely (p&lt;0.001) while INC program pts were less likely than CCC pts to be enrolled (OR 0.7, p=0.006). Pts with government insurance and other insurance were less likely to enroll in CT (OR 0.74, and 0.55, p &lt;0.001 and p=0.003, respectively) compared to private insurance. The odds of a patient with stage II, III, IV BC enrolling in CT was about 2, 3.5 and 4 times higher than a stage I pt (p -&lt;0.001). Pts with CDS 1 (OR 0.8, p=0.025) or 2 or more (OR 0.5, p=0.002) were less likely than CDS 0 pts to be enrolled. Pts who traveled 50-99 or 100-199 miles from the treatment center conducting CT, were 1.9 (p&lt;0.001) and 1.5 times (p&lt;0.05) more likely to be enrolled while those with &gt; 200 miles were less likely (OR 0.75, p=0.442). The group of pts who belonged to a residential area with the highest literacy rate (&lt;6.3% of no high school diploma) were 1.4 times more likely to accrue in CT (p&lt;0.001) than those with high school diploma rate between 6.3 and 10.8%. Compared to metro areas, pts from rural areas were less likely to be enrolled (OR 0.5, p=0.04) as was a lower median income &lt; $40,227 (OR 0.77, p= 0.016).Conclusion: CT enrollment is poor for initial therapy of BC treatment. We identify several modifiable factors including sociodemographics which are associated with BC pts not getting treated on CT. There are other factors that are non-modifiable, e.g., disease stage but may point to the need for more CT development in these areas. Addressing these disparities would lead to improved CT enrollment and overall advancement in BC management landscape. Citation Format: Pooja P Advani, Aaron Spaulding, Alexander Hochwald, Mizba Baksh, David Hodge, Saranya Chumsri, Shanada Monestime, Sikander Ailawadhi. Clinical trial enrollment for initial therapy of breast cancer: Exploring factors associated with poor accrual and significant disparities [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P2-11-15.

AbstractExtramedullary multiple myeloma is seen in advanced and aggressive disease and occurs due to plasma cell infiltration of sites other than the bone marrow. Myelomatous ascites or pleural effusion is seen in less than 1% of cases and can be differentiated from infectious etiologies based on fluid cytology.

Abstract Background: Concern exists that the clinical trial populations differ from respective cancer populations in terms of their age distribution affecting the generalizability of the results, especially the underrepresented minorities. We hypothesized that the clinical trials that do not report race are likely to suffer from a higher degree of age disparity as well and the issue should be addressed in conjunction with each other. Methods: Food and Drug Administration (FDA) drug approvals from 7/2007-6/2019 were reviewed to identify oncology approvals, and trials with age details were selected. The primary outcome was the weighted mean difference in age between the clinical trial population and realworld population for various cancers. The secondary outcomes were the prevalence of race reporting and association of age and race reporting with each other. Group comparisons for proportions were performed using the χ2 test while continuous variables were compared using multiple analysis of variance (MANOVA) test or students t-test as appropriate. P values &lt; .05 were considered significant. Results: Of the 261 trials, the race was reported in 223 (85.4%) of the trials while 38 trials (14.6%) had no mention of race. Race reporting improved minimally over time – 29 (85.3%) in 2007-2010 vs. 49 (80.3%) in 2011-2014 vs. 145 (85.4%) during 2015-2019 (p-value=0.41). No significant association between type of cancer and race reporting was noted – 147 (86.5%) of solid cancer trials vs. 76 (83.5%) of hematological cancer trials reported race (p-value=0.52). Age discrepancy between the clinical trial population and the real-world population was present for several cancer types. The discrepancy was higher for studies that did not report race, mean difference - 8.8 years 4 (95% CI -12.6 to -5.0 years) vs. studies that did report the race, mean difference -5.1 years, (95% CI -6.4 to -3.7 years), p-value=0.04. Conclusion: The study demonstrates that a significant number of clinical trials leading to cancer drug approvals suffer from racial and age disparity when compared to real-world populations and that the two factors may be interrelated. We recommend continued efforts to recruit diverse populations. In the meantime, reporting these characteristics for these crucial trials should be mandated. Citation Format: Thejus Jayakrishnan, Sonikpreet Aulakh, Mizba Baksh, Kianna Nguyen, Meghna Ailawadhi, Ayesha Samreen, Ricardo Parrondo, Taimur Sher, Vivek Roy, Rami Manochakian, Aneel Paulus, Asher Chanan-Khan, Sikander Ailawadhi. Disparity in race and age reporting in landmark cancer clinical trials: Underrepresentation of the traditionally underserved U.S. population [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-104.

AbstractWaldenström macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) is often differentiated from myeloma based on the presence of lytic bone lesions (LBL). However, WM/LPL can present with LBL, and management is poorly understood. We describe a case of an 81‐year‐old woman with LPL who presented with LBL and was successfully treated with chemoimmunotherapy.