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Publications
Partnering With All Patients: Ensuring Shared Decision Making and Evidence-Based Management for Underrepresented Groups With Multiple Myeloma
Cerchione C, Grant SJ, Ailawadhi S. Partnering With All Patients: Ensuring Shared Decision Making and Evidence-Based Management for Underrepresented Groups With Multiple Myeloma. Am Soc Clin Oncol Educ Book. 2023 May;43:e390202. doi: 10.1200/EDBK_390202. PubMed PMID: 37167570.
Abstract Several landmark therapeutic advances in multiple myeloma (MM) have led to an unprecedented number of options available to patients and their physicians as shared decision making is attempted. A myriad of factors need to be considered to ensure that patient-, disease-, and treatment-related factors are addressed to arrive at the most appropriate choice for patients at that time in their journey with myeloma. Some of these factors have traditionally remained underaddressed but have a clear association with patient outcomes, leading to underrepresented groups of patients with MM, including the elderly patients, racial-ethnic minorities, and those with specific advanced comorbidities, for example, renal insufficiency. Some of these factors may not be modifiable, but data suggest that they may give rise to implicit or explicit bias and affect treatment decisions. A growing body of literature is bringing these factors to light. However, their incorporation in day-to-day decision making for patients needs to be universal. It is imperative that prospective data are generated for all these and other underrepresented groups such that evidence-based medicine is applicable universally to all patients with MM, irrespective of clinical and sociodemographic factors.
A real-world data analysis of predictors of early mortality after a diagnosis of multiple myeloma
Grant SJ, Wildes TM, Rosko AE, Silberstein J, Giri S. A real-world data analysis of predictors of early mortality after a diagnosis of multiple myeloma. Cancer. 2023 Mar 29;. doi: 10.1002/cncr.34760. [Epub ahead of print] PubMed PMID: 36989073;
Abstract Background: Despite the increased availability and use of novel therapies for multiple myeloma, early mortality is a pervasive challenge with a significant impact on older adults. Reported rates and predictors of early mortality have varied in the literature, with most studies seldom focusing on community-treated patients. Methods: In this retrospective cohort analysis of a real-world electronic health record-derived deidentified database of 7512 patients newly diagnosed with multiple myeloma between January 1, 2011, and February 2, 2021, and treated primarily in US-based community oncology practices, factors associated with early mortality (defined as death within 6 months after the multiple myeloma diagnosis) were examined with the use of binary logistic regression. Results: The median age was 70 years overall. We found an overall early mortality rate of 8.3%, with 73% of early deaths occurring in those aged ≥70 years. Among the early deaths, only 49 patients (8.7%) had documented disease progression before death (median time to progression, 30 days [interquartile range, 7-53 days]). Baseline factors associated with higher odds of early mortality included an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2, Revised International Staging System (R-ISS) stage III, an age ≥ 70 years, receipt of proteasome inhibitor-doublet therapy, a light-chain isotype, and the presence of renal dysfunction (estimated glomerular filtration rate
Cross-Sectional Analysis of Clinical Trial Availability and North Carolina Neighborhood Social Vulnerability
Grant SJ, Jansen M, Kuo TM, Rubinstein SM, Wildes TM, Tuchman SA, Muss HB, Lichtman EI, Charlot M. Cross-Sectional Analysis of Clinical Trial Availability and North Carolina Neighborhood Social Vulnerability. JCO Oncol Pract. 2023 Feb;19(2):e248-e262. doi: 10.1200/OP.22.00325. Epub 2022 Dec 6. PubMed PMID: 36473128; PubMed Central PMCID: PMC9970296.
Abstract Purpose: Residents of communities facing social vulnerability (eg, poverty) have limited access to clinical trials, leaving them susceptible to experiencing poor health outcomes. We examined the association between North Carolina county-level social vulnerability and available multiple myeloma (MM) trials. Methods: Using a novel data linkage between ClinicalTrials.gov, the 2019 American Community Survey, and the Centers for Disease Control and Prevention's Social Vulnerability Index, we investigated at the county level (1) availability of MM trial sites and (2) the relationship between Social Vulnerability Index and MM trial site availability using logistic regression. Results: Between 2002 and 2021, 229 trials were registered across 462 nonunique trial sites in 34 counties. Nearly 50% of trial sites were in academic medical centers, 80% (n = 372) of all trials were industry-sponsored, 60% (n = 274) were early-phase, and 50% (n = 232) were for patients with relapsed or refractory MM. Counties with low as opposed to high poverty rates had six times greater odds of having ≥ 1 MM trial sites (odds ratio [OR], 5.60; 95% CI, 1.85 to 19.64; P = .004). Counties with the lowest percentage of Black Indigenous Persons of Color and non-native English speakers had 77% lower odds (OR, 0.23; 95% CI, 0.07 to 0.69; P = .011) of having ≥ 1 trial sites. The effect remained significant after accounting for the presence of five academic medical centers (n = 95; OR, 0.18; 95% CI, 0.05 to 0.6; P = .008) and adjustment for metropolitan, suburban, or rural status (OR, 0.25; 95% CI, 0.07 to 0.81; P = .025). Conclusion: Counties with the lowest poverty rates had more MM trial sites, whereas those with the lowest percentage of Black Indigenous Persons of Color populations had fewer MM trial sites. Multilevel efforts are needed to improve the availability and access to trials for socially vulnerable populations.
The prevalence and outcomes of frail older adults in clinical trials in multiple myeloma: A systematic review
Mian H, McCurdy A, Giri S, Grant S, Rochwerg B, Winks E, Rosko AE, Engelhardt M, Pawlyn C, Cook G, Jackson G, Bringhen S, Facon T, Larocca A, Zweegman S, Wildes TM. The prevalence and outcomes of frail older adults in clinical trials in multiple myeloma: A systematic review. Blood Cancer J. 2023 Jan 5;13(1):6. doi: 10.1038/s41408-022-00779-2. PubMed PMID: 36599867.
Abstract Multiple myeloma (MM) is an incurable blood cancer that primarily affects older adults. Several frailty tools have been developed to address the heterogeneity of aging in this population. Uptake of these measures has been variable, leading to a gap in knowledge regarding the proportion of enrolled trial participants considered frail and uncertainty in the treatment-related effects and outcomes among this high-risk population. We performed a systematic review of therapeutic interventional MM clinical trials reporting on frailty. We included 43 clinical trials (24 randomized controlled trials and 19 non-randomized trials) which met eligibility criteria. Frailty was increasingly incorporated in studies in more recent years with 41.9% of included studies being reported in the last two years. Commonly used frailty tools included the International Myeloma Working Group (IMWG) frailty index (41.8%), and the simplified frailty score (39.5%). Frailty status was categorized with 3 levels as (frail, intermediate fit, or fit) in 51.2% of the studies and dichotomized (frail, non-frail) in 18.6% of studies. Frailty prevalence greatly varied across trials ranging from 17.2% to 73.6% of the cohort. Of the included studies, 72.0% conducted subgroup analysis (planned or post-hoc) based on frailty status. Most studies demonstrated a consistent benefit of MM interventions among the frail and non-frail populations, however in general, frail patients had worse outcomes compared to the fit. Although frailty is increasingly being incorporated in MM clinical trials, due to the variation in both the definition and categorization of frailty, there remains heterogeneity in the prevalence of frailty and its potential associated impact on outcomes.
Paving the Way for Increased Representation of Black Faculty in Academic Medicine: The Role of Mentoring
Grant SJ, Oyedeji C, Gilmore N. Paving the Way for Increased Representation of Black Faculty in Academic Medicine: The Role of Mentoring. The Hematologist. 2022 October. doi: https://doi.org/10.1182/hem.V19.6.2022611.
Abstract Despite increasing ethnic and racial diversity within the United States, diversification of the academic medical workforce continues to lag far behind general U.S. trends. In 2021, 2,562 (11%) self-identified as Black. In 2020, Black scientists earned only 7 percent of all doctoral degrees.1 While the enrollment of Black students in either medical school or doctoral degree programs has increased over time, Black physicians and researchers remain underrepresented in academic medicine across all ranks.2, 3
Use of geriatric assessment in cancer clinical trials: A systematic review
Lee W, Cheng SJ, Grant SJ, Marcum ZA, Devine B. Use of geriatric assessment in cancer clinical trials: A systematic review. J Geriatr Oncol. 2022 Sep;13(7):907-913. doi: 10.1016/j.jgo.2022.04.014. Epub 2022 May 9. Review. PubMed PMID: 35550351; PubMed Central PMCID: PMC10129289.
Abstract Background: Older adults are underrepresented in cancer clinical trials despite accounting for most of the disease burden. Geriatric assessment (GA) could be used in clinical trials of cancer drugs for older adults to improve the clinical evidence for cancer drug use among older adults. Objective: To examine patterns of use of GA in cancer clinical trials. Methods: We undertook a systematic review of the studies reporting use of GA in a clinical trial setting for all cancer types and published between January 2010 and January 2020. Characteristics of GA use were extracted for each study, along with study phase, cancer type, and participant age (PROSPERO: CRD42020170584). Results: We identified 320 studies and 63 studies met the final inclusion criteria. Among 74 purposes of GA use, the most common was to examine the association between impairments in GA domains and clinical outcomes (28/74, 38%). Among 258 GA domains assessed across 63 studies, physical status (59/258, 23%) and comorbidities (50/258, 19%) were most often evaluated. There was significant heterogeneity in the instruments used to assess physical function (n = 16) and mood disorders (n = 7). Most studies were phase 2 (32/63, 51%). Conclusions: GA is most often used in clinical trial settings to examine associations between GA-identified deficits and clinical outcomes. Significant heterogeneity exists in the GA instruments used across trials. Comprehensive and consistent incorporation of GA into future cancer clinical trial designs could help collect more older adult-specific clinical information and adjust trial eligibility criteria to increase representation by older adults. Keywords: Cancer clinical trials; Geriatric assessment; Older adults.
Clinical Presentation, Risk Factors, and Outcomes of Immune Effector Cell-Associated Neurotoxicity Syndrome Following Chimeric Antigen Receptor T Cell Therapy: A Systematic Review
Grant SJ, Grimshaw AA, Silberstein J, Murdaugh D, Wildes TM, Rosko AE, Giri S. Clinical Presentation, Risk Factors, and Outcomes of Immune Effector Cell-Associated Neurotoxicity Syndrome Following Chimeric Antigen Receptor T Cell Therapy: A Systematic Review. Transplant Cell Ther. 2022 Jun;28(6):294-302. doi: 10.1016/j.jtct.2022.03.006. Epub 2022 Mar 11. Review. PubMed PMID: 35288347; PubMed Central PMCID: PMC9197870.