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Overall survival in soft tissue sarcomas (STS) in Hispanic vs non-Hispanic White patients: Single center experience.
Zamora, Diana, Ikram, Waleed, Braat, Jonathan , Dinh, Han, Azevedo, Chelsea, Patel, Shyamal , Wiseman, Jason T. , Vélez, Miguel González , Azevedo, Chelsea

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23526-e23526

10.1200/jco.2024.42.16_suppl.e23526 Get It

e23526 Background: Racial, ethnic, and socioeconomic factors have been implicated in the variability of survival rates among soft tissue sarcoma (STS). These disparities are multifactorial and may reflect differences in disease biology, access to care, treatment responses, and others. In situations where different racial groups have equitable access to healthcare, healthcare disparities can decrease, and survival gaps can narrow. Differences in survival in STS in racial minorities have been poorly studied. Recognizing the potential impact of such disparities, our study thereby contributes to the ongoing discourse on healthcare equity in STS outcomes. Methods: We conducted a retrospective analysis of 30 STS patients, stratifying them into Hispanic (H) and non-Hispanic white (NHW) groups at Dignity Health Cancer Institute in Phoenix, Arizona. The Mann-Whitney U test was chosen to compare survival distributions, given the non-normal distribution of our sample. Survival analysis was performed using the Kaplan-Meier method, and the log-rank test was applied to determine statistical significance. All analyses were executed in GraphPad Prism software. Results: Our cohort comprised 13 (43%) NHW and 17 (57%) H patients. The mean ages were 57.2 years for NHW and 48.9 years for H, with a balanced gender distribution across groups. The most common subtypes of STS in NHW were liposarcoma (n = 3, 23.1%), and spindle cell carcinoma (n = 2,15.4%). Comparatively, the most common subtypes of STS in H were liposarcoma (n = 5, 29.4%) and leiomyosarcoma (n = 3, 17.6%). All patients were diagnosed with Stage 4 STS. Treatment modalities differed marginally, with NHW patients undergoing more surgical interventions, while H patients were more frequently administered chemotherapy. Median overall survival from the start of first-line therapy was 412 days for NHW and 500 days for H patients. Despite the longer median overall survival observed in Hispanics, the intergroup difference did not reach statistical significance (P = 0.68). Conclusions: The similar survival times between H and NHW STS patients at our institution may hint at an equitable provision of care across racial demographics in a relatively controlled single-center experience. However, the trend of extended survival in the Hispanic group, while not statistically confirmed, raises questions that merit further inquiry. This study serves as a preliminary exploration into racial disparities in STS, advocating for larger-scale research with more diverse patient populations. Further studies are essential to understand these findings and identify and optimize factors contributing to narrowing the survival gap in minorities, with the goal of enhancing STS prognosis for all racial groups.
Use of CAR T cell vs non-CAR T cell therapy in the treatment of patients (pts) with multiple myeloma (MM) in the Medicare population.
An, Na, Qian, Xia , Ge, Wenzhen , Wu, Ning , Rodriguez-Lorenc, Karen, Kroog, Glenn S. , Jalbert, Jessica J. , Harnett, James , Roccia, Tito , Ma, Qiufei , Ailawadhi, Sikander , Inocencio, Timothy J. , An, Na, Humblet, Olivier , Wu, Ning

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23310-e23310

10.1200/jco.2024.42.16_suppl.e23310 Get It

e23310 Background: Chimeric antigen receptor T-cell therapy (CAR T) is FDA-approved in pts with triple-class exposed (TCE) relapsed/refractory (RR) MM after four or more prior lines of therapy (LOTs). Real-world access to CAR T remains challenging due to manufacturing capacity, financial barriers, and pt fitness. Pts with certain pre-existing comorbidities (e.g., central nervous system disease, heart disease, secondary malignancies) are commonly excluded from clinical trials, including those investigating CAR T. The objective of this study was to identify the factors associated with the use of CAR T in pts with TCE RRMM to better understand the unmet need in this population. Methods: We conducted an observational cohort study using Medicare fee-for-service data; each pt in the CAR T intention-to-treat (ITT) population between 2021 and 2023 was matched to three non-CAR T pts, without replacement. Pts were eligible if they had an initial MM diagnosis, were continuously enrolled, were TCE, and did not receive treatment in a clinical trial. The index date was the ITT date. Baseline characteristics included age, sex, race/ethnicity, census region, three comorbidity indexes (Charlson, Elixhauser, CMS hierarchical condition categories [HCCs]), a claims-based frailty index (CFI), and dual enrollment in Medicare and Medicaid (as a proxy to social economic status [SES]). Logistic regression was used to derive odds ratios (ORs) and 95% confidence intervals (CIs) comparing the characteristics of CAR T vs non-CAR T pts. Results: Seventy-three ITT CAR T pts (nine underwent apheresis but did not receive CAR T) were matched to 219 non-CAR T pts by LOT and index year. Matched pts were treated with varied standard regimens (daratumumab-containing: 63%). Median prior LOTs were similar in the two cohorts (8; range 2–13). Median time from MM diagnosis to index date was 44.6 and 51.9 months for CAR T and non-CAR T pts, respectively. Compared with non-CAR T pts, pts in the CAR T population were younger (aged < 75 years: 59% CAR T vs 36% non-CAR T), less frail (mean CFI: 0.18 vs 0.20) and had higher SES (without dual enrollment in Medicare and Medicaid: 96% vs 81%), but were similar in terms of sex, region, and race/ethnicity. Variation in individual comorbidity prevalence was observed between CAR T and non-CAR T pts. In a multivariable regression analysis, factors strongly associated with lower odds of CAR T use included age ≥75 years (OR 0.29; 95% CI 0.16–0.53), comorbidities (lung/other severe cancers [OR 0.39; 95% CI 0.20–0.74] and chronic obstructive pulmonary disease [OR 0.32; 95% CI 0.10–0.99] defined by HCCs), and SES (OR 0.09; 95% CI 0.02–0.37). Conclusions: Older age, certain comorbidities, and lower SES are associated with lower odds of receiving CAR T in real-world pts with TCE RRMM, demonstrating an unmet need for more accessible and effective treatment options with acceptable safety profiles for these pts.
Preferences among patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) in the era of B-cell maturation antigen (BCMA)-directed T-cell–engaging therapies.
Mansfield, Carol , Bussberg, Cooper , Chi, Lei, Harnett, James , Kroog, Glenn S. , Houvras, Yariv , Rodriguez-Lorenc, Karen, Ma, Qiufei , Ailawadhi, Sikander , Inocencio, Timothy J. , Chintakayala, Phani

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23309-e23309

10.1200/jco.2024.42.16_suppl.e23309 Get It

e23309 Background: BCMA-directed T-cell–engaging therapies have been introduced into clinical practice for the treatment of TCE RRMM. While efficacious, such treatments are associated with safety considerations such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and serious infections. These treatments also vary in reported efficacy, administration processes, and hospitalization requirements. The aim of this study is to quantify patient preferences and tradeoffs regarding these attributes. Methods: A discrete choice experiment (DCE) was designed to elicit preference weights corresponding to seven attributes related to efficacy (objective response rate [ORR], overall survival [OS]), safety (all-grade CRS, all-grade ICANS, serious infections) and treatment procedures (treatment administration, hospitalization requirements). Attribute levels were based on plausible ranges of potential values. Patients in the United States (US) with a physician-confirmed diagnosis of TCE RRMM were recruited. Pre-test interviews with patients were conducted and the final survey deployed online in 2023. A random-parameters logit model was used to estimate preference weights. Conditional relative importance (CRI) was calculated to rank the relative importance of each attribute. The minimum acceptable benefit (MAB) and maximum acceptable risk (MAR) were calculated to estimate the tradeoffs between efficacy and safety attributes. Results: The sample included 200 respondents (mean [standard deviation] age: 61 [6.4] years; 43% female; 46% White; 10% African American). A total of 197 participants reported having responded to prior treatment, of whom 195 had relapsed or become refractory. In the DCE, a 24-month increase in OS was found to be the most important attribute, with a CRI of 32.0%. Next most important were avoiding a 60% risk of serious infection (CRI 17.3%), avoiding 14-day hospitalization requirements (CRI 15.0%), and a 38% increase in ORR (CRI 13.7%). A treatment that could be started immediately and administered weekly or up to every 4 weeks was preferred over a CAR T-like procedure with a waiting period. Fewer initial hospitalization days was significantly preferred over more hospitalization days. The MABs for OS when the risk of serious infection was increased from 20% to 60%, CRS from 40% to 95%, and ICANS from 3% to 20% were 24.2, 17.1, and 18.0 months, respectively. When OS was increased from 12 to 36 months, the estimated MARs for serious infections, CRS, and ICANS were > 60%, > 95%, and > 20%, respectively. Conclusions: This study highlights US patient preferences regarding treatment attributes for TCE RRMM. Treatment benefits and risks and the mutual tradeoffs considered by patients should be evaluated when developing and selecting therapeutic approaches.
Efficacy and toxicity of BRAF targeted therapy in elderly patients with melanoma.
Markovic, Svetomir, Kottschade, Lisa A. , Montane, Heather N. , Yan, Yiyi , Tan, Winston, Dronca, Roxana , Seetharam, ­Mahesh , Chen, Ruqin , Block, Matthew S. , Stoff, Ronen , McWilliams, Robert R. , Dimou, Anastasios , Dudek, Arkadiusz Z.

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23270-e23270

10.1200/jco.2024.42.16_suppl.e23270 Get It

e23270 Background: Melanoma is the most lethal form of skin cancer which have seen drastic improvement in patient survival over the last decade. BRAF is the most common driver mutation in melanoma, seen in ≈50% of all patients (≈30% of patients > 65). The use of BRAF & MEK inhibitors yields high response rates, though it is limited by toxicity and development of acquired resistance. Acknowledging these limitations, we aimed at assessing the efficacy and toxicity of these agents in melanoma patients > 65. Methods: We identified electronic medical records of all melanoma patients > 65 that were treated with BRAF & MEK inhibitors at our institution over the years 2017-2023. Data was retrospectively collected including demographics, disease characteristics, treatment given, response patterns and toxicity. Results: 106 patients were identified. The median age was 71 (65-89), 55% were males. The median follow up was 28.9 months. 32 (30%) patients were treated at first line, 58 (55%) at second line and 16 (15%) at third line. 88 (83%) evaluable patients received treatment for unresectable/metastatic disease of which 84% had an objective response (60% partial response, 24% complete response). Response rate (RR) was 82%, 85% and 87% for first, second and third line respectively. RR was 86% for patients with an increased serum lactate dehydrogenase. 33% of patients had active central nervous system (CNS) metastases at treatment initiation, for whom the systemic RR was 80% and the CNS RR was 39%. The median progression free survival (PFS) was 7.9 months, with a PFS of 6, 8.3 and 13.4 months for first, second and third line respectively. The median PFS was 5.7 months for patients with active CNS disease. The median overall survival (OS) from treatment initiation was 15.7 months (12.5, 14.5, 31.9 for first, second & third line respectively). The median OS for patients with CNS disease was 9.8 months. 16 patients were treated in the adjuvant setting, of which 6 (37%) finished treatment as planned, 3 stopped due to disease progression (19%) and 6 stopped due to toxicity (37%). 88% of patients experienced adverse events (AEs) of any grade, with 27% having grade 3-4 toxicity. There were no grade 5 toxicities reported. 36% of patients experienced one AE, while 52% experienced two or more. 21% of patients stopped treatment due to toxicity, 28% needed a dose reduction and 20% changed to different BRAF/MEK inhibitors. 10% of patients needed systemic corticosteroids to treat AEs. The most common toxicities seen were fever (30%), fatigue (30%), skin rash (22%), elevated liver function tests (20%), arthralgia/myalgia (15%), nausea (14%) and diarrhea (11%). 7% had decrease in cardiac ejection fraction with one grade 3 leading to treatment discontinuation. Conclusions: Treatment with BRAF & MEK inhibitors is challenging in older patients, with a high prevalence of toxicity leading to treatment modifications and discontinuation. Efficacy seems to be the same as in the general population.
Efficacy and toxicity of KIT targeted therapy in elderly patients with melanoma.
Markovic, Svetomir, Yan, Yiyi , Tan, Winston , Seetharam, ­Mahesh , Block, Matthew S. , Stoff, Ronen , McWilliams, Robert R.

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23269-e23269

10.1200/jco.2024.42.16_suppl.e23269 Get It

e23269 Background: Most cases of malignant melanoma are cutaneous, with ≈50% having a BRAF driver mutation that predicts response to MAPK pathway inhibitors. A small minority of melanoma cases harbor an activating KIT mutation, most notably in mucosal and acral melanomas (15-20%) and occasionally in those arising from chronic sun-damaged skin (2-3%). Only about a third of KIT mutated melanomas respond to targeted therapy with Imatinib, yet data is scarce and limited, especially in older patients. We sought to characterize the efficacy and toxicity of Imatinib in KIT-mutated melanoma patients over 65. Methods: We identified electronic medical records of patients over 65 that were treated with Imatinib for KIT mutated melanoma at our institution over the years 2017-2023. Data was retrospectively collected including demographics, disease characteristics, response patterns and toxicity. Results: 10 patients were identified, 50% were males. The median age at treatment initiation was 75 years (71-100). 3 patients had cutaneous primary, 3 had Vulvar/vaginal primary, 3 had acral primary and 1 had anal canal primary. All patients had normal Lactate dehydrogenase at treatment initiation and ECOG performance status was 0-2 (median 0). 9 patients received Imatinib for stage IV disease with an overall response rate (ORR) of 55% (44% partial response, 11% complete response). Median duration of response was 4 months. Responses were seen in acral melanoma (67%), vulvar/vaginal melanoma (67%) and cutaneous melanoma (33%). Median Progression free survival was 4.3 months (1.8-44), median overall survival from treatment initiation was 22.6 months (4-64). 6 patients were treated as 2nd line with an ORR of 67% and 3 were treated as 3rd line with an ORR of 33%. There was one patient with M1d disease who did not respond to treatment either systematically or intracranially. 6 patients had Exon 11 mutations (V560D/G/E, N564S and L576P) of which 4 responded (67%). 2 had Exon 17 mutations (N822C/K) of which 1 responded (50%) and the 2 others had an Exon 14 (F681I) and Exon 13 (K642E) mutation that did not respond to treatment at all. Toxicity was moderate with 90% of patients experiencing any grade AE, yet only 1 experienced toxicity requiring dose interruption with two Grade 3 toxicities - Pneumonitis and decreased neutrophil count, leading to temporary treatment interruption, dose reduction and a course of corticosteroids. The rest of the patients experienced only Grade 1-2 toxicity. 4 patients needed dose reductions, there were no treatment discontinuations due to toxicity. Conclusions: Treatment with Imatinib for elderly KIT mutated melanoma patients is safe and well tolerated with no treatment discontinuations recorded. The response rate is encouraging yet seems to vary according to the KIT mutation present as previously reported. The duration of response is usually short-lived and alternative/combination treatments are still needed for this patient population.
Analyzing influential factors in suboptimal cervical cancer screening rates at Kline Health Center and implementing a subsequent initiative for improvement.
Ng, Wern Lynn , He, Alice , Barahona, Gabriela Calderon, Oli, Seema, Velazquez, Adan Martin Cuevas , Ng, Lay She , Khor, Si Yuan , Nasrollahi, Elham , Azhar, Maha, Martinez, Evelyn Calderon , Htoo, M., Bobrysheva, Hanna, Gavilanes, Diana, Seltun, Faith , Garg, Chandi, Atrash, Anas , He, Alice, Yilmaz, Fatma Betul, Tan, Jia Yi , Ge, Rongrong

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23252-e23252

10.1200/jco.2024.42.16_suppl.e23252 Get It

e23252 Background: The UPMC-Kline Health Center (KHC) in Harrisburg, PA, shows a lower cervical cancer screening rate compared to the general population in the USA (57.08% vs 78%, respectively, based on the Medical Group Fiscal Year 2023 Internal Quality Measures). To understand this gap, we distributed a comprehensive questionnaire to patients, aiming to pinpoint factors contributing to the lower screening rate and plan targeted interventions for improvement. Methods: We randomly distributed questionnaires to female patients aged 21 to 61 during appointment check-in at the KHC, considering our linguistically diverse patient population with surveys available in Spanish, English, and Nepali. Given the diverse linguistic landscape of our patient population, we prepared questionnaires in Spanish, English, and Nepali. The survey aims to identify and address specific clinic-related problems, with a follow-up assessment after a few months to gauge improvements following interventions targeting the underlying causes of screening gaps. Results: Over a three-month span, 65 questionnaires were completed. Among the participants, 38% (25 patients - 7 white/Caucasian, 11 black/African American, 1 Asian, 7 others; 12 Hispanic, 13 non-Hispanic) revealed that they had not undergone screening within the past three years. The analysis of this subgroup unveiled significant issues: 84% (21/25) did not receive paperwork to schedule the test, 88% (22/25) were not contacted to schedule the test, 76% (19/25) did not receive reminder notifications before appointments, and 72%(18/25) expressed concerns about the lack of insurance coverage for costs. Furthermore, 76% (19/25) indicated the requirement to pay a co-pay, and an equal percentage reported difficulties in obtaining the screening test. Additionally, 72%(18/25) mentioned that their healthcare providers did not discuss the screening's importance, while 76%(19/25) noted their providers did not explain the purpose of the test. Conclusions: These findings underscore critical gaps in communication, accessibility, and cost-related barriers to cervical cancer screening at KHC. This ongoing quality improvement project, scheduled for data recollection in a few months, encompasses proposed interventions such as automated reminders, technology integration for communication, and distributing flyers in clinic and waiting areas to foster open communication and address inadequate discussions about the importance of screening. The aim is to improve patient awareness, engagement, and ultimately prevent delayed cancer diagnoses. KHC is committed to enhancing the cervical cancer screening rate to minimize the likelihood of delayed cancer diagnoses.
An analysis of factors contributing to low colonoscopy rates at Kline Health Center in comparison to the national average in the USA (according to the internal quality measures of the medical group fiscal year 2023) and a follow-up initiative to improve co
Ng, Wern Lynn , He, Alice , Barahona, Gabriela Calderon, Oli, Seema, Velazquez, Adan Martin Cuevas , Ng, Lay She , Khor, Si Yuan , Nasrollahi, Elham , Azhar, Maha , Martinez, Evelyn Calderon , Htoo, M., Bobrysheva, Hanna, Gavilanes, Diana, Mirza, Hajira, Seltun, Faith , Ge, Rongrong, Garg, Chandi, Atrash, Anas , He, Alice, Yilmaz, Fatma Betul

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23244-e23244

10.1200/jco.2024.42.16_suppl.e23244 Get It

e23244 Background: The UPMC-Kline Health Center (KHC) located in Harrisburg, PA, has a lower colon cancer screening rate compared to the general patient population in the USA (26.03% vs 78%, respectively, according to the Medical Group Fiscal Year 2023 Internal Quality Measures). To understand the reasons behind this disparity, a comprehensive questionnaire was conducted aiming to identify factors contributing to the lower colonoscopy screening rate and to implement targeted interventions to improve the situation. Methods: Surveys were distributed to eligible patients aged 45 to 75 at the clinic, considering linguistic diversity by preparing questionnaires in Spanish, English, and Nepali. Distribution, randomized and conducted by medical assistants, aims to identify and address specific clinic-related issues. Subsequent assessment, after a few months, will determine improvements resulting from interventions targeting the underlying causes of screening gaps. Results: Over a three-month period, a total of 77 questionnaires were completed and collected. We analyzed responses from 33 patients (42%, 14 females, and 19 males; 16 white/Caucasian, 14 black/African American, 2 Asian, 1 other; 8 Hispanic/Latino, 25 non-Hispanic/Latino) who had not undergone a colonoscopy in the past 10 years. Findings revealed that 72% (24/33) of patients reported not receiving paperwork for scheduling, while 72% (24/33) were not contacted to schedule the test. Additionally, 78% (26/33) of patients did not receive a reminder call or message before their scheduled appointments. 51% (17/33) of patients highlighted a lack of insurance coverage for costs, with 63% (21/33) indicating the need for a co-pay. 57% (19/33) of patients reported difficulties in obtaining the screening test. 51% (17/33) of patients mentioned that their healthcare provider discussed the importance of the screening test, and 54% (18/33) of patients noted that their providers explained the purpose of the test. Conclusions: The survey identifies scheduling, communication, and cost-related barriers to colon cancer screening at KHC. Proposed interventions, including the implementation of automated reminders, integrating technology to facilitate communication, and incorporating flyers within the clinic and patient waiting areas. This quality improvement project is ongoing, with data scheduled for recollection in a few months. These measures are anticipated to foster improvements, aiding more patients in preventing delayed cancer diagnoses. KHC aims to create a patient-friendly environment by addressing scheduling inefficiencies, improving communication, and tackling financial concerns for timely and accessible colon cancer screenings.
Lifetime Health and Economic Outcomes of Biparametric Magnetic Resonance Imaging as First-Line Screening for Prostate Cancer
Gulati, Roman , Jiao, Boshen , Al‐Faouri, Ra'ad , Sharma, Vidit , Kaul, Sumedh, Fleishman, Aaron , Wymer, Kevin , Boorjian, Stephen A. , Olumi, Aria F. , Etzioni, Ruth , Gershman, Boris , Olumi, Aria F

Mayo Clinic

Annals of Internal Medicine | June 3, 2024 | Volume: 177 | Issue: 7 | Pages: 871-881

10.7326/m23-1504 | PMID 38830219 Get It

Corneal Backscatter, Pachymetric Indices, and Ectasia Indices for the Assessment of Fuchs Endothelial Corneal Dystrophy
Hodge, David O. , Baratz, Keith H. , Patel, Sanjay V , Patel, Sanjay V.

Mayo Clinic

Cornea | June 3, 2024 | Volume: 44 | Issue: 4 | Pages: 427-434

10.1097/ico.0000000000003577 | PMID 38830190 Get It

Purpose: To determine whether corneal backscatter, pachymetric indices, and ectasia indices derived from Scheimpflug tomography can identify Fuchs endothelial corneal dystrophy (FECD) corneas with abnormal tomography, the relationships between these parameters and tomographic edema in FECD, and if these parameters help predict improvement in central corneal thickness (CCT) after Descemet membrane endothelial keratoplasty (DMEK). Methods: Tomography maps of 132 eyes of 80 subjects with FECD were analyzed to determine how backscatter, pachymetric, and ectasia parameters compared with the instrument's normative database and if any predicted tomographic edema. Tomography maps from a separate group undergoing DMEK were split into derivation (48 eyes of 39 subjects) and validation (45 eyes of 41 subjects) subgroups to derive a predictive model of improvement in CCT after DMEK. Backscatter, pachymetric, and ectasia parameters were incorporated to determine if the model could be enhanced. Results: Among all ectasia, pachymetric, and backscatter parameters, at best only 65% of FECD corneas with definite tomographic edema could be identified based on the instrument's normative database. Among all parameters individually, the highest sensitivity for detecting tomographic edema was 77%. Anterior and mid-corneal backscatter featured in a model predicting improvement in CCT after DMEK with high performance in derivation (R2 = 0.79; 95% confidence interval, 0.65–0.87) and validation (R2 = 0.72; 95% confidence interval, 0.52–0.83) subgroups. Conclusions: The Scheimpflug camera software program could not reliably detect abnormal tomography in FECD from corneal backscatter, pachymetric indices, or ectasia indices. Corneal backscatter contributes to, but does not enhance, a predictive model of improvement in CCT after DMEK.
The effect of distance reiki on patient reported quality of life, correlated with changes in immune repertoires among patients with multiple myeloma: A pilot study.
Nyamao, Tiffany, Warsame, Rahma , Hwa, Yi L. , Fonder, Amie , Hobbs, Miriam, McCarty, Tammy, Aug, Sarah, Burtis, Michelle, Dooley, Katharine , Lacy, Martha Q. , Burtis, Michelle, Cook, Joselle , Dispenzieri, Angela

Mayo Clinic

Journal of Clinical Oncology | June 3, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e23199-e23199

10.1200/jco.2024.42.16_suppl.e23199 Get It

e23199 Background: Psychological distress and diminished health related quality of life (HRQOL) is associated with multiple myeloma (MM). Complementary and alternative medicine (CAM) is an adjunct to traditional medicine. T-cells are essential to the adaptive immune system. The complementarity determining region (CDR3) of the T cell receptor formed by combination of the V,D,J regions is highly variable and critical for antigen specificity. PCR is used to analyze the TCR-CDR3 to monitor T-cell clonotypes as a measure of antigen specific T cell responses and thereby cancer immunity. Reiki is a Japanese energy healing technique involving noninvasive light touch to modulate energy fields. The primary aim was feasibility and acceptability of Reiki within a structured medical paradigm. Secondary aims were changes in HRQOL and T-cell receptor repertoires with Reiki. Methods: Adult MM patients (pts) on a stable regimen were eligible. Pts randomized in a 1:1:1 to weekly True Reiki (Treiki), Simulated Reiki (Sreiki) or no intervention (NI). The PROMIS-29® assessed HRQOL. A “Was it Worth it” (WIWI) questionnaire was administered post intervention to assess the experience. TCR-CDR3 sequencing was performed on PBMCs at enrollment and end of therapy to determine immune repertoire changes. Samples underwent library preparation and next generation sequencing for TCR repertoire analysis by iRepertoire® Results: Thirty pts were randomized into 3 arms between 12/2020 to 4/2022. Median age 62.5 (range 27-76), 18/30 (60%) female, median time to diagnosis was 48 mo (Range 7-221), 50% had high risk FISH,(90%) had prior ASCT and received median 2 (range 1-13) lines of therapy prior to enrollment. No pts relapsed or progressed during study period. Using WIWI 100% of pts in Treiki and 75% in Sreiki arms found the therapy useful and would do it again; 100% Treiki pts and 87.5% in the Sreiki arm would recommend the study to others. No statistical difference between groups in any HRQOL domains. Among TCR repertoires, no statistically significant difference was observed between groups with respect to Richness, Shannon entropy, Clonality, Diversity 50 (D50) and Inverse Simpson indexes. Each pt showed substantial variability in certain TCR-CDR3 clones and clonal diversity. Conclusions: We successfully demonstrated acceptability and feasibility of Reiki among MM pts, although no impact on HRQOL was shown. Reiki intervention is an easy non-invasive additional option for pts’ to their conventional therapies. The TCR-CDR3 repertoires showed no difference with the reiki intervention but had significant variability. Further research comparing TCR repertoires between MM and age/sex matched healthy controls is ongoing. T-cell directed therapies are evolving in MM, we plan to analyze if changing diversity of TCR-CDR3 repertoires could define how best to sequence these treatments. Clinical trial information: NCT04783038 .