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Ailawadhi, Sikander

https://orcid.org/0000-0002-8377-8111

Mayo Clinic

Mayo Clinic

Citations 383

Factors Determining Utilization of Stem Cell Transplant (SCT) for Initial Therapy of Multiple Myeloma (MM) By Patient Race: Exploring Intra-Racial Healthcare Disparities
Frank, Ryan D. , Chimato, Nicolette T., Meghji, Zahara, Patel, Raj , Jani, Prachi, Kakar, Tanya Singh, Hodge, David O. , Sher, Taimur , Ailawadhi, Meghna, Alegria, Victoria R., Chanan‐Khan, Asher , Ailawadhi, Sikander , Patel, Raj, Fiala, Mark A. , Aulakh, Sonikpreet , Roy, Vivek , Vishnu, Prakash , Paulus, Aneel

Blood | April 6, 2021 | Volume: 130 | Issue: Suppl_1 | Pages: 860-860

10.1182/blood.v130.suppl_1.860.860 Get It

Abstract Background: SCT is a standard therapeutic approach for patients with MM and has contributed to improved outcomes. While SCT utilization in MM has increased for all racial-ethnic subgroups over time, population-based studies have repeatedly shown that racial minorities are less likely to receive it. We explored factors that determine SCT utilization among patients within a given race to understand intra-racial disparities and how to address them in order to maximize the use of this imperative treatment among eligible patients. Methods: The 2016 National Cancer Database (NCDB) for MM with patients diagnosed between 2004-2013 was studied. Cases without information on the selected patient or facility characteristics evaluated in this analysis, including SCT use, race, median income, insurance status or facility type of initial MM diagnosis and/or treatment were excluded. The association between utilization of SCT as part of initial therapy of MM and socio-demographic factors was studied stratifying patients into mutually exclusive racial-ethnic subgroups non-Hispanic Whites (NHW), non-Hispanic Blacks (NHB), Hispanics, non-Hispanic Asians (NHA) and others using multivariate GEE logistic regression analysis (clustered on facility ID). Interactions between race and patient/facility characteristics and SCT utilization were tested using similar methods but including all races. Results: Of the 123480 unique MM patients in NCDB diagnosed between 2004-2013, 111799 met the inclusion criteria. Of these, 15021 patients (13.4%) received SCT as part of initial MM therapy. Of those who received SCT, 77.5% were NHW (14.4% of all NHW), 15.1% NHB (10.3% of all NHB), 5.2% Hispanics (13.2% of all Hispanics), 2% NHA (15.5% of all NHA) and <1% others. There was no difference by gender but significantly reduced odds of receiving SCT were noted for every 10-year increase in age at diagnosis for all racial subgroups. NHA were the only subgroup not to have a significant year-wise increase over time in odds of receiving SCT between 2004-2013. A significant increase in SCT utilization was seen with increasing median income (quartiles; 2008-2012 data), for NHW and Hispanics but not for NHB and NHA, while increased education (% population with high-school degree; 2008-2012 data) was associated with a significant increase in SCT use for NHW and NHB, but not among Hispanics or NHA. An increase in great circle distance (GCD) from the treating facility as well as a lower Charlson-Deyo comorbidity index (CCI) was associated with significantly increased odds of receiving SCT for all racial groups. Insurancepayer status significantly affected odds of receiving SCT among all races with those having private insurance to be most likely to receive SCT among NHW, NHB and Hispanics while those with "other government" insurance payer type being most likely among NHA. Among treating facility characteristics, patients of all races were more likely to receive SCT if treated at an academic/researchfacility (including NCI-designated centers) or centers with highest quartile of patientvolume seen. For analysis by geographicalregion, NHW and NHA had the highest odds of receiving SCT in mountain region but there was no impact of geography on SCT for NHB or Hispanics. Odds ratio (OR) of receiving SCT as part of initial MM therapy by socio-demographic and facility characteristics for patients of individual racial subgroups are shown in Table 1. A significant interaction between odds of receiving SCT and various racial subgroups was noted for patient age at diagnosis (p<.001, decreased odds among NHW and NHA), GCD from treating facility (p=0.013, increased odds among NHB and NHA), CCI (p=0.043, decreased odds among NHA) and treatment facility volumes (p=0.046, increased odds among NHA and Hispanics). Conclusions: In the largest analysis exploring socio-demographic factors affecting SCT utilization in MM we note a significant disparity within races for who gets SCT as a part of initial MM management and who does not. While some of these factors are non-modifiable, others including access to healthcare, income, insurance and literacy levels, proximity to treatment center, treating facility type as well as volumes are modifiable and appear to be barriers to SCT among in some races, while not in others. These must be addressed to minimize disparities within racial subgroups, especially the minorities and realize maximal benefit of SCT for MM. Disclosures Ailawadhi: Novartis: Consultancy, Honoraria; Pharmacyclics: Research Funding; Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria. Sher: LAM Therapeutics, Inc: Research Funding.
Awareness of myeloma care and the global impact of treatment: An international internet-based prospective study
Ailawadhi, Sikander , Swaika, Abhisek, Advani, Pooja , Hodge, David O. , Paulus, Aneel , Khera, Nandita , Hashmi, Shahrukh K. , Alegria, Victoria R., Abdulazeez, Mays F , Bodepudi, Srilekha, Jamwal, Khushi, Sher, Taimur , Chanan‐Khan, Asher , Ailawadhi, Meghna, Hodge, David, Abdulazeez, Mays, Chanan-Khan, Asher, Ailawadhi, Sikander , Paulus, Aneel , Roy, Vivek

Journal of Oncology Pharmacy Practice | March 10, 2021 | Volume: 28 | Issue: 2 | Pages: 425-433

10.1177/10781552211001928 Get It

Objective Outcomes in multiple myeloma (MM) have significantly improved necessitating focus on survivorship. Methods We undertook a web-based survey in collaboration with International Myeloma Foundation (IMF) to explore patient awareness and psycho-physical impacts of MM. The survey was viewed on the IMF website by 1,324 individuals from 32 countries. Results The survey responses were available from 959 individuals, with 62% who completed the survey. Treating doctors were the most frequent source of MM-related information. Only 56% patients admitted full compliance with treatment. Treatment side effects bothered 86% responders, including >50% admitting to pain, peripheral neuropathy and asthenia. Majority (57%) reported some degree of depression, 82% had discontent with their quality of life and only 35% reported being satisfied with their coping mechanisms. Patients ≥65 years of age reported more peripheral neuropathy (p = 0.007) and difficulty with ability to work (p = 0.015). Conclusions We report the prevalence of psychologic, social and physical domains as well as patient-physician relationship dynamics. This knowledge can help improve MM survivorship.Introduction
A Panel Evaluation of the Changes in the General Public’s Social-Media-Following of United States’ Public Health Departments during COVID-19 Pandemic
Khokhar, Areej, Spaulding, Aaron , Niazi, Zuhair, Chanan‐Khan, Asher , Niazi, Shehzad K. , Sher, Taimur , Manochakian, Rami , Chanan-Khan, Asher, Niazi, Shehzad, Sher, Taimur , Spaulding, Aaron , Ailawadhi, Sikander

Journal of Primary Care & Community Health | March 2, 2021 | Volume: 12 | Issue: No issue available | Pages: No page available

10.1177/2150132721995450 Get It

Importance: Social media is widely used by various segments of society. Its role as a tool of communication by the Public Health Departments in the U.S. remains unknown. Objective: To determine the impact of the COVID-19 pandemic on social media following of the Public Health Departments of the 50 States of the U.S. Design, Setting, and Participants: Data were collected by visiting the Public Health Department web page for each social media platform. State-level demographics were collected from the U.S. Census Bureau. The Center for Disease Control and Prevention was utilized to collect information regarding the Governance of each State’s Public Health Department. Health rankings were collected from “America’s Health Rankings” 2019 Annual report from the United Health Foundation. The U.S. News and World Report Education Rankings were utilized to provide information regarding the public education of each State. Exposure: Data were pulled on 3 separate dates: first on March 5th (baseline and pre-national emergency declaration (NED) for COVID-19), March 18th (week following NED), and March 25th (2 weeks after NED). In addition, a variable identifying the total change across platforms was also created. All data were collected at the State level. Main Outcome: Overall, the social media following of the state Public Health Departments was very low. There was a significant increase in the public interest in following the Public Health Departments during the early phase of the COVID-19 pandemic. Results: With the declaration of National Emergency, there was a 150% increase in overall public following of the State Public Health Departments in the U.S. The increase was most noted in the Midwest and South regions of the U.S. The overall following in the pandemic “hotspots,” such as New York, California, and Florida, was significantly lower. Interesting correlations were noted between various demographic variables, health, and education ranking of the States and the social media following of their Health Departments. Conclusion and Relevance: Social media following of Public Health Departments across all States of the U.S. was very low. Though, the social media following significantly increased during the early course of the COVID-19 pandemic, but it still remains low. Significant opportunity exists for Public Health Departments to improve social media use to engage the public better.
Racial Disparities and Their Impact on Knowledge, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials Among Cancer Patients
Ailawadhi, Meghna, Abdulazeez, Mays F , Alegria, Victoria R., Sher, Taimur , Paulus, Aneel , Chanan‐Khan, Asher , Paulus, Aneel , Bojanini, Leyla , Roy, Vivek , Manochakian, Rami , Ailawadhi, Sikander

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 39-40

10.1182/blood-2020-140390 Get It

Background: Clinical trials are critical to drug development and the formulation of evidence-based guidelines which are essential to providing crucial and often life-saving treatment to cancer patients. Clinical trial participation is very poor in the United States overall, with a dismal representation of racial minorities. While this has been a focus of several efforts focused on education, targeted enrollment etc., there is a lack of understanding of the patient's knowledge and preferences, and how that may be shaping their decision to consider participation in clinical trials. We undertook a patient-reported survey to explore these factors and understand any underlying disparities. Methods: A 15-question paper-based anonymous questionnaire addressing the cancer patient's knowledge about their disease and clinical trials, as well as factors that may shape their understanding of, or may be barriers to their participation in clinical trials was used. This was administered to adult patients with lymphoid malignancies at the Mayo Clinic in Florida. Categorical and continuous variables between white and minority respondents were compared using the Chi-square test and U Mann Whitney with a significance level of 0.05. Results: The survey was completed by 203 cancer patients. Of these, 3 patients did not report race and ethnicity and so responses from 200 patients were included in the final analysis. Of the respondents, 73% (n=146) were white and 27% (n=54) were minorities. Whites were older than minorities, although not statistically significant (median 67 vs. 61.5 yrs, p=0.06). Minority patients had lower education level with 41% having ≤high school education as compared to 16% whites (p<0.001). Majority of white patients (53%) reported their physicians as the highest ranked source of information for cancer vs. 33% minority patients (p=0.01). Other sources of information explored were internet, nurses, family/friends, books/flyers or other patients. A higher number of white patients reported treatment and its side effects to be the topic of most importance to them at the time of cancer diagnosis as compared to minorities (33% vs. 15%, p=0.01). Similarly, prognosis was more important for a higher number of whites than minorities (21% vs. 15%, p=0.03). Understanding of the diagnosis and financial impact were also explored but not found to have any significant difference. Understanding their treatment and long-term treatment plan was the most frequent knowledge gap reported by whites (81%) vs. minorities (54%, p=0.004). Minorities had several knowledge gap areas (understanding the diagnosis, treatment, side effects, long-term treatment plan, financial impact, survival) more evenly distributed. Regarding clinical trials, minorities were more likely to agree that clinical trials were of benefit for patients (42% vs. 28%, p=0.05) and that in a clinical trial the experimental drug always works better than the one it is being compared to (65% vs. 38%, p<0.001). Minority patients were less likely to agree to participating in clinical trials just based on their doctor's recommendation and judgement (83% vs. 93%, p=0.03). A higher number of minority patients felt that pharmaceutical companies have a big influence on the result of a clinical trial (83% vs. 65%, p=0.01). Fear of not benefiting from clinical trials was the reason for not participating among a higher number of whites (36% vs. 19%, p=0.02) while minorities more frequently reported fear of being a guinea pig (22% vs. 14%) and fear of financial burden (17% vs. 8%) although these were not statistically significant. Conclusions: Racial disparities exist at various aspects of cancer-related knowledge resources, gaps and needs. Minorities have more widespread knowledge gaps and depend on more resources for cancer-related knowledge, which may affect their clinical trial participation and preferences. There appears to be mistrust and misinformation guiding minority patient's understanding, leading to more widespread fears of clinical trials. Knowledge gaps and misinformation needs to be addressed in order to achieve higher participation in clinical trials in general, and among minority patients in particular. Disclosures Manochakian: AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; Guardant health: Membership on an entity's Board of Directors or advisory committees; Novocure: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Ailawadhi:Phosplatin: Research Funding; Medimmune: Research Funding; BMS: Research Funding; Cellectar: Research Funding; Pharmacyclics: Research Funding; Janssen: Research Funding; Takeda: Honoraria; Amgen: Research Funding; Celgene: Honoraria.
Clinical Features and Survival Outcomes in Diabetic Patients with Newly Diagnosed Multiple Myeloma (NDMM) Enrolled in the Connect® MM Registry
La, Lisa, Durie, Brian G.M. , Gasparetto, Cristina, Hardin, James W. , Narang, Mohit , Omel, James, Rifkin, Robert M. , Terebelo, Howard R. , Toomey, Kathleen, Dhalla, Mazaher, Abonour, Rafat , Jagannath, Sundar , Ailawadhi, Sikander , Gasparetto, Cristina , Lee, Hans C. , Wagner, Lynne I. , Liu, Liang , Yang, Ling, Joshi, Prashant

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 49-50

10.1182/blood-2020-137309 Get It

Background: Multiple myeloma (MM) is typically diagnosed in patients (pts) aged 65-74 y (SEER: Myeloma. 2019); therefore, many pts present with concomitant metabolic disorders such as diabetes (18%-22% prevalence of type 2 diabetes [T2D; BMC Cancer. 2020;20:489]). Obesity (body mass index [BMI], ≥ 30 kg/m2) is associated with increased prevalence of T2D (Int J Clin Pract. 2007;61:737), and both are suggested risk factors for MM (Blood. 2012;119:4845; Bone Marrow Transpl. 2014;49:1009). Results from single-center, retrospective studies have shown poorer clinical features and survival outcomes in diabetic pts with MM vs their nondiabetic counterparts (Eur J Haematol. 2012;89:320, Br J Cancer. 2014;111:628). The Connect® MM Registry (NCT01081028) is a large, US, multicenter, prospective observational cohort study of largely community-based pts with NDMM. Reported here is a descriptive analysis assessing differences in baseline (BL) characteristics, treatment patterns, and survival outcomes in diabetic vs nondiabetic pts enrolled in the Connect MM Registry. Methods: Pts with NDMM (N = 3011) were enrolled at 250 community, academic, and government sites. Eligible pts were aged ≥ 18 y with symptomatic MM diagnosed ≤ 2 months (mo) pre-enrollment per International Myeloma Working Group criteria (Leukemia. 2009;23:3). Diabetic pts were defined as those with a history of diabetes and also receiving antidiabetic treatment at BL; those without a history of diabetes and not receiving antidiabetic treatment at BL were defined as nondiabetic pts. Descriptive statistics were used for BL characteristics and treatment regimens. Survival outcomes (progression-free survival [PFS] and overall survival [OS]) were analyzed using Cox regression and adjusted for covariates. Results: Of the 2845 pts included in this analysis, 467 (16%) were diabetic, and 2378 (84%) were nondiabetic. The median age was 69 y for diabetic pts and 66 y for nondiabetic pts, with fewer Black pts (12.2% vs 19.5%) in the nondiabetic group. The proportion of men was higher in the diabetic vs the nondiabetic group (61.9% vs 56.6%). Similar percentages of pts had ECOG PS of 0-1 in both groups (53.3% vs 55.3%). Obesity was more prevalent in diabetic vs nondiabetic pts (55.9% vs 30.4%). More diabetic pts had a history of hypertension requiring treatment vs nondiabetic pts (84.2% vs 52.5%). The prevalence of chromosomal abnormalities was comparable between the groups (within the limitation that data were missing in a substantial number of pts). Among MM-defining criteria, diabetic pts had a higher incidence of hypercalcemia (11.8% vs 8.5%), anemia (50.3% vs 46.5%), and increased creatinine (23.8% vs 19%), whereas measured kidney function was similar. A lower proportion of diabetic than nondiabetic pts received stem cell transplantation (SCT; 28.9% vs 41.5%) and triplet regimens during first induction (48.2% vs 52.8%%). The use of ≥ 2 novel agents during first line (1L) was lower in diabetic than nondiabetic pts (27.8% vs 34.6%), but use of a single novel agent (63.4% vs 60%) and alkylator in 1L (20.6% vs 22.4%) was comparable. The top five 1L regimens were similar for both groups, with lenalidomide + bortezomib + dexamethasone being the most common 1L regimen, and lenalidomide the most common maintenance therapy. Diabetic pts had significantly shorter adjusted median PFS (24.4 vs 31.5 mo; hazard ratio [HR], 1.24; P = 0.001; Fig. 1A) and median OS (60 vs 72.6 mo; HR, 1.29; P = 0.001; Fig. 1B) than nondiabetic pts. In a subgroup analysis by BMI, diabetic pts had significantly shorter OS than nondiabetic pts (for BMI < 30 [50.8 vs 73.1 mo; HR, 1.51; P = 0.0001] and BMI ≥ 30 [56.4 vs 78.6 mo; HR, 1.51; P < 0.0001]). Conclusions: Diabetic pts with NDMM had poorer BL features and were less likely to receive SCT and triplet regimens and/or aggressive upfront treatment. Regardless of BMI, diabetic pts had shorter median OS than nondiabetic pts, suggesting that diabetes might be a stronger factor for survival than obesity. These results support a previous analysis of the Connect MM Registry that identified history of diabetes as a predictive prognostic factor for poor OS (Br J Haematol. 2019;187:602). Limitations of this analysis include limited detail on the care/management of diabetes and steroid use/dosage (which can be challenging for glycemic control). These findings highlight the need to provide better supportive care for diabetes management in MM pts to improve survival. Disclosures La: Celgene BMS: Consultancy. Jagannath:BMS, Janssen, Karyopharm, Legend Biotech, Sanofi, Takeda: Consultancy. Ailawadhi:Amgen: Research Funding; Celgene: Honoraria; Takeda: Honoraria; Janssen: Research Funding; Pharmacyclics: Research Funding; Cellectar: Research Funding; BMS: Research Funding; Medimmune: Research Funding; Phosplatin: Research Funding. Durie:Amgen, Celgene, Johnson & Johnson, and Takeda: Consultancy. Gasparetto:Adaptive Biotechnologies: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Karyopharm: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Janssen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; GSK: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Honoraria. Hardin:Celgene Pharmaceutical Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES. Lee:Sanofi: Consultancy; Janssen: Consultancy, Research Funding; GlaxoSmithKline: Consultancy, Research Funding; Genentech: Consultancy; Takeda: Consultancy, Research Funding; Regeneron: Research Funding; Genentech: Consultancy; Amgen: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Daiichi Sankyo: Research Funding. Narang:Maryland Oncology Hematology: Current Employment; Beigene: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; J&J: Consultancy, Honoraria. Omel:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES; BMS/Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Rifkin:McKesson: Current equity holder in publicly-traded company, Ended employment in the past 24 months, Other: Stock ownership; Takeda, Amgen, Celgene, BMS, Mylan, Coherus BioSciences, Fresenius: Consultancy; AbbVie: Other: Investigator in AbbVie sponsored clinical trials; Takeda, Amgen, BMS (Celgene): Membership on an entity's Board of Directors or advisory committees. Terebelo:Newland Medical Associates: Current Employment; BMS: Membership on an entity's Board of Directors or advisory committees. Toomey:Celgene/BMS: Membership on an entity's Board of Directors or advisory committees. Wagner:Celgene Inc.: Membership on an entity's Board of Directors or advisory committees; Connect Multiple Myeloma Registry: Membership on an entity's Board of Directors or advisory committees. Dhalla:BMS: Current Employment, Current equity holder in publicly-traded company. Liu:TechData Inc: Consultancy. Yang:BMS: Current Employment, Current equity holder in publicly-traded company. Joshi:Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company; Eisai Inc.: Ended employment in the past 24 months. Abonour:Takeda: Consultancy; Janssen: Honoraria, Research Funding; Celgene: Consultancy; BMS: Consultancy, Research Funding.
Real-World Treatment Patterns and Outcomes of Proteasome Inhibitor (PI: Bortezomib [V], Carfilzomib [K], or Ixazomib [I])-Lenalidomide/Dexamethasone (Rd)-Triplets By Prior Lenalidomide-Exposure in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) E
Sanchez, Larysa , Cherepanov, Dasha , Romanus, Dorothy , Raju, Aditya , Blazer, Marlo, Farrelly, Eileen, Stull, Dawn Marie, Ailawadhi, Sikander

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 47-48

10.1182/blood-2020-136597 Get It

BACKGROUND: PIs combined with an Rd backbone are the most commonly used triplet combination regimens in patients (pts) with RRMM in the US. The hallmark trials supporting the efficacy of these regimens were predominantly in pts without prior exposure to lenalidomide (R).1,2 Real-world analyses have shown that R-based regimens are increasingly used in the front-line setting.3-5 Thus, real-world treatment patterns in pts with prior R exposure and the real-world comparative effectiveness of PI-Rd triplets in this population with RRMM needs further elucidation. METHODS: A retrospective cohort of RRMM pts initiating IRd, KRd, or VRd in line of therapy (LOT) ≥2 were followed between 7/2007-9/2018 in Optum's deidentified national electronic health records database. RRMM pts were defined as those initiating LOT ≥2 between 1/2014 and 9/2018 and were categorized as having or not having prior exposure to R (R-exposed; no-prior-R) in any prior LOT. Index regimen was the first use of I-/K-/or V-Rd. LOTs were defined via an algorithm developed with MM specialists to proxy the definition of a LOT in RCTs & in accordance with NCCN MM Guidelines.6 Baseline data included: CRAB (hyperCalcemia, Renal insufficiency, Anemia, and Bone lesions); high risk cytogenetics (defined as del[17p], 1q21 gain, t[4;14], or t[14;16]); Charlson Comorbidity Index (CCI) score; and modified frailty score using age and CCI score. Median duration of therapy (DOT) and time-to-next-treatment (TTNT) (a proxy for PFS; defined as time from index regimen start to subsequent LOT or death) were estimated using Kaplan-Meier methods and compared using covariate-adjusted Cox proportional hazard models (FIGURE). Observations were censored at time of loss to follow-up (f/u)/end of study period (9/30/2018). RESULTS: Of 650 pts included, 397 were R-exposed (IRd, n=112; KRd, n=115; VRd, n=170); 253 had no-prior-R (IRd, n=29; KRd, n=62; VRd, n=162). R-exposed pts, overall, were treated in later LOTs (LOT2: 55% v 78%) and had a longer median time from diagnosis to index LOT (26.7 v 13.4 months) than no-prior-R pts; this differed between treatment cohorts (TABLE). In R-exposed pts, more pts with symptomatic relapse (≥1 CRAB symptom, 87%) or high-risk cytogenetics (30%) received KRd than IRd (75% & 23%) or VRd (74% & 16%) (TABLE). More pts treated with IRd were ≥75 years old: 42% (IRd) v 36% (VRd) / 21% (KRd). In R-exposed pts, 35.3% of those receiving VRd in LOT ≥2 had prior V-IMID-based and 53.5% had IMID-based therapy (ie, IMID with no PI nor monoclonal antibody) in LOT1; >98% of LOT1 IMID use was R, across groups. In R-exposed pts, 56.5% of those receiving KRd had prior V-IMID-based and 16.5% had IMID-based therapy in LOT1; in IRd pts in LOT ≥2, 29.5% and 43.8% had prior V-IMID-based and IMID-based therapy in LOT1. In unadjusted analysis, at a median f/u of 11, 11.9, and 14.8 months for I-, K-, and V-Rd, median TTNT for R-exposed pts: 12.3 months (IRd), 7.8 months (KRd), and 13.9 months (VRd) (P=0.50); HRs for TTNTLOT stratified: 0.84 (IRd v KRd), 0.96 (IRd v VRd), 1.15 (KRd v VRd), and median regimen DOTs: 8.4 months (IRd), 7.5 months (KRd), and 9.5 months (VRd) (P=0.75). In no-prior-R pts, HRs for TTNTLOT stratified were significant for IRd v KRd (HR=0.33) and KRd v VRd (HR=1.62) (P<0.01, both); IRd v VRd (HR=0.53; P=0.11). In adjusted analysis, there were no significant differences for R-exposed pts by PI-Rd regimens for TTNT (FIGURE), nor for regimen DOT. For no-prior-R pts, adjusted HR for TTNT was significant for I- v K-Rd (HR=0.36; P=0.03) and for regimen DOT was significant for I- v V-Rd (HR=0.34; P=0.03). CONCLUSIONS: In this real-world study, the majority of pts received a PI-Rd combination after prior VRd or Rd in front-line. After controlling for baseline characteristics, including prior PI-exposure, PI-Rd triplets were comparable in TTNT in R-exposed pts treated in LOTs ≥2. TTNT was significantly longer for I- v K-Rd in pts with no-prior-R, although this is limited by small sample size. Published studies indicate that individualized treatment recommendations may improve real-world outcomes, such as IRd v KRd in frail pts which was associated with significantly longer TTNT.6 Prior-R exposure, in our analysis, does not appear to influence the relative PI-triplet regimen effectiveness in LOTs ≥2. With increasing use of R in earlier LOTs, understanding real-world treatment patterns and subsequent PI-Rd effectiveness in consequent LOTs is key for optimizing RRMM pt management. Disclosures Cherepanov: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Romanus:Takeda: Current Employment. Raju:Xcenda: Current Employment, Other: Xcenda received research funding from Takeda. Blazer:Xcenda: Current Employment, Other: Xcenda received research funding from Takeda. Farrelly:Xcenda: Current Employment, Other: Xcenda received research funding from Takeda. Stull:Takeda: Current Employment. Ailawadhi:Phosplatin: Research Funding; Celgene: Honoraria; Amgen: Research Funding; Takeda: Honoraria; Janssen: Research Funding; Pharmacyclics: Research Funding; Cellectar: Research Funding; BMS: Research Funding; Medimmune: Research Funding.
Daratumumab Plus Lenalidomide and Dexamethasone (DRd) Compared to Daratumumab Plus Pomalidomide and Dexamethasone (DPd) in Relapsed Lenalidomide-Exposed or Refractory Multiple Myeloma (MM) Patients: The Mayo Clinic Experience
Abdulazeez, Mays F , Sher, Taimur , Alegria, Victoria R., Warsame, Rahma , Larsen, Jeremy T. , Kourelis, Taxiarchis , Kapoor, Prashant , Hayman, Suzanne R. , Reeder, Craig B. , Agrawal, Arshi, Chanan‐Khan, Asher , Moustafa, Muhamad Alhaj , Parrondo, Ricardo D , Roy, Vivek , Gonsalves, Wilson I. , Fonseca, Rafaël , Buadi, Francis K. , Dingli, David , Ailawadhi, Sikander

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 1-2

10.1182/blood-2020-139929 Get It

Introduction: Daratumumab (D) is an anti-CD38 monoclonal antibody, used frequently in combination with immunomodulatory drugs (IMiDs), lenalidomide (Len) and pomalidomide (Pom). There are no studies comparing DRd to DPd in Len-exposed or refractory multiple myeloma (MM). We present the Mayo Clinic experience of DPd and DRd utilization and outcomes. Methods: We identified consecutive MM pts who received D, between 1/2015 and 4/2019 at Mayo Clinic. We included pts who were exposed (at least one full cycle, 21/28 days) or refractory (progression on full dose or maintenance Len during treatment or within 60 days of stopping Len) to Len prior to D and received 1 to 4 prior lines of therapy. Only Pts who received DRd and DPd were included. Results: Out of 411 evaluable pts 162 met the inclusion criteria; 67 were Len exposed, but not refractory and 95 were Len refractory. Pts' characteristics are shown in Table 1. DRd was used in 76 (47%) and DPd in 86 (53%) pts. Majority of pts (105; 65%) received DPd or DRd in the 2nd or 3rd line and 104 pts (64%) are still alive. In Len refractory pts, the median time from last dose of Len to D initiation was 1 mths (interquartile range 0-6.5). Seventy pts (43%) had high-risk cytogenetics (HR). Only 11 pts (7%) underwent autologous hematopoietic cell transplant after DPd or DRd regimen. There was no significant difference between pts who received DRd and DPd in terms of age (>65 years), gender, race, proportion exposed or refractory to Bortezomib, number of prior lines of treatment (>2), or HR status (p>0.05 for all). Pts who received DPd were 4 times more likely to be Len refractory compared to pts who received DRd, p=0.0008. Median follow up time for the whole cohort from initial diagnosis was 92 mths (CI 95%; 79.5-107), while from D start date was 30 mths (CI 95%; 27-34). Median PFS for the whole cohort was 21 mths (CI 95%; 15-25) and median OS was 138 mths (CI 95%; 111-193). In Len exposed but not refractory pts, n=67, the overall response rate (ORR) was 82% in the DRd group compared to 68% in the DPd group, p=0.2. There was no difference in median PFS; 25.5 mths (CI 95%; 23-NR) for DRd compared to 25 mths (CI 95%; 5-NR) for DPd, p=0.37. Similarly, there was no difference in median OS for DRd compared to DPd; NR mths (CI 95%; 138-NR) and 145.5 mths (CI 95%; 70-NR), respectively, p=0.06. In the 48 Len exposed but refractory pts who received DRd or DPd in 2nd or 3rd line, there was no difference in median PFS; 39 mths (CI 95%; 23-NR) for DRd compared to 21 mths (CI 95%; 3-NR) for DPd, p=0.11. Similarly, there was no difference in median OS for DRd compared to DPd; NR mths (CI 95%; NR-NR) and 145.5 mths (CI 95%; 36-NR), respectively, p=0.13. In Len refractory pts only, n=95, the ORR was 84% in the DRd group compared to 58% in the DPd group, p=0.009. There was no difference in median PFS; 25 mths (CI 95%; 13-32) for DRd compared to 9 mths (CI 95%; 5-15) for DPd, p=0.18. Similarly, there was no difference in median OS for DRd compared to DPd; 103 mths (CI 95%; 78-NR) and 106 mths (CI 95%; 66-183), respectively, p=0.5. In the 57 Len refractory pts who received DRd or DPd in 2nd or 3rd line, there was no difference in median PFS; 25 mths (CI 95%; 13-32) for DRd compared to 13 mths (CI 95%; 5-NR) for DPd, p=08. Similarly, there was no difference in median OS for DRd compared to DPd; 103 mths (CI 95%; 69-NR) and 105 mths (CI 95%; 47-NR), respectively, p=0.35. In the 16 Len exposed but not refractory pts with HR MM who received DRd or DPd in 2nd or 3rd line, the median PFS was better in the DRd group; 24.4 mths (CI 95%; 12-NR) compared to 3.3 mths (CI 95%; 1.9-27.5) for DPd, p=0.0093. However, there was no difference in median OS for DRd compared to DPd; NR mths (CI 95%; 51-NR) and NR mths (CI 95%; 18-NR), respectively, p=0.13. In the 29 Len refractory pts with HR MM who received DRd or DPd in 2nd or 3rd line, there was no statistically significant difference in median PFS; 18 mths (CI 95%; 6-43) for DRd compared to 6 mths (CI 95%; 4-13) for DPd, p=0.22.Similarly, there was no difference in median OS for DRd compared to DPd; 103 mths (CI 95%; 47-NR) and 53 mths (CI 95%; 26-105), respectively, p=0.2. Conclusions: D+IMiD regimens after prior Len exposure/refractoriness are commonly used in real-world, despite the lack of data from prospective clinical trials. Combining D with IMiDs in Len exposed or refractory pts is efficacious, whether the IMiD is Len or Pom. Our study shows that regardless of prior Len use, DRd is at least equivalent to DPd. Prospective studies should be done to confirm these observations. Disclosures Alhaj Moustafa: Acrotech: Consultancy. Larsen:Janssen Oncology: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Kapoor:Janssen: Research Funding; GlaxoSmithKline: Research Funding; Cellectar: Consultancy; Celgene: Honoraria; Amgen: Research Funding; Takeda: Honoraria, Research Funding; Sanofi: Consultancy, Research Funding. Fonseca:Amgen: Consultancy; BMS: Consultancy; Celgene: Consultancy; Takeda: Consultancy; Bayer: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Pharmacyclics: Consultancy; Sanofi: Consultancy; Merck: Consultancy; Juno: Consultancy; Kite: Consultancy; Aduro: Consultancy; OncoTracker: Consultancy, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy; GSK: Consultancy; AbbVie: Consultancy; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees. Dingli:Karyopharm Therapeutics: Research Funding; Rigel: Consultancy; Bristol Myers Squibb: Research Funding; Millenium: Consultancy; Sanofi-Genzyme: Consultancy; Janssen: Consultancy; Alexion: Consultancy; Apellis: Consultancy. Ailawadhi:Celgene: Honoraria; Amgen: Research Funding; Takeda: Honoraria; Janssen: Research Funding; Pharmacyclics: Research Funding; Cellectar: Research Funding; BMS: Research Funding; Medimmune: Research Funding; Phosplatin: Research Funding.
Initial treatment of patients with thyroid cancer: Outcomes and factors associated with care at academic versus nonacademic cancer centers
Alhumaidi, Hebah, Cochuyt, Jordan J., Chindriş, Ana Maria, Hodge, David O. , Abdulazeez, Mays F , David, Shishir, Biswas, Suman, Aggarwal, Chander Shekher , Smallridge, Robert C., Manochakian, Rami , Cochuyt, Jordan, Chindris, Ana, Hodge, David, Ailawadhi, Sikander , Ailawadhi, Sikander

Cancer | January 15, 2021 | Volume: 127 | Issue: 11 | Pages: 1770-1778

10.1002/cncr.33408 Get It

BackgroundFactors associated with receiving initial care for thyroid cancer (TC) at academic centers (ACs) versus nonacademic centers (NACs) and their impact on patient outcomes have not been reported.MethodsThe National Cancer Database with TC cases from 2004 to 2013 was evaluated for association of type of center for initial care with socioeconomic factors and disease and treatment characteristics, as well as overall survival (OS; all‐cause mortality).ResultsThe patients with TC (n = 200,824) included were predominantly women (74%), non‐Hispanic Whites (85%), and from metro areas (84%). Sixty percent received initial care at a NAC. There were no significant differences between treatment groups by age or gender. Among those treated at an AC, a higher proportion belonged to racial/ethnic minorities (16.5%) versus at a NAC (11.6%). Hormone therapy was used more in an AC versus a NAC (60% vs 47%). Patients with all TC pathologies combined had a lower likelihood of death when they received initial care at an AC (hazard ratio [HR], 0.948; P = .0006). Among individual pathologic subtypes, a lower likelihood of death was noted when initial care was received at an AC for follicular (HR, 0.828, P = .0010) and Hurthle cell cancers (HR, 792; P = .0008), as well as stage II papillary thyroid cancer (HR, 0.828; P = .0026), but not for other histopathologic subtypes.ConclusionsInitial care at an AC was associated with lower likelihood of death for patients with TC, especially for those with follicular or Hurthle cell subtypes. Optimal resource use with consideration of patients' socioeconomic and demographic factors is imperative to ensure the most appropriate management of patients with TC in various treatment settings.
Association of Race, Socioeconomic Factors, and Treatment Characteristics With Overall Survival in Patients With Limited-Stage Small Cell Lung Cancer
Zhou, Kexun , H, Shi , Chen, Ruqin , Cochuyt, Jordan J., Hodge, David O. , Zhao, Yujie , Lou, Yanyan , Shi, Huashan, Manochakian, Rami , Ailawadhi, Sikander

JAMA Network Open | January 14, 2021 | Volume: 4 | Issue: 1 | Pages: e2032276

10.1001/jamanetworkopen.2020.32276 Get It

Abstract PO-25: CLR 131 demonstrates 100% overall response rate in relapsed or refractory lymphoplasmacytic lymphoma (LPL)/Waldenstrom's macroglobulinemia (WM): initial results from ongoing phase 2 trial, CLOVER-1 study
Longcor, Jarrod , Oliver, Kate , Grachev, Igor D., Ailawadhi, Sikander , Oliver, Kate

Blood Cancer Discovery | December 3, 2020 | Volume: 1 | Issue: 3_Supplement | Pages: PO-25-PO-25

10.1158/2643-3249.lymphoma20-po-25 Get It

Abstract Introduction: CLR 131 (I-131-CLR1404) is a novel targeted radiotherapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Based on preclinical and clinical experience and the radiosensitivity of MM, CLR 131 is being examined in relapsed or refractory B-cell malignancies through an open-label, phase 2 trial, CLOVER-1 (NCT02952508); initial results in pts with LPL/WM are reported here. Procedures: The primary objective of this study is to determine the efficacy and safety of CLR 131 in select B-cell malignancies. Eligibility criteria include adult pts with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Wadenstrom's macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), or diffuse large B-cell lymphoma (DLBCL). Pts with LPL/WM must have received at least two prior treatment regimens unless ineligible to receive standard agents and have measurable disease: either a nodal lesion > 15 mm, an extranodal lesion > 10 mm, or measurable IgM. Prior external beam radiation therapy is allowed (< 20% of total marrow irradiated). CLR 131 is administered intravenously up to 30 minutes at total body doses (TBD) of <50 mCi, ~50 mCi, and ~75 mCi. Adverse events (AEs) are graded by NCI-CTCAE v4.03; responses are assessed by the 2012 WM Criteria for Response Assessment. Results: Four pts with LPL/WM have been enrolled in the study with data presented as of 1 Mar 2020. The median age was 70 (range 54-81) and included 2 females and 2 males who had a median of two prior regimens (range 1-5). The overall response rate was 100%, including one pt with a complete response, one pt with a partial response, and one pt with a minimal response; one pt remains under evaluation. The primary treatment-emergent AEs across all doses in pts with LPL/WM included neutropenia, thrombocytopenia, nausea, fatigue, anemia, and decreased white blood cell count, in line with experience to date with CLR 131 in other B-cell malignancies. Median time to resolution of cytopenias was 21 days. One pt received two cycles of CLR 131 with a TBD of ~100 mCi. The pt was determined to be a partial response 43 days post initial dose and a complete response at approximately 200 days; this was confirmed radiologically 406 days post initial dose. The duration of response for this pt is currently at 25 months and is ongoing. One pt received ~ 50 mCi CLR 131 and saw an 89% decrease in IgM at 64 days post infusion. One pt received ~ 75 mCi CLR 131 and had a 45% decrease in IgM at 64 days post infusion. One pt received two cycles of CLR 131 with a TBD of ~150 mCi, experiencing a 48% reduction in IgM to date and has not yet completed the evaluation period. Conclusions: CLR 131 is a unique, first-in-class targeted radiotherapeutic in development for multiple B-cell hematologic malignancies. The observed positive signals of efficacy and safety from this preliminary data in relapsed or refractory LPL/WM pts is encouraging and will be further explored. Citation Format: Sikander Ailawadhi, Jarrod Longcor, Kate Oliver, Igor D. Grachev. CLR 131 demonstrates 100% overall response rate in relapsed or refractory lymphoplasmacytic lymphoma (LPL)/Waldenstrom's macroglobulinemia (WM): initial results from ongoing phase 2 trial, CLOVER-1 study [abstract]. In: Proceedings of the AACR Virtual Meeting: Advances in Malignant Lymphoma; 2020 Aug 17-19. Philadelphia (PA): AACR; Blood Cancer Discov 2020;1(3_Suppl):Abstract nr PO-25.