12107 Background: Malnutrition (MN) is common in hospitalized cancer patients but often underdiagnosed. We evaluated the prevalence of MN risk, dietitian documented MN (DDMN), and physician coded malnutrition (PCMN) in a consecutive cohort of cancer inpatients in an academic, community-based medical center. Methods: Electronic medical records (EMR) were reviewed for inpatients with a solid tumor diagnosis staged I-IV and admitted to Atrium Health Carolinas Medical Center at least once between 1/1/2016 to 5/21/2019. All data were collected from the first admission EMR encounter closest to the cancer diagnosis date. High MN risk was a score ≥2 on the Malnutrition Screening Tool (MST) completed by an RN at admission. Registered Dietitian (RD) assessments were reviewed for DDMN and grade (mild, moderate, severe). PCMN diagnosis was based on MN ICD-10 codes extracted from the medical coder’s discharge summary. Multivariate logistic regression models identified associations between clinic-demographic factors and the prevalence of DDMN and PCMN with stepwise selection. Results: N=5,143; 48% females. Median age 63 (range 18-102) years. 70% White; 24% Black, 3% Latino. Most common cancers: thoracic 19% and digestive system (14% other, 11% colorectal). 28% had known stage IV disease. The MST was completed in 79%. Among those with MST ≥2 (N=1,005; 25%), DDMN and PCMN prevalence was 30% and 22%, respectively. In the entire cohort, 8% had DDMN; 7% PCMN; 4% both. Prevalence of MN risk, DDMN, and PCMN by cancer site are in the Table. DDMN (N=420) was mild 2%, moderate 16%; severe 66%; unspecified 16%. On discharge, PCMN (N=360) was mild 10%; moderate 0%; severe 69%; unspecified 21%. Male gender (OR 1.27 [1.01, 1.59]), Black race (OR 1.57 [1.25, 1.98]), stage IV disease (v. I-III) (OR 3.08 [2.49, 3.82]), and primary site were all independent predictors of DDMN (all p<0.05); Black race (OR 1.46 [1.14, 1.87]), stage IV disease (OR 2.70 [2.15, 3.39]), and primary site were independent predictors of PCMN (all p<0.05). Conclusions: 25% of cancer inpatients were at high risk for MN. Primary site, disease stage, and race were independent predictors of a greater risk. MN appears to be under-diagnosed compared to population studies. This is the first study to report the prevalence of MN in a large cancer inpatient database with a representative population.[Table: see text]

Background: There are limited data on venous thromboembolism (VTE) incidence and predictive factors in non-small cell lung cancer (NSCLC) across first-line therapies. Objective: To evaluate VTE incidence rates and identify predictive factors in NSCLC patients receiving first-line systemic therapies, including immune checkpoint inhibitors (ICIs). Patients/methods: This is a single institution retrospective study of adult NSCLC patients who received first-line treatment, including chemotherapy, ICIs (pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab), and/or targeted therapies (TTs) (erlotinib, gefitinib, afatinib, osimertinib, crizotinib, alectinib, ceritinib). Risk factors included Khorana score, cancer stage, central venous catheter, pacemaker, comorbidities, and prior VTE. The primary objective cumulative incidence of VTE at 6- and 12-months by treatment group - was compared using Gray's test. Univariable and multivariable competing risk analyses were used to identify predictors. Results: Of 1587 evaluable patients, 53% were male, 79% white, 18% black, median age was 66; 58% had adenocarcinoma, 32% squamous cell carcinoma, and 47% metastatic disease; 1043 received chemotherapy, 171 ICIs, 157 chemotherapy plus concomitant ICI, 107 chemotherapy and durvalumab maintenance, and 109 TTs. The 6-month cumulative incidence of VTE by treatment type was 5.0%, 7.6%, 9.9%, 9.4%, and 11.1%; 12-month incidence was 6.5%, 9.0%, 12.8%, 12.2%, and 13.1% per arm, respectively (p = 0.01). Treatment type (p = 0.034) and nicotine dependence (p = 0.048) were significantly associated with time to VTE in multivariable analyses. Conclusion: Treatment type and smoking status were predictive of time to VTE in NSCLC patients receiving various first-line therapies. Cumulative incidence was highest in those receiving TTs and combination chemotherapy plus ICI.

e21192 Background: Landmark trials have shown increased survival in pts who receive IO for NSCLC as compared to chemotherapy (chemo). Median overall survival (mOS) ranged from 17-26 months (mo); however, mOS in several published “real-world” retrospective studies are lower, ranging from 8-12 mo, with about 4-5 months on IO treatment. We sought to define mOS of pts with mNSCLC who received IO as monotherapy or in combination with chemo as first line therapy at Levine Cancer Institute. Methods: We retrospectively reviewed 315 adult pts with mNSCLC without driver mutations diagnosed between 2016 and 2019. The Kaplan-Meier method was used to estimate and compare OS between IO and IO + chemo. Univariate and multivariate Cox models were used to evaluate risk factors (RF) for OS. RFs considered included age, sex, race, smoking status, histology, first-line treatment type, and metastatic (mets) sites. Results: Baseline pt characteristics were: 40% female, 77% white, 20% Black, 34% current smokers and 60% former smokers. Median age was 69 years (45-88) in pts receiving IO alone and 63 years (28-84) in pts receiving IO + chemo. Tumor characteristics were: 76% adenocarcinoma and 17% squamous cell carcinoma. PD-L1 TPS distribution was: 39% for 0%, 22% for 1-49%, and 39% for ≥50%. Distribution of mets was 10% adrenal, 40% bone, 30% brain, 14% liver, 31% lung. mOS for pts receiving IO and IO + chemo as first line therapy was 17 and 14.8 mos, respectively (P = .209). Median duration of IO received was 4.25 months (0 to 43.6). mOS as stratified by PD-L1 TPS was 14.5 mos for PD-L1 0%, 13.3 mos for PD-L1 1-49%, and 19.5 mos for PD-L1 ≥50% (P = .163). OS was significantly different between IO and IO + chemo after adjusting for age. No OS differences were seen between white and Black or between all pts vs pts with brain mets (brain-specific interventions not reviewed). The table summarizes significant findings only (P < 0.05). Conclusions: Pts with mNSCLC treated first-line with IO either alone or with chemo at Levine Cancer Institute lived longer than those in similar published “real-world” cohorts. Median OS was highest in patients with PD-L1 TPS ≥50%, although not statistically significant. While not unusual to identify worse outcomes in those with bone and liver mets, interestingly brain metastasis was not associated with worse survival. In this cohort, when adjusted for age, IO alone trends toward improved survival. Although there was no OS difference based on race, further investigation will seek to uncover any other disparities contributing to outcomes, such as insurance status and zip code mapping. To our knowledge, this provides the largest analysis of this patient population outside of a clinical trial.[Table: see text]

e19293 Background: VTE incidence varies based on factors such as tumor type, stage, and treatment. There is limited data on VTE incidence and risk factors in NSCLC pts receiving first-line therapies, including immune checkpoint inhibitors (ICIs) and targeted therapies (TTs). Methods: This is a single institution retrospective cohort study of adult NSCLC pts who received first-line treatment between July 2003 and July 2019. Treatments included chemotherapy (chemo) (platinums, taxanes, pemetrexed, gemcitabine, etoposide, bevacizumab), ICI (pembrolizumab, nivolumab, atezolizumab, durvalumab), chemo + ICI, or TT (erlotinib, gefitinib, afatinib, osimertinib, crizotinib, alectinib, ceritinib). Diagnosis codes (ICD 9/10 codes) confirmed VTE (deep vein thrombosis and/or pulmonary embolism) and presence of risk factors which are summarized in Table. Landmark VTE incidence was estimated from cumulative incidence curves for time to VTE, death as a competing risk. Time to VTE distributions were compared between groups with Gray’s tests. Univariable and multivariable competing risk analyses identified risk factors for time to VTE. Results: In 1,618 evaluable pts, the median age was 66 years, 53% were male, 79% White, 18% Black, 58% had adenocarcinoma, 32% squamous cell carcinoma, and 47% metastatic disease. 1178 received chemo, 172 ICIs, 157 chemo + ICI, and 111 TTs. 6-month VTE rates per arm were 5.3%, 7.0%, 7.2%, and 12.0% and 12-month rates were 8.9%, 8.1%, 11.7%, and 13.3%, respectively. Cumulative incidence of VTE was not significantly different between treatment groups (p = .27). Univariable and multivariable analyses are summarized in the Table below. Conclusions: Treatment type was not associated with VTE risk in first-line NSCLC, but rates were numerically highest in pts receiving TTs. Khorana risk score was significantly associated with VTE risk and may identify those likely to benefit from thromboprophylaxis. [Table: see text]

Data are lacking regarding incidence and risk for thromboembolism (TE) in myeloma, including receipt of thromboprophylaxis. In a single-center evaluation of 485 patients, male sex and presence of any comorbidity were associated with time to TE. Thromboprophylaxis type was not associated with incidence despite a higher proportion of those in the anticoagulant group having >= 1 comorbidities. Background: We evaluated time to thromboembolism (TE) and risk factors in multiple myeloma (MM) patients after first exposure to immunomodulatory therapy, stratified by thromboprophylaxis. Patients and Methods: We retrospectively analyzed adult MM patients who received immunomodulatory therapy with or without dexamethasone between February 2012 and October 2017. Thromboprophylaxis included aspirin, anticoagulants (low-molecular-weight heparin, direct oral anticoagulants, or warfarin), or none. Primary endpoint was time to on-treatment TE by thromboprophylaxis type. Time to TE using death as a competing risk censored at 12 months was used in univariate and multivariable analyses to identify risk factors. Results: Of 485 evaluable patients, 57% were white and 36% African American; median age was 66. Most received lenalidomide (97.5%) and dexamethasone (90%). Half presented with >= 1 comorbidities. Sixty-nine had no documented receipt of prophylaxis, 357 aspirin, and 59 anticoagulation. More patients receiving anticoagulants had >= 1 comorbidities compared to aspirin or no-prophylaxis groups (P < .001). There was no difference in 12-month estimated cumulative incidence of TE (7.3%; 95% confidence interval, 5.2-9.9) between thromboprophylaxis groups (none 4.4%, aspirin 8.5%, anticoagulant 3.4%) (P= .24). In multivariable analyses, male sex (hazard ratio, 2.50; 95% confidence interval, 1.21-5.17; P = .014) and presence of any comorbidity (hazard ratio, 2.35; 95% confidence interval, 1.17-4.73; P = .016) were associated with TE incidence; thromboprophylaxis type was not (P = .12). Conclusion: Male sex and presence of any comorbidity were associated with time to TE. There were no differences in TE incidence between thromboprophylaxis groups despite a higher proportion of those in the anticoagulant group having >= 1 comorbidities. (C) 2020 Elsevier Inc. All rights reserved.

Background: Targeting B-cell maturation antigen (BCMA) with antibody-drug conjugates (ADCs), bispecific antibodies, or chimeric antigen receptor t-cells (CAR-Ts) has proven safe and effective in recent clinical trials, but relapses remain common. As most patients treated with BCMA targeting therapies are refractory to conventional anti-myeloma therapies, management of these patients poses unique challenges once they progress, with no data available to guide subsequent therapies. Methods: We performed a retrospective chart review of all relapsed refractory multiple myeloma (RRMM) patients at our institution who progressed while on or after a BCMA targeting therapy and were treated with subsequent therapies. We evaluated the best response achieved and overall survival (OS) measured from progression on BCMA targeting therapies. Kaplan Meier methods were used to estimate OS curves and landmarks between classes of BCMA targeting therapy received (ADC, bispecific antibody or CAR-T), and by type of subsequent therapy. Results: At a median follow up of 6 months, a total of 47 patients were treated with a BMCA targeting therapy. Of those, a total of 21 (44.7%) patients have progressed, with 18 (38.3%) receiving another therapy. Twelve-month overall survival of the patients who received a subsequent treatment was 51.1% (figure 1a), but varied considerably based on the class of BCMA therapy they received (figure 1b). Patients who progressed after a BCMA CAR-T had the best OS (N =2, 6 mo OS: 100%, 12 mo OS: Of the 18 patients who progressed and were treated with subsequent therapies, 7 (38.9%) received 2 lines of therapy, 5 (27.8%) received 3 lines of therapy, and 1 patient (5.6%) received 5 lines of therapy. In the first relapse, 4 (22.2%) patients received infusional chemotherapy with CAR-D PACE or CAR-DCEP, 4 (22.2%) received the combination of elotuzumab, pomalidomide, and dexamethasone (Elo-Pd; one of which was first treated with CAR-DCEP), 3 (16.7%) received selinexor based regimens. The best response seen after first-line post BCMA treatment was a partial response (PR) in 5 (27.8% of patients), whereas 8 (61.5%) patients who received second-line treatment post-BCMA therapy had a PR or better, including 3 (23.1%) who had a very good partial response (VGPR). In the third line post-BCMA, 1 (16.7%) had a VGPR, while 1 (16.7%) had stable disease as their best response. The use of Elo or Dara after anti-BCMA progression seemed to correlate with improved OS (see figure 1c below). While all these patients were Elo naïve, the majority (94.4%) were previously Dara exposed. Conclusions: Our data demonstrate that many RRMM patients who progress on BCMA targeting therapies still derive benefit from subsequent treatment. Early evidence from our experience suggests a survival advantage with monoclonal antibody-based therapies even in patients who had previously been exposed to these agents-suggesting a possible resensitization with BCMA directed therapy. Although our dataset is a single-center experience, to our knowledge it represents the first report of post-BCMA exposed management of RRMM and provides valuable insight into the treatment of this challenging and ever-expanding population. Disclosures Paul: Bristol-Myers Squibb: Other: Stock Ownership (prior employee); Amgen: Consultancy, Speakers Bureau; Regeneron: Membership on an entity's Board of Directors or advisory committees. Bhutani:BMS: Other: Clinical trial funding to institute, Speakers Bureau; Takeda: Other: Clinical trial funding to institute, Speakers Bureau; Prothena: Other: Clinical Trial Funding to Institute; Amgen: Speakers Bureau; MedImmune: Other: Clinical Trial Funding to Institute; Sanofi Genzyme: Consultancy; Janssen: Other: Clinical Trial Funding to Institute. Voorhees:Adaptive Biotechnologies: Other: Personal fees; Bristol-Myers Squibb: Other: Personal fees; Celgene: Other: Personal fees; Janssen: Other: Personal fees; Novartis: Other: Personal fees; Oncopeptides: Other: Personal fees; TeneoBio: Other: Personal fees; Levine Cancer Institute, Atrium Health: Current Employment. Usmani:Celgene: Other; Janssen: Consultancy, Honoraria, Other: Speaking Fees, Research Funding; SkylineDX: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Merck: Consultancy, Research Funding; Incyte: Research Funding; Pharmacyclics: Research Funding; Array Biopharma: Research Funding; GSK: Consultancy, Research Funding; Takeda: Consultancy, Honoraria, Other: Speaking Fees, Research Funding; Sanofi: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy; BMS, Celgene: Consultancy, Honoraria, Other: Speaking Fees, Research Funding; Amgen: Consultancy, Honoraria, Other: Speaking Fees, Research Funding. Atrash:BMS, Jansen oncology, Sanofi: Speakers Bureau; Takeda, Amgen, Karyopharm, BMS, Sanofi, Cellactar, Janssen and Celgene: Honoraria; Amgen, GSK, Karyopharm.: Research Funding.

Revised International Staging System combines beta-2 microglobulin, albumin, LDH, and high-risk FISH/cytogenetic features to provide prognostic information useful for stratification in multiple myeloma (MM). Ki-67 is a nuclear protein expressed by proliferating cells. The Ki-67 index has shown to impact the outcome in some types of lymphomas, but its prognostic value in MM is unclear. The aim of this study was to investigate the association of Ki-67 expression with survival outcomes in MM patients treated with novel therapies.

Abstract BACKGROUND: Multiple Myeloma (MM) is a heterogenous disease with variable outcomes based on both disease biology and burden. The revised international staging system (R-ISS) can distinguish 5-year overall survival (OS) however, it does not incorporate novel imaging that provide more accurate disease burden assessment (e.g., PET-CT). Previous studies (Usmani SZ et al Blood 2013) showed that the presence of more than 3 focal lesions (FL)s detected on PET-CT scan at baseline in newly diagnosed MM patients, or the persistence of any FL post induction therapy or post- autologous stem cell transplantation (ASCT), were associated with shorter progression free survival (PFS) and overall survival (OS) in Total Therapy trials. There is limited information available on the prognostic significance of PET-CT in the context of current standard 3-drug induction followed by ASCT in clinical practice. Herein, the investigators examined the prognostic implications of post-therapy PET-CT positivity in routine clinical practice. PATIENTS AND METHODS: The LCI MM database was interrogated (3/2014-5/2018) for NDMM patients who had undergone upfront ASCT and had PET-CT data available. Continuous variables were summarized with descriptive statistics, while categorical variables were summarized with frequencies and proportions. Survival distributions were estimated with Kaplan Meier techniques and compared using a log rank test PET-CT scan results were reported as negative or positive (defined as one FL having higher 18F-FDG uptake relative to uptake in mediastinum or surrounding background, with no similar activity seen on the contralateral side, or increased activity at any location incompatible with normal physiological distribution). RESULTS: A total of 198 MM patients were identified, 62 had pre-ASCT PET-CT scans and 80 patients had post-ASCT PET-CT. Median age at transplant was 62 years (range 25 - 77), 52.0% were female. R-ISS stage I (17.2%), stage II (41.4%), stage III (1.7%). The 3 years overall survival (OS) in patients with negative PET-CT post-ASCT vs. positive PET-CT post-ASCT was 96.6% vs. 74.2% (p-value 0.002) and median progression free survival (PFS) was 35 months vs. 13 months (p-value <0.001), respectively. Patients were then divided into three groups: Cohort 1- negative PET scan pre/post ASCT (n=35), cohort 2- positive PET-CT pre-ASCT/negative PET-CT post-ASCT(n=17), and cohort 3- positive PET-CT post-ASCT(n=6). Thirty-four patients had scans pre and post ASCT; an additional n = 24 had negative PET scans pre ASCT and did not require repeat PET scan post ASCT. At one-year landmark OS for cohort-1 was 100% vs cohort-2 100% vs cohort-3 66.7 (p-value 0.002). One-year PFS for cohort-1 92.5% vs. cohort-2 100% vs. cohort-3 66.7% (p-value 0.0513). CONCLUSIONS: Negative PET-CT imaging post ASCT is associated with better OS and PFS. Also, in our population, the absence of positive FL by PET-CT scan in newly diagnosed MM patients pre and post ASCT shows a trend towards better PFS and OS. Clearance of FL by PET scan trends towards improved PFS and OS. Longer follow up is needed to declare statistical significance between those cohorts. Figure. Figure. Disclosures Atrash: Takeda Oncology: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Membership on an entity's Board of Directors or advisory committees. Voorhees:Amgen Inc.: Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: served on an IRC; Novartis: Consultancy, Other: served on an IRC; TeneoBio: Consultancy, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: served on an IRC. Avalos:Juno: Membership on an entity's Board of Directors or advisory committees. Usmani:Amgen, BMS, Celgene, Janssen, Merck, Pharmacyclics,Sanofi, Seattle Genetics, Takeda: Research Funding; Abbvie, Amgen, Celgene, Genmab, Merck, MundiPharma, Janssen, Seattle Genetics: Consultancy.

Data indicate reversal of immune dysfunction with active treatment; however, the precise contribution of specific immune effector and immune suppressor components to achieve a minimal residual disease (MRD) state and immunomodulatory drug-mediated immunomodulatory effects in multiple myeloma (MM) patients remains poorly understood. In this prospective proof-of-principle study we sought to determine the dynamic alterations in natural killer (NK), NK-T, and T cells, including maturation and activating/inhibitory repertoire associated with MRDpos versus MRDneg status after autologous stem cell transplantation (ASCT) and during lenalidomide-based maintenance therapy. Of the 46 MM patients enrolled, 36 had bone marrow MRD assessment 60+ days post-ASCT, 30 had longitudinal blood immunotyping during maintenance (pretherapy and after cycles 1, 3, and 6), and 20 had both MRD assessment and longitudinal immunotyping. Multicolor flow cytometry was used for MRD and immunotyping. Although the absolute number of NK cells was significantly lower in patients with MRDpos response, phenotypically NK cells in these patients displayed higher expression of activating receptors KIRDS4 and decreased expression of inhibitory molecules NKG2A compared with the MRDneg group. Furthermore, we observed significantly lower frequencies of T cells displaying KIR3DL1 in MRDpos versus MRDneg patients. Longitudinal immunotyping during lenalidomide maintenance showed loss of mature NK effector function, augmentation of NK-T effector function, and acquisition of PD1 independent anergic state. Our findings also suggest skewing of T cells toward an exhausted state during the maintenance phase in MRDpos patients. Put together, these observations provide a distinctive signature for MRDneg and MRDpos groups. These data support exploration of immune profiling in prospective clinical trials according to MRD-defined responses to identify patients that may benefit from maintenance intensification/modification or maintenance withdrawal. (C) 2018 American Society for Blood and Marrow Transplantation.

Introduction: MM pts have one of the highest risks of TE among cancer pts. Use of IMiDs plus dex further increases this risk. Guidelines recommend thromboprophylaxis based on risk assessment; however, limited large-scale studies have attempted to validate previous and identify new patient-specific risk factors associated with TE in MM pts.