bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective review of SPEP orders confirms need for testing algorithm.
Authors: Mazzoni Sandra Ann , Neppalli Amarendra Kumar , Khalil Shadi , Jonahtan Bakos , Kalmuk James , El Nahas Georges , Bray Alexander , Litwin Christine , Greenberg Charles 
Published: May 2020

e19326 Background: Serum protein electrophoresis (SPEP) identifies monoclonal proteins associated with plasma cell disorders including multiple myeloma. There are no large prospective studies looking at clinical ordering patterns of SPEPs. This study will determine the percent of monoclonal proteins detected by SPEP testing and factors that are or are not associated with identifying monoclonal proteins. We predict that SPEP testing is commonly ordered and not thoroughly evaluated prompting a need for an algorithm to ensure appropriate use and follow up testing. Methods: In our academic center, we captured data on all SPEP tests ordered from March 17 to June 16, 2019. We chart reviewed each associated patient to collect the following: patient age and sex, SPEP result, hemoglobin, serum albumin, total serum protein, serum calcium, serum creatinine, presence of proteinuria, serum free light chains, immunoglobulins (IgG, IgA, IgM), serum immunofixation, urine protein electrophoresis, urine immunofixation, bone marrow biopsy report, imaging results (bone survey, PET, MRI) and echocardiograms. We ascertained the reason for ordering the SPEP, inpatient or outpatient status of the patient and the ordering department. Results: There were 929 SPEPs ordered. 410 (44%) ordered on “new” patients with no previously identified M-spike. Of the 410 “new” SPEP orders, 57 (14%) detected a M-spike. 8 (2%) led to a diagnosis requiring treatment: 7 new cases of myeloma and 1 case of AL amyloidosis. 108 (26%) of the 410 “new” SPEP orders were ordered in the inpatient setting with 20 “new” M-spikes identified. Only 4 of the 108 inpatient SPEP orders identified a diagnosis requiring treatment—4 cases of myeloma. These patients had SPEPs ordered due to pathologic fractures related to lytic lesions and acute renal failure with other associated CRAB features. Neurologic findings were the most common reason for ordering “new” SPEPs, 106 (26%) of the 410 with only 7 with M-spike—all low risk MGUS. Only 2 of 26 patients were found to have low risk MGUS when SPEP was ordered as part of a rheumatologic work up. All 6 patients with SPEP ordered for dermatologic reasons were negative for M-spike. 23 (40%) of the 57 “new” M-spikes had no follow up testing to determine the clinical significance. Conclusions: This prospective review on the use of SPEP orders in an academic medical center documents the need to provide an algorithm to aide effective use of testing to decrease inpatient ordering and provide guidance on appropriate follow up testing. We found a very low yield with SPEP testing for neurologic, rheumatologic and dermatologic reasons.
Treatment workload by stage and subtype in patients with breast cancer: A SEER-Medicare analysis.
Authors: Cheng Alex , Warner Jeremy Lyle , Levy Mia Alyce 
Published: May 2020

e19328 Background: Patients with breast cancer experience significant disruption to their daily lives when undergoing treatment. When treatment workload exceeds the capacity to manage that treatment, patients are less likely to adhere to care plans and likelier to have worse outcomes. The purpose of this study was to assess treatment workload in patients with operable breast cancer in the SEER-Medicare dataset. Methods: Operable (stage I-III) breast cancer patients diagnosed from 2010-2016, > 65 years old at diagnosis, and with 18 months of continuous Medicare part A, B, and D coverage after diagnosis were included in the cohort. We calculated the number of outpatient appointment days, total cumulative inpatient lengths of stay, and distance traveled for patients in the cohort in the 18 months following diagnosis. We compared treatment workload outcomes between patients with stage I and stage III disease and between patients with HER2+ and HER2-/ER+ disease. Results: 35,071 patients met the inclusion criteria. Compared to stage I patients, stage III patients had more median outpatient appointment days (71 vs 50), more median inpatient days (2 vs 0), and greater median distance traveled (1846 vs 1332 miles). Compared to patients with HER2-/ER+ disease, patients with HER2+ disease had more median outpatient appointment days (70 vs 51), and greater median distance traveled (1775 vs 1350 miles). All comparisons were with Mann Whitney U and were statistically significant with P < .001. Conclusions: Patients with operable breast cancer experience a high amount of treatment workload in the first 18 months after diagnosis. These workload measures derived from SEER-Medicare claims differentiate significantly by stage and subtype, with stage III and HER2+ patients experiencing greater treatment workload than stage I and HER2-/ER+ patients respectively. We suspect that greater treatment workload in stage III is attributed to higher intensity of treatment for later stage cancer and associated complications, while greater treatment workload in HER2+ patients is attributed to the use of trastuzumab. [Table: see text]
Long-term proteasome inhibition in US community multiple myeloma (MM) patients (pts) following in-class transition (iCT) from parenteral bortezomib (V) to oral ixazomib (I): Updated real-world (RW) data from US MM-6.
Authors: Girnius Saulius Kazmiems , Yimer Habte Aragaw , Manda Sudhir , Yasenchak Christopher A. , Charu Veena , Lyons Roger M. , Kambhampati Suman , Birhiray Reumu E. , Jhangiani Haresh S. , Boccia Ralph V. , Whidden Presley , Bogard Kim , Cherepanov Dasha , Noga Stephen Joseph , Rifkin Robert M. 
Published: May 2020

e19332 Background: US MM-6 is investigating iCT from parenteral V-based induction to all-oral I-lenalidomide-dexamethasone (IRd) with the aim of increasing proteasome inhibitor (PI)-based treatment adherence/duration while maintaining quality of life (QoL) & further improving outcomes in the diverse US community population. Methods: 21 US community sites, including VA hospitals, are enrolling non-transplant-eligible newly diagnosed MM pts with ≥stable disease after 3 cycles of V-based therapy to receive IRd. Pts use mobile & digital devices to collect actigraphy (activity/sleep) data, complete QoL & treatment satisfaction questionnaires, & self-report medication adherence. Primary endpoint: progression-free survival (PFS); key secondary endpoints include: response rates & duration of therapy. Results: As of Nov 18, 2019, 84 pts had been treated (median age 73 [range 49–90] yrs; 44% ≥75 yrs; 49% male; 15% black/African American; 10% Hispanic/Latino; 35% International Staging System stage III disease; 42% lytic bone disease). Comorbidities included hypertension (57%), anemia (44%), fatigue (43%), & peripheral neuropathy (13%). 85% of pts were receiving VRd at the time of iCT. 62% of pts are still on therapy & enrollment is ongoing. After initiating iCT, ≥complete response (CR) rate increased from 4% to 26% (Table). At 8 mos median follow-up, 6 pts had progressed & there were 2 on-study deaths. The 12-mo PFS rate was 86% (95% CI, 73–93) from the start of V-based regimen & from the start of IRd. During IRd treatment, 92% of pts had treatment-emergent adverse events (TEAEs) (48% grade [G] ≥3). G3 TEAEs (≥5% of pts) were diarrhea (7%), pneumonia (6%), syncope (6%), & anemia (5%). TEAEs led to study drug discontinuation in 7% of pts; 36% had serious TEAEs. I/R/d dose was adjusted due to AEs in 39%/39%/29% of pts. Medication adherence (cycles 1–5) was ‘excellent’/‘very good’ in ≥78% of pts reporting adherence. QoL/treatment satisfaction were maintained in pts completing questionnaires. Actigraphy data showed normal activity levels & sleep durations. Conclusions: US MM-6 pts are representative of the RW US MM population & results show that iCT to an oral PI may permit prolonged PI-based therapy with promising efficacy & without impacting pts’ QoL or treatment satisfaction. Clinical trial information: NCT03173092 . [Table: see text]
Overall survival (OS) in metastatic melanoma since the introduction of immunotherapy: A National Cancer Database analysis.
Authors: Singh Sunny R K , Malapati Sindhu Janarthanam , Kumar Rohit , Wang Ding 
Published: May 2020

e19333 Background: Metastatic melanoma historically had a very poor prognosis and survival until the utilization of immunotherapy. Ipilimumab, the first immune checkpoint (ICP) inhibitor was approved in March 2011, followed soon after by the approval of PD-1 and PD-L1 inhibitors. We aim to conduct a real-world analysis of survival outcomes before and after 2011 in metastatic melanoma and its subtypes. We will also explore the impact of race on the clinical presentation and outcomes of melanoma. Methods: Adults with metastatic melanoma were identified from the NCDB (2004-2015). Kaplan Meier method was used to estimate survival and Cox proportional hazards model was used to determine hazard ratio (HR) for death after adjusting for age, race, sex, comorbidity index, melanoma type, education, income, insurance, facility type and geographical location. Odds of having metastatic disease at diagnosis were estimated using multivariate log regression analysis. Results: Of the 20,691 metastatic melanoma cases, 19,492 (94.2%) were cutaneous, 326 (1.6%) were ocular and 873 (4.2%) were mucosal. The effect of immunotherapy use on survival in metastatic melanoma was assessed by comparing years 2011-2015 versus 2004-2010. After the introduction of immunotherapy in 2011, the adjusted survival for metastatic melanoma had improved in Caucasians (HR 0.80, p < 0.001, CI 0.77-0.83) but not in African Americans (HR 0.80, p value = 0.08, CI 0.62-1.03). Although, AA constituted a minority in each melanoma group (1.7% cases of cutaneous, 1.5% of ocular and 8.1% of mucosal melanoma), their odds of having metastatic disease at onset was higher in both cutaneous (OR 2.60, p < 0.001 CI 2.28-2.95) and mucosal melanoma (OR 1.85, p < 0.001 CI 1.39-2.47) compared to Caucasians. Conclusions: Real-world data suggested a 20% improvement in survival of metastatic melanoma since the introduction of ICP inhibitors except in the subgroups of ocular melanoma and African Americans. The disproportionately high odds of metastatic disease at presentation in African American patients with melanoma suggests the need for improvement in care delivery, specifically in terms of early detection. [Table: see text]
Outcomes of patients with left ventricular assist device receiving cancer directed therapies.
Authors: Schlam Ilana , Zaghlol Raja , Basyal Binaya , Mohammed Selma , Gallagher Christopher , Barac Ana 
Published: May 2020

e19335 Background: Left ventricular assist devices (LVAD) are increasingly utilized in advanced heart failure (HF). There is a paucity of data regarding outcomes of cancer-directed therapies (CDT) in patients with LVAD. The aim of this study was to describe outcomes in this newly identified group of patients. Methods: Institutional LVAD database review to identify patients with cancer diagnosis who had at least 6 months of follow up. Chart review to capture cancer history, CDT and high-severity complications. Results: 12 of the 588 patients who received LVAD were diagnosed with cancer and received CDT. Six patients were males, 9 African Americans and 3 Caucasians. Ischemic cardiomyopathy (CM) was the etiology of HF in 4 (33%) patients, 9 (66%) patients had non-ischemic CM (including: chemotherapy induced n = 3, idiopathic n = 3, myocarditis n = 1, sarcoidosis n = 1). Cancer diagnoses, staging and high severity complications are described in table. The median age of cancer diagnosis was 59 (41-72). The median time from LVAD placement to cancer diagnosis was 21.5 months (3-47). The median number of hospitalizations was 4 (range 1-7). Conclusions: Cancer diagnosis after LVAD placement requires a multidisciplinary approach due to high rates of adverse cardiovascular and cancer related outcomes. To the best of our knowledge this is the first report of patients with LVAD receiving chemo-immunotherapy, they did not tolerate the combination and immunotherapy was discontinued after one cycle, a larger study is required to assess safety in LVAD patients. Larger prospective studies are required to determine outcomes in this complex patient population. [Table: see text]
Real-world treatment patterns among patients with diffuse large B-cell lymphoma (DLBCL) treated with CD19-directed chimeric antigen receptor T-cell therapy (CAR T).
Authors: Jalbert Jessica J. , Arnason Jon E. , Ge Wenzhen , Chen Chieh-I , Ambati Srikanth R. , Wu Ning , Chaudhry Aafia 
Published: May 2020

e19351 Background: CAR T, approved in the US as of October 2017, impacted the treatment landscape for patients with relapsed or refractory (R/R) DLBCL after ≥2 lines of therapy, but there is little known about real-world (RW) treatment patterns in patients who fail or do not respond to CAR T. No treatments of proven benefits are available after CAR T treatment failure. The objective of this study was to describe RW treatment patterns after CAR T. Methods: From MarketScan Commercial/Medicare claims databases (2017‒2018) we identified adult DLBCL patients who received approved CD19-directed CAR T (treatment date = index date). Eligible patients had ≥6 months continuous health plan enrollment prior to index date (i.e. baseline period) and were followed until plan disenrollment or December 31, 2018. Patients with a diagnosis of acute lymphoblastic leukemia over the baseline period were excluded. We identified the first and second treatments after CAR T with systemic chemotherapy, targeted therapy, immunotherapy, hematopoietic stem cell transplant (SCT), radiation therapy (RT), or a second round of CAR T therapy. Kaplan–Meier estimators were used to estimate risk of subsequent treatment and time to next treatment. Results: We identified 56 patients with DLBCL treated with CAR T (mean age [SD]: 57.3 years [9.9]; 23.2% female; 80.4% commercially insured). All patients received CAR T in the inpatient setting, median (Q1‒Q3) length of stay was 15 days (12‒19). Out of 56 patients, 19 initiated a treatment following CAR T; risk of subsequent treatment at 6 months post index was 45.6% (95% CI: 25.4‒60.4%) and median days from CAR T to next treatment was 233 days (95% CI: 139‒NA). Out of 19 patients, 3 initiated a second treatment following CAR T, within 8‒69 days of the first treatment. Over a median (Q1‒Q3) follow-up of 139.5 days (90.5‒194) following CAR T, of the 19 patients treated after CAR T, 57.9% were treated with immunotherapy, 36.8% with RT, 26.3% with targeted therapy, 21.1% with SCT, 15.8% with chemotherapy, and 0% with a second round of CAR T. Conclusions: There are few multicenter studies reporting RW treatment patterns in patients who received CAR T. In this study, risk of subsequent treatment at 6 months following CAR T in a RW setting was almost 50%. Although limited by duration of follow-up, our results suggest that additional, effective salvage treatment strategies are needed for patients who do not respond to CAR T or do not achieve a durable response to CAR T. Updated results using 2019 data will be presented.
Incidence and prognosis of patients with pulmonary metastases at diagnosis of primary extrapulmonary malignancy: A population-based study.
Authors: Li Hao , Zhao Xiaoyi , Zhou Zuli , Ning Shaonan 
Published: May 2020

e19353 Background: As a sign of advanced malignancy, pulmonary metastases often predict poor prognosis and are notoriously difficult to treat, requiring an interdisciplinary combination of chemotherapy, surgery and radiotherapy. Large-scale and generalizable studies examining the incidence and prognosis of patients with pulmonary metastases are still lacking. Methods: We identified 2,649,261 patients with diagnoses of nonhematologic malignancies originating outside of the pulmonary between 2010 and 2016 from the Surveillance, Epidemiology, and End Results (SEER) program. We described the incidence proportion and survival of patients with pulmonary metastases, and determined risk factors and prognostic factors of for pulmonary metastasis. Results: We identified 68,474 patients with pulmonary metastases at diagnosis, accounting for 3.19% of all patients with cancer and 35.94% of those patients with metastatic disease. Tumors with higher lung metastasis rates were pancreas cancer, esophageal cancer, sarcoma, renal cancer, hepatobiliary cancer, all other type of cancer, ovarian cancer and gastric cancer (10.54%, 9.32%, 8.75%, 7.48%, 6.43%, 5.96%, 5.79% and 5.26%, respectively). When considering only patients with distant metastases at diagnosis, The top five types of cancer with pulmonary metastasis were testicular cancer (82.82%), thyroid cancer (72.80%), endometrial cancer (66.87%), renal cancer (66.59%) and cervical cancer (64.89%). Multivariable logistic regression identified several oncology characteristics, such as synchronal bone, brain or liver metastasis (vs without), higher N-stage, and tumor poor pathological differentiation were associated with higher risk of pulmonary metastases. Similar to the risk factors for incidence, more distant metastasis, poor differentiation, higher staging, positive lymph node might also associate with shorter overall survival and cancer-specific survival. Surgery of primary site was a protect factor for survival. Conclusions: For the first time, we provided current generalizable estimates of the incidence and prognosis of patients with pulmonary metastases at diagnosis of an extrapulmonary malignancy. This data may lead to evaluation of early screening of the pulmonary using chest CT scan among patients with newly diagnosed primary extrapulmonary malignancies, and further shape the development of screening and treatment guidelines about pulmonary metastases.
Does targeted therapy dominate in terms of a higher level of effectiveness for a given cost compared to wild-type treatment? An analysis of cost and outcome of metastatic lung cancer patients in Saudi Arabia.
Authors: Da'ar Omar B. , Alkhybri Ali , Alshareed Saud , Alkaiyat Mohammad , Jazieh Abdul Rahman 
Published: May 2020

e19361 Background: This study computed and analyzed aggregate and sub-aggregate healthcare costs of lung cancer care by demographic profiles, resource utilization, clinical conditions, and target therapy. Methods: This is a retrospective chart-review and descriptive analysis of resource use and direct medical cost for lung cancer care had at the Oncology Department, King Abdulaziz Medical City for the period 2016-2018. The cost difference between patients receiving targeted therapy (TT) and those with wild-type tumors and the incremental cost-effectiveness ratio (ICER) was performed. The relationship between aggregate cost and demographic profiles, resource utilization, clinical conditions, and treatment therapies using multivariate regression technique was conducted. Results: A total of 35 patients of lung cancer patients with non-small cell lung cancer were analyzed, of which, 34% received targeted therapy; the median age was 62 years (29-84), 43% were ≥ 65 years, 20% were alive; 74% were in stage IV, 69% had visited ED more than twice, and 69% were admitted for non-ICU-related issues. The mean aggregate cost for all patients was USD 197,300 and it was USD 176,000 for TT patients compared with USD 210,600 for non-TT patients. The mean cost for targeted patients was higher for medication components, which accounts for 87.8% of all the costs. On average, the targeted group had USD 34,600 less cost compared with wild type. At least in terms of non-ICU admissions, both groups had on average two admissions. Thus, in terms of ICER, the targeted therapy dominates as it shows lower average aggregate cost for a given level of effectiveness. While longevity (survival) was associated with a higher cost, having stage IV was associated with lower cost for the targeted group compared with wild-type. Generally, being female, > 65 years of age, non-Saudi, and insurance eligibility were associated with lower costs. Conclusions: TT patients had a lower aggregate average cost in spite of expensive medications treatment. This lower aggregate cost presents an added value to the known advantages of patient survival and quality of life.
A cost-utility analysis of apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Authors: Parmar Ambika , Timilshina Narhari , Emmenegger Urban , Alibhai Shabbir M.H. , Smoragiewicz Martin , Sander Beate , Chan Kelvin K. 
Published: May 2020

e19369 Background: The therapeutic landscape for patients with mCSPC has evolved over the last decade given the growing body of evidence demonstrating efficacy for the earlier application of oral androgen receptor signaling inhibitors, such as with abiraterone and enzalutamide. Recently the success of the TITAN trial established the superior efficacy of apalutamide combined with androgen deprivation therapy (ADT), with a 33% reduction in mortality versus ADT alone, and a tolerable toxicity profile. However, with substantially higher costs than ADT alone, the cost-effectiveness of this combination is critical to evaluate. Methods: A cost-utility analysis of apalutamide+ADT versus ADT alone was conducted from the Canadian healthcare perspective. A state-transition model with probabilistic analysis was used to compare the two strategies over a lifetime horizon. Model inputs were informed by the TITAN trial (transition probabilities, adverse events [AE], subsequent therapy), published literature (utilities) and Canadian costing resources (systemic therapy [initial and subsequent], routine care [physician visits, imaging], AE, end-of-life care costs). Primary outcomes included expected life-year gains (LYG), quality-adjusted life-years (QALY), lifetime cost (in 2018 Canadian dollars), and the incremental cost-effectiveness ratio (ICER). Multiple scenario analyses were conducted to assess parameter and model uncertainty. Cost and effectiveness were discounted at 1.5% as per Canadian guidelines. Results: From the base-case analysis expected LYG and QALY for ADT and apalutamide+ADT were 4.11, 5.57 and 3.50, 4.85, respectively. Expected cost over a lifetime horizon was $37,553 and $254,205, respectively. The ICER for apalutamide+ADT as compared to ADT alone was $160,483/QALY. Through scenario analysis, cost-effectiveness of apaluatmide+ADT was achieved with apalutamide price reductions of >50%, relative to a cost-effectiveness threshold (CET) of $100,000/QALY. Scenario analysis of alternative long-term survival expectations with apalutamide+ADT demonstrated cost-effectiveness (relative to CET $100,000/QALY) with expected improvements in the 5-year survival rate of 29% as compared to ADT (versus base-case expected improvement in 5-year survival of 15%). Conclusions: Apalutamide+ADT is unlikely to be cost-effective from the Canadian healthcare perspective at current list prices. Improvement in cost-effectiveness is most likely to be achieved through price reductions in apalutamide drug costs.