bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world healthcare resource utilization (HRU)/costs associated with venetoclax treatment among chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients.
Authors: Rogers Kerry Anne , Emond Bruno , Manceur Ameur M , Kinkead Frederic , Lafeuille Marie-Hélène , Lefebvre Patrick , Huang Qing 
Published: May 2020

e19354 Background: Ibrutinib (Ibr) is an established standard of care in CLL/SLL patients across lines, regardless of age, comorbidities and risk status. With the introduction of venetoclax (Ven) in the treatment landscape, there is a need to understand the real-world treatment sequencing of targeted oral agents, and the implication of sequencing on HRU/costs. This retrospective study evaluated HRU/costs associated with Ven treatment in various sequencing scenarios, including prior use of Ibr. Methods: Optum Clinformatics Extended DataMart De-Identified Databases (4/11/2015-6/30/2019) were used to identify adults with CLL/SLL treated with Ven (excluding investigational combination therapies). The index date was the start of the first Ven-based line of therapy (index LOT) and the baseline period was the 12-month period pre-index. Mean all-cause HRU/costs per patient per month (PPPM) were calculated during the index LOT and the Ven ramp-up period (first 30 days post-index). Results: Among a total of 11,861 CLL/SLL patients receiving ≥1 LOT, 121 patients (1.0%) were treated with Ven, including 25 patients (64.0% single agent) using Ven in first line (1L cohort), 30 (90.0% single agent) in second line (2L cohort), and 66 (83.3% single agent) in third line or later (3L+ cohort). Mean age was 71.6 years; 33.1% were female; mean baseline Quan-Charlson Comorbidity Index score was 4.7; median follow up from the start of 1L was 25.3 months; median duration of index LOT was 4.2 months. The majority of 2L+ Ven patients were previously treated with Ibr (2L: 56.7%, 3L+: 74.2%). Patients in all 3 cohorts had frequent outpatient (OP) visits PPPM during their index LOT (1L: 4.58; 2L: 4.75; 3L+: 5.71). Total costs PPPM during the index LOT were highest in the 1L cohort (1L: $21,762; 2L: $17,697; 3L+: $20,900), driven by higher OP costs (1L $9,402; 2L: $5,633; 3L+: $7,701). Increased total costs PPPM were observed during Ven ramp-up (1L: $31,707; 2L: $21,036; 3L+: $25,362). Compared to the overall 2L cohort, those treated with Ibr in 1L had lower total costs PPPM (index LOT: $15,350; V ramp-up: $15,882). Conclusions: In this descriptive study, the highest costs PPPM were observed for Ven treatment in the 1L. Prior treatment with Ibr was common among 2L and 3L+ CLL/SLL patients treated with Ven. Among 2L Ven patients, those previously treated with Ibr in 1L had $2,347 and $5,154 lower costs PPPM during 2L and Ven ramp-up, respectively, suggesting that previous Ibr treatment may help reduce costs in subsequent V treatment.
Real-World data (RWD) of physician’s advice on BRCA genetic testing for ovary (OC) and breast cancer (BC) patients (pts).
Authors: Vorobiof Daniel A. 
Published: May 2020

e19357 Background: The 2019 US Preventive Services Task Force (USPSTF) recommends that women with a personal and familiar history of BC and OC undergo a BRCA genetic testing so that risk assessment, prevention options and treatment changes are considered. Methods: BC and OC members of Belong.life global mobile application for cancer pts and caregivers, replied to a 9 question's survey regarding the incidence of BRCA testing. The survey included questions on demographics, BRCA testing performed, who advised it, and on treatment changes. This RWD was analyzed by data scientists using AI and machine learning engines. Results: 377 pts with BC (302/80%) and OC (75/20%) replied to the survey. BC pts ages were < 50 yrs in 32%, 36% were 51-60 yrs and 32% > 61 yrs. 24% of OC pts were < 50 yrs, 35% were 51-60 yrs and 41% > 61 yrs. 73% of BC pts were USA based and 27% from rest of the world (RoW). OC pts were 62% from USA and 38% from RoW. Most of BC pts were stage 1-2 (58%) and 35% stages 3-4. OC pts stages were 3-4 (73%) and 15% stage 1-2. BRCA testing was performed in 192/302 BC pts (64%). In the OC group 60/75 pts (80%) had BRCA testing. Physicians advised to have BRCA testing to 57% of BC pts and 76% of OC, while families/friends suggested it to 4% of BC and OC pts. BRCA test was positive in 19% of BC and 48% of OC pts. 110 BC pts(36%) didn’t undergo the test of whom 74 pts (67%) didn’t receive physician’s advice to have it . Of those pts, 24 (32%) fell under the USPSTF recommendation criteria for testing. Conclusions: BRCA testing should be recommended for all pts with recently diagnosed BC and OC and in those with a higher chance of having a mutation, as defined by the USPSTF guidelines. In this RWD evaluation of Belong.life BC and OC pts, BRCA testing in BC was done in 192/302 pts (64%) while in OC pts it was done in 60/75 pts (80%). Overall, physicians requested the BRCA test in only 57% of BC pts and 76% of the OC pts. In spite of the current USPSTF guidelines, a number of BC pts who didn’t receive advise from their physician (32%) fell under those recommendations, most having their disease diagnosed at < 50 yrs and triple negative disease < 60 yrs. Physicians should be encouraged to follow published guidelines recommendations for BRCA testing for all newly diagnosed BC and OC pts.
Incidence and economic burden of infections in cancer patients receiving immune checkpoint inhibitors.
Authors: nalluru swarna sri , Piranavan Paramarajan , Narimiti Anvesh , Shah Shanil , Siddiqui Ahmad Daniyal , Abraham George 
Published: May 2020

e19365 Background: Along with antitumor effects, Immune Checkpoint Inhibitors (ICPI) have shown great potential in treating chronic infections such as HIV, Hepatitis B, and malaria, in ex-vivo studies. However, several case reports and case series suggested increased infection risk in cancer patients receiving ICPI. The purpose of our study is to assess the risk of infections in cancer patients receiving ICPI. We also attempted to evaluate the role of a multidisciplinary approach (Oncology and Infectious disease specialists) and the cost associated with treatment. Methods: Records on all cancer patients over age ≥18 years old who had received at least one dose of ICPI from 2015 to 2018 at two major community teaching hospitals in the Central Massachusetts region were reviewed. Several risk factors associated with infection were identified. Two-tailed unpaired t-test was used to analyze the association between risk factors and infection. We calculated the average length of stay (LOS) and cost per admission with a multidisciplinary vs. non-multidisciplinary approach. The calculated total average cost per admission was compared with a random set of non-oncologic population admitted with similar infections noted in our study to estimate the economic burden. Results: Thirty-seven (21.8%) patients developed sixty-two episodes of infection. Microbiological confirmation was available in 13 episodes. Risk factors like COPD (P = 0.01), prior chemotherapy (P = 0.03), and steroid use (P = 0.003) were significantly associated with infections. An infection-associated mortality rate was noted to be 2.3%. With the involvement of multidisciplinary team, the average LOS increased from 5.9 to 8.1 days. Yet, the average cost per admission approximately remained the same (52,047$ vs. 54,510$). Upon comparison with a non-oncologic patient, the average cost per admission for an infection in cancer patients receiving ICPI increased from 11,527$ to 35,484$. Conclusions: Surprisingly, a significant incidence of infections and associated health care resource utilization continue to prevail in cancer patients despite the utility of ICPI. Although the economic burden due to the infections in this set of patients is remarkably high when compared to the general population, the multidisciplinary approach did not increase the hospital costs.
Watch-and-wait policy versus robotic resection in locally advanced rectal cancer patients after clinical complete response following chemoradiotherapy: A cost-effectiveness study (RECCOSTE).
Authors: Rodriguez-Pascual Jesus , Nuñez-Alfonsel Javier , Ielpo Benedetto , Lopez Mercedes , Alvarez-Gallego Rafael , Muñoz Cesar Gregorio , Quijano Yolanda , De Vicente Emilio , Cubillo Gracián Antonio , Saborido Carlos 
Published: May 2020

e19374 Background: Chemoradiotheray (CR) followed by standard Surgical Resection (SR) is the standard treatment for distal locally-advanced rectal cancer (LARC) patients after a clinical compete response (cCR). Some novel approach suggested better functional results using robotic rectal resection (RRR) or avoiding surgical procedure, called Watch and Wait (WW) strategy. Methods: A Markov model-based, cost-utility analysis estimating mean costs and QALYs per patient was performed to compare SR, RRR and WW strategies for patients achieving a cCR to CRT. Rates of local regrowth, recurrence and distant metastasis were derived from series comparing WW to SR and from our previous comparative study of RRR versus SR. Lifetime incremental cost-utility ratio was calculated between strategies, and sensitivity analysis were performed to study model uncertainly. A willingness-to-pay of 30.000 per Quality Adjusted-Life Year (QALY) was used as a threshold to determine the most cost-effective treatment. Results: The base case 15-years cancer-specific survival was 93.5% (95% confidence interval [CI] 91.5-94.9] on a WW program, compared to 95.9% [95%CI 93.6-97.7] after RRR. WW was dominant relative to RRR with cost savings of $48,566.58 (95%CI $47,635.77 - $49,497.39 ) and incremental QALY of 7.47 (95%CI 1.46 – 7.48). WW was also dominant relative to LRR, with cost savings of $48,764.49 (95%CI $47,768.49 - $49,760.48 ) and incremental QALY of 7.44 (95%CI 7,43 – 7.45). WW remained dominant in sensitivity analysis unless the rate of SR fell to 73.0%). Conclusions: This study provides data of cost-effectiveness differences between SR, RRR, WW approaches in LARC after cCR, showing a benefit for WW.
A community oncology practice financial experience in oncology care model pilot (OCM).
Authors: Akhtar Adil Jamal , Margolis Jeffrey H. , Sheth Karna , Maxwell Karma , Muskovitz Andrew A. , Zekman Richard Philip , Howard George , Ballouz Samer , Qamruzzaman Yusuf , Balaraman Savitha , Ibrahim Mohammed , Fabbiano Maria , Folbe Mitchell , Ogaily Mohammed S. , Stortz Lexi , Pancholi Shehnaz , Tauquir Anoosha Maria 
Published: May 2020

e19379 Background: Oncology Division of Michigan Health Professionals (MHP) participates in OCM, which requires effort from all MHP OCM providers to coordinate care at same or lower cost to Medicare. Palliative Care, Care Management, and End of Life Care programs established by MHP, in collaboration with Premiere Hospice and Integra Connect, have shown cost and quality benefits in the OCM patients. Quality improvement initiatives included monthly OCM provider meetings to review OCM results, identify cost & quality opportunities, and to design training and education sessions. In order to assess the impact of such a concerted initiative, this study aims to evaluate MHP OCM provider impact in OCM total cost of care relative to historical period. Methods: Retrospective review of reconciliation results provided by Centers for Medicare and Medicaid Innovation (CMMI) for OCM performance periods 1-4 (pp1-4). Total cost of care (ACTUAL) and cost categories were the summarized and adjusted expenditures during 6-month OCM period as reported by CMMI. ACTUAL and cost category experience was compared by OCM performance period to the trended-mean of matched historical OCM-eligible patients (Baseline Episodes from CMMI). Patients were matched by cancer type, comorbidity count, age group, radiation, surgery, and low-intensity/-risk cancer sub-type for prostate, bladder and breast cancers. Results: The largest pp1-4 cost category reductions were acute inpatient ($2.2M), physician services excluding drug-cost, imaging and labs ($1.2M), skilled nursing facility ($0.5M), ancillary which consists of imaging and lab ($0.5M), inpatient rehab ($0.3M), home health agency ($0.3M), radiation oncology ($0.1M). The largest pp1-4 increase in OCM expense relative to historical was Part D Drugs ($1.7M). Conclusions: MHP decreased non-drug costs by $5.1M compared to historical cost for matched patients. OCM costs were lower in facility (hospital and SNF) and physician sites of care. Drug costs increased by $1.7M. Study was limited by OCM claims available as of December 2019. Results may be refreshed as more data becomes available. [Table: see text]
Cost-effectiveness of combined atezolizumab/nab-paclitaxel for advanced triple-negative breast cancer.
Authors: Salans Mia A , Cherry Daniel R , Yip Anthony T , Courtney Patrick T , Kumar Abhishek , Murphy James Don 
Published: May 2020

e19388 Background: The IMpassion 130 trial found prolonged progression-free and overall survival among PD-L1-positive, advanced triple-negative breast cancer (TNBC) patients receiving atezolizumab and nab-paclitaxel versus nab-paclitaxel alone. These results were the basis of the first FDA approval of a breast cancer immunotherapeutic agent. With the high cost of combined therapy we present a cost-effectiveness analysis of the addition of atezolizumab to nab-paclitaxel for the treatment of advanced TNBC in PD-L1-positive patients. Methods: We constructed a Markov model to simulate cancer progression, survival, and toxicity in advanced TNBC patients receiving atezolizumab and nab-paclitaxel compared to nab-paclitaxel alone. Transition probabilities were derived from the IMpassion 130 trial, while costs (in 2019 US dollars) and health utilities were estimated from the literature. Cost effectiveness was assessed with incremental cost-effectiveness ratios (ICERs), expressed as dollar per quality-adjusted life-year (QALY), with values of less than $100,000/QALY considered cost effective. We conducted one-way and probabilistic sensitivity analyses to examine model uncertainty. Results: Our base-case model found that treatment with atezolizumab and nab-paclitaxel increased overall cost by $120,800 and improved effectiveness by 0.11 QALYs compared with nab-paclitaxel alone, leading to an ICER of $1,101,000/QALY. The base-case model was not sensitive to any single variable. Women in the combined atezolizumab and nab-paclitaxel arm spent more time with stable disease before progression and with progressive disease before death compared to those treated with nab-paclitaxel alone. In our base-case analysis the addition of atezolizumab was not cost effective at any price of atezolizumab secondary to the high costs of stable and progressive disease. If we assumed lower costs of stable disease and progression, our model became sensitive to the cost of atezolizumab. A probabilistic sensitivity analysis found that adding atezolizumab would be cost ineffective 99.9% of the time at a willingness-to-pay of $100,000/QALY. Conclusions: Despite improved clinical outcomes, the addition of atezolizumab would not be considered cost effective in part due to the high costs of stable disease and disease progression among women with advanced TNBC. Novel therapeutics in this costly patient cohort will need to bend the cost curve of stable and progressive disease before becoming cost effective at thresholds acceptable by today’s standards.
Comparing total cost of care for Medicare FFS patients with pancreatic cancer by chemotherapy regimen.
Authors: Hirsch Jared , Dieguez Gabriela , Cockrum Paul 
Published: May 2020

e19394 Background: To analyze total cost of care for patients with pancreatic cancer by common therapeutic regimens. Methods: Cancer episodes were identified using a methodology similar to the Medicare Oncology Care Model (OCM) in the 2014-2016 100% Medicare Limited Data Set (LDS) claims files. Index dates for chemotherapy claims could not occur within 6 months of another chemotherapy claim for all Medicare FFS beneficiaries. Cancer episodes were defined as the 6-month period following an index date. Each episode was assigned a cancer type based on the plurality of cancer ICD 9/10 diagnosis codes that occurred on chemotherapy claims in the episode. Episode costs were calculated from claims paid amounts. DME and other Part B spending was estimated using episodes from the 5% Medicare LDS files using the same methodology. We analyzed total episode costs for five pancreatic cancer treatment regimens: gemcitabine plus nab-paclitaxel (gem-nab), FOLFIRINOX, liposomal irinotecan, FOLFOX, and FOLFIRI. Results: We identified 110,618 cancer episodes in 2016, of which 4,018 were pancreatic cancer. Pancreatic cancer patients in these episodes were treated with gem-nab (45% of episodes), FOLFIRINOX (14%), FOLFOX (8%), FOLFIRI (6%), and liposomal irinotecan (4%). The main drivers of episode costs among regimens were Part B chemotherapy, other Part B drugs, and inpatient services. Episode costs were $41,749, $42,086, $35,601, $36,169, and $45,851 for patients receiving gem-nab, FOLFIRINOX, FOLFOX, FOLFIRI, and liposomal irinotecan, respectively. Part B chemotherapy costs were $13,065 (gem-nab), $3,095 (FOLFIRINOX), $4,853 (FOLFOX), $3,204 (FOLFIRI), and $18,474 (liposomal irinotecan); other Part B drug costs were $7,343 (gem-nab), $17,013 (FOLFIRINOX), $11,131 (FOLFOX), $15,377 (FOLFIRI), and $10,479 (liposomal irinotecan); and inpatient service costs were $9,044 (gem-nab), $9,069 (FOLFIRINOX), $7,701 (FOLFOX), $5,838 (FOLFIRI), and $5,108 (liposomal irinotecan). Conclusions: Total episode costs for pancreatic cancer care ranged from $35,601 (FOLFOX) to $45,851 (liposomal irinotecan), but the cost components varied by regimen. Episodes with liposomal irinotecan had the largest Part B chemotherapy costs but the lowest inpatient service costs. Episodes with FOLFIRINOX and gem-nab had similar inpatient service costs, which were higher than episodes with liposomal irinotecan, FOLFOX, or FOLFIRI. Episodes with FOLFIRINOX and FOLFIRI had higher other Part B drug costs than episodes with FOLFOX, liposomal irinotecan, or gem-nab.
Experience of financial burden and distress among people with ovarian cancer.
Authors: DeRosa Branlyn W. , Zaleta Alexandra Katherine , Johnson Angela J. , Clark Kelly A. , Ackourey Jemeille , DeFeo Sarah , Donziger Marcia , Friedman Sue J. , La Cava Shannon , Lee Nita Karnik , Salani Ritu , Wright Alexi A. 
Published: May 2020

e19400 Background: The impact of ovarian cancer (OC) is wide-reaching; this study explored cancer-related financial burden related to cost of care in people ever diagnosed with OC. Methods: 64 OC patients enrolled in Cancer Support Community’s Cancer Experience Registry. Participants provided demographic and clinical history, and completed 1) CancerSupportSource, a validated 25-item tool with anxiety and depression risk subscales, and 2) the 11-item COmprehensive Score for financial Toxicity (COST). Descriptive statistics were calculated for responses; Pearson/Spearman correlations and one-way ANOVA (Tukey post-hoc) were used to explore bivariate associations between financial burden, depression/anxiety risk, and demographic/clinical variables. Results: Participants were 91% non-Hispanic White, mean age = 57 years, SD= 15. 55% were currently receiving treatment (47% chemotherapy); 33% ever experienced metastatic disease. 22% reported annual income of ≤$40,000; 19% were not-employed due to disability. 13% spent $500+/month on out-of-pocket costs; 63% reported that a health care team member did not discuss cost of care with them. 36% did not know if they had enough assets to cover cancer treatment costs; 1 in 10 (11%) reported they could not meet monthly expenses. 1 in 3 reported (“quite a bit” to “very much”) worry about future financial problems resulting from illness/treatment (39%) and frustration that they cannot work or contribute as much as usual (34%). Greater financial burden was associated with lower income ( r= -.40, p= .001), greater out-of-pocket costs ( r= .24, p= .03), and not working due to disability F(5,58) = 3.84, p= .01. Among respondents, 38% were at risk for clinical depression; 44% for anxiety; greater financial burden was related to depression risk ( r = .51, p< .001) and anxiety risk ( r= .32, p= .012). Conclusions: Financial burden affects many people with ovarian cancer and is associated with poorer psychosocial outcomes. Ovarian cancer patients and survivors can benefit from access to comprehensive supportive care resources, including financial counseling. Cancer Support Community offers resources that may help, including a toll-free Helpline with a dedicated financial counselor. Future work will examine multivariate predictors of financial burden in ovarian cancer. Clinical trial information: NCT02333604 .
Impact of value frameworks on the magnitude of clinical benefit: Evaluating a decade of randomized trials for systemic therapy in solid malignancies.
Authors: Cusano Ellen , Wong Chelsea , Vaska Marcus , Nixon Nancy Alice , Karim Safiya , Abedin Tasnima , Tang Patricia A. , Heng Daniel Yick Chin , Ezeife Doreen Anuli 
Published: May 2020

e19410 Background: In the era of rapid development of new, expensive cancer therapies, value frameworks were developed to quantify clinical benefit. We assessed the evolution of the magnitude of clinical benefit since the 2015 introduction of the ASCO and ESMO value frameworks. Methods: Randomized phase II and III clinical trials assessing systemic therapies for solid malignancies from January 2010 to July 2019 were evaluated. Study characteristics were recorded, and magnitude of clinical benefit (Δ) was calculated for the endpoints overall survival (OS), progression-free survival (PFS), response rate (RR), and quality of life (QoL). Multivariable analyses compared ΔOS, ΔPFS, and ΔRR in 2010-2014 [pre-value frameworks (PRE)] to 2015-2019 [post-value frameworks (POST)]. Results: In the 290 studies analyzed [60 (21%) PRE and 230 (79%) POST], the most common primary endpoint was PFS (46%), followed by OS (20%), RR (16%), and QoL (8%), with a non-significant increase in OS and decrease in RR as a primary endpoint in the POST era (Table). Studies evaluating immunotherapy and palliative therapy significantly increased POST [0 (0%) v 39 (17%), Fisher’s exact p<0.01 and 25 (42%) v 142 (62%), Chi squared p=0.01, respectively]. Studies reporting improvement in QoL doubled POST [3 (5%) v 22 (10%) Fisher’s exact p=0.56], however not statistically significant. Median ΔOS was significantly greater POST (N= 140 evaluable studies, 1.3 v -0.2 months, Wilcoxon p=0.005) but there was no significant difference in median ΔPFS or ΔRR. Multivariable analyses revealed significant improvement in ΔOS POST (OR 3.08, 95% CI 0.54-5.62, p=0.02) while adjusting for drug mechanism of action, line of therapy, disease setting, and primary endpoint. Conclusions: After the development of value frameworks, median OS improved minimally. The impact of value frameworks has yet to be fully realized in randomized clinical trials. Efforts to include endpoints shown to impact value, such as QoL, into clinical trials are warranted. [Table: see text]