bluuebunny/crossref_metadata_2025_split huggingface dataset:
Combination of statin/vitamin D and metastatic castration-resistant prostate cancer (mCRPC): A post-hoc analysis of two randomized clinical trials.
Authors: de Velasco Guillermo , Lora David , Carretero-Gonzalez Alberto , Martin Soberón Maria Cruz , Sepulveda Sanchez Juan Manuel Manuel , Lorente David , Castellano Daniel E. 
Published: May 2019

6617 Background: Retrospective database studies have suggested that statins and vitamin D have a positive impact on prostate cancer survival and specifically in mCRPC patients (pt). Methods: We conducted a post-hoc analysis of individual pt data of mCRPC pts treated with abiraterone (AA) and/or Prednisone (P) on two randomized phase III clinical trials COU -AA-301 and COU-AA-302 to analyze the impact of statins and vitamin D in overall survival (OS). Statistical analyses were performed using the Kaplan Meier method and Independent predictors were investigated using Cox regression analysis. This study, carried out under YODA Project #2016-1136, used data obtained from the Yale University Open Data Access Project. Results: These two studies included 2280 patients (1340 treated with AA/P and 640 with P). Use of Statin + vitamin D was associated with a 38% reduction in mortality in the postdocetaxel setting and 32% in the predocetaxel setting in patients treated with abiraterone (Table 1 and 2). No significant reduction in the rate of skeletal-related events was seen in patients treated with vitamin D or statins. Conclusions: To our knowledge this is the first report suggesting the impact of vitamin D+statin in mCPRC treated with abiraterone. The potential benefits of vitamin D do not seem to be secondary to concomitant statin use in this population. Further studies are needed to confirm these results. [Table: see text][Table: see text]
Impact of Oncology Care Model (OCM) reporting requirements on quality of care.
Authors: Castellanos Emily , Orlando Abigail , Hamrick James , Ma Xinran , O'Connell Gillian , Meropol Neal J. , Adamson Blythe J.S. 
Published: May 2019

6620 Background: The OCM is a voluntary Center for Medicare and Medicaid Innovation alternative payment model pilot program. As of Oct 2017, OCM practices are required to report the biomarker status for NSCLC pts. Our objective was to assess the effect of OCM reporting on quality of care in aNSCLC. Methods: We developed a decision-analytic model to compare the likelihood of receiving biomarker testing and corresponding appropriate therapy. We populated the model using real-world data from pts (n=7,075) at OCM sites (n=45) and non-OCM sites (n=105) in the Flatiron Health electronic health record (EHR)-derived database. The pre-period control included pts diagnosed with aNSCLC from Jan 1, 2011 - Dec 31, 2015; the post-period included pts diagnosed Oct 2017 - Nov 2018. For OCM vs non-OCM sites, we estimated probabilities and unadjusted odds ratio (OR) of biomarker testing (EGFR, ROS1, or ALK) and subsequent delivery of appropriate therapy, defined as use of a biomarker-guided tyrosine kinase inhibitor (TKI) for positive pts, or non-TKI therapy for negative pts. Results: No differences in rates of biomarker testing or delivery of appropriate therapy were detected between OCM and non-OCM practices prior to the reporting requirement. In the post-period, OCM was associated with higher odds of biomarker testing and appropriate therapy (Table). Conclusions: To our knowledge, this is the first study of the association of OCM reporting requirements with downstream quality of care. Our results suggest that OCM documentation and reporting requirements are associated with modestly higher quality of care for pts with aNSCLC. Ongoing sensitivity analyses will determine the relative contribution of provider and practice characteristics to these findings. Careful measurement of the impact of reporting requirements is essential to measure the impact of payment reform interventions and inform policy. [Table: see text]
Virtual visits for children, adolescents, and young adults with cancer.
Authors: Anderson Peter Meade , Zahler Stacey , Harter Lynn , Hanna Rabi 
Published: May 2019

6622 Background: Children, adolescents, and young adults have rare cancers and standard-of-care treatment is commonly very aggressive. Virtual visits provide include many of the nuances of face-to face communication. These are much friendlier than phone calls or email and can be scheduled and structured to provide a large amount of information efficiently. Methods: Cleveland Clinic uses HIPPA-compliant software from American Well (Boston, MA) that allows the health care provider and patient to use a phone, tablet, or desktop computer for video visits. Our intake process involves obtaining a Medical Record Number (MRN), sending a brief summary, uploading or sending a CD with images in DICOM, and having an administrative assistant schedule the virtual visit. Telemedicine sessions typically last <60 minutes. During the visit a summary is updated, images are reviewed, and this and other information shared via email after the visit. Results: In 2017+ 2018 we conducted 223 virtual visits; 85% were <30 years old (table). The summary has been a key to efficient and effective organization and includes not only contact information and past medical history, but also an “Opportunities to Improve Health" section (problem list /action plan). Topics discussed in solid tumor patients include: 1) local control, 2) medical therapy (chemotherapy), 3) imaging and tumor markers, 4) control of side effects and nutrition, 5) social issues and goals of care (which can include palliative care and hospice), and 6) follow-up. A power point with key images and the updated summary and articles are emailed at the end of the visit to the patient & caregivers and often referring physician, NP, or PA . Visit diagnoses have included osteosarcoma and Ewing sarcoma (73%), but also other rare cancers such as rhabdomyosarcoma, DSRCT, paraganglioma, and adrenal cortical carcinoma. Survivorship and cGVHD have also been discussed. Conclusions: A structured virtual visit to help young people and their caregivers understand complex multi-disciplinary cancer care is now possible for all regions of North America. A major source of satisfaction has been two-way sharing of information to improve not only cancer control, but also improved nutrition, communication, and proactive toxicity reduction. [Table: see text]
Evaluating the American Society of Clinical Oncology (ASCO) and European Society of Medical Oncology (ESMO) value frameworks for Food and Drug Administration (FDA) approved checkpoint inhibitors (CIs).
Authors: Feng Sophie , Cao Yanshuo , Amir Eitan , Chen Eric Xueyu 
Published: May 2019

6624 Background: Although the development of CIs has led to a dramatic change in the oncology landscape, these agents are associated with significant costs and toxicity. ASCO and ESMO have developed separate frameworks to define the value of emerging cancer treatments in order to encourage cost-effective therapies. We apply these frameworks to trials supporting FDA approvals of CIs and explore the correlation between these two scoring systems. Methods: We searched the FDA database for CIs and indications approved between January 1, 2011 and January 1, 2019. Only randomized phase II/III trials for solid tumors were included. Data on survival, toxicity and quality of life were extracted from the most recent publications by two reviewers independently. A trial showing a substantial benefit was defined as an ASCO score of ≥ 45, or ESMO Grade 4-5 (palliative setting) or Grade A/B (curative setting). Concordance for substantial benefit was assessed using Cohen’s Kappa while Spearman coefficients were used to determine the degree of correlation in individual scores. Results: We identified 40 FDA indications for 7 CIs. Of these, 18 indications based on Phase I/II single-arm trials were excluded. The remaining 22 indications were based on 21 randomized phase II/III trials (3 adjuvant, 18 metastatic). In the palliative setting, 73% and 86% trials showed substantial benefit based on ASCO and ESMO frameworks respectively [median ASCO score: 54.8, interquartile range (IQR) 46.2-64.0; median ESMO score: 5, IQR: 4-5]. 27% of trials were scored intermediate or low benefit by ASCO, while 9% were ineligible for ESMO scoring. Weighted kappa was 0.719 between the two frameworks. Spearman rho was 0.84. All 3 adjuvant trials were assigned ESMO grade A but low benefit with ASCO (median 37.7, IQR 20.5-40.9). Conclusions: In the palliative setting, the majority of trials supporting FDA approved CI indications demonstrated substantial benefit using both ASCO and ESMO frameworks. There was a strong correlation between the two frameworks. However, in the curative setting scores were discordant. The ASCO framework may require further refinement for adjuvant trials.
Followup mammography after breast conservation therapy: Is 3D Tomosynthesis(3DT) worth it?
Authors: Hasan Shaakir , Gresswell Steven , Colosimo Brittany , Weinberger Kevin , Anderson Sidney , Bigbey Matthew , Wegner Rodney E , Shindel Beth , Julian Thomas B. , Trombetta Mark G. 
Published: May 2019

6628 Background: Screening three-dimensional tomosynthesis mammography (3DT) is more cost-effective than two-dimensional mammography (2DM) for detecting breast cancer, however cost-effectiveness as a follow-up for treated breast cancer is unknown. We retrospectively analyzed the downstream workup and costs associated with 3DT compared to 2DM when employed as initial follow-up imaging in breast conservation therapy (BCT). Methods: Between the years 2015-2017, 450 consecutive BCT patients ages 32 – 89 with a follow-up 3DT (n = 162) or 2DM (n = 288) were reviewed in this IRB-approved study. The primary endpoint was further workup after follow-up mammogram and associated healthcare costs at 1 year. Downstream workup was secondarily tested for correlation with clinical and treatment-related variables. A single 3DT cost an estimated $149 compared to $111 for a 2DM, based on Centers for Medicare claims data Oncology Care Model. Results: Patient clinical characteristics were : 6% DCIS, 10% T1a, 29% T1b, 35% T1c, 19% T2, 88% N0, 9% N1, 3% N2, 76% ER+/PR+/HerNeu2-, 12% TNBC, and 14% Her2Neu+. Whole breast radiation was given with conventional (59%) and hypo (39%) fractionation (81% with a boost), and 10% received accelerated partial breast irradiation. First post-treatment mammogram was received within 3 months (20%), 3-6 months (32%), and after 6 months (48%) following RT. There were no differences in breast density, patient age, T/N stage, receptor status, type of RT, or mammogram timing between those in the 2DM and 3DT groups. The following downstream workup ensued for 3DT compared to 2D imaging: 18% vs 29% short-interval (6-month) mammogram (OR = 1.83, P = 0.01), 6% vs 11% breast MRI (OR = 1.90, P = 0.08), 4% ultrasound for each, and 3% biopsy for each (1 positive in the 2D group). Including downstream workup, the estimated cost per patient in the 3DT group = $249.00 compared to $253.64 in the 2D group. With multivariable analysis the independent predictors for reduced downstream workup was the use of 3DT and follow-up mammogram at least 6 months after radiation (P < 0.05). Conclusions: Excess workup was reduced with 3DT compared to 2DM in the post-treatment setting. A single 3DT costs approximately 34% more than 2DM, however in this study the associated reduction in downstream workup with 3DT actually made it more cost-effective.
The effect of guideline-concordant novel therapy use on meeting cost targets in OCM: Results from a large community oncology network.
Authors: Schleicher Stephen Matthew , Chaudhry Basit , Waynick Christopher A. , Crouse Cheryl A. , Shipley Johnathan D. , Dickson Natalie R. , Patton Jeffrey , Supalla Susanna N. , Soudek Daniel , Lyss Aaron J. 
Published: May 2019

6635 Background: The Oncology Care Model (OCM) is intended to incentivize physicians to improve the quality and reduce the cost of cancer care. In OCM, providers are accountable for all costs during six month episodes of care relative to target costs (TC) derived from a baseline spending period (BSP; 2013-2015). This accountability is intended to foster care coordination to reduce preventable emergency department visits and hospitalizations (EDH). Benefits of reducing EDH may be diluted when new treatment indications for costly immunotherapies (IO) are introduced into clinical practice after BSP. Methods: We identified all non-small cell lung cancer (NSCLC) and bladder cancer (BC) OCM episodes attributed to Tennessee Oncology (TO), a large community oncology network of over 90 oncologists, during performance period 2 (PP2; the most recent PP with available data). We selected NSCLC and BC because both diseases have IO indications that became standard of care after BSP. Using claims data analytics software, we identified all NSCLC and BC episodes with spending above TC, and found a subset of these above target episodes (ATEs) without any EDH that remained above TC due to IO use. Two medical oncologists reviewed these cases in duplicate to assess guideline concordance of IO. Results: During PP2 there were 2,623 OCM episodes attributed to TO, including 240 NSCLC and 31 BC episodes. Spending was above TC in 118 (49%) and 13 (42%) of NSCLC and BC episodes, respectively. For these NSCLC and BC ATEs, EDH was prevented in 62 (53%) and 5 (38%) of cases, respectively. In NSCLC and BC ATEs without EDH, 43 (69%) and 5 (100%) of episodes included IO, respectively. Clinician review in duplicate (S.M.S.; C.A.W.) found that the use of IO was NCCN guideline concordant in 33 (77%) and 4 (80%) of these NSCLC and BC cases, respectively (K = 0.87). Conclusions: Guideline-concordant use of expensive IO as its treatment indications expand poses substantial challenges to meeting cost targets in OCM, even when practices prevent EDH. [Table: see text]
Burden of cytokine release syndrome (CRS) and neurologic events (NE) in patients (Pts) with relapsed/refractory non-Hodgkin lymphoma (NHL) receiving lisocabtagene maraleucel (Liso-cel; JCAR017) in TRANSCEND NHL 001.
Authors: Abramson Jeremy S. , Siddiqi Tanya , Garcia Jacob , Dehner Christine , Nguyen Andy , Snyder Sophie , Gitlin Matthew , Chung Karen C. 
Published: May 2019

6637 Background: We assessed incidence, healthcare resource utilization (HCRU), and costs of CRS and NE in pts in TRANSCEND receiving liso-cel, an investigational, anti-CD19 CAR T cell product administered as a defined composition of CD4+/CD8+ CAR T cells. Methods: HCRU within the dates of onset and resolution of CRS and NE was identified from case report forms and trial management guidelines. Costs associated with grade (G) of CRS or NE were applied using public databases and literature on national average costs from a provider perspective. Results: Of 102 pts, 21 (21%) had CRS only (no G≥3), 6 (6%) had NE only (no G≥4), 6 (6%) had nonconcurrent CRS and NE, and 11 (11%) had concurrent CRS and NE (including 1 G4 CRS). Most pts had G≤2 events (31/44, 70%). Of pts with both CRS and NE, 16/17 (94%) had CRS first. Of pts with nonconcurrent events, NE developed a median of 2 days after CRS resolved. Of 10/11 pts with concurrent events and CRS before NE, NE developed a median of 3.5 days after CRS onset. 11/38 pts with CRS (29%) received tocilizumab and 21/44 with CRS and/or NE (48%) received dexamethasone. Overall median costs for G≤2 vs G≥3 CRS and/or NE were $16,479 vs $70,549. Management costs for CRS and/or NE were largely driven by hospitalizations (Table), and ranged $177–24,947 for G≤2 CRS or NE only, $30,749 for G≤2 concurrent CRS and NE, and $43,974–264,149 for G≥3 CRS and/or NE. Conclusions: In TRANSCEND, incidences of G≥3 CRS and NE were low. G≥3 events resulted in a 328% increase in overall median costs vs G≤2 events. Clinical trial information: NCT02631044. [Table: see text]
Clinical benefit and prices of cancer drugs in the United States and Europe.
Authors: Vokinger Kerstin Noëlle , Hwang Thomas J , Tibau Martorell Ariadna , Rosemann Thomas J , Kesselheim Aaron S 
Published: May 2019

6638 Background: Given rising cancer drug costs, Medicare recently proposed to tie some US drug prices to average prices paid by comparable countries. To understand the potential scope of this policy, we assessed differences in cancer drug prices in the US and selected European countries. We also evaluated the correlation between drug prices and their clinical benefit, as measured by two value frameworks: the American Society of Clinical Oncology Value Framework v2 (ASCO VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale v1.1 (ESMO-MCBS). Methods: We identified all new drugs for adult solid and hematologic cancers, approved by the FDA from 2009-2017 and that have also been approved by the EMA by December 31, 2018. US average sales prices (and if not available, wholesale acquisition costs) were extracted as of February 1, 2019, and compared to comparable currency-adjusted ex-factory drug costs in England, France, Germany, and Switzerland. ASCO VF and ESMO-MCBS scores were assessed for pivotal trials supporting solid tumor drugs; in case of multiple trials, we focused on the highest score. Consistent with the developers of the rating scales, “high benefit” was defined as scores of A-B (neo/adjuvant setting) and 4-5 (palliative setting) on the ESMO-MCBS scale and scores≥45 on the ASCO VF. Linear regression models and non-parametric Kruskal-Wallis test and were used to assess the association between drug prices and benefit scores. Results: The study cohort included 63 drugs approved by the FDA and the EMA during the study period. 46 (73%) were approved for solid tumors, and 17 (27%) were approved for hematologic malignancies. Overall, median cancer drug prices in included European countries were 52% (interquartile range: 37-72%) lower than US prices. There was no statistically significant association between monthly treatment cost and ASCO-VF or ESMO-MCBS scores in any country. There was also no association between price differential between US and median European drug prices and either ASCO-VF (P = 0.599) or ESMO-MBCS (P = 0.321) scores. Conclusions: Cancer drug prices in the US were significantly higher than in the compared European countries. Drug prices of cancer drugs were not associated with clinical benefit in the US or in European countries.
A cost-utility analysis of atezolizumab in the second-line treatment of metastatic urothelial carcinoma.
Authors: Parmar Ambika , Richardson Marina , Sander Beate , Cheng Susanna Y. , Chan Kelvin K. 
Published: May 2019

6639 Background: Despite early promising results, IMvigor211 failed to demonstrate an overall survival benefit for atezolizumab, compared to chemotherapy, in the second-line treatment of metastatic urothelial carcinoma. However, given improvements in adverse events (AE) and quality of life with atezolizumab, there may still be investment value. We conducted a cost-utility analysis (CUA) of atezolizumab compared to chemotherapy from a public-payer healthcare perspective. Methods: We developed a partitioned survival model to evaluate atezolizumab versus chemotherapy (i.e. docetaxel, paclitaxel or vinflunine). IMvigor211 informed rates of treatment receipt (initial and subsequent), AE, effectiveness and utility estimates. Cost for treatment, AE and death were based on published literature (adjusted to 2018 Canadian dollars). Per health state, cost of treatment (initial and subsequent) and AE were incorporated. Outcomes included quality-adjusted life-years (QALY), cost per treatment, and incremental cost-effectiveness ratio (ICER). QALY and cost were discounted at 1.5% (Canadian guidelines). Parameter uncertainty was assessed through one-way and scenario analyses. Time horizons of 2 (within trial) and 5 years (extrapolated lifetime) were evaluated. Results: QALY of atezolizumab and chemotherapy over 2 years (lifetime) were 0.65 (0.93) and 0.58 (0.64), respectively. Cost of atezolizumab and chemotherapy over 2 years (lifetime) was $77,614.64, ($92,484.34), and $62,212.35 ($67,606.65), respectively. ICER over 2 years and lifetime was $220,032.71/QALY and $85,785.14/QALY. Scenario analysis from a North American perspective with only taxane chemotherapy with and without third line immunotherapy (IO) revealed an ICER of $80,144.90/QALY, $125,332.76/QALY over a lifetime horizon, respectively. Conclusions: The difference in ICER dependent on time horizon, driven by extrapolated survival benefits, highlights the importance of long-term follow-up to examine whether early evidence for durable response translates into long-term survival and improvements in cost-effectiveness. Thus, CUA of IO require careful interpretation and warrant dynamic assessment as new data becomes available.
Cost-effectiveness of CHOP in treating DLBCL in Malawi.
Authors: Painschab Matthew , Kohler Racquel Elizabeth , Wheeler Stephanie B. , Gopal Satish 
Published: May 2019

6644 Background: DLBCL is common in Africa, and often curable, but treatment costs and cost-effectiveness are key considerations. WHO defines extremely cost-effective interventions as having an incremental cost-effectiveness ratio (ICER) < GDP per capita. Methods: We used a decision tree model to conduct a cost-effectiveness and budget impact analysis from a health systems perspective in Malawi (2017 GDP per capita $340). Comparisons were made between CHOP vs. palliative care with diagnosis (PC+D), and palliative care without diagnosis (PC-D). Microcosting and clinical outcomes were derived from published prospective data. Costs reflect treatment and 2 years of follow-up. Outcomes reflect a lifetime time horizon. Life expectancies were derived from UNdata, and disability-adjusted life year (DALY) weights from the Global Burden of Disease Study. Costs were analyzed in 2017 US $, and costs and outcomes were discounted at 3% annually. Annual estimates for new DLBCL cases (n=161) were used as input incidence. Probablistic sensitivity analysis was conducted using Crystal Ball software over 1000 simulations. Results: For the base case, the ICER of CHOP versus PC+D is $150/DALY averted, and versus PC-D is $200/DALY averted (Table). The ICER was stable across a wide range of sensitivity analyses. The ICER varied most across the range of progression-free survival estimates ($117-209), and range of costs for CHOP plus follow-up ($71-308). CHOP was extremely cost-effective by the WHO definition in 99% of simulations versus PC+D, and 94% of simulations versus PC-D. In the base case, total annual cost of DLBCL treatment with CHOP in Malawi was $306,221. Conclusions: This is one of the first rigorous cost-effectiveness and budget impact analyses for cancer treatment in a low-income country. CHOP is extremely cost-effective compared to palliative care, with ~$300,000 needed annually to treat all DLBCL cases in Malawi. These findings merit external validation, and support continued regional investments in cancer care. [Table: see text]