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Background: There is limited information on the burden of metastatic breast cancer (mBC) with a central nervous system (CNS) metastasis in the literature. The objective of this study was to quantify the total all-cause healthcare resource utilization (HCRU) and costs among adult mBC patients administered HER2-targeted therapy with/without a CNS metastasis. Methods: Retrospective study included continuously enrolled patients with a diagnosis (ICD-9 / ICD-10 codes) of BC and mBC (stage III/IV metastasis) and a pharmacy claim of anti-HER2 therapy (index date) between 1/1/12-9/30/17 identified from IQVIA’s Real World Adjudicated Claims – US Database. After excluding patients with breast-related surgery and radiation procedure in the 6-month baseline period, 3 mutually exclusive treatment groups were created: trastuzumuab (T), T + chemotherapy (TC [including capecitabine or taxanes]) and lapatinib group (L [with or without chemotherapy]), each further stratified by presence/absence of CNS metastasis (identified by diagnosis codes/brain radiation procedures). Overall treatment groups were propensity score matched 1:1:1. All-cause HCRU and costs were evaluated over the 1-year follow-up period. Results: 5,895 HER2-targeted therapy patients were initially identified with 172 patients in each of the 3 treatment groups post-matching. Among these patients, 56.4%, 57.6% and 59.3% patients had a CNS metastasis in T, TC and L groups, respectively. The mean overall age of patients was 52.8, 52.3 and 52.6 years in T, TC and L groups, respectively, with a higher proportion of patients in the 55-64 age group. Majority of patients had arthritis/pain and cardiovascular diseases or were de novo metastatic in the baseline period. Baseline mean all-cause total costs were $77,069 among T group (CNS: $83,164; no CNS: $69,186), $62,164 among TC group (CNS: $66,906; no CNS: $55,733) and $81,007 among L group (CNS: $95,803; no CNS: $59,447). Costs were mainly driven by pharmacy (Rx)/outpatient (OP) setting. Over the 1-year follow-up period, mean total Rx costs were $115,453 (mean visits: 86.3), $81,091 (mean visits: 127.1) and $119,319 (mean visits: 83.3) among T, TC and L groups, respectively. This was followed by OP costs with $45,498 (mean visits: 189.2) in T, $62,263 (mean visits: 259.8) in TC and $69,654 (mean visits: 196.6) in L group. Inpatient (IP) costs were $13,319 (average hospital length of stay (LOS): 2.9 days), $18,177 (LOS: 2.2 days) and $10,239 (LOS: 1.4 days) among T, TC and L groups, respectively. CNS patients had higher mean total costs compared to the no CNS group among these treatment groups (T: $192,252 vs $153,784; TC: $237,376 vs $221,647 amd L: $205,637 vs $191,219). Conclusions: Costs among mBC patients administered HER2-targeted therapy were highest for Rx, followed by OP and then IP over the 1-year follow-up period. Among each of the treatment groups, CNS metastasis patients incurred higher costs compared to patients without a CNS metastasis. Table 1: HCRU and CostsCosts/HCRU (Mean (SD))T TC L Overall (172)CNS (97)No CNS (75)Overall (172)CNS (99)No CNS (73)Overall (172)CNS (102)No CNS (70)Total costs ($)175,479 (110,859)192,252 (117,801)153,784 (97,728)230,700 (118,127)237,376 (104,470)221,647 (134,688)199,769 (128,546)205,637 (123,428)191,219 (136,112)Rx visits86.3 (59.9)91.4 (66.0)79.6 (50.6)127.1 (51.4)130.5 (52.9)122.4 (49.3)83.3 (60.0)83.7 (60.5)82.6 (59.6)Total Rx costs ($)115,435 (90,443)118,388 (93,686)111,616 (86,543)149,609 (87,173)149,154 (84,852)150,226 (90,814)119,319 (99,587)119,754 (95,819)118,687 (105,539)OP visits189.2 (107.8)213.0 (119.0)158.4 (82.4)259.8 (97.5)269.6 (99.0)246.5 (94.5)196.6 (109.9)197.7 (102.1)195.0 (121.1)Total OP costs ($)45,498 (36,510)54,805 (41,792)33,462 (23,539)62,263 (40,151)69,685 (40,531)52,198 (37,607)69,654 (67,930)74,504 (68,010)62,588 (67,676) Citation Format: Andres Forero-Torres, Vamshi Ruthwik Anupindi, Jason Yeaw, Mitch DeKoven, Joseph Feliciano, Akshara Richhariya. The economic burden of HER2-targeted therapy among metastatic breast cancer patients [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-18-17.

Purpose Hodgkin lymphoma (HL) survivors face long-term, elevated risk of treatment-related sequelae, including psychosocial distress associated with poor health outcomes. The magnitude and sources of distress are not well described in the routine care of HL outside of clinical trials. Methods We conducted a retrospective cohort study of patients visiting a tertiary-care center for treatment or long-term follow-up of HL. Patient-reported distress was documented using the National Comprehensive Cancer Network Distress Thermometer (DT) and Problem List. Three survivor groups were compared using descriptive methods: on treatment, surviving

The number needed to treat (NNT) with brentuximab vedotin consolidation therapy post-autologous stem cell transplant (ASCT) versus placebo in the phase 3 AETHERA trial to avoid one additional event of disease progression/death was evaluated. AETHERA included 329 Hodgkin lymphoma patients at increased risk of progression post-ASCT who received brentuximab vedotin 1.8 mg/kg (n = 165) or placebo (n = 164) on day 1 of each 21-d cycle (up to 16 cycles). Over 60 months, the NNT with brentuximab vedotin ranged from 4.08 to 7.79 for the intent-to-treat population, 3.18–6.07 for patients with ≥2 risk factors, and 2.98–5.65 for patients with ≥3 risk factors. At various time points, and dependent on the risk group, 3–8 patients would need to be treated with brentuximab vedotin consolidation therapy to prevent a disease progression/death, compared with placebo. Patients with increased risk of relapse may benefit most from brentuximab vedotin.

Background: Numerous studies demonstrate that, even with use of statins, many patients are unable to meet their LDL-C goals. This study examined modifications to statin and/or ezetimibe therapy among patients with hyperlipidemia and prior history of cardiovascular (CV) events in a US commercially insured population. Methods: Adults (age ≥18 years) initiating statins and/or ezetimibe between 1 January 2007 and 31 December 2008 were identified from HealthCore Integrated Research Database. The index date was the initiation date of statins and/or ezetimibe. All patients had ≥1 medical claims related to myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, coronary artery bypass graft, or percutaneous coronary intervention within 12 months prior to the index date. Treatment modifications to statins and/or ezetimibe initiated on the index date (index therapy) included permanent discontinuation of any lipid lowering therapy (LLT), rechallenge, switching, subtraction, augmentation, and dose changes. Results: Among 17,902 patients, around 90% initiated with statin monotherapy, followed by statin and ezetimibe combination (3.0%: 18–64 years; 3.8%: ≥65 years). Ten percent or less initiated on high intensity statins. Most common treatment modifications were rechallenging index therapy (25.2%: 18–64 years, 27.0%: ≥65 years), switching (27.5%: 18–64 years, 24.6%: ≥65 years), and permanent discontinuation of any LLT (18.6%: 18–64 years, 21.0%: ≥65 years). Only 10% of patients in both groups underwent dose escalation. Conclusions: Real-world evidence indicates that few high-risk patients initiate therapy with high-intensity statins. More than 50% of patients underwent a rechallenge or switching. Despite high CVD risk profile, approximately 20% of patients permanently discontinued any LLT. Key limitations: Pharmacy claims do not provide information on whether patients who had a pharmacy fill actually took the medication as prescribed. It is unknown whether rechallenge was a simple delay in filling a prescription or an actual rechallenge of their index therapy. Reasons for treatment discontinuations or modifications were unavailable in claims data.

Background: Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined. Methods: QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires. Results: Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (–27.96 versus –8.62); the difference, –18.9 (95% confidence interval –26.6, –11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0–12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus –2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was –35.54 versus –11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores. Conclusions: In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients. Clinical trial registration: NCT01578499.

Summary Brentuximab vedotin (BV) significantly improved progression-free survival in a phase 3 study in patients with relapsed or refractory Hodgkin lymphoma (RR-HL) post-autologous-haematopoietic stem cell transplant (auto-HSCT); we report the impact of BV on quality of life (QOL) from this trial. The European Quality of Life five dimensions questionnaire was administered at the beginning of each cycle, end of treatment, and every 3 months during follow-up; index value scores were calculated using the time trade-off (TTO) method for UK-weighted value sets. Questionnaire adherence during the trial was 87·5% (N = 329). In an intent-to-treat analysis, compared with placebo, TTO scores in the BV arm did not exceed the minimally important difference (MID) of 0·08 except at month 15 (−0·084; 95% confidence interval, −0·143 to −0·025). On-treatment index scores were similar between arms and did not reach the MID at any time point; mixed-effect modelling showed that BV treatment effect was not significant (P = 0·2127). BV-associated peripheral neuropathy did not meaningfully impact QOL. Utility scores for patients who progressed declined compared with those who did not; TTO scores between these patients exceeded the MID beginning at month 15. In conclusion, QOL decreased modestly with BV consolidation treatment in patients with RR-HL at high risk of relapse after auto-HSCT.

Machaon Bonafede,1 Joseph Feliciano,2 Qian Cai,1 Virginia Noxon,1 Nicole Princic,1 Akshara Richhariya,2 David J Straus3,4 1IBM Watson Health, Cambridge, MA, USA; 2Seattle Genetics, Inc., Bothell, WA, USA; 3Memorial Sloan Kettering Cancer Center, New York, NY, USA; 4John P Leonard Department of Medicine, Weill Cornell Medicine, New York, NY, USA Purpose: The purpose of this study was to evaluate the economic burden of frontline failure (FLF) among classical Hodgkin lymphoma (HL) patients during and after treatment.Patients and methods: The population consisted of adult HL patients identified from January 2010 through September 2015 without any other primary cancer prior to HL diagnosis, who also had a frontline (FL) regimen indicative of curative intent. Patients were characterized as FLF (those who restart, switch to any chemotherapy; had a hematopoietic stem cell transplant; or newly initiated radiation therapy [RT] after discontinuing FL) or non-FLF (those not considered as FLF). Direct health care utilization and expenditures were measured over both fixed and variable length follow-up periods and during FL therapy.Results: There were 77 FLF and 602 non-FLF patients who met the final inclusion criteria. FLF and non-FLF patients were demographically similar with mean age 38.5 years and 47.5% females. Average per patient per month (PPPM) costs were significantly higher for FLF patients during all follow-up (US$20,266 vs US$7,772, P

Background Acute cardiovascular (CV) events have been evaluated in patients with specific comorbidities but have not focused on patients with hyperlipidemia or on the their long-term costs. Objectives To evaluate incidence of CV events, costs, and resource utilization among patients with hyperlipidemia and baseline risk of CV disease (CVD). Methods Patients (age 18 to 64 years) diagnosed with hyperlipidemia or using lipid-modifying medications were identified from administrative claims. Patients were categorized into 3 cohorts based on pre-index clinical characteristics—secondary prevention (SP; history of CV event, n = 15 613); high risk (HR; CVD, n = 47 600); and primary prevention (PP; no CV event history or CVD, n = 60 637)—and followed up to 2 years after the CV event. Results During follow-up, ≥1 new CV event occurred in 43.0% of the SP cohort, 33.9% of HR, and 20.9% of PP; and ≥3 new events occurred in 19.8% of the SP cohort, 12.9% of HR, and 5.5% of PP. Incremental total costs were $19 320 for SP, $20 003 for HR, and $17 650 for PP. Compared with patients with only 1 CV event, the mean 2-year cost was 30% higher in patients with 2 CV events and 48% higher in patients with 3 CV events. Only 50% of HR patients (with or without CV events) received statins. Conclusions Patients with recurrent CV events had higher total health care costs during 24-month follow-up for each type of CV event. Total health care costs among patients with a CV event were higher for the initial as well as subsequent events. Statins and lipid-modifying medications were significantly underutilized in all cohorts, despite the presence of CVD.

Approximately 20,000 hematopoietic cell transplantation (HCT) procedures are performed in the US annually. This study aims to study the healthcare resource utilization and costs among commercially-insured patients with hematologic malignancies who received autologous HCT (auto-HCT) and allogeneic HCT (allo-HCT) in the US.Adult patients with hematologic malignancies undergoing auto- or allo-HCT between January 1, 2011 and June 30, 2014 were identified in the Truven Health MarketScan Research Databases. Patients with 12 months of continuous pharmacy and medical enrollment pre- and post-HCT were included. Patients with prior HCT were excluded. Controls were selected from patients without any claims for HCT and matched with HCT recipients in a 3:1 ratio based on age, gender, insurance type, and Deyo-Charlson Comorbidity Index categories. Total healthcare resource uses and costs were compared between auto- or allo-HCT recipients and controls.In total, 10,527 patients (HCT, n = 2,672 vs control, n = 7,855) were included, with the majority of HCT recipients (63.6%) undergoing auto-HCT. During the 6-month pre-index and 12-month post-index period, auto-HCT recipients incurred $313,562 (p .01) higher all-cause costs than controls, attributable to inpatient admission (54.1%), outpatient services (33.4%), and prescriptions (12.5%). The all-cause costs for allo-HCT recipients were $621,895 (p .01) higher vs controls during the 18-month observation period, attributable to inpatient admissions (75.5%), outpatient services (22.1%), and prescriptions (2.4%).The use of HCT among patients with hematologic malignancies is associated with considerable economic burden in direct healthcare costs in a commercially insured population. Incremental costs for HCT recipients were mainly driven by costs related to hospitalization and other medical services.

Approximately 20,000 hematopoietic cell transplantation (HCT) procedures are performed annually in the United States. Real-world data on the costs associated with post-transplantation complications are limited. Patients with hematologic malignancies aged ≥18 years undergoing autologous HCT (auto-HCT) or allogeneic HCT (allo-HCT) between January 1, 2011, and June 30, 2014, were identified in the Truven Health MarketScan Research Databases. Patients were required to have 12 months of continuous medical and pharmacy enrollment before and after HCT; patients who experience inpatient death within 12 months post-HCT were also included. Patients with previous HCT were excluded. Potential HCT-related complications were identified if they had a medical claim with a diagnosis code for relapse; infection; cardiovascular, renal, neurologic, pulmonary, hepatic, or gastrointestinal disease; secondary malignancy; thrombotic microangiopathy; or posterior reversible encephalopathy syndrome within 1 year post-HCT. Healthcare costs attributable to these complications were evaluated by comparing total costs in HCT recipients with complications and those without complications. The MarketScan Research Databases were further linked to the Social Security Administration's Master Death File to obtain patient death events in a subset of patients. A total of 2672 HCT recipients were included in the analysis. The mean ± SD age of recipients was 54.5 ± 11.6 years, and the majority of recipients (63.6%) underwent auto-HCT. Complications were identified in 81% of auto-HCT recipients and in 95.5% of allo-HCT recipients. Most complications occurred within 180 days post-HCT. Compared with Auto-HCT recipients without complications, those with complications incurred $51,475 higher adjusted total costs (P .01). Compared with allo-HCT recipients without complications, those with complications incurred $181,473 higher adjusted total costs (P .01). Among the patients with mortality data, auto-HCT recipients with complications had a higher mortality rate (13.4% vs 5.7%, P .01) and a lower probability of survival (P .01) compared with those without complications. In allo-HCT recipients, however, the mortality rate and probability of survival were not significantly different between those with complications and those without complications. HCT recipients with complications were associated with considerable economic burden in terms of direct healthcare costs in a commercially insured population, and in the case of auto-HCT, a higher mortality rate was observed in those with complications.

To document the risk of skeletal complications in patients with bone metastases from breast cancer (BC), lung cancer (LC), or prostate cancer (PC) in routine clinical practice. We used data from two large US health systems to identify patients aged ≥18 years with primary BC, LC, or PC and newly diagnosed bone metastases between January 1, 1995 and December 31, 2009. Beginning with the date of diagnosis of bone metastasis, we estimated the cumulative incidence of skeletal-related events (SREs) (spinal cord compression, pathologic fracture, radiation to bone, bone surgery), based on review of medical records, accounting for death as a competing risk. We identified a total of 621 BC, 477 LC, and 721 PC patients with newly diagnosed bone metastases. SREs were present at diagnosis of bone metastasis in 22.4, 22.4, and 10.0 % of BC, LC, and PC patients, respectively. Relatively few LC or PC patients received intravenous bisphosphonates (14.8 and 20.2 %, respectively); use was higher in patients with BC, however (55.8 %). In BC, cumulative incidence of SREs during follow-up was 38.7 % at 6 months, 45.4 % at 12 months, and 54.2 % at 24 months; in LC, it was 41.0, 45.4, and 47.7 %; and in PC, it was 21.5, 30.4, and 41.9 %. More than one half of patients with bone metastases had evidence of SREs (BC: 62.6 %; LC: 58.7 %; PC: 51.7 %), either at diagnosis of bone metastases or subsequently. SREs are a frequent complication in patients with solid tumors and bone metastases, and are much more common than previously recognized in women with BC.

e22070Background: Multi-agent chemotherapy including bleomycin has been the standard of care for initial treatment of Hodgkin lymphoma (HL) for over 30 years. The incidence of pulmonary events asso...

Machaon M Bonafede,1 Barbara H Johnson,1 Akshara Richhariya,2 Shravanthi R Gandra2 1Outcomes Research, Truven Health Analytics, Cambridge, MA, USA; 2Global Health Economics, Amgen, Thousand Oaks, CA, USA Objectives: This study descriptively examined acute and longer term direct medical costs associated with a major cardiovascular (CV) event among high-risk coronary heart disease risk-equivalent (CHD-RE) patients. It also gives a firsthand look at fatal versus nonfatal CV events. Methods: The MarketScan® Commercial Claims and Encounters Database was used to identify adults with a CV event in 2006–2012 with hyperlipidemia or lipid-lowering therapy use in the 18 months prior to one of the following inpatient CV events: myocardial infarction, ischemic stroke, unstable angina, transient ischemic attack, percutaneous coronary intervention, or coronary artery bypass graft (CABG). Patients were required to have a preindex diagnosis of at least one of the following: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, or diabetes. A subset analysis was conducted with patients with data linkable to the Social Security Administration Master Death File. Direct medical costs were reported for each quarter following a CV event, for up to 36 months after the first CV event. Results: In total, 38,609 CHD-RE patients were included, mean age 57 years, 31% female. CABG, myocardial infarction, and percutaneous coronary intervention were the most frequent and most expensive first CV events, accounting for >75% of all first CV events with mean first quarter costs ranging from $17,454 (nonfatal transient ischemic attack) to $125,690 (fatal CABG). Overall, 15% of those with a first CV event went on to have a second event during the 36-month study period with mean first quarter nonfatal and fatal costs similar to first event levels. Third CV events were rare, happening in less than 3% of patients. Conclusion: CV events among CHD-RE patients were costly regardless of sequence, averaging $47,433 in the first 90 days following an event and remaining high, never returning to preevent levels. When fatal, first CV event costs were 1.2 to 2.9 times higher than when nonfatal. Keywords: coronary heart disease risk equivalent, economic burden, subsequent CV event, fatal CV event

Background: Hyperlipidemia is associated with increased risk of cardiovascular (CV) events, especially among adults with a history of cardiovascular disease (CVD). It is unclear whether the increased risk is similar between men and women. Purpose: This study evaluated the occurrence of subsequent cardiovascular events among high-risk patients with hyperlipidemia and a history of prior CV events who were enrolled in US health plans, stratified by gender. Methods: Patients (age 18-64) with a hyperlipidemia diagnosis or using lipid-lowering therapy (LLT) from 1/1/2007 to 12/31/2008, and a history of ≥ 1 CV events (myocardial infarction [MI], ischemic stroke [IS], unstable angina [UA], coronary artery bypass graft (CABG) or percutaneous coronary intervention [PCI]) in the 12 months prior to hyperlipidemia diagnosis or LLT use were selected from the large payer claims database (HealthCore Integrated Research Database SM ). Patientswere followed until the end of study period (02/28/2013) or end of health plan eligibility or death (whichever occurred first). Incidence and time to subsequent CV events were calculated. Results: In the CV event history cohort (n=9890, mean age=55 years), 67% were men and 33% were women. A significantly greater proportion of women (44.6%) had ≥1 subsequent CV event compared with men (40.5%, p Conclusions: Among high-risk patients (i.e. history of CV events) enrolled in US health plans, women were more likely to have a subsequent CV event and multiple CV events sooner than men. Further research is needed to ascertain whether the gender differences might reflect differences in the intensity of treatment for hyperlipidemia between men and women.

Background: This study evaluated the real-world patterns and time to first and recurrent cardiovascular (CV) events among patients with hyperlipidemia. Methods: Patients (age 18-64) with hyperlipidemia diagnosis or using lipid-lowering therapy (LLT) from 1/1/2007 to 12/31/2008 were selected from the HealthCore Integrated Research Database SM (HIRD) and followed until the end of study period (02/28/2013) or health plan enrollment or death (whichever occurred first). Patients who had ≥ 1 CV events (myocardial infarction, ischemic stroke, unstable angina, coronary artery bypass graft or percutaneous coronary intervention) 12 months before the first occurrence of hyperlipidemia diagnosis or LLT use (baseline period) were included in the CV event history cohort. Patients without any CV event(s), but who had ischemic heart disease, stable angina, peripheral arterial disease, abdominal aortic aneurysm, transient ischemic attack, or type 2 diabetes during the baseline period were included in the modified CV RE cohort. Baseline use of LLT, incidence and time to first and subsequent CV events were quantified. Results: In the CV event history cohort (n=9890, mean age=55 years), 41.8% had ≥1 new CV event with 18.9% having 3 or more new CV events; 33.3% of patients with CV RE (n=27,352, mean age=55 years) had ≥1 new CV event with 12.5% having 3 or more new CV events. At baseline, in both cohorts, about 64% were using LLT. In the CV event history cohort, time to first new CV event was 786 days and time between the first and second and second and third CV events was 270 days and 208 days, respectively. In the CV RE cohort, time to first new CV event was 939 days and time between the first and second and second and third CV events was 258 days and 193 days, respectively. Mean 1-year total cost of the second CV event and the third CV event was 30%-48% and 34%-46% higher than the first CV event in both cohorts. Conclusions: CV event-related risk and long-term costs are significantly greater among high-risk patients with shorter time intervals between recurrent CV events. Underutilization of LLTs in these patients highlights the need for improving clinical management and treatment options for these patients.

Background: This real-world retrospective cohort study estimated the rate of heart failure events and total healthcare costs among patients with hyperlipidemia. Methods: Patients (aged 18-64 years) with hyperlipidemia diagnosis and/or lipid-lowering medications were identified from the HealthCore Integrated Research Database SM from 1/1/2007 to 12/31/2008 and followed until 2/28/2013. Patients were stratified by cardiovascular (CV) risk level as (1) secondary prevention with a history of myocardial infarction, stroke, unstable angina, or revascularization, (2) modified coronary heart disease (CHD) risk equivalent (RE) without a history of CV events but with peripheral artery disease, type 2 diabetes, abdominal aortic aneurysm, ischemic heart disease, stable angina, or TIA, and (3) primary prevention without a history of CV events or CHD RE. Patients with new CV event hospitalization during follow-up were propensity score-matched to patients without new CV events within each cohort. Proportion of patients with heart failure events and incremental total costs during 2 years of follow-up were evaluated. Results: Before matching, 62,427 patients had ≥1 CV event (13.2% secondary prevention, 38.4% CHD RE, 48.5% primary prevention). For patients with ≥1 CV event during follow-up, 38.8% of secondary prevention, 42.6% of CHD RE, and 30.0% of primary prevention had heart failure as their index event. Of patients with heart failure index event, 58.3% of secondary prevention, 47.3% of CHD RE, and 30.5% of primary prevention patients had 1 or more heart failure events over 2 years. Among patients with ≥1 heart failure events, 36.2% of secondary prevention, 30.0% of CHD RE, and 17.7% of primary prevention patients had ≥3 heart failure events over 2 years. Among matched patients (85-87% of patients), incremental total cost over 2 years for patients with heart failure as their index event compared with patients without CV events was $56,078 for secondary prevention, $53,247 for CV RE, and $49,637 for primary prevention cohorts. Conclusions: The rate and recurrence of heart failure among hyperlipidemic patients is very high and the long term healthcare costs substantial in this real-world 2-year study.

Background: Advances in cardiovascular (CV) disease management have reduced acute CV event risk; however, the burden of these events remains substantial. We identified a cohort of high risk coronary heart disease risk equivalent patients to examine the incidence of subsequent inpatient CV events and cost of first, subsequent and fatal inpatient CV events. Methods: The Truven Health MarketScan® Commercial Database was used to identify adults with hyperlipidemia or lipid-lowering therapy in the 18 months prior to one of the following new inpatient CV events: myocardial infarction (MI), ischemic stroke, unstable angina (UA), revascularization without MI, UA, or stroke (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]), or heart failure between 2006 and 2012. Patients were required to have a pre-index diagnosis of peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease or diabetes (CHD RE). Direct medical costs were reported for each three-month quarter following a CV event, for up to 36 months after the first CV event. Fatal CV events were identified for a subset of patients with Social Security Administration Master Death File (SSAMDF) data to determine presence of death within 90 days of a CV event. Results: A total of 38,609 CHD RE patients met the study criteria (mean age 57 years, 69% male). CABG, MI and PCI were the most frequent and most expensive first CV events, accounting for >75% of all first CV events. Mean quarter 1 (Q1) non-fatal and fatal direct costs were highest for CABG ($77,701 and $125,690), followed by MI ($47,869 and $56,577) and PCI ($38,744 and $64,387). First event stroke, TIA and UA mean Q1 direct costs ranged from a low of $17,454 (non-fatal TIA) to a high of $72,449 (fatal UA). Overall, 15% of those with a first CV event went on to have a second event during the 36 month study period, with an average time to event of 217 days. Of patients with SSAMDF availability, 1.8% of acute CV events were fatal (range 1-4% by event type) and average Q1 costs for fatal events were 1.5 times higher than average costs for non-fatal events (range 1.2-5.5 times). Overall, 2.8% of patients went on to have a third acute CV event, occurring on average 230 days following the second event. Mean quarterly costs in Q2 drop substantially to between 8.2% (CABG) and 33.6% (TIA) of Q1 event costs. Average quarterly costs stabilized at approximately 1.4 times higher than average pre-event costs for Q3 through Q12; costs never returned to pre-event levels. Conclusions: MI was the most common first inpatient CV event in high risk CHD RE patients. Recurrent CV events are common and occur, on average, within 8 months. CV events were costly, regardless of sequence, averaging $47,433 in the first 90 days following an event. During the follow-up period, costs never returned to their pre-event levels. Though uncommon, fatal CV events have substantially higher costs than non-fatal events.

BACKGROUND: Acute cardiovascular (CV) events have been evaluated in patients with specific comorbidities but have not focused on patients with hyperlipidemia or on the their long‐term costs. OBJECTIVES: To evaluate incidence of CV events, costs, and resource utilization among patients with hyperlipidemia and baseline risk of CV disease (CVD). METHODS: Patients (age 18 to 64 years) diagnosed with hyperlipidemia or using lipid‐modifying medications were identified from administrative claims. Patients were categorized into 3 cohorts based on pre‐index clinical characteristics—secondary prevention (SP; history of CV event, n = 15 613); high risk (HR; CVD, n = 47 600); and primary prevention (PP; no CV event history or CVD, n = 60 637)—and followed up to 2 years after the CV event. RESULTS: During follow‐up, ≥1 new CV event occurred in 43.0% of the SP cohort, 33.9% of HR, and 20.9% of PP; and ≥3 new events occurred in 19.8% of the SP cohort, 12.9% of HR, and 5.5% of PP. Incremental total costs were $19 320 for SP, $20 003 for HR, and $17 650 for PP. Compared with patients with only 1 CV event, the mean 2‐year cost was 30% higher in patients with 2 CV events and 48% higher in patients with 3 CV events. Only 50% of HR patients (with or without CV events) received statins. CONCLUSIONS: Patients with recurrent CV events had higher total health care costs during 24‐month follow‐up for each type of CV event. Total health care costs among patients with a CV event were higher for the initial as well as subsequent events. Statins and lipid‐modifying medications were significantly underutilized in all cohorts, despite the presence of CVD.

The purpose of this paper is to document the use of intravenous (IV) bisphosphonates for prevention of skeletal-related events (SREs) in patients with bone metastases (BM) due to breast cancer (BC), lung cancer (LC), or prostate cancer (PC).Using data from two large US health systems, we identified all patients aged ≥ 18 years with primary BC, LC, or PC and newly diagnosed BM between 1/1/1995 and 12/31/2009. Starting with the diagnosis of BM, we reviewed medical and administrative records for evidence of receipt of IV bisphosphonates (zoledronic acid or pamidronate) and occurrence of SREs. Initiation of IV bisphosphonates prior to occurrence of an SRE was designated "primary prophylaxis"; use following an SRE was designated "secondary prophylaxis".We identified a total of 1,193 patients with newly diagnosed BM, including 400 with BC, 332 with LC, and 461 with PC. Use of IV bisphosphonates was substantially higher in BC (55.8 % of all patients) than in LC (14.8 %) or PC (20.2 %). Use of IV bisphosphonates was fairly evenly split between primary and secondary prophylaxis in BC (26.3 vs. 29.5 %, respectively) and PC (10.6 vs 9.5 %); in LC, however, primary prophylaxis was much less common than secondary prophylaxis (4.8 vs 9.9 %).Almost one half of all patients with BM due to BC, and substantially more with LC and PC, do not receive IV bisphosphonates. Among patients receiving such therapy, treatment often is not initiated until after the occurrence of an SRE. Our study suggests that IV bisphosphonates may be substantially underutilized in patients with BM due to these common cancers.

Introduction: Acute myeloid leukemia (AML) consists of a group of relatively well-defined hematopoietic neoplasms, while myelodysplastic syndrome (MDS) comprises a heterogeneous group of hematopoietic stem cell disorders. These disorders may occur de novo or may arise secondary to prior malignancies for which patients received cytotoxic chemotherapy and/or radiation therapy. While AML and MDS are reported in a number of national cancer registries, competing classifications prior to 2001 often preclude comparison of results globally. We conducted a systematic literature review in order to identify global rates of the incidence and prevalence of AML and MDS. Methods: We searched Embase and MEDLINE for published studies and recent conference abstracts on the incidence and/or prevalence of AML and MDS for data collected from 2001-2016. This time period parallels the introduction of the World Health Organization (WHO) classification of hematopoietic neoplasms. Two reviewers independently screened all abstracts and selected articles, and subsequently abstracted multiple data elements including: AML or MDS, geographic region, standardized incidence and/or prevalence rates, years of data collection, disease classification criteria (e.g. WHO, French American British (FAB), ICD-O-3, ICD-9/10), if condition was diagnosed de novo or treatment associated, age category, and gender. Incidence rates and prevalence by sub-disease classification were also abstracted when available. Results: Literature Review: Our search strategy yielded 874 abstracts initially reviewed for applicability. Of these, 84 were selected for article screening; 44 articles were excluded after screening and 40 articles proceeded to data abstraction and were included in analyses. 25 studies reported on MDS incidence and 2 on MDS prevalence; 17 studies reported on AML incidence and 4 on AML prevalence (some studies report both AML and MDS and incidence and prevalence). While the majority of studies are based on existing regional disease registries, a number describe analyses based on administrative claims data, or patient charts. Nine (9) studies reported on therapy associated incidence. Classification of AML or MDS was based on FAB (9 studies), WHO (10 studies), ICD-O-3 (11 studies) or ICD-9/10 (7 studies) criteria. Three studies were classified on the basis of chart review and/or clinical diagnosis by a physician. Regional distribution was: North America (10 studies), Europe (17 studies), Australia (4 studies), and the Rest of World (including 3 studies in Asia, 2 studies in Africa, 2 in South America and 2 in the Middle East). Analysis: Incidence rates are reported in Figure 1 by region for those studies reporting overall rates across clinical factors, age and gender (27 articles). Incidence of AML as a result of treatment for another cancer ranged from 0.06-2.6 per 100,000 and for MDS from 0.06-0.26 per 100,000. In general, incidence rates increased with increasing age in studies that reported results by age group. Prevalence of AML ranged from 0.6-11.0 per 100,000 and for MDS ranged from 0.22-13.2 per 100,000 for all age categories, genders and ethnicities. Discussion:This is the first study to report on the global incidence of AML and MDS and whether or not the disease occurs as a result of treatment for another oncologic condition or occurs de novo. Variation in study designs and heterogeneous population characteristics make interpretation of results challenging. Figure 1 Overall Incidence Rates for AML and MDS by Geographic Region Figure 1. Overall Incidence Rates for AML and MDS by Geographic Region Disclosures Lubeck: Outcomes Insights: Employment. Danese:Outcomes Insights: Employment. Jennifer:Outcomes Insights: Employment. Miller:Outcomes Insights: Consultancy. Richhariya:Seattle Genetics, Inc.: Employment. Garfin:Seattle Genetics, Inc.: Employment.

Introduction: Hematopoietic cell transplantation (HCT) is a potentially curative treatment for patients with hematologic malignancies. Previous work using a national claims database identified the high cost of HCT, but was limited to the first 100 days. This study describes the rate of complications, medication use, and incremental total costs over a 2-year period among commercially insured patients who received autologous (auto-) or allogeneic (allo-) HCT in the US. Methods: Patients with hematologic malignancies aged ≥18 years undergoing auto-HCT or allo-HCT (ICD-9 procedure codes 41.01-41.09) between January 1, 2011 and June 30, 2014 were identified in the Truven Health MarketScan Research Databases. Patients were required to have 12-month continuous enrollment pre- and post-HCT (index event), and those with prior HCT were excluded. Controls were selected from a pool of patients without HCT and matched in up to a 3:1 ratio on age, gender, insurance type, Deyo-Charlson comorbidity index, and diagnosis. Control patient index dates were randomly assigned based on the HCT index date distribution. Potential HCT-related complications were defined as having a medical claim with a diagnosis code for relapse, infection, cardiovascular, renal disease, neurological, pulmonary, hepatic, gastrointestinal, secondary malignancy, thrombotic microangiopathy or posterior reversible encephalopathy syndrome during the 12-month post index period. Total healthcare costs were defined as sum of health plan and patient paid costs for prescriptions and medical services, including inpatient admissions, emergency room and physician office visits, and other outpatient services. Incremental costs approach was used to examine the excess post-index all-cause costs of HCT by comparing auto-HCT or allo-HCT cohorts with corresponding controls. Results: 10,527 patients (HCT = 2,672; controls = 7,855) were included, with 95.7% of HCT recipients matched with 3 controls. The mean (± SD) age of HCT recipients was 54.5 (±11.6) years, 40.5% were female, and 63.6% underwent auto-HCT. Acute myeloid leukemia, myelodysplastic syndrome, myelofibrosis and myeloproliferative disease (69.1%) were the most common indications for allo-HCT, while lymphoma (39.5%) was the most common indication for auto-HCT. Compared with their controls, allo-HCT recipients had a significantly higher use of antivirals (91.5% vs 21.5%, p Conclusions: Hematologic malignancies are associated with considerable clinical and economic burdens. This analysis demonstrates that HCT adds significantly to the burden of therapy, with HCT recipients incurring about 10 times the cost of care during the 12-month post-transplantation period compared to controls. This analysis does not compare the long-term (e.g., ≥12-months) outcomes, and also underestimates total costs as it does not include indirect costs, caregiver burden, or donor costs. As expected, post-HCT complications further contribute to costs and this should encourage strategies that decrease complications and reduce costs. Disclosures Josephson: Seattle Genetics: Employment. Garfin:Seattle Genetics, Inc.: Employment. Richhariya:Seattle Genetics, Inc.: Employment. Bonafede:Truven Health: Other: I am an employee of Truven Health, which received a research contract to conduct this study with Seattle Genetics. . Donna:Truven Health: Other: I am an employee of Truven Health, which received a research contract to conduct this study with Seattle Genetics. . Cai:Truven Health Analytics: Other: I am an employee of Truven Health, which received a research contract to conduct this study with Seattle Genetics. , Research Funding.

Introduction: Bleomycin has been a component of chemotherapeutic regimens for decades, typically among young individuals who may survive for long periods. Yet, toxicity from bleomycin may result in short-term and long-term health problems. The study objectives were to characterize the occurrence and severity of bleomycin toxicities and identify risk factors for bleomycin toxicity among patients with Hodgkin lymphoma. Methods: A systematic literature review of the burden of bleomycin treatment in cancer patients was conducted using the PRISMA checklist. PubMed, EMBASE, and Cochrane Database were searched for English language articles between 1980 and March 2016 providing data on bleomycin toxicity in studies with >10 patients. Results: Overall, 18 original research articles of good to moderate quality were included in the systematic review for patients with Hodgkin lymphoma. Pulmonary toxicity ranged from dyspnea, pulmonary fibrosis, and pneumonitis, to acute respiratory distress syndrome and respiratory tract disorders or infections. For Hodgkin lymphoma, the proportion of patients experiencing pulmonary toxicity was >5% in 12 of 17 studies, with 8 studies reporting toxicity in 13% - 28% of patients. Other studies (n=5) reported that 0% - 4.7% of patients experienced pulmonary toxicity. About 4% -5% of Hodgkin lymphoma patients had fatal pulmonary toxicity. Skin toxicity ranged from skin rash to dermatitis and erythema, with 1% - 5% of Hodgkin lymphoma patients experiencing skin toxicity after bleomycin exposure. In the 4 studies that investigated risk factors for bleomycin-induced pulmonary toxicity among patients with Hodgkin lymphoma, low albumin level ( Conclusions: Long-term pulmonary toxicity was not consistently evaluated in the studies and may understate the true burden on patients. Many patients treated with bleomycin may experience toxicity and sometimes fatal toxicity. Since Hodgkin lymphoma is a highly curable malignant disease and to further improve patient outcomes, attention needs to be focused on reducing treatment-related toxicities, particularly long-term morbidity and death associated with pulmonary events. Disclosures Fox: Seattle Genetics: Research Funding. Josephson:Seattle Genetics: Employment. Richhariya:Seattle Genetics, Inc.: Employment.

19 Background: In 2015, the Scottish Medicines Consortium (SMC) made a positive recommandation for brentuximab vedotin (BV) in patients with relapsed or refractory (R/R) Hodgkin lymphoma (HL) who have received autologous stem cell transplantation (ASCT) based on 3-year follow-up data from the pivotal phase 2 single-arm trial (SG035-0003; NCT00848926). At 3-years, the incremental cost-effectiveness ratio (ICER) for brentuximab vedotin compared with chemotherapy +/- radiotherapy (C/R) was £43,731 per quality-adjusted life year (QALY). This study re-evaluated the cost-effectiveness analysis with 5-year follow-up data from the pivotal trial. Methods: A partitioned survival model was developed using a Scottish health system perspective over a lifetime time-horizon. Three health states were evaluated: progression-free survival (PFS), post-progression survival, and death. The relevant comparators were C/R, or C/R with intent to allogeneic stem cell transplantation. Clinical outcomes (PFS and overall survival [OS]) for BV were estimated based on data from the pivotal trial in 102 patients. A naïve comparison with the specified comparators was conducted using published survival data. ICERs were calculated with measures of the clinical outcomes, direct costs and QALYs. Deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness of the model. Results: The 5-year follow-up data reduced the base case ICER for BV from £43,731 to £38,769 per QALY versus C/R and increased the probability of cost-effectiveness. The variation in ICER for BV generated by the deterministic sensitivity analyses was also reduced resulting from reduced uncertainty in the estimation of long term clinical outcomes. Conclusions: This update has strengthened the cost-effectiveness evidence for BV in patients with R/R HL post-ASCT. The 5-year follow-up has reduced the uncertainty in the long term outcomes and reduced the ICER, which is low in comparison to other treatments for orphan diseases approved by UK agencies. BV may therefore represent a cost-effective treatment option for this patient group.

20 Background: AETHERA (NCT01100502) is a randomized Phase 3 study of BV and best supportive care (BSC) vs placebo (PBO) and BSC in the treatment of pts at risk of residual HL post-ASCT. BV consolidation therapy post-ASCT significantly improved progression-free survival (PFS) by independent review vs PBO (HR = 0.57, P = 0.001) and was FDA approved. Most common grade ≥ 3 adverse events were neutropenia (29% BV vs 10% PBO) and peripheral sensory neuropathy (10% vs 1%). The aim of this study was to determine the NNT with BV to avoid 1 additional event, disease progression/death. Methods: The NNT with BV was calculated as the inverse of the absolute risk reduction (ARR); ARR was the PFS event rate per investigator (INV) assessment in the PBO arm minus the event rate in the BV arm of the AETHERA trial. The AETHERA trial recruited pts ≥ 18 yrs at risk of residual HL post-ASCT defined by ≥ 1 of: history of refractory HL; relapse/progression < 12 months after frontline therapy; extranodal involvement at time of pre-ASCT relapse. Pts were randomized to receive BV 1.8 mg/kg or PBO on day 1 of each 21-day cycle, for up to 16 cycles/disease progression. Results: 329 pts (median age 32 yrs [range 18–76]; 53% male) received BV (n = 165) or PBO (n = 164). Fewer PFS events per INV analysis were experienced by pts in the BV arm vs PBO arm. The NNT with BV to prevent a disease progression/death ranged from 4.08 (95% CI 2.94, 6.96) to 7.79 pts (95% CI 5.05, 16.4) over 48 months (Table). At 24 months (time majority of pts have progressed post-ASCT), the NNT to prevent a disease progression/death was 4.92 pts (95% CI 3.29, 10.39). Conclusions: AETHERA data suggest that, at various time points, 1 in every 5–8 pts treated with BV consolidation therapy will benefit by avoiding disease progression/death. This further demonstrates BV’s clinical benefit in the post-ASCT consolidation setting. Clinical trial information: NCT01100502. [Table: see text]

18 Background: Systemic anaplastic large cell lymphoma (sALCL) is a rare T-cell lymphoma. For patients who fail front-line therapy, outcomes are poor and there is no current defined standard of care. Brentuximab vedotin has demonstrated high objective response rates and is approved for patients with relapsed or refractory (R/R) sALCL. However, the cost-effectiveness of brentuximab vedotin compared with conventional chemotherapy has not been explored. Methods: A lifetime Excel-based partitioned survival model was used to compare survival outcomes from the pivotal phase-2 single-arm brentuximab vedotin trial of 58 R/R sALCL patients with good Eastern Corporative Oncology Group (ECOG) performance status after one or more prior therapies (SG035-0004); with 40 sALCL patients from a Canadian cancer registry receiving first-line conventional salvage chemotherapy (65% with ECOG 0 or 1) between 1980 and 2012 and followed for up to 20 years. Extrapolation of brentuximab vedotin survival after the trial period assumed the same rate of change as for conventional chemotherapy. A United Kingdom National Health Service perspective was adopted. Costs included drug acquisition and administration, and medical care for adverse events and pre- and post-progression. Utility values elicited by response and by progression, and disutilities associated with adverse events were applied to estimate quality-adjusted life years (QALYs). Results: The incremental cost-effectiveness ratio (ICER) for brentuximab vedotin was £35,390 per QALY gained versus conventional chemotherapy. ICERs were between £28,112 and £61,921 across a range of alternative model assumptions. Comparing only first-line salvage patients in both groups reduced the ICER to £26,766. Conversely, considering only patients with good ECOG performance status increased the ICER to £38,186. Using probabilistic sensitivity analysis, at willingness-to-pay of £38,000, the probability that brentuximab vedotin is cost-effective was > 50%. Conclusions: Brentuximab vedotin may represent a cost-effective intervention compared to conventional chemotherapy for this patient population with limited therapeutic options.

e19630 Background: Bony metastases (mets) are a common source of morbidity in patients (pts) with cancer, cause spinal cord compression (SCC), pathological fracture (PF), and bone pain, and often require radiotherapy (RT) and/or surgery to bone (SB). Methods: Using the tumor registry and electronic data stores at a large U.S. Midwest healthcare system that serves approximately 800,000 persons, we retrospectively identified all pts aged ≥18 years with primary breast, lung, or prostate cancer diagnosed between 1995 and 2009. Registry and electronic medical records were then used to identify pts with diagnosis of bone mets at initial cancer diagnosis or at recurrence. Trained technicians reviewed medical records for occurrence of SCC, PF, RT and SB—outcomes that have been collectively referred to as SREs. Cumulative incidence of these events was calculated in the presence of competing risk of death. Results: We identified 378 pts with breast cancer and bone mets, 272 with lung cancer and bone mets, and 420 with prostate cancer and bone mets. SREs were present at initial diagnosis of bone mets in 23% of breast cancer pts, 24% of lung cancer pts, and 10% of prostate cancer pts (Table). At 12 months, cumulative incidence of SREs was 57.3% for breast cancer (SCC, 5.1%; PF, 37.9%; SCC and/or PF, 40.2%; SB, 5.9%; RT, 27.4%), 62.7% for lung cancer (SCC, 8.9%; PF, 37.8%; SCC and/or PF, 43.3%; SB, 3.5%; RT, 32.4%), and 38.4% for prostate cancer (SCC, 7.9%; PF, 21.3%; SCC and/or PF, 26.7%; SB, 4.0%; RT, 22.9%). Use of bisphosphonates was largely confined to pts with breast cancer. Conclusions: Though breast, lung, and prostate cancers differ considerably in presentation, clinical course, and treatment, SREs are a common and serious problem in all three cancers among patients with bone mets. [Table: see text]

e15197 Background: Bone is a common site of metastatic involvement in patients (pts) with PC. Bony metastases (mets) are often associated with SREs (spinal cord compression [SCC], pathologic fracture [PF], surgery to bone [SB], radiotherapy to bone [RT]). Skeletal complications cause significant morbidity and mortality. Current estimates of SRE risk come principally from randomized clinical trials. Information from routine clinical practice is limited. Methods: Using the tumor registry and electronic data stores at a large U.S. Midwest healthcare system that serves approximately 800,000 persons, we retrospectively identified all pts aged ≥18 yrs with primary PC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Electronic medical records were reviewed by trained abstractors for evidence of SREs between date of bone mets diagnosis and death, loss to follow-up, or end of study for evidence of first SRE. Cumulative incidence of SREs was estimated in the presence of competing risk of death. Results: We identified a total of 420 men with primary PC and newly diagnosed bone mets; 42 pts had evidence of SREs at initial diagnosis of bone mets and were excluded from the analyses. Among the remaining 378 pts, mean (SD) age was 72.7 yrs (9.8 yrs); 38% were Caucasian and 58% were African-American. Median duration of follow-up after diagnosis of bone mets was 17.1 months (mos). At 12 mos, cumulative incidence of SREs was 31.6% (SCC, 6.1%; PF, 15.0%; SCC and/or PF, 19.1%; SB, 3.9%; RT, 24.4%) (Table). Corresponding figures at 24 mos were 45.3% (SCC, 12.5%; PF, 22.2%; SCC and/or PF, 30.2%; SB, 6.2%; RT, 34.9%). Relatively few pts (14.6%) received intravenous bisphosphonates prior to SRE. Conclusions: Pts with PC in routine clinical practice are at high risk of SREs following initial diagnosis of bone mets. [Table: see text]

e18107 Background: Bone is a common site of metastatic involvement in patients (pts) with LC. Bony metastases (mets) are often associated with SREs (spinal cord compression [SCC], pathologic fracture [PF], surgery to bone [SB], radiotherapy to bone [RT]). Skeletal complications cause significant morbidity and mortality. Current estimates of SRE risk come principally from randomized clinical trials. Information from routine clinical practice is limited. Methods: Using the tumor registry and electronic data stores at a large U.S. Midwest healthcare system that serves approximately 800,000 persons, we retrospectively identified all pts aged ≥18 yrs with primary LC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Electronic medical records were reviewed by trained abstractors for evidence of SREs between date of bone mets diagnosis and death, loss to follow-up, or end of study. Cumulative incidence of SREs was estimated in the presence of competing risk of death. Results: We identified a total of 272 pts with primary LC and newly diagnosed bone mets; 66 pts had evidence of SREs at initial diagnosis of bone mets and were excluded from the analyses. Among the remaining 206 pts, mean (SD) age was 65.7 yrs (10.5 yrs) and 66% were male; 47% were Caucasian and 50% were African-American. Median duration of follow-up after diagnosis of bone mets was 3.0 months (mos). At 6 mos, cumulative incidence of SREs was 45.6% (SCC, 6.9%; PF, 20.6%; SCC and/or PF, 25.0%; SB, 4.1%; RT, 34.7%) (Table). Corresponding figures at 12 mos were 50.8% (SCC, 6.9%; PF, 24.1%; SCC and/or PF, 28.3%; SB, 4.1%; RT, 39.8%). Relatively few pts (17.5%) received intravenous bisphosphonates prior to SRE. Conclusions: Pts with LC in routine clinical practice are at high risk of SREs following initial diagnosis of bone mets. [Table: see text]

e12024 Background: Bone is a common site of metastatic involvement in patients (pts) with BC. Bony metastases (mets) are often associated with SREs (spinal cord compression [SCC], pathologic fracture [PF], surgery to bone [SB], radiotherapy to bone [RT]). Skeletal complications cause significant morbidity and mortality. Current estimates of SRE risk come principally from randomized clinical trials. Information from routine clinical practice is limited. Methods: Using the tumor registry and electronic data stores at a large US Midwest healthcare system that serves approximately 800,000 persons, we retrospectively identified all pts aged ≥18 yrs with primary BC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Electronic medical records were reviewed by trained abstractors for evidence of SREs between date of bone mets diagnosis and death, loss to follow-up, or end of study. Cumulative incidence of SREs was estimated in the presence of competing risk of death. Results: We identified a total of 378 pts with primary BC and newly diagnosed bone mets; 87 pts had evidence of SREs at initial diagnosis of bone mets and were excluded from the analyses. Among the remaining 291 pts, mean (SD) age was 58.2 yrs (14.3 yrs), and 99% were women; 46% were Caucasian and 48% were African-American. Median duration of follow-up after diagnosis of bone mets was 16.1 months (mos). At 12 mos, cumulative incidence of SREs was 44.5% (SCC, 5.2%; PF, 21.0%; SCC and/or PF, 23.3%; SB, 7.6%; RT, 34.3%) (Table). Corresponding figures at 24 mos were 53.8% (SCC, 7.5%; PF, 29.3%; SCC and/or PF, 32.5%; SB, 9.4%; RT, 41.7%). Approximately one-half (45.0%) of study subjects received intravenous bisphosphonates prior to SRE. Conclusions: Pts with BC in routine clinical practice are at high risk of SREs following initial diagnosis of bone mets. [Table: see text]

e19514 Background: Bone metastases (BM) are common in patients (pts) with solid tumors and may result in skeletal related events (SREs) such as spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiation to bone (RT). SREs result in significant morbidity, debilitating pain, decreased health-related quality of life and increased health resource utilization (HRU). Data from 3 registrational phase 3 trials that showed superiority of denosumab over zoledronic acid in patients with solid tumors and BM were combined to assess HRU associated with different SRE types. Methods: Data through 41 weeks for pts with solid tumors and ≥ 1 BM enrolled in these randomized, active-controlled trials were included in this posthoc analysis. HRU were evaluated by SRE type and data were compared between pts with ≥ 1 on-study SRE and those not experiencing an on-study SRE. The index date for pts with on-study SREs was defined as the date that the first SRE was reported. The median time from randomization to incidence of first SRE for each SRE type was used to establish an index date for the control (no SRE) group. The HRU window encompassed a 3-month period (i.e.1 month before and 2 months after the index date) and was assessed by mean number of various types of medical visits during this window. Results: Data from 5,543 pts were included. PF was the most common type of first SRE (n=1,017), followed by RT (n=940), SCC (n=156), and SB (n=74). 3,618 pts did not have an on-study SRE. For all types of medical visits, HRU was higher for pts with an on-study SRE than those without (Table). Conclusions: SREs are associated with increased health resource utilization, reflecting an increased burden for patients with solid tumors and bone metastases. [Table: see text]

Akshara Richhariya1, Yi Qian2, Yufan Zhao2, Karen Chung11Amgen Inc, Global Health Economics, Thousand Oaks, CA, USA; 2Amgen Inc, Global Biostatistical Sciences, Thousand Oaks, CA, USAPurpose: Intravenous (IV) zoledronic acid (ZA) is commonly used to delay skeletal complications secondary to bone metastases. However, the time associated with ZA administration may represent a significant burden to healthcare providers and patients. This study assessed the time associated with IV ZA infusion in patients with bone metastases secondary to breast or prostate cancer (BC or PC) in the clinic setting.Methods: Eligible BC or PC patients with bone metastases scheduled to receive IV ZA were observed at seven US-based oncology clinics. Trained observers recorded the time for preinfusion tasks, ZA drug preparation, intravenous infusion, and follow-up activities.Results: Data are reported for 39 patients (BC: 24; PC: 15). Mean administration time was 69 (standard deviation [SD] 42) minutes for all patients combined, 72 (SD 47) minutes for BC, and 65 (SD 33) minutes for PC. Activity times were comparable between tumor types. Mean time for preinfusion tasks (eg, assessment of vital signs, blood draw) and ZA preparation were 12 (SD 20) minutes and 2 (SD 1) minutes, respectively. Mean time required for intravenous infusion (ZA infusion and hydration, when provided) and follow-up activities were 54 (SD 31) minutes and 2 (SD 1) minutes, respectively.Conclusion: Infusion time was the greatest time commitment associated with IV ZA administration, representing 78% of the total time on average. Time for preinfusion activities varied substantially. Overall, the mean time for ZA administration represents a notable time burden for healthcare providers and patients.Keywords: time and motion, bisphosphonates, zoledronic acid, intravenous administration