Clinical outcomes by Child-Pugh Class in patients with advanced hepatocellular carcinoma in a community oncology setting.

Aim: Many pivotal trials in advanced hepatocellular carcinoma (HCC) require participants to have Child-Pugh A disease. However, many patients in real-world practice are Child-Pugh B or C. This study examined treatment patterns and clinical outcomes in patients with advanced HCC treated with first-line systemic therapy. Materials & methods: In this retrospective study, patients with HCC treated with first-line systemic therapy (2010-2017) were identified from US Oncology Network records. Outcomes included overall survival and progression-free survival, by Child-Pugh Class and prior liver-directed therapy. Results: Of 352 patients, 78.7% were Child-Pugh A or B, 96.6% received first-line sorafenib, and 33.8% received first-line-prior liver-directed therapy. Survival outcomes were similar for Child-Pugh A or B, and longer after first-line prior liver-directed therapy. Conclusion: First-line systemic therapy is beneficial in patients with Child-Pugh A or B, and after first-line prior liver-directed therapy. These findings may help position systemic therapy in the community setting.

Real-World Analysis of Treatment Patterns, Healthcare Utilization, Costs, and Mortality Among People with Biliary Tract Cancers in the USA.

INTRODUCTION: People with advanced biliary tract cancers (BTCs) have a 5-year survival of approximately 2% in the USA. Most cases are inoperable or require systemic treatment following surgery. This study adds to current literature by describing treatment patterns, healthcare resource utilization (HCRU), costs, and mortality among people with BTCs. METHODS: Adults diagnosed with BTCs were identified in the Merative MarketScan administrative claims databases from 1 January 2016 to 30 June 2020. Descriptive analysis was used to measure treatment patterns (i.e., regimen types, therapy duration) during three lines of therapy (LOT). All-cause and disease-related HCRU and costs were measured per-patient-per-month (PPPM) during the entire follow-up and in each LOT. Mortality was reported among the subset linked to the National Death Index (NDI). RESULTS: There were 2648 eligible people with BTCs [mean age 64.0 (standard deviation [SD] 12.4) years, 51.5% female, average follow-up 11.9 (SD 11.1) months]. Treatment was received by 56.3% (n = 1490), and 20.9% (n = 5534) and 7.1% (n = 187) moved on to a second and third LOT, respectively. The average treatment duration decreased across LOTs, from 3.8 (SD 3.1) months in LOT1 to 2.6 (SD 2.4) months in LOT3. Gemcitabine + cisplatin was the most common regimen in LOT1 (44.6%). Total all-cause mean healthcare costs PPPM increased after LOT1 (mean $21,517, $29,721, and $28,557, for LOT1, LOT2, and LOT3, respectively) and the majority (71.2%) were related to BTCs. Of people with BTCs linked to the NDI (n = 2168), 66.1% died and average time to death was 11.3 (SD 11.2) months. CONCLUSIONS: These findings, showing a high rate of mortality, a decrease in treatment duration, and an increase in costs as people progress after LOT1, add recent data to current literature highlighting the unmet need for more effective treatment options for people with BTCs.

Real-world Treatment Patterns and Reasons for Therapy Selection in Patients with Advanced Hepatocellular Carcinoma in US Oncology Practices.

BACKGROUND: The treatment landscape for advanced hepatocellular carcinoma (aHCC) is rapidly expanding beyond tyrosine kinase inhibitors (TKIs) in the first-line (1L) setting, with multiple TKIs and immune-checkpoint inhibitors (ICIs) now being evaluated in combination. Real-world evidence describing current treatment patterns and reasons for 1L and 2L treatment selection in aHCC is sparse. PATIENTS AND METHODS: A retrospective cohort study with a cross-sectional survey element was conducted using Cardinal Health's Oncology Provider Extended Network. U.S. medical oncologists identified adult aHCC patients initiating 1L systemic therapy between January 1, 2017 and July 31, 2019 and abstracted data from patient medical records. Data included provider characteristics, patient demographics and clinical characteristics, treatment regimens, and physician rationale for treatment regimen choice. RESULTS: A total of 44 medical oncologists provided data on 284 aHCC patients. The median age at 1L initiation was 61.5 years, and the majority were male (78%) and white (66%). Nearly half (47%) initiated 1L treatment in 2019, 34% were ECOG performance status 2+, and 63% were Child-Pugh Class B/C. Among the 284 aHCC patients, TKIs were used by 94% of patients in the 1L setting, comprised predominantly of sorafenib (54%) and lenvatinib (38%). ICIs were most common among the 90 patients (66%) who received 2L treatment. CONCLUSION: In the community-oncology practice setting, nearly all aHCC patients received sorafenib or lenvatinib in the 1L setting, while the majority of patients received an ICI in the 2L setting. With recent ICI approvals in aHCC, this marks the beginning of an increased use of ICIs in the 1L setting.

Patient and Caregiver Preferences for First-Line Treatments of Metastatic Non-Small Cell Lung Cancer: A Discrete Choice Experiment.

PURPOSE: The approval of immune checkpoint inhibitors for metastatic non-small-cell lung carcinomas (mNSCLC) treatment has presented more care options. Therefore, it is important to identify the benefit-risk trade-offs patients and caregivers are willing to make among potential treatment options. This study quantified the preferences of patients and caregivers for attributes of mNSCLC treatment. METHODS: Patients with mNSCLC and caregivers completed an online survey assessing preferences using a discrete choice experiment. Respondents chose between hypothetical treatment profiles, with varying levels for 7 attributes associated with first-line treatment, including overall survival (OS), progression-free survival, select adverse events (AEs), and regimen (caregivers). Hierarchical Bayesian modeling was used to estimate attribute-level preference weights. RESULTS: Patients (n = 308) and caregivers (n = 166) most valued increasing OS from 11 to 30 months, followed by decreasing the risk of a serious AE (grade 3/4) that may lead to hospitalization from 70% to 18%. These attributes were over twice as important to both sets of respondents as the other attributes measured. Patients and caregivers would accept increases in the risks of a serious AE (grade 3/4) from 18% to 70% and all grades nausea from 10% to 69% if OS increased by 16.8 and 4.0 months, respectively. The least valued attributes were all grades of pneumonitis (patients) and all grades of skin rash (caregivers). CONCLUSION: Patients and caregivers are willing to make trade-offs between efficacy and toxicity and may require up to 1.5 years of increased OS to accept a higher risk of AEs. These results can provide guidance to oncologists when engaging in shared-decision making discussions.

Healthcare costs related to adverse events in hepatocellular carcinoma treatment: A retrospective observational claims study.

BACKGROUND: Hepatocellular carcinoma (HCC) is an aggressive form of liver cancer with increasing incidence and mortality worldwide. For metastatic disease, systemic treatment is recommended. In addition to tumor characteristics, adverse events (AEs) may influence regimen choice. AIM: To analyze healthcare burden among patients with advanced HCC, by treatment type and AEs observed. METHODS: Included were adult commercial and Medicare Advantage enrollees with ≥2 non-diagnostic claims coded for HCC (the first setting the index date); ≥1 claim for systemic treatment of advanced/metastatic HCC; and continuous enrollment for a 6-month pre-index baseline period to ≥1 month post-index (follow-up). Patients were excluded by lack of systemic treatment; incomplete demographic information; pregnancy, liver transplant, other cancers during baseline or clinical trial participation. We describe patient characteristics, common AEs, overall survival, and healthcare burden in 2017 USD up to 12 months after initiation of tyrosine kinase inhibitor (TKI) monotherapy; immune checkpoint inhibitor (ICI) monotherapy; or FOLFOX combination therapy. RESULTS: The analytic sample consisted of 322 patients (median age 65.8 years, 76% male) who had 12 months' (unless death occurred prior) available follow-up, with median follow-up of 9 months. Among these, 241 (75%) had TKI monotherapy, 23 (7%) had ICI monotherapy, and 58 had FOLFOX (18%) first-line treatment. Overall, patients had a high burden of AEs (mean 3.2), with the most prevalent being pain (75%), infection (39%), ascites (34%), and bleeding (29%). After adjusting for covariates, infection ($50 374), fever ($47 443), and diarrhea ($29 912) imposed the highest incremental annual costs versus patients without the AE. Up to 90% of costs were attributable to inpatient admissions, with 56% to 60% involving intensive care. Median 1-year survival was 32%. CONCLUSIONS: This real-world study demonstrated AE burden in alignment with previous clinical studies. Regardless of regimen used, AEs are associated with substantial healthcare costs due to inpatient care.

Management of hepatocellular carcinoma from diagnosis in routine clinical practice.

Aim: To assess real-world management of patients diagnosed with hepatocellular carcinoma (HCC) within an integrated delivery network. Materials & methods: A retrospective cohort analysis of adults newly diagnosed with HCC from January 2014 to March 2019. Overall survival and treatment journey were assessed over the entire available follow-up period per patient. Results: Of the 462 patients, 85% had ≥1 treatment. The 24-month overall survival rate (95% CI) from first treatment was 77% (72-82%). Majority of Child-Pugh class A (71%) and B (60%) patients received locoregional therapy first. Half (53.6%) of the patients with liver transplantation first were Child-Pugh class C patients. Sorafenib was the predominant systemic therapy. Conclusion: This integrated delivery network data analysis offers a comprehensive insight into the real-world management of HCC.

Clinical Characteristics, Treatment Patterns, and Healthcare Costs and Utilization for Hepatocellular Carcinoma (HCC) Patients Treated at a Large Referral Center in Washington State 2007-2018.

INTRODUCTION: Though the treatment landscape for hepatocellular carcinoma (HCC) has evolved significantly with the refinement of liver-directed therapy techniques and the introduction of new drugs, few studies have investigated the impact of the changing treatment landscape on lifetime treatment costs, particularly in Barcelona Clinic Liver Cancer (BCLC) stage C disease. We sought to investigate real-world clinical characteristics, treatment patterns, and healthcare costs in a cohort of HCC patients treated at a single high-volume institution in Washington (WA) state. METHODS: We conducted a retrospective cohort study of patients diagnosed with HCC between 2007 and 2018 using abstracted electronic medical record (EMR) data linked to cancer registry data and health claims from commercial plans, Medicare, and Medicaid. We described clinical and treatment characteristics, including BCLC stage and Child Pugh score. We investigated median survival and mean lifetime treatment costs by BCLC stage using Kaplan-Meier cost estimator methods. A multivariate Cox proportional hazards model was used to investigate factors associated with overall survival. RESULTS: The final cohort included 215 patients, the majority of whom were white (71%), male (68%), and with underlying hepatitis C (61%). Mean per patient lifetime costs were highest in BCLC A and BCLC C patients. Mean lifetime costs in BCLC A patients ($292,134) was driven by surgery, hospital, pharmacy, imaging, and outpatient costs. Chemotherapy costs were highest in BCLC C patients, though not the predominant area of spending. Median survival was highest in patients with BCLC 0 and A disease; BCLC stage C and higher area deprivation index (ADI) were associated with poorer survival. CONCLUSION: In a cohort of WA state HCC patients, mean lifetime costs were highest in patients with BCLC A disease, attributable to surgery and hospital costs. As increased utilization of newer and less toxic therapies improves survival in BCLC C patients, mean lifetime costs in this group may also rise.

Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US.

IMPORTANCE: Updated estimates of non-small cell lung cancer (NSCLC) in the US are needed. OBJECTIVE: To calculate the most recent epidemiologic estimates of NSCLC in the US. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional epidemiological analysis used the most recently released data from US cancer registries. The population-based US Cancer Statistics (USCS) database (2010-2017), comprised of the Surveillance, Epidemiology, and End Results (SEER) program and the National Program of Cancer Registries (NPCR) (collectively, SEER-NPCR) provided the NSCLC incidence estimate. The SEER-18 database provided data for incidence, prevalence, survival, and initial treatment by NSCLC stage. Adults aged 18 years or older diagnosed with NSCLC identified by International Classification of Diseases for Oncology, Third Edition, morphology codes were included. MAIN OUTCOMES AND MEASURES: Annual age-adjusted NSCLC incidence per 100 000 persons; annual prevalence per 100 000 persons; survival rate; initial treatment. Due to database release delays, incidence data were available through 2017, and other parameters through 2016. The analysis was conducted from June 2020 to July 2020. RESULTS: There were 1.28 million new NSCLC cases recorded during 2010 to 2017 in the US (SEER-NPCR: 53% male; 67% ≥ 65 years). From 2010 to 2017, NSCLC incidence per 100 000 decreased from 46.4 to 40.9 overall (age <65 years: 15.5 to 13.5; age ≥65 years: 259.9 to 230.0); the incidence of stage II, IIIA, and IIIB NSCLC was stable, and stage IV decreased slightly from 21.7 to 19.6, whereas stage I incidence increased from 10.8 to 13.2. From 2010 to 2016, NSCLC prevalence per 100 000 increased from 175.3 to 198.3 (nationwide projection of SEER-18); prevalence increased among younger patients (77.5 to 87.9) but decreased among older patients (825.1 to 812.4). Period survival analysis found that 26.4% of patients survived 5 years, which is higher than previously reported. The proportion of stage I NSCLC treated with radiation as single initial treatment rose markedly from 14.7% in 2010 to 25.7% in 2016. Patients with stage IV NSCLC aged 65 years or older were most likely to be untreated (38.3%). CONCLUSIONS AND RELEVANCE: The findings of this cross-sectional epidemiological analysis suggest that the increased incidence of stage I NSCLC at diagnosis likely reflected improved evaluation of incidental nodules. A smaller proportion of patients aged 65 years or older with stage IV NSCLC were treated. Earlier detection and availability of effective treatments may underlie increased overall NSCLC prevalence, and higher than previously reported survival.

Locoregional therapy patterns and healthcare economic burden of patients with hepatocellular carcinoma in the USA.

AIM: To examine the locoregional therapy (LRT) patterns and the healthcare economic burden of patients with hepatocellular carcinoma (HCC) in the USA. PATIENTS & METHODS: Patients with newly diagnosed HCC were identified from the MarketScan® databases (1 July 2015-31 May 2018). The LRTs received and all-cause and HCC-related healthcare costs were measured. RESULTS: Among 2101 patients with HCC, most received embolization therapy as their first LRT treatment (57.8%, n = 1215); 17.1% (n = 360) received ablative therapy and 8.7% (n = 182) radiation therapy; 16.4% (n = 344) received multiple LRTs. After patients received their first LRT treatment, total all-cause healthcare costs averaged $20,316 per patient per month; 70.7% ($14,359) were HCC related. CONCLUSION: Among newly diagnosed HCC patients treated with LRT in the USA, the economic burden is high.

Chemoradiation treatment patterns among United States Veteran Health Administration patients with unresectable stage III non-small cell lung cancer.

BACKGROUND: The Veterans Health Administration (VHA) is the largest integrated health care system in the United States (US). Among VHA patients, the rate of use of concurrent chemoradiation therapy (CCRT) among those with unresectable, stage III non-small cell lung cancer (NSCLC) is unknown. The objective was to report recent CCRT treatment patterns in VHA patients and identify characteristics associated with receipt of CCRT. METHODS: Using Department of Veteran Affairs (VA) Cancer Registry System data linked to VA electronic medical records, we determined rates of CCRT, sequential CRT (SCRT), radiation therapy (RT) only, chemotherapy (CT) only, and neither treatment. RESULTS: Among 4054 VHA patients who met study criteria, CCRT rates slightly increased from 44 to 50% between 2013 and 2017. Factors associated with decreased odds of CCRT receipt compared to any other treatment included increasing age (adjusted odds ratio [aOR] per 10 years = 0.67; 95% CI: 0.60-0.76) and Charlson-Deyo comorbidity score (aOR = 0.94; 95% CI: 0.91-0.97). White race was associated with increased odds of CCRT receipt (aOR = 1.24; 95% CI: 1.004-1.53). In a chart review sample of 200 patients, less than half (n = 85) had a documented reason for not receiving CCRT. Among these, 29% declined treatment, and 71% did not receive CCRT due to "not being a candidate" for reasons related to frailty or lung nodules being too far apart for radiation therapy. CONCLUSIONS: CCRT rates among VHA patients with unresectable, stage III NSCLC slightly increased from 2013 to 2017; however in 2017, only half were receiving CCRT. Older patients and those with multiple comorbidities were less likely to receive CCRT and even when controlling for these factors, non-white patients were less likely to receive CCRT.

Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective.

BACKGROUND: Durvalumab was approved by the FDA in February 2018 for patients with unresectable stage III NSCLC that has not progressed after platinum-based concurrent chemoradiotherapy (cCRT), and this regimen is the current standard of care. The objective of this study was to examine the cost-effectiveness of durvalumab following cCRT versus cCRT alone in patients with locally advanced, unresectable stage III NSCLC. METHODS: A 3-state semi-Markov model was used. Modeling was performed in a US healthcare setting from Medicare and commercial payer perspectives over a 30-year time horizon. Clinical efficacy (progression-free and post progression survival) and utility inputs were based on PACIFIC study data (ClinicalTrials.gov identifier: NCT02125461; data cutoff March 22, 2018). Overall survival extrapolation was validated using overall survival data from a later data cutoff (January 31, 2019). The main outcome was the incremental cost-effectiveness ratio (ICER) of durvalumab following cCRT versus cCRT alone, calculated as the difference in total costs between treatment strategies per quality-adjusted life-year (QALY) gained. RESULTS: In the base-case analysis, durvalumab following cCRT was cost-effective versus cCRT alone from Medicare and commercial insurance perspectives, with ICERs of $55,285 and $61,111, respectively, per QALY gained. Durvalumab was thus considered cost-effective at the $100,000 willingness-to-pay (WTP) threshold. Sensitivity analyses revealed the model was particularly affected by variables associated with subsequent treatment, although no tested variable increased the ICER above the WTP threshold. Scenario analyses showed the model was most sensitive to assumptions regarding time horizon, treatment effect duration, choice of fitted progression-free survival curve, subsequent immunotherapy treatment duration, and use of a partitioned survival model structure. CONCLUSIONS: In a US healthcare setting, durvalumab was cost-effective compared with cCRT alone, further supporting the adoption of durvalumab following cCRT as the new standard of care in patients with unresectable stage III NSCLC.

Long-term survival trends in patients with unresectable stage III non-small cell lung cancer receiving chemotherapy and radiation therapy: a SEER cancer registry analysis.

BACKGROUND: To evaluate the value of new therapies for non-small cell lung cancer (NSCLC), it is necessary to understand overall survival (OS) rates associated with previous standard therapies and how these rates have evolved over time. METHODS: We retrospectively analyzed data from patients enrolled in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. Adults with unresectable, stage III NSCLC treated with chemoradiotherapy were grouped by diagnosis year (2000-2002; 2003-2005; 2006-2008; 2009-2011; 2012-2013). The primary endpoint was OS (data cut-off, December 31, 2014), estimated using the Kaplan-Meier estimator. Temporal survival-trend significance was tested using a two-sided log-rank trend test. RESULTS: Of 12,865 eligible patients, 59.1% were male, 59.9% had stage IIIB disease, and 62.7% had non-squamous histology. Median age at diagnosis was 67 years. Overall, 10,899 (84.7%) patients died and 1966 (15.3%) were censored/lost to follow-up. Median follow-up (95% confidence interval [CI]) was 80 (77-82) months; median OS (95% CI) was 15 (15-16) months; 1- and 3-year survival probabilities (95% CI) were 57.7% (56.9-58.6) and 24.1% (23.3-24.8), respectively. Stratification by diagnosis year showed consistent improvements in survival over time (p < 0.0001 for trend). Median OS was 12, 14, 15, 18, and 19 months in successive cohorts. CONCLUSIONS: OS in patients diagnosed with unresectable, stage III NSCLC between 2003 and 2013 was consistent with that from clinical studies of sequential/concurrent chemoradiotherapy. Despite improvement over time, median OS was < 2 years and mortality remained high during the first year post-diagnosis.

Real-world treatment patterns for patients with metastatic head and neck squamous cell carcinoma treated with immuno-oncology therapy.

BACKGROUND: Real-world use of immuno-oncology (IO) therapies (nivolumab and pembrolizumab) in metastatic head and neck squamous cell carcinoma (mHNSCC) has not been well studied. METHODS: mHNSCC patients treated with an IO therapy were identified from a large US claims database from 2016 to 2017. Treatment patterns before and after initiation of IO therapy (index date) were described. RESULTS: Among 416 mHNSCC patients, 85% had ≥1 regimen prior to IO therapy. Ninety-seven percent of patients initiated IO as monotherapy and 3% initiated IO combined with another systemic treatment. One hundred seventeen (28%) patients had a subsequent regimen, usually chemotherapy (n = 58, 50%) or IO monotherapy (n = 27, 23%), of which 22 patients restarted the same IO therapy and 5 switched to another IO monotherapy. CONCLUSION: The majority of mHNSCC patients initiated IO as a monotherapy. Approximately half of patients with a subsequent regimen received chemotherapy and one-fourth received IO monotherapy.

Real-world incidence and cost of pneumonitis post-chemoradiotherapy for Stage III non-small-cell lung cancer.

Aim: To estimate the real-world incidence and timing of radiation pneumonitis following chemoradiotherapy for Stage III non-small-cell lung cancer and compare costs between patients with and without radiation pneumonitis. Methods: Retrospective analysis using the Symphony Health Integrated Dataverse. Results: Pneumonitis incidence was 12.4% with a 177-day mean time to onset. Patients with versus without pneumonitis were more frequently admitted to the hospital (33.8 vs 19.2%, p < 0.0001) and seen in the emergency room (51.9 vs 35.8%, p < 0.0001) and had higher mean total healthcare costs (US$4251 vs US$3969 per-patient per-month; p = 0.0163). Conclusion: Although pneumonitis significantly increased healthcare resource utilization and costs in chemoradiotherapy-treated Stage III non-small-cell lung cancer, the per-patient per-month differential was <10%. Such financial assessments are critical for cost-benefit analysis.

Adverse events, resource use, and economic burden associated with mantle cell lymphoma: a real-world assessment of privately insured patients in the United States.

In view of recent therapeutic advances in mantle cell lymphoma (MCL), the aim of this retrospective cohort analysis was to assess treatment patterns, adverse events (AEs), resource utilization, and health care costs in patients with MCL in a US-based commercial claims database. A total of 783 patients with MCL (median age = 65 years) were selected. Among patients receiving systemic therapy (n = 457), the most common treatment regimens were bendamustine/rituximab (BR) (41.1%), rituximab/cyclophosphamide/doxorubicin/vincristine (RCHOP) (26.7%), rituximab monotherapy (20.4%), and ibrutinib monotherapy (14.2%). Mean monthly costs during treatments with BR, RCHOP, rituximab, and ibrutinib were $12,958, $24,719, $13,153, and $21,690, respectively. Mean monthly cost during follow-up was $13,650 among patients with ≥6 AEs versus $5131 among those without AEs. The costs of MCL varied considerably by treatment regimen and care setting. The overall economic burden of managing patients with MCL can be substantially affected by costs associated with managing AEs occurring during treatment.

An Approach to Identify Delivery of Palliative Radiation Therapy Using Health Care Claims Data: A Proof-of-Concept Application of a Visual Analytics Tool.

PURPOSE: There is limited information on the use of data visualization tools for health services research applications. We provide a proof-of-concept application that focuses on claims-based measures of palliative radiation therapy. We investigate whether a guided, data-driven investigation contributes information for subsequent statistical analysis and algorithm development. METHODS: This retrospective cohort study used linked registry and claims data on men who were diagnosed with stage IV M0 or stage IV M1b prostate cancer between 2005 and 2009, with associated claims from 2005 through 2010, and receiving radiation therapy. Preprocessing of data was accomplished by using EventFlow software to investigate longitudinal patterns in claims for radiation therapy in the 13 months after cancer diagnosis. Guided by results from EventFlow, we developed descriptive statistics to investigate the length of radiation therapy, use of bone metastasis coding, and mortality between M1b and M0 patients. RESULTS: A total of 1,151 patients met the inclusion criteria. Taking advantage of the novel aggregation capability of EventFlow, we observed differences in the length of radiation therapy and the use of bone metastasis coding between men with (M1b) and without (M0) a diagnosis of bone metastasis. Seventy-nine percent of M1b patients received radiation for a duration ≤ 4 weeks, which suggested palliative radiation (to the bone). Seventy-six percent of M0 patients received radiation for ≥ 6 weeks, which suggested radiation to the prostate. Mortality was higher among those who received a shorter duration of radiation therapy compared with those who received a longer duration of therapy. CONCLUSION: Use of EventFlow, followed by statistical analysis of the linked registry and claims data, identified useful components of a claims-based measure of radiation to the bone.

Real-world effectiveness of brentuximab vedotin versus physicians' choice chemotherapy in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplantation in the United Kingdom and Germany.

This retrospective study compared effectiveness of (brentuximab vedotin) BV to other chemotherapies in patients with rrHL following an autologous stem cell transplant (ASCT). Data originated from a medical chart review of patients treated in real-world clinical settings at 50 sites in the United Kingdom and Germany. Inverse probability of treatment weights based on propensity scores were used to adjust for differences in baseline characteristics between treatment groups. Among 312 rrHL patients included, 196 received BV and 116 received physicians' choice chemotherapy. Median PFS was significantly longer (27.0 months vs. 13.4 months; p = .0144) and 12-month OS survival greater (78.1% vs. 65.9%; p = .0129) with BV compared to chemotherapy. Documented adverse events included leukopenia (12.8%) and peripheral neuropathy (8.7%) for BV and leukopenia (12.1%), anemia (5.2%) and diarrhea (5.2%) for chemotherapy. In this real-world study, rrHL patients treated for relapse after ASCT with BV had longer median PFS and 12-month OS than patients receiving chemotherapy.

Brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma who are Ineligible for autologous stem cell transplant: A Germany and United Kingdom retrospective study.

OBJECTIVE: Brentuximab vedotin (BV) is an anti-CD30 antibody-drug conjugate licensed for the treatment of relapsed/refractory Hodgkin lymphoma (rrHL) following autologous stem cell transplant (ASCT) or at least two prior therapies when ASCT or multiagent chemotherapy is not an option. The objective of this study was to describe real-world outcomes with BV in patients with rrHL considered ASCT ineligible or who refuse ASCT. METHODS: This was a retrospective medical chart review study that enrolled patients ≥18 years old who were initially diagnosed with HL between January 1, 2008 and June 30, 2014, considered ASCT ineligible, and treated in routine care with BV for progressive disease after multidrug chemotherapy regimens. Clinical outcomes included best response to treatment, progression-free survival (PFS), overall survival (OS), and adverse events. RESULTS: A total of 136 patients were included, with a median age of 70 years at initial HL diagnosis. The most common reasons for ASCT ineligibility were comorbidities (74%) and age (57%). Overall response rate was 74%, and PFS and OS were 15.1 and 17.8 months, respectively. Peripheral neuropathy was observed in 9.6% of patients. CONCLUSION: The results of this study provide real-world evidence on the feasibility and effectiveness of BV in elderly or frail ASCT-ineligible patients with rrHL in a real-world setting.

Evaluation of Healthcare Interventions and Big Data: Review of Associated Data Issues.

Although the analysis of 'big data' holds tremendous potential to improve patient care, there remain significant challenges before it can be realized. Accuracy and completeness of data, linkage of disparate data sources, and access to data are areas that require particular focus. This article discusses these areas and shares strategies to promote progress. Improvement in clinical coding, innovative matching methodologies, and investment in data standardization are potential solutions to data validation and linkage problems. Challenges to data access still require significant attention with data ownership, security needs, and costs representing significant barriers to access.

Skeletal-related events and mortality among men diagnosed with advanced prostate cancer: The impact of alternative measures of radiation to the bone.

PURPOSE/OBJECTIVE(S): Skeletal-related events (SREs), which include radiation to the bone (RtB), can occur among patients with bone metastasis (BM). There is a recognized potential for misclassification of RtB when using claims data. We compared alternative measures of RtB to better understand their impact on SRE prevalence and SRE-related mortality. METHODS AND MATERIALS: We analyzed data for stage IV prostate cancer (PCa) cases identified between 2005 and 2009 in the Surveillance, Epidemiology, and End Results registry linked with Medicare claims. We created two measures of RtB: 1) a literature-based measure requiring the presence of a prior claim with a BM code; 2) a new measure requiring either that the BM code coincided with the radiation episode or that the duration of the radiation episode was less than or equal to 4 weeks. We estimated adjusted hazard ratios of an SRE using both measures among stratified samples: no metastasis (M0), metastasis to bone (M1b) and other sites (M1c). RESULTS: The study sample included 5,074 men with stage IV PCa (median age 77 years), of whom 22% had M0, 54% had M1b, and 24% had M1c disease at time of PCa diagnosis. Based on Approaches 1 and 2, the proportion with probable RtB was 5% and 8% among M0, 30% and 30% among M1b, and 25% and 27% among M1c patients. Among M0 patients, the adjusted hazard ratio (AHR) associated with an SRE was 1.27 when using Approach 1 (95% confidence interval, CI: 0.95-1.7) and 1.49 when using Approach 2 (95% CI: 1.14-1.96). However, the impact of SREs on mortality did not differ between both approaches among M1b and M1c patients. CONCLUSION: We found that alternative measures used to define RtB as SRE in claims data impact conclusions regarding the effect of SREs on mortality among M0 but not M1 patients.