Elisabetta Malangone

An adjusted indirect comparison of everolimus and sorafenib therapy in sunitinib-refractory metastatic renal cell carcinoma patients using repeated matched samples

Objective: To date, no trial data exist comparing treatment outcomes for everolimus versus sorafenib. The current analysis indirectly compares the overall survival (OS) benefit of everolimus and sorafenib as second-line treatment options. Research design and methods: A single-arm sorafenib study is selected as a basis to match an everolimus sunitinib-refractory subpopulation of the RECORD-1 trial. Only patients with clear cell histology are included. An adjusted matching approach is taken where 1000 repeated random samples matched to the sorafenib population on risk score distribution are produced, and a 95% CI around the mean of all sampled median OS is generated. Main outcome measures: The main outcome measures include adjusted median OS and progression-free survival. Results: In all, 45 clear cell histology sorafenib patients and 1000 samples of N = 41 sunitinib-refractory everolimus patients are considered for analysis. After adjusted matching, the estimated median OS benefit is 32.7 weeks (95% CI: 22, 64) and 81.5 weeks (95% CI: 78, 86) for sorafenib and everolimus patients, respectively. Conclusion: Results suggest that sunitinib-refractory metastatic renal cell carcinoma patients treated with everolimus may experience significantly improved OS outcomes compared to those treated with sorafenib. However, because this is not a randomized controlled trial, the results should be interpreted as those from an observational study.

A quantitative assessment of patient barriers to insulin

Aim:  To assess diabetes treatment preferences with a focus on patient barriers to insulin treatment.

Real-world treatment patterns in third-line patients with metastatic renal cell carcinoma (mRCC): The changing landscape in the United States.

390 Background: Several targeted therapies (TTs) have become available in mRCC in recent years for first- and second-line use, including sorafenib (So), sunitinib (Su), bevacizumab (Be), temsirolimus (Te), everolimus (Ev), pazopanib (Pa), and most recently, axitinib (Ax). This study aimed to examine the current treatment patterns in mRCC patients who fail second-line therapy. METHODS Data were obtained from a large national U.S. claims database for patients with an RCC diagnosis and at least 3 lines of TT between January 1, 2004, and June 30, 2011. Patients were age 18 or older at diagnosis with at least 3 months of follow-up prior to initiation of third-line therapy. Patient characteristics and treatment patterns were examined for the final population. RESULTS A total of 812 mRCC patients initiated third-line therapy with So, Su, Be, Te, Ev, or Pa. The sample was majority male (70%) with a mean age of 60 years (SD=10.7). A large proportion of patients were from the South (42%), and the majority of the sample (72%) had commercial insurance. The most common sites of metastases at any time were lung (71%) and bone (52%). The most common first-line agent was Su (52%) and the most common second-line single agents were Te (25%) and Ev (17%). The most frequently used single-agents in third-line were Te (21%) and Ev (19%). Third-line treatment choice differed by year; Te (51%) was most common in 2007 while Ev and Pa were most common between 2009 and 2011. Additionally, the most frequently prescribed sequences of single agents were VEGF→mTOR→VEGF (25%), VEGF→mTOR→mTOR (25%), and VEGF→VEGF→mTOR (22%). CONCLUSIONS The results demonstrate a rapidly changing therapeutic scenario for mRCC in the United States. The number of targeted therapies prescribed in third-line increased from 1 in 2006 to 4 in 2007 and 6 in 2011. This evolution of third-line therapies is possibly due to physicians adapting their practice with the advent of novel mRCC treatment options. These results are in line with the NCCN guidelines, with VEGF and mTOR being the most commonly prescribed first- and second-line single agents, respectively.

Treatment sequencing patterns of novel agents in patients with prostate cancer.

296 Background: The National Comprehensive Cancer Network (NCCN) guidelines recommend chemotherapy, immunotherapy or anti-androgen therapies for the treatment of advanced castration-resistant prostate cancer (CRPC). This study evaluated treatment sequencing of recently approved agents for CRPC [abiraterone (ABI), enzalutamide (ENZ), docetaxel (DOC), cabazitaxel (CAB), or sipuleucel-T (SIP)] among men with PC. METHODS This retrospective, observational study evaluated adult men with PC in the MarketScan Oncology EMR database, which includes data from over 900 contributing oncologists from over 100 community practices. Inclusion required a diagnosis of PC (ICD-9-CM diagnosis code 185) from 07/01/2011-03/31/2014, no treatment with ABI, ENZ, DOC, CAB, or SIP prior to 09/01/2012, no other primary cancers, and six months of medical record history prior to index date. The index date was the date of first prescription of ABI, ENZ, DOC, CAB or SIP between 09/01/2012 and 03/31/2014. First-, second- and subsequent-line treatments were evaluated prior to end of data availability or end of study. RESULTS In total, 812 PC patients were identified; mean age was 75 years and 68% had recorded metastasis. A single line of therapy was observed for 544 patients (67%). ABI was the most common first-line treatment (443; 55%), followed by DOC (167; 21%), ENZ (113; 14%), SIP (82; 10%) and CAB (7; 1%). A second line of therapy occurred in 268 patients (33%) and third line in 8%. The table below describes first-line and the two most common second-line therapies for those moving on to second-line. CONCLUSIONS Of the five agents of interest, ABI was the most commonly prescribed first-line medication for advanced PC in this patient cohort. First-line DOC was more common than first-line CAB or SIP. Further studies with longer follow-up and other treatments are warranted. [Table: see text].

Healthcare charges in patients with glaucoma who undergo laser trabeculoplasty.

IntroductionThe objective of this study was to assess the impact of laser trabeculoplasty (LTP) on healthcare charges in patients with primary open-angle glaucoma (POAG).MethodsUsing a managed care database (PharMetrics; Watertown, MA, USA), we formed a case-control group nested within a POAG cohort (n=72,412) formed using International Classification of Disease, Ninth Edition (ICD-9) coding data. Cases (n=1145) had LTP (Current Procedural Terminology code: 65855) with ≥1 year of continuous enrollment both prior to, and following LTP index date in PharMetrics from 1998–2005. Using the date of LTP as the index date, controls (n=2290) without LTP were matched to cases on gender, age, and index year in a 2:1 ratio. Cases and controls had ≥6 months of continuous enrollment in PharMetrics prior to receiving a diagnosis of POAG (ICD-9 code: 365.11). One-year total and ophthalmology healthcare charges were calculated in the year pre- and post-index date (excluding charges for LTP at the index date). Conditional logistic regression models and multiple linear regression models determined the impact of LTP on healthcare charges, while controlling for glaucoma duration and other key covariates.ResultsWhile the mean age of cases (60.1±13.1 years) and controls (60.3±13.6 years) was similar (P=0.5589), cases had more comorbid systemic conditions (P<0.05) and underwent more cataract surgery in the year after index date (4.4% vs. 2.1%; P=0.002). In the year after index date, ophthalmology-related charges increased by

PMC3 A NOVEL APPROACH TO MATCHING ADJUSTED INDIRECT COMPARISON ANALYSIS USING COMMON SAS 9.2 PROCEDURES

1364 for cases vs.

Healthcare charges in patients who transition from ocular hypertension to primary open-angle glaucoma based on ophthalmic coding data.

30 for controls (P=0.0003). Total healthcare charges increased by

Real-world practices to prevent venous thromboembolism with pharmacological prophylaxis in US orthopedic surgery patients: an analysis of an integrated healthcare database

5084 for cases and

Real-world treatment patterns in U.S. mRCC patients who fail two lines of targeted therapy.

1594 for controls in the year after index date (P=0.0085). Cases and controls experienced similar increases in ophthalmology-related pharmacy charges from the year pre- to the year post-index date (

Survival outcomes in U.S. patients with metastatic colorectal cancer (mCRC).

26 vs.