Real-world outcomes among patients with advanced or metastatic biliary tract cancers initiating second-line treatment.

BACKGROUND: Limited data are available regarding second-line (2 L) treatment for advanced or metastatic biliary tract cancers (BTC) in the US real-world setting. This study explores the rapidly evolving and growing treatment landscape in the 2 L setting for advanced or metastatic BTC with a large cohort of patients treated in a community oncology setting. METHODS: Adult patients with BTC initiating 2 L treatment after a platinum-containing first-line between 1/1/10- and 6/30/19 were identified from the US Oncology Network electronic healthcare record database and followed through 12/31/19. Baseline patient and treatment characteristics were analyzed descriptively, including overall response rate (ORR) in the real-world clinical setting. Kaplan-Meier methods were used to measure duration of response, progression-free survival (PFS), and overall survival (OS). RESULTS: The overall population (N = 160) included 74 patients (46.3%) with intrahepatic cholangiocarcinoma, 41 (25.6%) with extrahepatic cholangiocarcinoma, and 45 (28.1%) with gallbladder cancer. Thirty unique 2 L regimens were recorded for the study population, with folinic acid, fluorouracil and oxaliplatin (FOLFOX, 34.4%) and capecitabine monotherapy (20.0%) being the most common. ORR was 7.5% (95% CI, 3.9%-12.7%). From 2 L initiation, median PFS was 2.8 months (95% CI, 2.4-3.3 months), and median OS was 5.2 months (95% CI, 4.2-6.7 months). CONCLUSION: Results from this study provide real-world evidence that although patients treated in the community oncology setting receive a wide variety of 2 L treatments, the regimens are consistent with those recommended by guidelines. Although responses are observed with 2 L treatment, duration is brief and associated with poor OS in patients with advanced or metastatic disease.

Costs associated with cardiovascular events in patients with hypertension in US managed care settings.

Study quantified incremental cost of cardiovascular (CV) events in 6 high-risk and compelling indication subgroups: post-myocardial infarction (MI), diabetes, diabetic nephropathy, elderly, chronic kidney disease, and prior stroke. Based on claims data from privately insured individuals with 2+ hypertension (HTN) diagnoses in 2004-2006, we estimated regression-adjusted per-member-per-month healthcare costs after CVE. Costs were compared between patients with and without a CV events, and before and after CV events in each subgroup. The following CVevents were studied: acute MI, acute coronary syndrome, angina, ventricular arrhythmia, atrial arrhythmia, heart failure, coronary artery disease, left ventricular hypertrophy, stroke, and sinus tachycardia. Of 1,598,890 HTN patients, 510,118 had >/=1 CV event. Compared with controls, healthcare costs among patients with events were significantly greater across all cost components (inpatient, outpatient, and prescription drug). Acute MI and congestive heart failure generally had the largest incremental total healthcare costs. First-quarter post-event costs were attributable to inpatient costs. CV events are costly sequelae of hypertension in high-risk and CI subgroups.