Introductionnab-Paclitaxel plus gemcitabine (nab-P + G) and FOLFIRINOX (FFX) are among the most common first-line (1L) therapies for metastatic adenocarcinoma of the pancreas (MPAC), but real-world data on their comparative effectiveness are limited.MethodsThis retrospective cohort study compared the efficacy and safety of 1L nab-P + G versus FFX, overall and under specific treatment sequences. Medical records were reviewed by 215 US physicians who provided information on MPAC patients who initiated 1L therapy with nab-P + G or FFX between April 1, 2015 and December 31, 2015. Study outcomes were overall survival (OS) and tolerability. OS was compared using Kaplan–Meier curves and adjusted Cox proportional hazards models.ResultsIn total, 654 medical records were reviewed, including those of 337 and 317 patients initiated on nab-P + G and FFX as 1L MPAC therapy, respectively. nab-P + G-initiated patients were older, less likely to have ECOG ≤ 1, and had more comorbidities than FFX-initiated patients. Median OS (mOS) was 12.1 and 13.8 months for nab-P + G- and FFX-initiated patients, respectively (HR = 0.99, P = 0.96). Among patients with ECOG ≤ 1, mOS was 14.1 and 13.7 months, respectively (HR = 1.00, P = 0.99). Among patients with 1L nab-P + G and FFX, 36.1% and 41.3% received 2L therapy and experienced mOS of 16.3 and 16.6 months, respectively (HR = 1.04, P = 0.76). The rates of diarrhea, fatigue, mucositis, and nausea and vomiting were significantly higher in the FFX than nab-P + G cohort.ConclusionThe real-world survival was similar between patients receiving 1L nab-P + G or FFX both overall and among patients who received active 2L treatments. In addition, nab-P + G was associated with significantly lower rates of common AEs compared with FFX.FundingCelgene.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0784-z) contains supplementary material, which is available to authorized users.
IntroductionThere are limited data on the cost of hyperkalemia.MethodsThis retrospective analysis of the Truven MarketScan claims database assessed the economic burden of hyperkalemia among selected adult patients with hyperkalemia and matched controls.ResultsA total of 39,626 cases (patients with hyperkalemia) were matched to 39,626 controls (patients without hyperkalemia) based on age, dialysis, chronic kidney disease (CKD) stage, heart failure, and renin-angiotensin aldosterone system inhibitor use. Compared with controls, cases incurred $4128 (95% confidence interval [CI] $3893–$4363) higher 30-day total health care costs ($5994 vs. $1865) and $15,983 (95% CI $15,026–$16,940) higher 1-year costs ($31,844 vs. $15,861). Among 11,221 matched pairs of patients with CKD and/or heart failure, cases incurred $5553 (95% CI $5059–$6047) higher 30-day total health care costs ($8165 vs. $2612) and $24,133 (95% CI $21,748–$26,518) higher 1-year costs ($48,994 vs. $24,861) than controls. The multivariable adjusted 1-year total health care cost difference was $15,606 (95% CI $14,648–$16,576) among all patients and $25,156 (95% CI $23,529–$26,757) among patients with CKD and/or heart failure. Cases had higher resource utilization rates including inpatient admissions (30-day: 0.14 vs. 0.03; 1-year: 0.44 vs. 0.19), outpatient visits (30-day: 3.33 vs. 2.28; 1-year: 26.58 vs. 18.53), and emergency department visits (30-day: 0.16 vs. 0.06; 1-year: 0.86 vs. 0.50) (all P < 0.001). When hospitalized, cases stayed 1.51 days (95% CI 1.22–1.80) longer and were 40% more likely to be readmitted.ConclusionThese data indicate that hyperkalemia is associated with a significant economic burden on afflicted patients and the health care system.
Xie (2019) Clinical burden and healthcare resource utilization among patients with chronic hypoparathyroidism, overall and by adequately vs not adequately controlled disease: a multi-country chart review,
PurposeShort bowel syndrome (SBS) is a serious rare disorder that is usually managed with parenteral nutrition. Central venous catheter (CVC)-related complications are known to occur, but their incidence rates (IRs) in Japan are unknown. The aim of this study was to estimate the incidence of complications in Japanese patients with CVCs, including patients with SBS using CVCs.Patients and methodsA retrospective cohort study in 64,817 patients with CVCs, including 81 patients with SBS, between April 2008 and October 2016 using a claims database in Japan was conducted. IRs of complications were calculated as total events divided by total catheter-days among all patients with CVCs and among patients with SBS.ResultsThe majority (>90%) of patients in the CVC and SBS cohorts were ≥18 years old. Overall, IRs of any type of complication were numerically higher in patients with SBS compared with all patients with CVCs (2.68 vs 1.95 cases per 1,000 catheter-days, respectively). Among patients with SBS, septicemia, infection, and inflammatory reaction were the only complications observed. The complications with the highest incidence were catheter-related bloodstream infections (CRBSIs) in both the overall CVC cohort and the SBS cohort with IRs of 1.35 and 2.68 cases per 1,000 catheter-days, respectively. The IR of any CVC-related complication was numerically higher in patients with SBS with cancer vs without cancer (3.44 vs 1.86 cases per 1,000 catheter-days, respectively).ConclusionOur study quantifies the incidence of complications in patients with CVCs, including those with SBS, in Japan.
BackgroundPreference valuations of health status are essential in health technology and economic appraisal. This study estimated utilities for treatment-related health states of acute myeloid leukemia (AML) and disutilities of severe adverse events (SAEs) using a representative sample of adults from the general population in the United States (US).MethodsTreatment-related AML health states, defined based on literature and interviews with clinicians, included complete remission (CR), no CR, relapse, stem cell transplant (SCT), and post SCT short-term recovery. Six attributes with varying levels, including fever, lack of energy, problems with daily function, anxiety/depression, blood transfusions, and hospitalization, were used to define health states. An online survey using discrete choice experiment methodology was designed to capture preferences for health status scenarios including the identified attributes and key grade 3/4 chemotherapy-related SAEs. Health state utilities and SAE disutilities were generated from a conditional logistic regression with generalized estimating equations.ResultsOf the 300 survey participants, the demographic distributions were within a 3% margin of those in the 2010 US Census. CR had the highest utility value (0.875), followed by post-SCT short-term recovery (0.398), relapse (0.355), no CR (0.262), and SCT (0.158). Of the SAEs, serious infection had the highest decline in utility (0.218), followed by severe diarrhea (0.176), abnormally low blood cell counts (0.100), and severe redness/skin peeling (0.060).ConclusionsAML and treatments can result in reduced quality of life and impaired ability to perform daily activities. Findings of this study underline the value that society places on treatment-related AML health states and SAEs.
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