Clinical outcomes in pediatric hemodialysis patients in the USA: lessons from CMS’ ESRD CPM Project

48 Background: We assessed real-life clinical outcomes in patients with mCRPC treated in the USA who received sequential first-line (1L)/second-line (2L) NAH (abiraterone/enzalutamide or enzalutamide/abiraterone) or switched to a different mechanism of action (alpha-emitter Ra-223) after progression on 1L NAH. Methods: This was a retrospective study (PHENIX, NCT03896984) of the Flatiron electronic health record database in patients with mCRPC that progressed on 1L NAH and started 2L monotherapy with Ra-223 (n=120) or NAH (n=226) between Jan 2013 and Dec 2018. Patient characteristics, overall survival (OS) from 2L start, and symptomatic skeletal events (SSEs) were analyzed descriptively. Results: The two cohorts were generally similar at 2L start, including similar rates of bone-health agent (BHA) use, but the Ra-223 cohort had a higher incidence of bone-only metastases, shorter duration of 1L NAH, and higher rate of prior SSEs than the 2L NAH cohort (Table). Median treatment duration was 5.6 mo (median 4.5 doses) for Ra-223 and 4.7 mo for 2L NAH. Median OS from 2L start was 10.8 mo for Ra-223 and 11.2 mo for 2L NAH, with 49% and 39%, respectively, receiving subsequent therapy. Among those who received subsequent therapy, the proportion who received subsequent taxane was lower in the Ra-223 cohort (47%) than in the 2L NAH cohort (76%). SSEs were observed after 2L start in 32 patients (27%) on Ra-223 and 49 (22%) on 2L NAH. Conclusions: OS from start of 2L mCRPC treatment was similar for patients who received Ra-223 or alternative NAH in 2L. Slightly more patients received subsequent therapy in the Ra-223 cohort than in the 2L NAH cohort. Patients who received subsequent therapy were more likely to receive chemotherapy in the 2L NAH cohort, which is unsurprising as 2L NAH after 1L NAH is not highly active. Although the prior SSE rate before 2L start was higher in the Ra-223 cohort than in the 2L NAH cohort, and the two cohorts had similar rates of BHA use at 2L start, the rate of SSEs after 2L start was similar in both cohorts. Clinical trial information: NCT03896984. [Table: see text]

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TCT-638 Clinical Outcomes of Hemodialysis Patients With Coronary Artery Disease After Newer Generation Drug-Eluting Stent Implantation

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2018.08.1843 ◽

2018 ◽

Vol 72 (13) ◽

pp. B255

Author(s):

Shota Okuno ◽

Takayuki Ishihara ◽

Mitsutoshi Asai ◽

Osamu Iida ◽

Masaharu Masuda ◽

...

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Clinical Outcomes ◽

Stent Implantation ◽

Hemodialysis Patients ◽

Drug Eluting Stent ◽

Drug Eluting ◽

Artery Disease

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Steroid switching in dystrophinopathy treatment: a US chart review of patient characteristics and clinical outcomes

Journal of Comparative Effectiveness Research ◽

10.2217/cer-2021-0110 ◽

2021 ◽

Author(s):

Jessica R Marden ◽

Claudio Santos ◽

Brian Pfister ◽

Richard Able ◽

Henry Lane ◽

...

Keyword(s):

Muscular Dystrophy ◽

Clinical Outcomes ◽

Clinical Characteristics ◽

Chart Review ◽

Patient Characteristics ◽

Becker Muscular Dystrophy ◽

Slow Disease Progression ◽

Primary Physician ◽

The Usa ◽

The Mean

Aim: To describe reasons for switching from prednisone/prednisolone to deflazacort and associated clinical outcomes among patients with Duchenne and Becker muscular dystrophy (DMD and BMD, respectively) in the USA. Methods: A chart review of patients with DMD (n = 62) or BMD (n = 30) who switched from prednisone to deflazacort (02/2017–12/2018) collected demographic/clinical characteristics, reasons for switching, outcomes and common adverse events. Results: The mean ages at switch were 20.1 (DMD) and 9.2 (BMD) years. The primary physician-reported reasons for switching were ‘to slow disease progression’ (DMD: 83%, BMD: 79%) and ‘tolerability’ (67 and 47%). Switching was ‘very’ or ‘somewhat’ effective at addressing the primary reasons in 90–95% of patients. Conclusion: Physician-reported outcomes were consistent with deflazacort addressing patients' primary reasons for switching.

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The Relationship of a Novel Marker of Inflammation (Neutrophil-to-Lymphocyte Ratio) to Nutritional Status, Diet and Clinical Outcomes in Hemodialysis Patients

10.25148/etd.fidc007708 ◽

2019 ◽

Author(s):

Janet Diaz Martinez

Keyword(s):

Nutritional Status ◽

Clinical Outcomes ◽

Hemodialysis Patients ◽

Neutrophil To Lymphocyte Ratio ◽

Lymphocyte Ratio ◽

Relationship Of ◽

The Relationship

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Real-world clinical outcomes with first-line avelumab in locally advanced/metastatic Merkel cell carcinoma in the USA: SPEAR-Merkel

Future Oncology ◽

10.2217/fon-2020-1250 ◽

2021 ◽

Author(s):

Charles Lance Cowey ◽

Frank X Liu ◽

Ruth Kim ◽

Marley Boyd ◽

Nicole Fulcher ◽

...

Keyword(s):

Cell Carcinoma ◽

Clinical Outcomes ◽

Merkel Cell Carcinoma ◽

Real World ◽

Locally Advanced ◽

Progression Free Survival ◽

Response Rates ◽

Merkel Cell ◽

First Line ◽

The Usa

Aim: To assess clinical outcomes in patients with locally advanced (la) or metastatic (m) Merkel cell carcinoma (MCC) initiating first-line (1L) avelumab in a USA community oncology setting. Materials & methods: Adults with laMCC or mMCC initiating 1L avelumab were identified from The US Oncology Network electronic health record database and chart review. Results: Median overall survival and progression-free survival were not reached in laMCC (n = 9) vs 20.2 and 10.0 months in mMCC (n = 19); response rates were similar (66.7% vs 63.2%). Conclusion: This is the first study to show clinical benefit in patients with laMCC receiving 1L avelumab in a US real-world setting. Response rates in patients with mMCC were consistent with pivotal trials.

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P1515IMPACT OF POLYPHARMACY ON ALL-CAUSE MORTALITY, ALL-CAUSE HOSPITALIZATION AND CARDIOVASCULAR EVENTS IN INITIAL JAPANESE HEMODIALYSIS PATIENTS

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p1515 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Tatsunori Toida ◽

Reiko Toida ◽

Shou Ebihara ◽

Shigehiro Uezono ◽

Hiroyuki Komatsu ◽

...

Keyword(s):

Cohort Study ◽

Clinical Outcomes ◽

Cardiovascular Events ◽

Chronic Renal Disease ◽

Risk Index ◽

Hemodialysis Patients ◽

Drug Prescriptions ◽

Increased Risk ◽

All Cause Mortality

Abstract Background and Aims Polypharmacy (PP) is common in end-stage chronic renal disease patients, largely because of the existence of multiple comorbid conditions. PP has the potential for harm and benefits, and the association between PP and mortality and morbidity in hemodialysis patients currently remains unclear. We examined the association of PP and the risk of clinical outcomes, such as all-cause mortality, all-cause hospitalization and cardiovascular events, in initial hemodialysis patients at admission and discharge. Method Study design: Cohort study. Setting: Participants: One hundred and fifty-two initial hemodialysis patients (female vs. male, 88 vs. 64; mean age, 70.3 years) were enrolled between February 2015 and March 2018 at the Nobeoka Prefectural Hospital and Chiyoda Hospital. Predictor: Patients were divided into 2 groups according to PP (6 or more drug prescriptions, or less) during admission and discharge for the initiation of hemodialysis. Outcomes: All-cause mortality, all-cause hospitalization and cardiovascular events (hospitalization due to stroke, ischemic heart disease or peripheral artery disease) during the mean 2.8-year follow-up. Measurements: Hazard ratios (HRs) were estimated using Cox’s model for the relationships between PP and the clinical outcomes, and adjusted for potential confounders, including age, sex, body mass index, systolic and diastolic blood pressure, Charlson comorbidity risk index, hemoglobin, serum levels of albumin, albumin-corrected Ca, phosphate, parathyroid hormone, C-reactive protein and NT-proBNP; and use of erythropoietin stimulating agents. The group with 5 or less drug prescriptions was set as reference. Results Among the patients in this cohort study, the number of prescribed drugs per patient averaged 7.4 at admission and 6.9 at discharge for initial hemodialysis. One hundred (65.8%) and 94 patients (61.8%) had PP at admission and discharge, respectively. During follow-up, 20 patients died, 71 patients were hospitalized and 25 patients had cardiovascular events. PP at admission is significantly associated with cardiovascular events (HR 8.50, 95%CI 1.45-49.68). Furthermore, PP at discharge is significantly associated with all-cause hospitalization and cardiovascular events (HR 1.95, 95%CI 1.01-3.70; HR 53.16, 95%CI 2.70-104.62, respectively). However, PP is not significantly associated with all-cause mortality at admission or discharge. Conclusion Among Japanese patients starting hemodialysis, PP may be associated with clinical outcomes. However, it remains unclear whether PP is the direct cause of the outcomes or is simply a marker for increased risk of outcomes.

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