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Real-World Effectiveness of Chemotherapy in Elderly Patients With Metastatic Bladder Cancer in the United States.

ABSTRACT: Background:Outcomes for patients with metastatic bladder cancer (mBC) are generally poor and progressively worse following first-line (1L) chemotherapy. Objective:To evaluate treatment patterns, survival outcomes, and characteristics of a large, real-world US population of elderly patients with advanced mBC receiving 1L and second-line (2L) treatment retrospectively. Methods:We identified patients with advanced mBC (aged ?66 years)-newly diagnosed between January 1, 2004, and December 31, 2011-in the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program-Medicare linked database and assessed their palliative systemic chemotherapy treatments and survival outcomes. Results:Of 1703 eligible patients, 42% received 1L chemotherapy; 1L-treated patients tended to be younger and healthier than nontreated patients. Only 27% of 1L-treated patients received cisplatin-based chemotherapy, most commonly cisplatin-gemcitabine. Cisplatin-treated patients were younger and had fewer comorbidities than non-cisplatin-treated patients. Thirty-five percent of 1L-treated patients subsequently received 2L chemotherapy. Patients received a variety of 2L agents as combination chemotherapy (52%) or single-agent chemotherapy (39%). Median overall survival durations in 1L-treated and 2L-treated patients were 8.5 and 7.9 months, respectively. Conclusions:Results from this retrospective SEER-Medicare database analysis underscore the historical inadequacies of 1L and 2L treatments in elderly patients with advanced mBC. Few patients were treated with 1L chemotherapy, a minority of whom received 1L cisplatin-based chemotherapy, and even fewer received 2L chemotherapy. These findings highlight the disconnect between 1L treatment in clinical trials and treatment in the real-world setting and the lack of standard approaches to 2L treatment in the United States.

SUBMITTER: Galsky MD

PROVIDER: S-EPMC5929305 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Real-World Effectiveness of Chemotherapy in Elderly Patients With Metastatic Bladder Cancer in the United States.

Galsky Matthew D MD Pal Sumanta Kumar SK Lin Shih-Wen SW Ogale Sarika S Zivkovic Marko M Simpson Joseph J Derleth Christina C Schiff Christina C Sonpavde Guru G

Bladder cancer (Amsterdam, Netherlands) 20180426 2

<h4>Background</h4>Outcomes for patients with metastatic bladder cancer (mBC) are generally poor and progressively worse following first-line (1L) chemotherapy.<h4>Objective</h4>To evaluate treatment patterns, survival outcomes, and characteristics of a large, real-world US population of elderly patients with advanced mBC receiving 1L and second-line (2L) treatment retrospectively.<h4>Methods</h4>We identified patients with advanced mBC (aged ≥66 years)-newly diagnosed between January 1, 2004, a ...[more]

PMID: 29732393

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Project description:Rationale & objectiveSome US hemodialysis (HD) facilities switched from oral cinacalcet to intravenous etelcalcetide as the primary calcimimetic therapy to control parathyroid hormone (PTH) levels after the introduction of etelcalcetide in 2017. Although clinical trials have demonstrated the superior efficacy of etelcalcetide versus cinacalcet, evidence comparing real-world effectiveness is lacking.Study designProspective cohort.Setting & participantsPatients receiving HD enrolled in US Dialysis Outcomes and Practice Patterns Study facilities.ExposureWe classified HD facilities on the basis of whether >75% of calcimimetic users were prescribed etelcalcetide ("etelcalcetide-first") or cinacalcet ("cinacalcet-first") from March-August 2019.OutcomesPTH, calcium, and phosphorus levels among calcimimetic users, all averaged in the 6 months after the exposure assessment period.Analytical approachWe used adjusted linear regression to compare outcomes using 2 approaches: (1) cross-sectional comparison of etelcalcetide-first and cinacalcet-first HD facilities; (2) pre-post comparison of HD facilities that switched from cinacalcet-first to etelcalcetide-first using facilities that remained cinacalcet-first as a comparison group.ResultsWe identified 45 etelcalcetide-first and 67 cinacalcet-first HD facilities; etelcalcetide-first (vs cinacalcet-first) facilities were more likely to be from small or independent dialysis organizations (86% vs 22%) and had higher total calcimimetic use (43% vs 29%) and lower active vitamin D use (66% vs 82%). In the cross-sectional analysis comparing etelcalcetide-first and cinacalcet-first HD facilities, the adjusted mean difference in PTH levels was -115 pg/mL (95% CI, -196 to -34) and the prevalence of a PTH level of >600 pg/mL was lower (prevalence difference, -11.4%; 95% CI, -19.3% to -3.5%). Among facilities that switched to etelcalcetide-first, the mean PTH level decreased from 671 to 484 pg/mL and the prevalence of a PTH level of >600 pg/mL decreased from 39% to 21%. Among facilities that remained cinacalcet-first, the mean PTH level increased from 632 to 698 pg/mL and the prevalence of a PTH level of >600 pg/mL increased from 37% to 43%. The adjusted difference-in-difference between the switch to etelcalcetide-first and the continuation of cinacalcet-first was -169 pg/mL (-249 to -90 pg/mL) for the mean PTH and -14.4% (-22.0% to -6.8%) for a PTH level of >600 pg/mL. We also observed slightly lower serum calcium levels and minimal differences in serum phosphorus levels between the etelcalcetide-first and the cinacalcet-first facilities.LimitationsResidual confounding.ConclusionsWe observed better PTH control in HD facilities that switched from using cinacalcet to etelcalcetide as the primary calcimimetic therapy. Further research is needed to investigate how the greater real-world effectiveness of intravenous etelcalcetide (vs oral cinacalcet) may affect clinical outcomes.

Project description:IntroductionIxekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24 weeks.ObjectiveTo describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Customer Support Program.MethodsThis was a 24-week prospective, observational study of commercially insured diagnosis-confirmed adults with PsO. Surveys were completed at weeks 0 (baseline), 2, 4, 8, 12, and 24 and included the Patient Report of Extent of Psoriasis Involvement questionnaire to assess the extent of body surface area (BSA) affected by PsO, itch and pain numeric rating scales, Patient Global Assessment of Disease Severity (PatGA), and Dermatology Life Quality Index (DLQI).Results523 patients were included in the analysis. Proportions of patients with ≤ 2% BSA involvement were 34.5%, 40.1%, 50.9%, and 79.9% at weeks 0, 2, 4, and 24, respectively; 54.8% and 75.1% achieved National Psoriasis Foundation preferred (BSA ≤ 1%) and acceptable (BSA ≤ 3% or ≥ 75% improvement) responses at week 12, respectively. Improvements of ≥ 4 points in itch and pain were seen by week 2 in 21.1% and 28.0% of patients, respectively, which increased to 63.1% and 64.8% at week 24. Proportions of patients with PatGA scores of 0 (clear) or 1 were 13.4%, 24.1%, 34.0%, and 69.6% at weeks 0, 2, 4, and 24, respectively; and proportions with DLQI total scores of 0 or 1 [no or minimal impact] were 8.4%, 17.6%, 27.3%, and 53.8% at weeks 0, 2, 4, and 24, respectively.ConclusionPatient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2 weeks after initiation and continued through week 24.

Project description:IntroductionRecent changes in antiretroviral therapies (ARTs) may have affected medication adherence of people living with human immunodeficiency virus-1 (HIV-1). In this study adherence to ART regimens among patients with HIV-1 (PWH) across the US during a recent time period was examined and study findings were stratified by US region and state.MethodsA retrospective observational study using the Symphony Health Solution Integrated Dataverse database was conducted. Patients ≥ 18 years of age who had a diagnosis of HIV-1 (without an HIV-2 diagnosis) and who were treated with ART between July 2017 and September 2018 (first pharmacy record: index date) were selected from the data source. Both patients who had not been previously treated with ART and those who were treatment experienced were included. Patients were required to have ≥ 1 medical/pharmacy record ≥ 12 months after their index date (follow-up period). Patient characteristics were examined during a 12-month pre-index period. During the follow-up, medication adherence, measured as the proportion of days covered (PDC), was examined for all patients and stratified by US region and state.ResultsAmong 206,474 adult PWH treated with ART, mean age was 47.9 years, 73.4% were male, and 30.0% were Caucasian. The most prevalent comorbid conditions were hyperlipidemia (25.1%), depressive disorders (14.8%), and type 2 diabetes (12.1%). During the follow-up period, mean (standard deviation) PDC was 74.1% (25.9%) among PWH across the US [Midwest: 74.4% (25.5%); Northeast: 74.3% (26.1%); South: 73.2% (26.3%); West: 76.4% (24.8%)]. Across all US regions, > 60% of PWH had adherence < 90% and > 40% had adherence < 80%; the West had the highest adherent population.ConclusionsAmong PWH treated with ART across the US, a majority had suboptimal adherence. Implementation of strategies to improve ART adherence, including clinical consideration of ARTs with high genetic barriers to resistance, is needed in the US.

Dataset Information

Real-World Effectiveness of Chemotherapy in Elderly Patients With Metastatic Bladder Cancer in the United States.

Publications

Real-World Effectiveness of Chemotherapy in Elderly Patients With Metastatic Bladder Cancer in the United States.

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