Endoscopic Variceal Ligation Outperforms Injection Sclerotherapyin Controlling Actively Bleeding OesophagealVaricesin Decompensated Cirrhotic Patients: A Real World Comparative Cohort Analysis

51 Background: The landscape of M0 CRPC has changed with the recent demonstration of metastasis-free survival (MFS) and overall survival (OS) improvements with the use of ARPIs in clinical trial settings. However, the extrapolation of this data to clinical practice is limited by strict exclusion criteria in these trials, including prior or concurrent malignancy, cardiovascular disease, or hypertension. The purpose of this study was to assess real-world outcomes in patients with M0 CRPC treated with ARPIs compared to historical controls. Methods: We designed a retrospective cohort study with the inclusion of patients in Alberta, Canada diagnosed with M0 CRPC between 2001-2020. Via chart review, we identified baseline characteristics, potential confounders, treatment details, and clinical outcomes. The primary outcome of interest was MFS. Secondary outcomes included: second progression-free survival (PFS2) and OS. Median survival times were measured using the Kaplan-Meier method and the log-rank test was used for comparison of outcomes based on ARPI exposure. Cox proportional hazard regression models were used to calculate hazard ratios (HR) accounting for impact of PSA doubling time (PSADT), use of osteoclast inhibiting agents, and presence of pelvic lymphadenopathy. Results: We identified 211 patients across multiple centres in Alberta with M0 CRPC, with 54 having received apalutamide (40/54), enzalutamide (7/54), or darolutamide (7/54). Median age at M0 CRPC diagnosis was 74 years; median PSADT was 4.4 months; and 19% of patients (40/211) had pelvic lymphadenopathy at diagnosis. Median MFS in patients treated with ARPIs was 47.5 months compared to 20.6 months in those not treated with ARPIs (HR, 0.23; 95% confidence interval [CI], 0.11-0.49; p < 0.001). Median PFS2 in ARPI treated patients was 66.3 months compared with 35.6 months (HR, 0.40; 95% CI, 0.18-0.87; p = 0.022). Median OS for patients treated with ARPI was not reached. Conclusions: Given the older age of men with advanced prostate cancer, real-world outcomes that include patients with comorbidities are important adjuncts to the interpretation of clinical trials exploring the benefit of novel therapeutics. Here, we demonstrate that in a real-world, unselected population of men with M0 CRPC, apalutamide, enzalutamide, and darolutamide seem to confer similar MFS and PFS2 benefits to those demonstrated in the SPARTAN, PROSPER, and ARAMIS studies. Real-world OS data remain immature and will be an important addition to these findings.

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Abstract P212: Benchmark Analysis of Genetic Testing Practice Patterns in a Real-World Population of Patients Receiving Clopidogrel or Prasugrel Therapy

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.4.suppl_2.ap212 ◽

2011 ◽

Vol 4 (suppl_2) ◽

Author(s):

Cynthia H Ewel ◽

Barnabie C Agatep ◽

Vivian Herrera ◽

Nathan J Markward ◽

Eric J Stanek ◽

...

Keyword(s):

Genetic Testing ◽

Real World ◽

Cohort Analysis ◽

Routine Practice ◽

World Population ◽

Provider Education ◽

Stroke Event ◽

Pharmacy Claims ◽

Prescription Date ◽

The Impact

BACKGROUND: Cytochrome P450 2C19 genotype has been shown to modify cardiovascular outcomes on clopidogrel therapy in patients post-acute coronary syndromes or percutaneous coronary interventions. Recent clopidogrel label changes have incorporated this information; however real-world application of genetic testing in patients receiving thienopyridine antiplatelet therapy is unknown. METHODS: A retrospective, integrated medical and pharmacy claims database, cohort analysis was conducted in patients with new clopidogrel or prasugrel prescriptions between 7/1/08-6/30/10, and continuous eligibility for 6 months pre- and 3 months post-initiation. Genetic testing was identified using CPT-4 codes present 1 month prior and 3 months post the index prescription date. Genetic testing incidence was calculated, and univariate comparisons of prescriber information, and patient demographic and clinical characteristics in cases tested vs not tested were performed. RESULTS: The analysis included 95,381 clopidogrel and 1,819 prasugrel patients. Genetic testing was recorded in 522 (0.6%) clopidogrel and 15 (0.8%) prasugrel patients, rendering the latter sample too small for detailed analysis. Clopidogrel patients receiving genetic testing (vs patients not tested) were a mean age of 58±13 yrs (68±13 yrs, p<0.001), 29% were ≥65 yrs old (61%, p<0.001), 56% were male (59%), 33% were Western US residents (18%, p<0.001), 35% were recently hospitalized for stroke (8%, p<0.001), and were less often prescribed clopidogrel by a cardiologist (22% vs 32%, p<0.001) and more often by a neurology specialist (8% vs 2%, p<0.001). The incidence of genetic testing did not vary over time. CONCLUSION: Although the FDA has provided numerous advisories that have lead to changes in clopidogrel provider information sheets, genetic testing is rarely employed in routine practice in patients prescribed clopidogrel or prasugrel therapy. Testing was biased toward younger clopidogrel patients with a recent stroke event, and non-cardiologist prescribers. While these data establish a national benchmark for future comparison, further exploration of barriers to testing, provider education and patient selection, and the impact of programmatic approaches to testing are warranted.

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