IMPORTANCE People with chronic kidney disease (CKD) are risk-stratified for adverse events based on estimated glomerular filtration rate (eGFR) and albuminuria level. CKD has often a favorable course (CKD regression) regardless of eGFR. Determining whether lower albuminuria is associated with CKD regression may have implications on CKD management. OBJECTIVE To assess the 5-year probability of CKD regression across albuminuria categories accounting for the competing risks of CKD progression and death in people with newly diagnosed CKD and the association between albuminuria level and CKD regression. DESIGN, SETTING, AND PARTICIPANTSThis population-based cohort study used administrative and laboratory data from Alberta, Canada, for adults with incident moderate to severe CKD (defined as sustained eGFR of 15-44 mL/min/1.73 m 2 for >90 days), between April 1, 2008, and March 31, 2017, and albuminuria measures before cohort entry. Data analysis occurred in January to June 2022. EXPOSURE Albuminuria categories were defined by albumin to creatinine ratios (ACRs): A1 (ACR, <3 mg/mmol), A2 (ACR, 3-29 mg/mmol), A3 <60 (ACR, 30-59 mg/mmol), and A3 Ն60 (ACR, Ն60 mg/mmol). MAIN OUTCOMES AND MEASURESThe main outcome was time to the earliest of CKD regression or progression (sustained change in CKD stage for >3 months and Ն25% increase or decrease in eGFR from baseline or kidney failure, respectively), death, or censoring (outmigration or study end date: March 31, 2019). Cumulative incidence functions were used to estimate absolute risks, and cause-specific Cox models were used to assess the association between albuminuria and CKD regression, accounting for age, sex, eGFR, comorbidities, and health services use indicators. RESULTSOf 58 004 people with moderate to severe CKD (mean [SD] age, 77 [12] years; 31 725[55%] women), 35 360 had A1 albuminuria (61%), 15 597 had A2 albuminuria (27%), 1527 had A3 <60 albuminuria (3%), and 5520 had A3 Ն60 albuminuria (10%). Five-year probability of regression was highest with A1 (22.6%), followed by A2 (16.5%), and A3 <60 (11.6%) and lowest with A3 Ն60 (5.3%).Using A1 albuminuria as the reference group, the hazard of regression was highest for A2 (hazard ratio [HR], 0.75; 95% CI, 0.72-0.79), then A3 <60 (HR, 0.47; 95% CI, 0.40-0.54), and lowest for A3 Ն60 (HR, 0.27; 95% CI, 0.24-0.30). CONCLUSIONS AND RELEVANCEIn this cohort study of people with moderate to severe CKD, albuminuria levels were inversely associated with CKD regression. These findings extend the key prognostic role of albuminuria, offering novel opportunities to discuss both favorable and adverse outcomes in people with CKD and inform CKD management.
9053 Background: Immune checkpoint inhibitors (ICIs) have revolutionized the treatment paradigm of non-small cell lung cancer (NSCLC). Despite the high prevalence of patients with poor Eastern Cooperative Oncology Group (ECOG) performance status (PS ≥2) in real-world practice, landmark studies have typically excluded this patient group from enrolment. The primary objective of this study was to evaluate the impact of ECOG PS on clinical outcomes and health care utilization in a large cohort of NSCLC patients treated with ICI in real-world practice. Methods: Using the Alberta Immunotherapy Database, we identified consecutive patients who received at least one dose of Pembrolizumab or Nivolumab for the treatment of advanced NSCLC between 1/1/2010 and 12/30/2019. The data cut-off date was 10/1/2020. Baseline clinical, pathological, and laboratory-based data were collected retrospectively. The primary outcome was median overall survival (mOS), as stratified by ECOG PS. The secondary outcomes were median time-to-treatment failure (mTTF) and metrics of health care utilization, including emergency department (ED) visits, hospitalizations, and death in hospital. Kaplan-Meier survival curves were used to determine survival outcomes, and compared with the log-rank test. The association between ECOG PS and healthcare utilization were represented with risk ratios and evaluated using chi-square tests. Results: A total of 790 patients were included. Median follow-up time was 20.6 months. 29.2% (n = 231) had PS ≥2 at the time of ICI initiation. As compared with the favorable PS group (PS < 2), patients with PS ≥2 had significantly lower mOS - 3.3 months (95% CI 2.5-4.0) versus 13.4 months (95% CI 11.7-16.0) (HR, 3.0; 95% CI 2.5-3.6, p < 0.0001), and mTTF – 1.4 months (95% CI 0.9-1.8) versus 4.9 months (95% CI 4.4-5.6) (HR, 2.2; 95% CI 1.9-2.6, p < 0.0001). 3- and 12-month survival rates were also significantly lower in the PS ≥2 group as compared with the PS < 2 group (52.8% versus 86.4% and 13.4% versus 41.0%, p < 0.0001 for both comparisons). Patients with PS ≥2 were also significantly more likely to present to the ED (RR 1.6; 95% CI, 1.3-2.0, p < 0.001) and be admitted to hospital (RR 2.3; 95% CI 1.7-3.0, p < 0.0001) within the first month after treatment initiation. These patients were also significantly more likely to die in hospital during their first admission (RR 2.7; 95% CI 1.8-4.1, p < 0.0001), as well as at any point during treatment (RR 2.2; 95% CI 1.60-3.0, p < 0.0001). Conclusions: NSCLC patients with poor ECOG PS at the time of ICI initiation had significantly worse survival outcomes and were significantly more likely to utilize health care services than those with favorable ECOG PS. The large proportion of patients with poor ECOG PS further justifies the urgent need for randomized trials evaluating the efficacy of ICI in this high-risk population.
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