Owen, Emily

PURPOSE Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer. Early-stage, high-risk patients with TNBC are treated with chemotherapy and pembrolizumab per the KEYNOTE-522 regimen. This report examines real-world clinical effectiveness and toxicity of this regimen. METHODS This 19-site retrospective analysis included all patients who received at least one dose of the KEYNOTE-522 regimen. Safety, efficacy, and health care encounters were collected. RESULTS 675 patients from 19 sites in the United States who received chemotherapy and pembrolizumab for early-stage TNBC were included. 547 (81.0%) patients underwent surgery and 250 (54.7%) patients had a pathologic complete response (pCR). No baseline characteristics were predictive of pCR status. 224 patients (33.2%) had an adverse drug event resulting in ≥1 dose reduction of chemotherapy and were significantly more likely to have residual disease. Immune-related adverse events (irAEs) were observed in 388 (57.5%) patients and grade 3+ irAEs were observed in 176 (26.1%) patients. There was no difference in pCR status between provider's choice chemotherapy schedules. There was no difference of pCR rate between Black and White patients (55.6% v 51.6%, P = .489). White patients were significantly more likely to have any grade and grade 3+ irAEs. Older patients (age ≥65 years) had similar pCR rates compared with younger patients; however, older patients were significantly more likely to have grade 3+ irAEs. CONCLUSIONS In this multi-institutional real-world cohort, we observed a lower pCR rate, higher rates of toxicity, frequent emergency health care utilization, and the reporting of rare irAEs at higher frequency than the KEYNOTE-522 regimen. These findings have important implications for clinical management of patients with early-stage TNBC and warrant further validation with real-world data sets.

Abstract Purpose Albumin, the most abundant and arguably most important protein in the human body, plays a unique role in decompensated cirrhosis because its structure and function are quantitatively and qualitatively affected. A literature review was performed to provide insights into albumin use. The manuscript was developed using a multidisciplinary approach; 2 hepatologists, a nephrologist, a hospitalist, and a pharmacist, who are all members of or work closely with the Chronic Liver Disease Foundation, collaborated to write this expert perspective review. Summary Cirrhosis represents the potential end in the spectrum of all chronic liver diseases. Decompensated cirrhosis, defined by the overt manifestation of liver failure (eg, ascites, hepatic encephalopathy, variceal bleeding), is the inflection point associated with increased mortality. Human serum albumin (HSA) infusion serves an important role in the treatment of advanced liver disease. The benefits of HSA administration in patients with cirrhosis are widely accepted, and its use has been advocated by several professional societies. However, inappropriate HSA use can lead to significant adverse patient events. This paper discusses the rationale for the administration of HSA in the treatment of complications of cirrhosis, analyzes the data on the use of HSA in cirrhosis, and streamlines practical recommendations set forth in published guidance. Conclusion Use of HSA in clinical practice needs to be improved. The objective of this paper is to empower pharmacists to facilitate and improve the use of HSA in patients with cirrhosis at their practice sites.