Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial.

Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+HER2-) metastatic breast cancer (mBC) in the global TROPiCS-02 study. TROPiCS-02 enrolled few Asian patients. Here we report results of SG in Asian patients with HR+HER2- mBC from the EVER-132-002 study. Patients were randomized to SG (n = 166) or chemotherapy (n = 165). The primary endpoint was met: PFS was improved with SG versus chemotherapy (hazard ratio of 0.67, 95% confidence interval 0.52-0.87; P = 0.0028; median 4.3 versus 4.2 months). OS also improved with SG versus chemotherapy (hazard ratio of 0.64, 95% confidence interval 0.47-0.88; P = 0.0061; median 21.0 versus 15.3 months). The most common grade ≥3 treatment-emergent adverse events were neutropenia, leukopenia and anemia. SG demonstrated significant and clinically meaningful improvement in PFS and OS versus chemotherapy, with a manageable safety profile consistent with prior studies. SG represents a promising treatment option for Asian patients with HR+HER2- mBC (ClinicalTrials.gov identifier no. NCT04639986 ).

Real-World Outcomes of First-Line Treatment With Anti-PD(L)1-Based Combination Therapy for Nonsquamous Metastatic Non-Small Cell Lung Cancer: A Multiregional Chart Review in Europe, Japan, and the United States.

PURPOSE: Anti-PD-1/PD(L)1-based combination therapy is the standard of care in first line (1L) for metastatic nonsquamous non-small cell lung cancer (mnsqNSCLC) without driver alterations. This study aimed to evaluate real-world clinical outcomes in this population. METHODS: Eligible physicians in the United States, Europe, and Japan abstracted information from medical charts of eligible adult patients with mnsqNSCLC (without EGFR/ALK, no known ROS1 alterations) who initiated 1L anti-PD(L)1-based combination therapy for mnsqNSCLC between 2017 and 2021. Kaplan-Meier analyses were used to assess overall survival (OS), time-to-treatment discontinuation (TTD), and real-world progression-free survival (rwPFS) after 1L initiation. RESULTS: Overall, 142 physicians contributed deidentified data from 430 patients' medical charts. The distribution of PD-L1 expression levels was 31.2% with tumor proportion score (TPS) <1%, 42.3% with TPS 1%-49%, and 26.5% with TPS ≥50%. In 1L, patients received anti-PD(L)1 + chemotherapy (84.6%), anti-PD(L)1 + anti-CTLA4 with or without chemotherapy (11.9%), and anti-PD(L)1 + chemotherapy + anti-vascular endothelial growth factor receptor (3.5%). The median OS was 21.7 months (TPS <1%: 18.3 months; TPS 1%-49%: 21.6 months; TPS ≥50%: 24.0 months). The median TTD was 11.0 months (TPS <1%: 9.1 months; TPS 1%-49%: 10.9 months; TPS ≥50%: 12.2 months). The median rwPFS was 11.2 months (TPS <1%: 9.3 months; TPS 1%-49%: 11.1 months; TPS ≥50%: 13.2 months). CONCLUSION: This study assessed the real-world clinical effectiveness of 1L anti-PD(L)1-based combination therapy for mnsqNSCLC. Results from this study were generally consistent with previous clinical trials and published real-world evidence in 1L mnsqNSCLC.

Real-World Treatment Patterns and Clinical Outcomes After Platinum-Doublet Chemotherapy and Immunotherapy in Metastatic Non-Small Cell Lung Cancer: A Multiregional Chart Review in the United States, Europe, and Japan.

PURPOSE: To characterize treatment patterns and real-world clinical outcomes of patients with metastatic non-small cell lung cancer (mNSCLC) who developed progression on an anti-PD-1/anti-PD-L1, herein referred to as anti-PD-(L)1, and platinum-doublet chemotherapy. METHODS: Eligible oncologists/pulmonologists in the United States, Europe (France, Germany, and United Kingdom), and Japan completed electronic case report forms for patients with mNSCLC (no evidence of EGFR/ALK/ROS1 alterations). Eligible patients had disease progression on/after an anti-PD-(L)1 and platinum-doublet chemotherapy (received concurrently or sequentially), initiated a subsequent line of therapy (LOT) between 2017 and 2021, and had an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 at this subsequent LOT initiation (index date). Overall survival (OS), time to treatment discontinuation (TTD), and real-world progression-free survival (rwPFS) after index were assessed using Kaplan-Meier analysis. RESULTS: Overall, 160 physicians (academic, 54.4%; community, 45.6%) provided deidentified data from 487 patient charts (United States, 141; Europe, 218; Japan, 128; at mNSCLC diagnosis: median age 66 years, 64.7% male, 81.3% nonsquamous, 86.2% de novo mNSCLC; at line of interest initiation: 86.0% ECOG 0-1, 39.6% liver metastases, 18.9% brain metastases, 79.1% smoking history). The most common treatment regimens upon progression after anti-PD-(L)1/platinum-doublet chemotherapy were nonplatinum chemotherapy (50.5%), nonplatinum chemotherapy plus vascular endothelial growth factor receptor inhibitor (12.9%), and platinum-doublet chemotherapy (6.6%). Median OS was 8.8 months (squamous, 7.8 months; nonsquamous, 9.5 months). Median TTD was 4.3 months (squamous, 4.1 months; nonsquamous, 4.3 months). Median rwPFS was 5.1 months (squamous, 4.6 months; nonsquamous, 5.4 months). CONCLUSION: In this multiregional, real-world analysis of pooled patient chart data, patients with mNSCLC who had disease progression after anti-PD-(L)1/platinum-doublet chemotherapy had poor clinical outcomes with various treatment regimens, demonstrating an unmet clinical need for effective options after failure on anti-PD-(L)1 and platinum-doublet chemotherapy treatments.

How well do clinical and demographic characteristics predict Patient Health Questionnaire-9 scores among patients with treatment-resistant major depressive disorder in a real-world setting?

OBJECTIVES: To create and validate a model to predict depression symptom severity among patients with treatment-resistant depression (TRD) using commonly recorded variables within medical claims databases. METHODS: Adults with TRD (here defined as > 2 antidepressant treatments in an episode, suggestive of nonresponse) and ≥ 1 Patient Health Questionnaire (PHQ)-9 record on or after the index TRD date were identified (2013-2018) in Decision Resource Group's Real World Data Repository, which links an electronic health record database to a medical claims database. A total of 116 clinical/demographic variables were utilized as predictors of the study outcome of depression symptom severity, which was measured by PHQ-9 total score category (score: 0-9 = none to mild, 10-14 = moderate, 15-27 = moderately severe to severe). A random forest approach was applied to develop and validate the predictive model. RESULTS: Among 5,356 PHQ-9 scores in the study population, the mean (standard deviation) PHQ-9 score was 10.1 (7.2). The model yielded an accuracy of 62.7%. For each predicted depression symptom severity category, the mean observed scores (8.0, 12.2, and 16.2) fell within the appropriate range. CONCLUSIONS: While there is room for improvement in its accuracy, the use of a machine learning tool that predicts depression symptom severity of patients with TRD can potentially have wide population-level applications. Healthcare systems and payers can build upon this groundwork and use the variables identified and the predictive modeling approach to create an algorithm specific to their population.

Treatment Pattern and Outcomes in Newly Diagnosed Multiple Myeloma Patients Who Did Not Receive Autologous Stem Cell Transplantation: A Real-World Observational Study : Treatment pattern and outcomes in patients with multiple myeloma.

INTRODUCTION: The objective of this study was to describe the treatment patterns among patients with newly diagnosed multiple myeloma (MM) who had not received autologous stem cell transplantation (ASCT). It further compares the safety and clinical outcomes across different frontline regimens as well as explores whether treatment duration predicts outcomes. METHODS: Patients with MM (> 45 years) who had not received ASCT were retrospectively identified from the US SEER-Medicare (Jan 2007-Dec 2016) and Optum (Jan 2007-Sep 2018) databases. Cox proportional hazard models were used to compare overall survival (OS) among bortezomib + lenalidomide + dexamethasone regimen (VRd), lenalidomide + dexamethasone regimen (Rd), cyclophosphamide + bortezomib + dexamethasone regimen (CyBorD), bortezomib + dexamethasone regimen (Vd), and other bortezomib-containing therapies based on propensity score matching. To address immortal time bias, time-fixed and time-dependent Cox models were employed to estimate the association of longer frontline treatment exposure with outcomes. RESULTS: Mean (standard deviation; SD) age was 71 (9.8) years; and 49.51% were women. Bortezomib and lenalidomide-based combinations were the most common treatment modalities. After matching, the HR (95% CI) of OS by frontline therapies comparing VRd with Vd was 0.76 (0.66, 0.86), CyBorD was 0.87 (0.75, 1.05), for other bortezomib-based therapies was 0.56 (0.49, 0.64), Rd was 0.83 (0.73, 0.95), and for other therapies was 0.70 (0.61, 0.80). Longer frontline treatment duration was associated with better OS for overall frontline [HR (95% CI) 0.86 (0.82, 0.90)]; Vd [0.81 (0.74, 0.89)]; CyBorD [0.79 (0.64, 0.98)] and Rd [0.86 (0.78, 0.95)]. CONCLUSION: Results demonstrated that the frontline therapies prescribed to most patients who did not receive ASCT for MM in the United States were consistent with the NCCN guideline recommendations. Longer frontline treatment duration was associated with improved OS.

Descriptive analysis of workflow variables associated with barcode-based approach to medication administration.

Bedside barcode technology is used during medication administration to ensure patient safety. This study evaluated the workflow variables related to a bedside barcode technology-based medication administration process. A time-and-motion technique was used to assess the observational episodes related to medication administration conducted by registered nurses. In an observational episode, nurses spent adequate time in "documenting medications" and "giving medications." Nurses were primarily engaged in tasks at the patient's bedside.

Effect of bar-code-assisted medication administration on nurses' activities in an intensive care unit: a time-motion study.

PURPOSE: The effect of bar-code-assisted medication administration (BCMA) on nurses' activities in an intensive care unit was evaluated. METHODS: A prospective, observational, time-motion study was conducted by considering two approaches to medication administration in an intensive care unit: paper-based medication administration (PBMA) and BCMA. The time spent on nursing activities was measured using a prevalidated time-motion observation instrument and categorized based on workflow factors such as direct patient care, indirect patient care, administration, and miscellaneous or other. A descriptive analysis was conducted with the amount of time spent on each of the nursing activities. A multivariate analysis of covariance was conducted to assess the difference between the two approaches for the amount of time spent on various categorized nursing activities. Covariates included in the analysis were patient characteristics, medication administration characteristics, and number of nurses involved in medication administration. RESULTS: A total of 101 PBMAs and 151 BCMAs were reviewed. The mean duration of total medication administration time was higher in the BCMA phase compared with the PBMA phase, as was the mean time spent on direct patient care activity. However, nurses spent less time on administration activity during BCMA. Statistical analysis revealed that the medication administration approach (BCMA versus PBMA) had a significant effect on time spent on direct patient care and medication administration activities. CONCLUSION: The implementation of BCMA led to a reduction in the time spent by nurses on medication administration activities and increased the time spent on direct patient care activities.

Evaluating equivalence and noninferiority trials.

PURPOSE: The conceptual issues related to the design of equivalence and non-inferiority trials and considerations for interpreting the findings of such trials are described. SUMMARY: Comparative effectiveness research (CER) has recently gained importance in the evaluation of different treatment alternatives. Large, prospective, randomized controlled trials (RCTs) conducted with patient populations under routine practice conditions can yield high-quality CER results. A Phase III RCT, usually conducted for establishing superiority of one treatment over another, is called a superiority trial, and the statistical test associated with it is known as a superiority test. In a pragmatic equivalence trial, a researcher aims to test if two treatments are identical (within a specified range) with respect to some predefined clinical criteria. Pragmatic noninferiority trials aim to show if a test therapy is no worse than a standard therapy with respect to achieving the primary treatment outcome. A nonsignificant result obtained from a superiority test does not indicate that the two treatment options are similar. In other words, the lack of evidence of superiority does not guarantee a lack of difference in the performance shown by the therapies. A researcher can only demonstrate identical effects of two treatments in an equivalence trial. In a noninferiority trial, the test therapy is preferred when there is evidence about its benefits over the standard treatment in terms of secondary outcomes such as cost, adherence, and adverse effects. CONCLUSION: Equivalence and noninferiority trials are designed differently from superiority trials. The overall quality of equivalence and noninferiority studies depends on study design and the manner in which the results are reported.

Pharmacists' utilization and interest in usage of personal digital assistants in their professional responsibilities.

BACKGROUND AND OBJECTIVES: Pharmacists use PDAs for performing various activities related to their profession. The objective of this study was to examine pharmacists' utilization pattern and interest in usage of personal digital assistants (PDAs) in various facets of health care. METHODS: A cross-sectional survey was conducted by distributing a pre-validated 23-item instrument to a convenience sample of pharmacists (n = 295) in the Houston area. Usage frequency (0 = never to 5 = frequently) and interest in future use (1 = extremely disinterested to 5 = extremely interested) of PDAs for various activities were evaluated and compared across pharmacy practice settings. RESULTS: Most pharmacists reported maximum use of PDAs, as personal organizers (3.7 +/- 1.8), in obtaining drug information (2.9 +/- 1.8) and as medical calculators (2.6 +/- 1.9). Similar results were obtained while evaluating interest of pharmacists who did not have PDAs and have never used PDAs for these three activities. Hospital pharmacists owned and used PDAs significantly (P < 0.05) more often than community pharmacists. CONCLUSIONS: Pharmacists used PDAs for basic functions in their profession role. Application of PDA technology in community pharmacy settings may result in its better adoption in both the settings.

Application of the Extended Technology Acceptance Model in predicting pharmacists' intention to use personal digital assistants.

OBJECTIVE: To evaluate pharmacists' behavioral intention to use personal digital assistants (PDAs) in their profession, by means of the Extended Technology Acceptance Model (ETAM). DESIGN: Prospective cross-sectional study. SETTING: Hospital and community pharmacies in Houston, TX, in 2004. PARTICIPANTS: Convenience sample of 295 practicing pharmacists. INTERVENTION: A prevalidated survey containing 30 items, evaluated on a 5-point Likert scale (1, strongly disagree, to 5, strongly agree), which measured the ETAM variables. MAIN OUTCOME MEASURES: Predictors of intention to use PDA for pharmacists owning the device. RESULTS: Among the surveyed population, 49% of pharmacists owned PDAs. Overall, the ETAM constructs showed fairly good reliability. Stepwise regression analysis showed that the ETAM explained 69% of the variance in intention to use PDAs for pharmacists owning the device. Result demonstrability (beta = 0.53), subjective norm (beta = 0.25), and voluntariness (beta = -0.10) were significant (P < 0.05) predictors of pharmacists' intention to use PDAs. CONCLUSION: ETAM proved useful in predicting pharmacists' behavior in using PDAs. With improvements in technology, PDAs be an effective tool for pharmacists in providing better patient care.