483 Background: Overall survival (OS) remains the gold standard for demonstrating clinical benefi... more 483 Background: Overall survival (OS) remains the gold standard for demonstrating clinical benefit in advanced hepatocellular carcinoma (HCC). While surrogate radiology-based endpoints for OS, such as progression-free survival (PFS) and objective response rate (ORR) are commonly used in the field of oncology, they remain controversial in the setting of HCC where antiangiogenic agents were the mainstay of treatment until recently. Immune checkpoint inhibitors (CPIs) as monotherapy or in combination have shifted the treatment paradigm in HCC. We investigated the surrogacy of radiology-based endpoints from CPI clinical trials in advanced HCC. Methods: Study level data were collected for disclosures published in EMBASE, PubMed, Clinicaltrials.gov and conference abstracts. Keywords used included (abbreviated here): immune CPIs, advanced or metastatic HCC and ORR, PFS and OS. Key inclusion criteria included: Phase I, II and III trial data, and patients with advanced or metastatic HCC who ...
Nurses have been required to provide more patient-centered, efficient, and cost effective care. I... more Nurses have been required to provide more patient-centered, efficient, and cost effective care. In order to do so, they need to work at the top of their license. We conducted a time motion study to document nursing activities on communication, hands-on tasks, and locations (where activities occurred), and compared differences between different time blocks (7am-11am, 11am-3pm, and 3pm-7pm). We found that nurses spent most of their time communicating with patients and in patient rooms. Nurses also spent most of their time charting and reviewing information in EHR, mostly at the nursing station. Nurses' work was not distributed equally across a 12-hour shift. We found that greater frequency and duration in hands-on tasks occurred between 7am-11am. In addition, nurses spent approximately 10% of their time on delegable and non-nursing activities, which could be used more effectively for patient care. The study results provide evidence to assist nursing leaders to develop strategies f...
Supplemental Digital Content is available in the text. LY3381916 is an orally available, highly s... more Supplemental Digital Content is available in the text. LY3381916 is an orally available, highly selective, potent inhibitor of indoleamine 2,3-dioxygenase 1. This study explored the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of LY3381916 monotherapy and in combination with a programmed death-ligand 1 (PD-L1) inhibitor (LY3300054) in patients with advanced solid tumors. During dose escalation, patients received escalating doses of LY3381916 at 60–600 mg once daily (qd) and 240 mg twice daily in monotherapy (n=21) and in combination with PD-L1 inhibitor at 700 mg every 2 weeks (n=21). A modified toxicity probability interval method was used to guide dose escalation. Dose-limiting toxicities occurred in 3 patients; 1 at LY3381916 240 mg twice daily (alanine aminotransferase/aspartate aminotransferase increase and systemic inflammatory response syndrome) and 2 at LY3381916 240 mg qd in combination with PD-L1 inhibitor (fatigue and immune-related hep...
Glioblastoma (GBM) show significant inter- and intra-tumoral heterogeneity, impacting response to... more Glioblastoma (GBM) show significant inter- and intra-tumoral heterogeneity, impacting response to treatment and overall survival time of 12-15 months. To study glioblastoma phenotypic heterogeneity, multi-parametric magnetic resonance images (MRI) of 85 glioblastoma patients from The Cancer Genome Atlas were analyzed to characterize tumor-derived spatial habitats for their relationship with outcome (overall survival) and to identify their molecular correlates (i.e., determine associated tumor signaling pathways correlated with imaging-derived habitat measurements). Tumor sub-regions based on four sequences (fluid attenuated inversion recovery, T1-weighted, post-contrast T1-weighted, and T2-weighted) were defined by automated segmentation. From relative intensity of pixels in the 3-dimensional tumor region, "imaging habitats" were identified and analyzed for their association to clinical and genetic data using survival modeling and Dirichlet regression, respectively. Sixtee...
483 Background: Overall survival (OS) remains the gold standard for demonstrating clinical benefi... more 483 Background: Overall survival (OS) remains the gold standard for demonstrating clinical benefit in advanced hepatocellular carcinoma (HCC). While surrogate radiology-based endpoints for OS, such as progression-free survival (PFS) and objective response rate (ORR) are commonly used in the field of oncology, they remain controversial in the setting of HCC where antiangiogenic agents were the mainstay of treatment until recently. Immune checkpoint inhibitors (CPIs) as monotherapy or in combination have shifted the treatment paradigm in HCC. We investigated the surrogacy of radiology-based endpoints from CPI clinical trials in advanced HCC. Methods: Study level data were collected for disclosures published in EMBASE, PubMed, Clinicaltrials.gov and conference abstracts. Keywords used included (abbreviated here): immune CPIs, advanced or metastatic HCC and ORR, PFS and OS. Key inclusion criteria included: Phase I, II and III trial data, and patients with advanced or metastatic HCC who ...
Nurses have been required to provide more patient-centered, efficient, and cost effective care. I... more Nurses have been required to provide more patient-centered, efficient, and cost effective care. In order to do so, they need to work at the top of their license. We conducted a time motion study to document nursing activities on communication, hands-on tasks, and locations (where activities occurred), and compared differences between different time blocks (7am-11am, 11am-3pm, and 3pm-7pm). We found that nurses spent most of their time communicating with patients and in patient rooms. Nurses also spent most of their time charting and reviewing information in EHR, mostly at the nursing station. Nurses' work was not distributed equally across a 12-hour shift. We found that greater frequency and duration in hands-on tasks occurred between 7am-11am. In addition, nurses spent approximately 10% of their time on delegable and non-nursing activities, which could be used more effectively for patient care. The study results provide evidence to assist nursing leaders to develop strategies f...
Supplemental Digital Content is available in the text. LY3381916 is an orally available, highly s... more Supplemental Digital Content is available in the text. LY3381916 is an orally available, highly selective, potent inhibitor of indoleamine 2,3-dioxygenase 1. This study explored the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of LY3381916 monotherapy and in combination with a programmed death-ligand 1 (PD-L1) inhibitor (LY3300054) in patients with advanced solid tumors. During dose escalation, patients received escalating doses of LY3381916 at 60–600 mg once daily (qd) and 240 mg twice daily in monotherapy (n=21) and in combination with PD-L1 inhibitor at 700 mg every 2 weeks (n=21). A modified toxicity probability interval method was used to guide dose escalation. Dose-limiting toxicities occurred in 3 patients; 1 at LY3381916 240 mg twice daily (alanine aminotransferase/aspartate aminotransferase increase and systemic inflammatory response syndrome) and 2 at LY3381916 240 mg qd in combination with PD-L1 inhibitor (fatigue and immune-related hep...
Glioblastoma (GBM) show significant inter- and intra-tumoral heterogeneity, impacting response to... more Glioblastoma (GBM) show significant inter- and intra-tumoral heterogeneity, impacting response to treatment and overall survival time of 12-15 months. To study glioblastoma phenotypic heterogeneity, multi-parametric magnetic resonance images (MRI) of 85 glioblastoma patients from The Cancer Genome Atlas were analyzed to characterize tumor-derived spatial habitats for their relationship with outcome (overall survival) and to identify their molecular correlates (i.e., determine associated tumor signaling pathways correlated with imaging-derived habitat measurements). Tumor sub-regions based on four sequences (fluid attenuated inversion recovery, T1-weighted, post-contrast T1-weighted, and T2-weighted) were defined by automated segmentation. From relative intensity of pixels in the 3-dimensional tumor region, "imaging habitats" were identified and analyzed for their association to clinical and genetic data using survival modeling and Dirichlet regression, respectively. Sixtee...
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