PURPOSE OF THE STUDY:The purpose of the study was to evaluate the safety and efficacy of the iStent Trabecular Micro-Bypass stent in pseudophakic patients with open-angle glaucoma.
...METHODS:Retrospective, consecutive case series from October 2012 to May 2015 with no exclusion criteria. The series comprised 42 pseudophakic eyes with open-angle glaucoma that were implanted with 1 iStent. Data were collected preoperatively, and postoperative data were collected at 1 day, 1 week, 1, 3 and 6 months, 1 year, 18 months and 2 years. Data included intraocular pressure (IOP), number of glaucoma medications, the incidence of postoperative IOP pressure spikes ≥15 mm Hg at any timepoint, and the need for additional surgery.
RESULTS:The mean preoperative IOP was 20.26±6.00 mm Hg. At 1 year postoperatively, the mean IOP was 16.34±3.78 mm Hg (P<0.01). At 2 years postoperatively, the mean IOP was 13.62±4.55 (P<0.01). The mean number of glaucoma medications was 1.95±1.01 preoperative and 1.69±1.28 (P>0.05) at 1 year postoperatively. Postoperatively, 3 eyes (7%) experienced an IOP increase of 15 mm Hg above their baseline IOP that responded to topical therapy. In total, 96% of patients with an IOP≥19 mm Hg achieved a reduction in IOP at their last collected follow-up.
CONCLUSIONS:The insertion of the iStent Trabecular Micro-Bypass stent effectively lowers IOP in pseudophakic patients with open-angle glaucoma. Although medication use was not significantly reduced postoperatively at 1 year, 80% of patients either experienced a reduction or no change in medication use. The safety profile appears favorable with a low rate of IOP spikes and only 1 patient requiring additional surgery.
INTRODUCTION:
Metastatic lesions of the pancreas present with varying clinical features and biological behaviors. They account for approximately 2% of all pancreatic lesions. This study was conducted ...to investigate metastatic pancreatic lesions distinctive clinical and EUS features compared to primary solid pancreatic neoplasms.
METHODS:
Patients who underwent EUS-FNA at a tertiary referral center between July 15
th
, 2011 and November 30
th
, 2017 for a solid pancreatic neoplasm were identified. Data on clinical features, cross-sectional imaging findings, EUS findings, and cytology results were collected. The clinical and EUS features in patients with metastatic pancreatic lesions were compared with those with intrinsic solid pancreatic tumors (adenocarcinoma and neuroendocrine tumors).
RESULTS:
8 patients who underwent 9 EUS-FNA procedures were diagnosed with a metastatic pancreatic lesion while 184 cases of solid primary pancreatic neoplasms (157 adenocarcinomas and 27 neuroendocrine tumors) were found. 5 of 8 metastatic pancreatic lesions were renal cell carcinoma (62.5%). Patients in the metastatic pancreatic lesions group were less likely to present with abdominal pain (33.3% vs. 71.7%,
P
= 0.014). Patients with metastatic pancreatic lesions also had lower CA 19-9 values (mean value: 82.50 U/mL vs. 4374 U/mL) and more frequently manifested as having multiple pancreatic locations involvement (55.6% vs. 4.9%).
CONCLUSION:
The most common metastatic pancreatic lesion is renal cell carcinoma. The clinical manifestation of metastatic pancreatic lesion patients is more insidious and is mostly identified by using surveillance imaging to identify the primary malignancy. A high index of clinical suspicion is needed for diagnosing these cases.
4504
Background: C, a multitargeted receptor tyrosine kinase inhibitor (TKI), promotes an immune-permissive environment that may enhance response to immune checkpoint inhibitors (ICIs). COSMIC-021, a ...multicenter phase 1b study, is evaluating C + A (anti‒PD-L1 therapy) in various solid tumors (NCT03170960). C + A demonstrated encouraging clinical activity in cohort 2 of COSMIC-021 in patients (pts) with UC previously treated with platinum-containing chemotherapy (chemo) (Pal S et al. ASCO 2020. Abstract 5013). Outcomes of C + A from 3 other UC cohorts (C3, C4, C5) are presented. Methods: Pts with inoperable locally advanced/metastatic UC with transitional cell histology and ECOG PS 0‒1 were eligible. Pts enrolled in C3 and C4 had no prior therapy and were cisplatin-based chemo ineligible (C3) or eligible (C4). C5 enrolled pts with one prior ICI and no prior VEGFR-TKI therapy. Pts received C 40 mg PO QD and A 1200 mg IV Q3W. CT/MRI scans were performed Q6W for first year and Q12W thereafter. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by investigator. Other endpoints: safety, duration of response (DOR), PFS, and OS. Results: Thirty pts each were enrolled in C3 and C4, and 31 in C5. Baseline characteristics for C3, C4, and C5, respectively: median age, 74 y, 66 y, 68 y; male, 67%, 73%, 55%; ECOG PS 1, 63%, 57%, 74%; lung/liver metastasis; 33%/17%, 40%/20%, 58%/23%; ≥3 tumor sites, 30%, 43%, 45%; bladder as primary site, 67%, 70%, 71%. As of Nov 30, 2021, the median follow-up for C3, C4, and C5 was 27.9, 19.1, and 32.9 mo, respectively, with 1, 6, and 1 pts on treatment. C + A demonstrated clinical benefit across all cohorts (Table). Most common treatment-related adverse events (TRAEs) of any grade across C3, C4, and C5, respectively, were diarrhea (43%, 33%, 35%), nausea (27%, 17%, 26%), fatigue (27%, 27%, 48%), and decreased appetite (33%, 27%, 39%); grade 3/4 TRAEs occurred in 63%, 43%, and 45%, and there was no grade 5 TRAE. Conclusions: C + A demonstrated encouraging clinical activity with manageable toxicity in inoperable locally advanced/metastatic UC as first-line systemic therapy in cisplatin-based chemo eligible/ineligible pts and as second- or later line in pts who received prior ICI. Clinical trial information: NCT03170960. Table: see text
9005
Background: C, a multitargeted receptor tyrosine kinase inhibitor (TKI), promotes an immune-permissive environment that may enhance ICI activity. COSMIC-021 (NCT03170960) is a multicenter phase ...1b study evaluating C + A in advanced solid tumors. In COSMIC-021, C + A demonstrated encouraging clinical activity in the cohort of pts with aNSCLC previously treated with ICIs (cohort 7 C7) (Neal. ASCO 2020. Abstr 9610). Updated outcomes of C + A in expanded C7 and outcomes for C alone in exploratory cohort 20 (C20) are presented. Methods: Pts with stage IV nonsquamous NSCLC without mutations in EGFR, ALK, ROS1, or BRAF V600E who progressed on one prior ICI and ≤2 prior lines of systemic anticancer therapy but no prior VEGFR TKI were eligible. Cohorts were not accrued contemporaneously. Pts received C 40 mg PO QD plus A 1200 mg IV Q3W (C7) or C alone 60 mg PO QD (C20). Primary endpoint was objective response rate (ORR) per RECIST v1.1 by investigator. Other endpoints included safety, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). CT/MRI scans were performed Q6W for the first year and Q12W thereafter. Results: A total of 81 and 31 pts received C + A and C, respectively; baseline characteristics were as follows: median age, 67 y, 70 y; male, 57%, 58%; ECOG PS 1, 64%, 71%; liver metastasis, 21%, 23%; refractory to prior ICI (progressive disease PD as best response), 32%, 45%; median number of prior systemic therapies, 3 and 3. As of Nov 30, 2021, median follow-up (range) (mo) was 24.7 (10.7, 42.8) and 21.5 (17.3, 27.6) for C + A and C, respectively, with 6 (7%) and 1 (3%) on study treatment. Clinical activity was observed for C + A and C alone (Table). Most common treatment-related adverse events (TRAEs) of any grade for C + A and C, respectively, included diarrhea (40%, 42%), nausea (22%, 45%), decreased appetite (25%, 26%), vomiting (14%, 23%), and fatigue (28%, 19%); grade 3/4 TRAEs occurred in 44% and 52% and one grade 5 TRAE occurred in each cohort (pneumonitis C + A and gastric ulcer hemorrhage C). Conclusions: C + A and C demonstrated encouraging clinical activity with manageable toxicity in pts with aNSCLC previously treated with ICIs. A phase 3 trial (CONTACT-01; NCT04471428) of C + A vs docetaxel is ongoing in NSCLC previously treated with an ICI and platinum-containing chemotherapy. Clinical trial information: NCT03170960. Table: see text
Abstract only
121
Background: Cabozantinib, a multiple receptor tyrosine kinase inhibitor, promotes an immune-permissive environment which may enhance the activity of immune checkpoint inhibitors. ...COSMIC-021 (NCT03170960) is evaluating the combination of cabozantinib with atezolizumab, an anti-PD-L1 inhibitor, in patients with advanced solid tumors. Outcomes in patients (pts) with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-containing therapy are presented. Methods: Pts with mCRC and an ECOG PS of 0–1 who progressed during or following systemic chemotherapy including fluoropyrimidine plus oxaliplatin or irinotecan were eligible. Up to 2 prior lines of anti-cancer therapy including EGFR-targeted therapy were allowed. Microsatellite instability high (MSI-H) and/or mismatch repair (MMR)-deficient pts were excluded. Pts received cabozantinib 40 mg PO QD plus atezolizumab 1200 mg IV Q3W. The primary endpoint was objective response rate (ORR) per RECIST 1.1 by investigator. Other endpoints included safety, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). CT/MRI scans were performed Q6W for the first year and Q12W thereafter. Results: 31 pts received cabozantinib plus atezolizumab (median age, 60 y range 31, 79; male, 58%; ECOG PS 1, 61%; 2 prior lines of therapy, 71%; prior EGFR inhibitor, 16%; ≥3 tumor sites, 52%; tumors in left colorectum, 71%). Median follow-up was 28.1 mo (range, 24.2, 31.3) as of July 21, 2021. Cabozantinib plus atezolizumab demonstrated clinical activity in pts with mCRC (Table). Patients with wild-type RAS (n = 12) had numerically longer PFS and OS and higher ORR vs those with mutations (n = 19) (Table). Treatment-related adverse events (TRAEs) of any grade occurred in 28 (90%); the most common were diarrhea (52%), fatigue (42%), and nausea (35%). Grade 3-4 TRAEs occurred in 16 (52%); the most common were hypertension (10%), fatigue (6%), and lipase increased (6%); no Grade 5 events were reported. Conclusions: Cabozantinib plus atezolizumab demonstrated encouraging clinical activity with manageable toxicity in pts with previously treated advanced non-MSI-H/MMR-proficient CRC. Clinical trial information: NCT03170960. Table: see text
Background: Cabozantinib is approved for previously treated advanced hepatocellular carcinoma (aHCC) and has been investigated in gastric cancer (GC) and gastroesophageal junction adenocarcinoma ...(GEJ). Atezolizumab plus bevacizumab is approved for unresectable or metastatic HCC untreated with prior systemic therapy. We evaluated efficacy and safety of cabozantinib plus atezolizumab in aHCC previously untreated with systemic anticancer therapy or previously treated GC/GEJ. Methods: COSMIC-021 (ClinicalTrials.gov, NCT03170960) is an open-label, phase 1b study in solid tumours with a dose-escalation stage followed by tumour-specific expansion cohorts, including aHCC (cohort 14) and GC/GEJ (cohort 15). Eligible patients were aged ≥18 years with measurable locally advanced, metastatic, or recurrent disease per RECIST version 1.1. Patients received oral cabozantinib 40 mg daily and intravenous atezolizumab 1200 mg once every 3 weeks until progressive disease or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate per RECIST version 1.1. Findings: Patients were screened between February 14, 2019, and May 7, 2020, and 61 (30 aHCC, 31 GC/GEJ) were enrolled and received at least one dose of study treatment. Median duration of follow-up was 31.2 months (IQR 28.5–32.7) for aHCC and 30.4 months (28.7–31.9) for GC/GEJ. Objective response rate was 13% (4/30, 95% CI 4–31) for aHCC and 0% (95% CI 0–11) for GC/GEJ. Six (20%) aHCC patients and three (10%) GC/GEJ patients had treatment-related adverse events resulting in discontinuation of either study drug. Interpretation: Cabozantinib plus atezolizumab had clinical activity with a manageable safety profile in aHCC previously untreated with systemic anticancer therapy. Clinical activity of cabozantinib plus atezolizumab was minimal in previously treated GC/GEJ. Funding: Exelixis, Inc., Alameda, CA, USA.
Cabozantinib is approved for previously treated advanced hepatocellular carcinoma (aHCC) and has been investigated in gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ). ...Atezolizumab plus bevacizumab is approved for unresectable or metastatic HCC untreated with prior systemic therapy. We evaluated efficacy and safety of cabozantinib plus atezolizumab in aHCC previously untreated with systemic anticancer therapy or previously treated GC/GEJ.
COSMIC-021 (ClinicalTrials.gov, NCT03170960) is an open-label, phase 1b study in solid tumours with a dose-escalation stage followed by tumour-specific expansion cohorts, including aHCC (cohort 14) and GC/GEJ (cohort 15). Eligible patients were aged ≥18 years with measurable locally advanced, metastatic, or recurrent disease per RECIST version 1.1. Patients received oral cabozantinib 40 mg daily and intravenous atezolizumab 1200 mg once every 3 weeks until progressive disease or unacceptable toxicity. The primary endpoint was investigator-assessed objective response rate per RECIST version 1.1.
Patients were screened between February 14, 2019, and May 7, 2020, and 61 (30 aHCC, 31 GC/GEJ) were enrolled and received at least one dose of study treatment. Median duration of follow-up was 31.2 months (IQR 28.5–32.7) for aHCC and 30.4 months (28.7–31.9) for GC/GEJ. Objective response rate was 13% (4/30, 95% CI 4–31) for aHCC and 0% (95% CI 0–11) for GC/GEJ. Six (20%) aHCC patients and three (10%) GC/GEJ patients had treatment-related adverse events resulting in discontinuation of either study drug.
Cabozantinib plus atezolizumab had clinical activity with a manageable safety profile in aHCC previously untreated with systemic anticancer therapy. Clinical activity of cabozantinib plus atezolizumab was minimal in previously treated GC/GEJ.
Exelixis, Inc., Alameda, CA, USA.
The study examined subjective well-being of 10- to 12-year-old children from rural South Korea (n=489) and rural United States (n=1286) using the Children's Worlds Survey within the framework of the ...ecological, relationship-based model of children's subjective well-being. Applying Structural Equation Modeling to the analysis, a large proportion of the variance was explained and children's subjective well-being was predicted in both countries by microsystem factors of family relationships, parent involvement, and school quality, and individual factors of age (younger), and gender (male). Additional microsystem factors predicting subjective well-being were neighborhood quality in South Korea, and peer relationships in the United States, which may reflect contextual influences of collectivistic (South Korea) and individualistic (United States) macrosystems.
•Children’s subjective well-being assessed in rural South Korea and rural United States.•In both countries, children tell us that families, parents, and schools matter for their well-being.•South Korea children reported neighborhood quality while United States children reported peer relationships as important to their well-being.•Macrosystems of collectivism in South Korea and individualism in the United States may provide context for microsystem structures affecting children’s well-being.
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