scholarly journals Pemetrexed Plus Platinum With or Without Pembrolizumab in Patients With Previously Untreated Metastatic Nonsquamous NSCLC: Protocol-Specified Final Analysis From KEYNOTE-189

2021 ◽  
Author(s):  
D. Rodríguez-Abreu ◽  
S.F. Powell ◽  
M.J. Hochmair ◽  
S. Gadgeel ◽  
E. Esteban ◽  
...  
Keyword(s):  
Final Analysis ◽  
Nonsquamous Nsclc

Final analysis of KEYNOTE-189: Pemetrexed-platinum chemotherapy (chemo) with or without pembrolizumab (pembro) in patients (pts) with previously untreated metastatic nonsquamous non-small cell lung cancer (NSCLC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9582-9582
Author(s):  
Delvys Rodriguez-Abreu ◽  
Steven Francis Powell ◽  
Maximilian Hochmair ◽  
Shirish M. Gadgeel ◽  
Emilio Esteban ◽  
...  
Keyword(s):  
Final Analysis ◽  
Phase Iii ◽  
First Line ◽  
Primary Endpoints ◽  
Improved Outcomes ◽  
Grade 3 ◽  
Platinum Chemotherapy ◽  
To Receive ◽  
Clinical Trial Information ◽  
Nonsquamous Nsclc

9582 Background: The phase III KEYNOTE-189 study (NCT02578680), showed significant improvements in OS and PFS with pembro + chemo vs placebo + chemo in pts with previously untreated metastatic nonsquamous NSCLC without sensitizing EGFR/ALK mutations. We report the protocol-specified final analysis of KEYNOTE-189. Methods: Pts were randomized 2:1 to receive 35 cycles of pembro 200 mg Q3W (n = 410) or placebo Q3W (n = 206) plus 4 cycles of pemetrexed (pem) and carboplatin/cisplatin followed by maintenance pem. Pts in the placebo + chemo arm could crossover to pembro upon PD. PFS and OS were primary endpoints; ORR was a secondary endpoint. PFS2 (time from randomization to objective tumor progression on next-line treatment/death), was an exploratory endpoint. Results: At data cutoff (May 20, 2019), median (range) time from randomization to data cutoff was 31.0 (26.5–38.8) mo. 17 pts in the pembro + chemo arm and 1 pt in the placebo + chemo arm were receiving initially assigned treatment; 84 pts crossed over to pembro. Median (95% CI) OS (22.0 [19.5–24.5] vs 10.6 [8.7–13.6] mo; HR 0.56 [95% CI, 0.46–0.69]) and PFS (9.0 [8.1–10.4] vs 4.9 [4.7–5.5] mo; HR 0.49 [95% CI, 0.41–0.59]) were longer with pembro + chemo vs placebo + chemo (Table). The 2-y OS rate was 45.7% vs 27.3% and the 2-y PFS rate was 22.0% vs 3.4%. ORR was 48.3% with pembro + chemo vs 19.9% with placebo + chemo. 56 pts in the pembro + chemo arm completed 35 cycles of pembro among whom ORR was 85.7% (4 CR, 44 PR, 8 SD) and median OS was not reached. 292 (72.1%) pts in the pembro + chemo arm and 135 (66.8%) pts in the placebo + chemo arm had grade 3–5 AEs. Conclusions: Pembro + chemo continued to show improved outcomes in OS, PFS, ORR and PFS2 compared with placebo + chemo, with manageable toxicity. These findings support first-line pembro + chemo in pts with previously untreated metastatic nonsquamous NSCLC. Clinical trial information: NCT02578680 . [Table: see text]

Preventive Debt Restructuring and the Nigerian Draft Insolvency Legislation: Lessons from a Comparative Perspective

2020 ◽  
Vol 28 (1) ◽  
pp. 66-84
Author(s):  
Sanford U. Mba
Keyword(s):  
European Union ◽  
Economic Crisis ◽  
Final Analysis ◽  
The European Union ◽  
Debt Restructuring ◽  
The Us ◽  
Financially Distressed ◽  
Bankruptcy Code ◽  
Second Chance

Recently, the Nigerian Senate passed the Bankruptcy and Insolvency (Repeal and Re-enactment) Bill. This is no doubt a welcome development following the continued demand by insolvency practitioners, academics and other stakeholders for such legislation. The call has not only been for the enactment of just about any legislation, but (consistent with the economic challenges faced by businesses in the country), one that is favourably disposed to the successful restructuring of financially distressed businesses, allowing them to weather the storm of (impending) insolvency, emerge from it and continue to operate within the economy. This article seeks to situate this draft legislative instrument within the present wave of preventive restructuring ably espoused in the European Union Recommendation on New Approaches to Business Rescue and to Give Entrepreneurs a Second Chance (2014), which itself draws largely from Chapter 11 of the US Bankruptcy Code. The article draws a parallel between the economic crisis that gave rise to the preventive restructuring approach of the Recommendation and the present economic situation in Nigeria; it then examines the chances of such restructuring under the Nigerian draft bankruptcy and insolvency legislation. It argues in the final analysis that the draft legislation does not provide for a prophylactic recourse regime for financially distressed businesses. Consequently, a case is made for such an approach.

Identification of Current Best Practices for Short-term Medical Mission Trips and Adherence to Current Common Principles and Guidelines

2020 ◽  
Vol 7 (2) ◽  
pp. 67-82
Author(s):  
Susan Andrews
Keyword(s):  
Best Practices ◽  
Global Health ◽  
Language Proficiency ◽  
Survey Methodology ◽  
Healthcare Providers ◽  
Final Analysis ◽  
Short Term ◽  
Convenience Sample ◽  
Operational Practices ◽  
Descriptive Survey

Background:  Recent reviews of published guidelines for conducting short-term medical missions (STMM) identify significant concerns about the lack of adherence and of formal regulations concurrent with the increasing number of individuals and organizations participating in STMM. Method: A descriptive survey methodology was used. A 44-item survey that identifies current practices utilized by healthcare providers (HCP) who have participated in STMM was used based on the literature and prior research, and distributed electronically to HCP participating in STTM to identify current best practices and compare findings with the most recent recommendations for short-term global health activities. A focus on current operational practices was surveyed and analyzed to develop operational recommendations for the ethical and safe care provided during STMM. Results: Eighty-seven surveys were included in the final analysis, with 33% (N=29) serving as coordinators for the trip. The majority of the respondents were female (67%) and the primary roles represented were: MD (N=17; 20%), nurse practitioner (N=20; 23%), and registered nurse (N=18; 21%). A majority (N=48; 67%) traveled to South America or Latin America, with 38% (N=33) having participated in four or more STMM. Language proficiency was reported as deficient (N=35; 40%) along with little or no knowledge of the basic culture (N=39; 45%). Additional data were collected on trip preparation, clinic operations, and outcomes follow up. Conclusions: Using a convenience sample, the results of the survey provide information on the current best practices utilized by HCP who have participated in STMM and compare the findings to assess for adherence with the most recent recommendations for short-term global health activities. There was variation in the degree to which HCP were knowledgeable about specific aspects related to knowledge of local culture, language proficiency, and adherence to recommended practices for STMM. Additional research on STMM is needed, along with further exploration of how evidence based practices for STMM can be implemented to improve access and safety to the care provided while in the host country.

PENGARUH PEMBERIAN KONSENTRASI BIOINSEKTISIDA DAUN DAN BIJI MIMBA (Azadirachta indica) TERHADAP KEMATIAN ULAT GRAYAK (Spodoptera litura)

2018 ◽  
Vol 10 (02) ◽  
Author(s):  
P. S. Ajiningrum ◽  
I. A. K. Pramushinta
Keyword(s):  
Spodoptera Litura ◽  
Leaf Extract ◽  
Final Analysis ◽  
Seed Extract ◽  
Mortality Data ◽  
Botanical Insecticide ◽  
Nutritional Content ◽  
Variant Analysis ◽  
The Tropics ◽  
Army Worm

Red spinach (Alternanthera amoena) is one of the vegetable commodities that many people in demand for consumption because of its high nutritional content. Efforts to increase the production of red spinach often experience various obstacles. The main obstacle that limits the productivity of red spinach in the tropics is the number of Plant Disturbing Organisms  in the form of pests and potential diseases that can attack and decrease the production of spinach. One of the pests that often attack spinach is the existence of army worm (Spodoptera litura F.). Therefore, farmers need a way to eradicate the pest. This research is experimental using Random Complete Group. The data obtained were analyzed with variant analysis (ANOVA) in one direction and continued with LSD (Least Significant Different) test. Provision of botanical insecticide done by spraying the extract of leaves and seeds mimba with concentration dose 0%, 5%, 10% and 15%. In the final analysis of mortality data of army worm (Spodoptera litura F.) treated with mimba leaf extract obtained significant value of 76.263 at a significant level of 0.05 so it can be concluded that there is influence of mimba leaf extract on mortality of army worm. In the final analysis of mortality data of army worm (Spodoptera litura F.) treated with mimba seed extract obtained significant value of 78.625 at a significant level of 0.05 so it can be concluded that there is an effect of mimba seeds extract on mortality army worm.   Keywords: mimba leaf extract,  mimba seed extract, red spinach (Alternanthera amoena), army worm (Spodoptera litura F.), botanical insecticide

Immuno-biological Assessments of Temporomandibular Joint Disease in Patients with Immune-mediated Rheumatic Conditions. A cross sectional study of 273 cases

2018 ◽  
Vol 68 (12) ◽  
pp. 2987-2991
Author(s):  
Cristina Iordache ◽  
Bogdan Vascu ◽  
Eugen Ancuta ◽  
Rodica Chirieac ◽  
Cristina Pomirleanu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Temporomandibular Joint ◽  
Final Analysis ◽  
Cross Sectional Study ◽  
Joint Disease ◽  
Sectional Study ◽  
Cross Sectional ◽  
Immune Parameters ◽  
Immune Mediated

Temporomandibular joint (TMJ) is commonly involved in various immune-mediated rheumatic disorders accounting for significant disability and impaired quality of life. The aim of our study was to assess inflammatory and immune parameters in patients with TMJ arthritis related to rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) and to identify potential relation with severity and dysfunction of TMJ pathology. We performed a cross-sectional study in a cohort of 433 consecutive RA, 32 JIA, 258 AS, and 103 PsA. Only patients presenting with clinically significant TMJ involvement (273) related to their rheumatic condition were included in the final analysis. TMJ involvement is traditionally described in chronic inflammatory rheumatic disorders, particularly in patients with higher levels of inflammation as detected in rheumatoid arthritis and psoriatic arthritis. Disease activity and severity, as well as biological and positive serological assessments (rheumatoid factor, anti-cyclic citrullinated peptide, IL-1) remain significant determinants of the severity of TMJ arthritis.

The “Green Revolution”, Ethics and Engineering in the USA

1992 ◽  
Vol 25 (9) ◽  
pp. 235-243 ◽  
Author(s):  
W. F. Garber ◽  
D. R. Anderson
Keyword(s):  
Green Revolution ◽  
Final Analysis ◽  
Clean Water ◽  
Ethical Decisions ◽  
Societal Needs ◽  
Economic Methods ◽  
The Usa ◽  
Scientific Technical ◽  
The Many ◽  
Technical Organizations

Ethical behavior applied to any activity within our society is, in the final analysis, the responsibility of each of the individuals involved in that activity. The “Green Revolution”, which erupted in the U.S.A. resulted in conditions which presented difficult ethical decisions to individuals and organizations working on ecological/environmental questions. The problems posed are best observed in an examination of the enforcement of the U.S.A. Clean Water Act where construction workers, the media, regulators, lawyers, politicians, environmentalists, treatment facility operators, scientists, engineers, academics and scientific/technical organizations all substantially benefited. Unfortunately this legislation does not require ecological or net environmental improvement. It requires equitable distribution of the costs of compliance throughout the nation. This has encouraged nonscientific standards and criteria, and a narrow focus, which have in turn resulted in both nonresponsible environmental results, and costs such that other important ecological/societal needs cannot be funded. All societies, whether developing or industrialized, must conserve their resources by utilizing scientific/economic methods to attack clean water and similar problems if they are to really improve their ecology/environment. Since this procedure is minimally used in the U.S.A., what should or can be the ethical positions of the many individuals and groups now benefiting by the present flawed system?

The Role of Atrial Fibrosis Detected by Delayed - Enhancement MRI in Atrial Fibrillation Ablation

2020 ◽  
Vol 16 (2) ◽  
pp. 135-144 ◽  
Author(s):  
Zsuzsanna Kis ◽  
Astrid Amanda Hendriks ◽  
Taulant Muka ◽  
Wichor M. Bramer ◽  
Istvan Kovacs ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Imaging Modality ◽  
Final Analysis ◽  
Atrial Fibrosis ◽  
Atrial Wall ◽  
Af Ablation ◽  
Left Atrial Wall ◽  
Cmr Imaging

Introduction: Atrial Fibrillation (AF) is associated with remodeling of the atrial tissue, which leads to fibrosis that can contribute to the initiation and maintenance of AF. Delayed- Enhanced Cardiac Magnetic Resonance (DE-CMR) imaging for atrial wall fibrosis detection was used in several studies to guide AF ablation. The aim of present study was to systematically review the literature on the role of atrial fibrosis detected by DE-CMR imaging on AF ablation outcome. Methods: Eight bibliographic electronic databases were searched to identify all published relevant studies until 21st of March, 2016. Search of the scientific literature was performed for studies describing DE-CMR imaging on atrial fibrosis in AF patients underwent Pulmonary Vein Isolation (PVI). Results: Of the 763 citations reviewed for eligibility, 5 articles (enrolling a total of 1040 patients) were included into the final analysis. The overall recurrence of AF ranged from 24.4 - 40.9% with median follow-up of 324 to 540 days after PVI. With less than 5-10% fibrosis in the atrial wall there was a maximum of 10% recurrence of AF after ablation. With more than 35% fibrosis in the atrial wall there was 86% recurrence of AF after ablation. Conclusion: Our analysis suggests that more extensive left atrial wall fibrosis prior ablation predicts the higher arrhythmia recurrence rate after PVI. The DE-CMR imaging modality seems to be a useful method for identifying the ideal candidate for catheter ablation. Our findings encourage wider usage of DE-CMR in distinct AF patients in a pre-ablation setting.

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