bluuebunny/crossref_metadata_2025_split huggingface dataset:
Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults: a randomised feasibility study
Authors: Shvedko Anastasia V. , Thompson Janice L. , Greig Carolyn A. , Whittaker Anna C. 
Published: May 2020

Abstract
Background
Low quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other health benefits. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness.

Methods
The PAIL feasibility study was a 12-week randomized controlled feasibility trial (RCT) conducted in Birmingham, United Kingdom, from February 2018 to August 2018, and ran in two waves of data collection. Eligible participants were community-dwelling adults aged 60 years and older, sedentary (less than 20 min of moderate-to-vigorous PA (MVPA) a week), and at risk of loneliness. The intervention included once-weekly group walk and health education workshop up to 90 min per session in total, with a wait-listed (WL) control group. The primary feasibility outcomes were to estimate recruitment, retention rates and adherence to the intervention. Secondary outcome measures (not blinded assessment) were body mass index, blood pressure, physical activity and psychosocial variables. Process and outcome evaluations were conducted using focus groups interviews. The recruitment and retention progression criteria for the definitive large-scale RCT was set a-priori.

Results
Forty-eight participants were recruited over 4 months with a recruitment rate of 25% (48/195); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomised into the intervention (n = 12) and WL control groups (n = 13). Participants were 25 older adults (mean (SD) 68.5(8.05) years), 14 (56%) female, and 18 (72%) white. At 12 weeks, 10/12 (83.3%) intervention and 10/13 (76.9%) control participants completed the final assessments. The average attendance rate was 58.3% for the intervention group (range 33.0%-75.0%) and 42.3% (range 23.1%–69.2%) among controls. The a priori recruitment and retention criteria for progression were not met. No serious adverse events occurred. The focus group results identified three themes which showed overall positive experiences of participation in PAIL in terms of (1) study design and intervention; (2) walking sessions; and (3) health education workshops.

Conclusions
The findings suggest that community-dwelling older adults at risk of loneliness found the intervention and measures acceptable and could safely participate. However, a more extensive and robust strategy would be needed to support adequate recruitment of lonely older adults and adherence into a definitive RCT.

Trial registration
Clinicaltrials.gov, NCT03458793
Improving the freight transport of a developing economy: a case of Boankra inland port
Authors: Ansah Richmond Kwesi , Obiri-Yeboah Kwabena , Akipelu Grace 
Published: May 2020

Abstract
Purpose
Shippers and Freight Forwarding Agents spend much time clearing their cargo from the Ghanaian ports. As a result, the cost of doing business in Ghana through the Tema and Takoradi ports is high. This research investigates the potential impact the establishment of an inland port will have on a reduction in congestion at the Tema and Takoradi ports and on the efficiency of the freight transport system.

Methodology/approach
This study used questionnaires to gather data through an experience survey conducted at the Ghana Sea Ports and Boankra inland port.

Findings
The study found out that for the inland Port to work effectively, there should be a connection from the Boankra inland port to the Takoradi and Tema Sea Ports as well as the container depots of the neighboring landlocked Sub-Saharan African Countries.. The study discovered that the implementation of the Boankra inland port will result in the decongestion and efficiency of Ghanaian seaports. Factors such as the increase in skills and experience of personnel; the use of management information systems; formulation of programmes and policies in decongesting the two main Ghanaian seaports; enhanced road network; adaptation of new technologies in the cargo handling process; and reduced bureaucracy in clearing processes at the ports are arbitrating factors through which the establishment of the Boankra inland port may have an impact on the seaports and the Freight transport industry at large. It was found that the challenges which may impede the improvement of freight transport in Ghana are inefficiencies and distortions in the trading system; unnecessary bureaucratic clearing processes; weak regulatory framework; Poor quality control;, inadequate staff; political interference, and lack of capital. It was found that for the Boankra Inland Port to be efficient, the officials and stakeholders must be trained; the various institutions in the transport chain must be empowered; corruption among port officials must be managed; there must be minimal political interference in the port operations; there must be more investment into the freight transport system; and there must be trade regulations to govern the freight transport system.

Originality
This novel study differentiates itself from existing studies on Port System by focusing on inland ports in Africa and their influence on the efficiency and decongestion of seaports.
Patient adherence to antihypertensive medications in upper Egypt: a cross-sectional study
Authors: Hussein Ahmed , Awad Mohammad Shafiq , Mahmoud Hossam Eldin M. 
Published: May 2020

Abstract
Background
Control of hypertension is a very difficult issue. Non-adherence to medications is a well-recognized factor contributing to uncontrolled hypertension. It is required to detect factors that affect adherence of patients to antihypertensive medications at different societies and good planning with the collaboration of governments, universities, media, pharmaceutical companies, and civil society to create intervention programs ensuring good adherence to medications. In our study, we aimed to determine different factors affecting adherence to antihypertensive medications in Upper Egypt societies.

Results
From September 2015 to September 2019, we conducted a large cross-sectional multi-center study among 2420 hypertensive patients attending the out-patient cardiac clinics at three different university hospitals. Data was collected through a personal interview with the patients using a questionnaire to cover a variety of items.
In the total of 2420 patients, we found that 1116 (46.12%) patients were adherent to medications and 1304 (53.88%) were non-adherent. From the final regression analysis of the results, we found that age > 65 years, illiterate patients, low income, associated comorbidities, using three or more antihypertensive pills, and living in rural areas were statistically significant socio-demographic factors associated with non-adherence to treatment. Also, missing doses of medication and lack of complying with dietary regimen were statistically significant behavioral causes associated with non-adherence.

Conclusion
Many factors are predictors of good adherence to antihypertensive drugs, including young age, urban residence, a smaller number of pills, absence of comorbid conditions, high income, and high education level. Also missed doses of drugs and absence of complies with dietary regimen were the significant causes of non-adherence. Health institutions and governmental efforts should be directed toward improving adherence by creating effective intervention programs targeting these factors. Therefore, it might be concluded that patients who are more health ware are more adherent to medications than non-health aware patients.
Ipilimumab (IPI) alone or in combination with anti-PD-1 (IPI+PD1) in patients (pts) with metastatic melanoma (MM) resistant to PD1 monotherapy.
Authors: Pires Da Silva Ines , Ahmed Tasnia , Lo Serigne , Reijers Irene L.M. , Weppler Alison , Betof Warner Allison , Patrinely James Randall , Serra-Bellver Patricio , Lebbe Celeste , Mangana Joanna , Nguyen Khang , Zimmer Lisa , Ascierto Paolo Antonio , Stout Dan , Lyle Megan , Klein Oliver , Gerard Camille Lea , Blank Christian U. , Menzies Alexander M. , Long Georgina V. 
Published: May 2020

10005 Background: PD1 induces long-term responses in approximately 30% of MM pts, however 2/3 are resistant (innate or acquired) and will require further treatment. A subset of these pts will benefit from IPI or IPI+PD1, but these pts are yet to be identified. We sought to determine; i) response rate (RR) and survival to IPI+/-PD1 after PD1 progression, and ii) clinical predictors of response and survival to IPI+/-PD1. Methods: MM pts resistant to PD1 and then treated with IPI+/-PD1 were studied. Demographics, disease characteristics and baseline blood parameters were examined. Univariate, multivariate and backward elimination technique analyses were performed to create predictive models of response and overall survival (OS). Results: Of 330 MM pts resistant to PD1 (median time to prog 2.9 months [0.5 – 42.3], 12% adjuvant, 88% metastatic; 70% innate, 30% acquired), 161 (49%) had subsequent IPI and 169 (51%) had IPI+PD1. Characteristics at start of IPI+/-PD1 were similar in IPI vs IPI+PD1 groups (stage M1D 27% vs 34%; elevated LDH 38% vs 40%), except IPI group had more ECOG ≥1 (60% vs 34%) and less BRAF mutation (mut) (21% vs 37%). Median follow-up from start of IPI+/-PD1 was 22.3 months (19.8 - 25.8); RR was 22%, higher in IPI+PD1 (31%) vs IPI (12%) (p < 0.01). PFS and OS at 1 year were 20% and 48%, respectively; better with IPI+PD1 (27%/57%) vs IPI (13%/38%) (p < 0.01). PD1 setting (adjuvant/metastatic) and response did not impact response to IPI+/-PD1. Most pts progressing on adjuvant PD1 had IPI+PD1 (88%) and RR was 33%. Neither the interval between PD1 and IPI+/-PD1 nor use of other drugs affected response to IPI+/-PD1. RR was similar in BRAF WT (23%) vs BRAF mut (RR 21%) pts. In BRAF WT pts, RR was higher with IPI+PD1 vs IPI (38% vs 9%, p < 0.01), while RR was similar with IPI (24%) or IPI+PD1 (19%) in BRAF mut pts. One third of BRAF mut pts had BRAF inhibitors (BRAFi) prior to IPI+/-PD1 and lower RR (13%) vs those without BRAFi (RR = 25%, p > 0.05). High grade (≥G3) toxicity (tox) was similar with IPI+PD1 (30%) or IPI (34%, p = 0.48), and was not associated with response. Stage III/M1A/M1B, normal LDH and treatment with IPI+PD1 were the best predictors of response (AUC = 0.69). These factors, in addition to sex (male), ECOG PS = 0, BRAF mut, progressed/recurred > 3 months on PD1, and absence of bone mets were the best predictors of longer OS (AUC = 0.74). Conclusions: In pts resistant to PD1, IPI+PD1 has higher RR, longer survival, yet similar high grade tox than IPI alone. Predictive models of response & survival will help select pts for IPI+/-PD1 after progressing on PD1.
Autoantibodies as predictors for survival and immune-related adverse events in checkpoint inhibition therapy of metastasized melanoma.
Authors: Hassel Jessica Cecile , Zucht Hans-Dieter , Mangana Joanna , Dummer Reinhard , Pföhler Claudia , Wistuba-Hamprecht Kilian , Weide Benjamin , Hakim-Meibodi Lara Elena , Meier Friedegund Elke , Schulz Carsten , Bräutigam Manuel , Budde Petra 
Published: May 2020

10011 Background: Increasing evidence suggests that the B cell response in cancer patients is an important component of anti-tumour immunity. Autoantibodies targeting tumour and self-antigens may serve as biomarkers of anti-tumour and auto-immunity. As they can be measured in patient' sera, they have great potential as clinical routine biomarkers. The objective of this study was to explore if autoantibodies are associated with survival and immune related adverse events (irAE) in patients with metastatic melanoma under checkpoint inhitibor (CPI) therapy. Methods: Pre-treatment serum samples from 333 metastatic melanoma patients receiving CPI therapy at 5 European centers were retrospectively used to identify autoantibody signatures for survival and irAE. We designed a cancer immunotherapy antigen array comprising 832 autoimmune and tumour antigens as well as immune and cancer pathway proteins. Statistical tests were separately performed for patients treated with anti-CTLA4 (alone or in combination) and with anti-PD1 antibody monotherapy. Cox-regression analysis and univariate statistical tests were applied for biomarker discovery. Progression free and overall survival was measured from treatment initiation to tumor progression or death date. irAE were recorded including onset date and grade (CTC-AE). Results: For each therapy group we identified a set of autoantibody reactivities in untreated melanoma patients that were associated with the development of irAEs and/or survival. The identified autoantibodies target a diverse set of antigens comprising neoantigens (p53), cancer testis antigens (MAGEB4), paraneoplastic antigens (gephyrin), autoantigens (ribosomal proteins, Nor-90) and FGFR1. Autoantigens that correlated with irAE and survival were e.g. anti-MAGEB4 and anti-FGFR1. Elevated anti-MAGEB4 pre-treatment levels were associated with longer overall survival (p = 0.002, HR = 0.77) and the development of irAEs (p = 0.002, HR = 1.27) in ipilimumab +/- nivolumab treated patients. Higher pre-treatment anti-FGFR1 antibodies were associated with shorter survival (p = 0.008, HR = 1.27) and a lower a lower frequency of irAEs (p = 0.04, HR = 0.69) in these patients. Conclusions: We identified autoantibody targets suggesting a diverse B cell response to antigens expressed in tumours and those associated with autoimmunity. Depending on the specific antigen, the immune response towards those antigens may be associated with anti-tumour or pro-tumour responses.
The nature and management of acquired resistance to PD1-based therapy in melanoma.
Authors: Hepner Adriana , Versluis Judith M. , Gerard Camille Lea , Brown Lauren Julia , Wallace Roslyn , Bhave Prachi , Jansen Yanina , Klein Oliver , Warner Allison Betof , Mangana Joanna , Atkinson Victoria , Lo Serigne , Long Georgina V. , Johnson Douglas Buckner , McQuade Jennifer Leigh , Ascierto Paolo Antonio , Zimmer Lisa , Lebbe Celeste , Blank Christian U. , Menzies Alexander M. 
Published: May 2020

10014 Background: Anti-PD1 therapy (PD1), either alone or in combination with anti-CTLA4, has high initial response rates, but 20% of patients (pts) with complete response (CR) and 60% with partial response (PR) experience disease progression by 5 years. The nature and best management of this acquired resistance (AR) remains unknown. Methods: Consecutive pts from 16 centers who achieved CR or PR to PD1-based therapy and who later progressed were examined. Demographics, disease characteristics, nature of progression and subsequent treatments were examined. Results: 300 pts were identified, median age was 64y, 133 (44%) BRAF mutant and 55 (18%) had target therapy (TT) prior to PD1-based therapy. 173 (58%) received PD1 alone, 114 (38%) PD1+CTLA4 and 13 (4%) PD1 + an investigational drug. 89 (30%) pts had CR, 210 (70%) pts had PR. Median time to AR was 12.6 mo (95% CI, 11.3, 14.2) and 142 (47%) progressed while still on drug. Most pts (N = 194, 65%) progressed in a single organ site, and in a solitary lesion (N = 154, 51%). 38 (25%) progressed in the brain only. AR was in new lesion in 136 (45%), existing lesions in 106 (35%), and both new and existing lesions in 58 (19%). For those with solitary lesion progression, 51 (33%) had local (L) treatment alone, 54 (35%) had local and systemic (L+ST), 46 (30%) had systemic therapy alone (ST) and 3 (2%) had no further treatment (BSC). If progression was non-solitary, 89 (61%) had ST, 33 (23%) L+ST, 17 (12%) L alone and 7 (5%) BSC. For those who received ST after AR, first ST (ST1) was PD1 alone in 130 (51%) [53, 41% continuation, 77, 59% reinduction], PD1+CTLA4 in 31 (12%), CTLA4 alone in 15 (6%), targeted therapy in 49 (19%) and investigational drugs in 29 (11%). Median follow-up from AR was 20 mo (95% CI 18-22). The ORR to ST1 was 46% for PD1 alone (56% continuation, 42% reinduction), 56% for PD1+ CTLA4, 0% for CTLA4 alone, 20% for investigational drugs and 67% for TT. Median OS from AR was 38 mo (95% CI, 34.6-NR). 2y-OS was 69% in those with solitary progression compared to 55% for the pts that had a non-solitary progression (p < 0.001). There was no difference in OS by ST1 class. Detailed analyses including nature and management of AR while on PD1 or after discontinuation will be presented, as will site-specific AR outcomes. Conclusions: Acquired resistance to PD1-based therapy in melanoma is usually oligometastatic, occurring approximately one year after PD1 start. Most pts with isolated progression have local therapy, and the most frequent subsequent systemic therapy is PD1-alone. Patients with AR can have meaningful survival, with median OS over 3 years from AR.
Does body mass index really predict the response to systemic therapies in metastatic melanoma: A multicenter study from the MelBase French National Cohort?
Authors: Di Filippo Yoann , Dalle Stéphane , Mortier Laurent , Dutriaux Caroline , Dalac Sophie , Leccia Marie Thérèse , Legoupil Delphine , Saiag Philippe , Brunet-Possenti Florence , Arnault Jean-Philippe , Maubec Eve , Granel-Brocard Florence , De Quatrebarbes Julie , Aubin Francois , Lesimple Thierry , Stoebner Pierre-Emmanuel , Lefevre Wendy , Dereure Olivier , Lebbe Celeste , Montaudie Henri ,   Team Melbase, Groupe de Canérologie Cutanée
Published: May 2020

10031 Background: Obesity is an established risk factor for several cancers and higher body mass index (BMI) is associated with poor prognosis. These data are still debated in melanoma. Furthermore, recently the concept of “obesity paradox” has emerged. In a large cohort published by McQuade JL et al, higher BMI was associated with better survival in patients with metastatic melanoma (MM) especially for those treated with targeted therapy (TT) and immune checkpoint inhibitors (ICI). We studied the association between BMI and progression-free survival (PFS) and overall survival (OS) in patients with MM treated with systemic therapies. Methods: This study was conducted from the prospective MelBase cohort (NCT02828202). Patients with MM treated with first-line ICI, TT, or CT were included. BMI was categorized by WHO criteria. Underweight patients were excluded. The co-primary outcomes were the associations between BMI and PFS or OS, stratified by treatment, sex and age. Multivariate analyses were performed. Results: A total of 1214 patients were analyzed. The majority of them were treated with ICI, followed by TT. Obese patients represented 22% of cohort (Table). Median follow-up was 13.5 months. The patients who were overweight or obese did not have different PFS (p = 0.88) or OS (p = 0.25) than patients with normal BMI. Stratifying this cohort by treatment received, age, sex and others parameters (such as LDH, number of metastatic site) did not revealed any difference. Multivariate analysis did not change the results. Conclusions: BMI was not associated with clinical outcomes in our cohort, especially in ICI and TT groups. Thus, we did not confirm the results presented by McQuade Jl et al. with a cohort quite similar in term of size. Because BMI is too simplistic and then an imperfect measure of body composition, the published data are not reproducible. We caution the oncologists, about BMI as valuable predictive marker of survival for melanoma patients. [Table: see text]
Health-related quality of life (HRQL) in patients with advanced cutaneous squamous cell carcinoma (CSCC) treated with cemiplimab: Post hoc exploratory analyses of a phase II clinical trial.
Authors: Migden Michael Robert , Rischin Danny , Sasane Medha , Mastey Vera , Pavlick Anna , Schmults Chrysalyne D. , Chen Zhen , Guminski Alexander David , Hauschild Axel , Bury Denise , Chang Anne Lynn S. , Rabinowits Guilherme , Ibrahim Sherrif F. , Lowy Israel , Fury Matthew G. , Li Siyu , Chen Chieh-I 
Published: May 2020

10033 Background: Cemiplimab-rwlc (cemiplimab), a PD-1 Inhibitor, showed a robust clinical response in patients (pts) with metastatic (mCSCC) or locally advanced (laCSCC) CSCC not eligible for curative surgery/radiation. This post hoc exploratory analysis examined data from the EORTC cancer specific 30-item HRQL questionnaire (QLQ-C30) for pts participating in a cemiplimab phase 2 clinical trial (clinicaltrials.gov NCT02760498). Methods: Adults (N = 193) with invasive CSCC, ≥1 lesion and ECOG performance status ≤1 received IV cemiplimab 3mg/kg q2w (mCSCC n = 59; laCSCC n = 78) or 350mg q3w (mCSCC n = 56). At baseline (BL) and day 1 of each treatment cycle, pts were administered the QLQ-C30. Mixed effects repeated measures (MMRM) models were used to estimate mean change from BL to cycle 5 (C5) for domains/items of the QLQ-C30. For pts with data from BL to C5, the proportion who reported clinically meaningful improvement or worsening (≥10 points) or maintenance (those who did not have ≥10 point change) on each domain was determined for combined and individual treatment groups. Results: BL scores indicated moderate to high levels of functioning and low symptom burden. From BL to C5, a clinically meaningful improvement in pain score was observed (least squares [LS] mean [standard error] change -12.1 [2.1]; P< .0001); other domains/items remained stable or showed a trend towards improvement (LS mean changes < 10 points). By C5, the majority of pts experienced clinically meaningful improvement or remained stable across key domains (Table). Similar findings were observed on individual symptoms (85%-94% for dyspnea, nausea/vomiting, diarrhea, constipation, appetite loss) and in each treatment group. Conclusions: Cemiplimab-treated patients achieved a clinically meaningful reduction in pain and most pts either improved or maintained their HRQL, function with low symptom burden. Clinical trial information: NCT02760498. [Table: see text]