The aim of this study was to determine the feasibility and acceptability of collecting outcome data from parents of very low birth weight (VLBW) infants and to explore the psychological and social ...adaptation of fathers. Questionnaires were distributed to 38 parents of VLBW infants and 36 parents of term infants within a hospital Neonatal Intensive Care Unit. Field notes were also taken. Parents indicated collecting outcome data in this population was feasible and acceptable, but barriers and difficulties in data collection were identified, particularly for fathers. Furthermore, parents highlighted a lack of emotional support for fathers. In conclusion, research with parents of VLBW infants should happen with consultation, flexibility and measures designed specifically for this population.
Guidelines addressing melanoma in-transit metastasis (ITM) recommend immune checkpoint inhibitors (ICI) as a first-line treatment option, despite the fact that there are no efficacy data available ...from prospective trials for exclusively ITM disease. The study aims to analyze the outcome of patients with ITM treated with ICI based on data from a large cohort of patients treated at international referral clinics.
A multicenter retrospective cohort study of patients treated between January 2015 and December 2020 from Australia, Europe, and the USA, evaluating treatment with ICI for ITM with or without nodal involvement (AJCC8 N1c, N2c, and N3c) and without distant disease (M0). Treatment was with PD-1 inhibitor (nivolumab or pembrolizumab) and/or CTLA-4 inhibitor (ipilimumab). The response was evaluated according to the RECIST criteria modified for cutaneous lesions.
A total of 287 patients from 21 institutions in eight countries were included. Immunotherapy was first-line treatment in 64 (22%) patients. PD-1 or CTLA-4 inhibitor monotherapy was given in 233 (81%) and 23 (8%) patients, respectively, while 31 (11%) received both in combination. The overall response rate was 56%, complete response (CR) rate was 36%, and progressive disease (PD) rate was 32%. Median PFS was ten months (95% CI 7.4–12.6 months) with a one-, two-, and five-year PFS rate of 48%, 33%, and 18%, respectively. Median MSS was not reached, and the one-, two-, and five-year MSS rates were 95%, 83%, and 71%, respectively.
Systemic immunotherapy is an effective treatment for melanoma ITM. Future studies should evaluate the role of systemic immunotherapy in the context of multimodality therapy, including locoregional treatments such as surgery, intralesional therapy, and regional therapies.
•The efficacy of immunotherapy for melanoma in-transit metastases is unknown.•An international multicenter retrospective cohort study.•Systemic immunotherapy is an effective treatment for melanoma in-transit metastases.
The COVID Stress Scales (CSS) assess health- and contamination-related distress in the face of a medical outbreak like the ongoing COVID-19 pandemic. Though the CSS is translated into 21 languages, ...it has not been validated in a Swedish national sample.
Our general objective is to provide a translation, replication, and validation of the CSS and test its convergent- and discriminant validity in relation to anxiety, health anxiety, depression, and stress in the general Swedish population. We also present latent psychometric properties by modelling based on item response theory.
Participants consisted of 3044 Swedish adults (> 18 years) from a pre-stratified (gender, age, and education) sample from The Swedish Citizen Panel. Mental health status was assessed by validated instruments, including the CSS, PHQ-4, SHAI-14, and PSS-10.
Results indicate that our Swedish translation of CSS has good psychometric properties and consists of 5 correlated factors.
The CSS is useful either as a unidimensional or multidimensional construct using the CSS scales to measure key facets of pandemic-related stress.
The findings support the cross-cultural validity of the CSS and its potential utility in understanding many of the emotional challenges posed by the current and future pandemics.
We aimed to develop a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) module tailored for patients with advanced (resectable or unresectable stage III/IV) ...melanoma receiving immune checkpoint inhibitors or targeted therapy.
Following the EORTC QoL Group module development guidelines, we conducted phases 1 and 2 of the development process. In phase 1, we generated a list of health-related (HR)QoL issues through a systematic literature review and semi-structured interviews with healthcare professionals (HCPs) and patients with advanced melanoma. In phase 2, these issues were converted into questionnaire items to create the preliminary module.
Phase 1: we retrieved 8006 articles for the literature review, of which 35 were deemed relevant, resulting in 84 HRQoL issues being extracted to create the initial issue list. Semi-structured interviews with 18 HCPs and 28 patients with advanced melanoma resulted in 28 issues being added to the initial issue list. Following EORTC module development criteria, 26 issues were removed, and two issues were added after review by patient advocates.
Phase 2: To ensure uniformity and avoid duplication, 16 issues were consolidated into eight items. Additionally, an independent expert contributed one new item, resulting in a preliminary module comprising 80 HRQoL items.
We identified a range of HRQoL issues (dry skin, xerostomia, and arthralgia) relevant to patients with stage III/IV melanoma. Future module development phases will refine the questionnaire. Once completed, this module will enable standardized assessment of HRQoL in patients with (locally) advanced melanoma.
•We aimed to create a HRQoL module tailored for patients with advanced melanoma.•We identified the most important symptomatic HRQoL issues associated with ICI and TT.•Our study highlights the benefit of using a disease-specific instrument to measure HRQoL.
Background
For patients with sentinel lymph node (SLN)‐positive cutaneous melanoma, the Second Multicenter Selective Lymphadenectomy trial demonstrated equivalent disease‐specific survival (DSS) with ...active surveillance using nodal ultrasound versus completion lymph node dissection (CLND). Adoption and outcomes of active surveillance in clinical practice and in adjuvant therapy recipients are unknown.
Methods
In a retrospective cohort of SLN‐positive adults treated at 21 institutions in Australia, Europe, and the United States from June 2017 to November 2019, the authors evaluated the impact of active surveillance and adjuvant therapy on all‐site recurrence‐free survival (RFS), isolated nodal RFS, distant metastasis‐free survival (DMFS), and DSS using Kaplan‐Meier curves and Cox proportional hazard models.
Results
Among 6347 SLN biopsies, 1154 (18%) were positive and had initial negative distant staging. In total, 965 patients (84%) received active surveillance, 189 (16%) underwent CLND. Four hundred thirty‐nine patients received adjuvant therapy (surveillance, 38%; CLND, 39%), with the majority (83%) receiving anti–PD‐1 immunotherapy. After a median follow‐up of 11 months, 220 patients developed recurrent disease (surveillance, 19%; CLND, 22%), and 24 died of melanoma (surveillance, 2%; CLND, 4%). Sixty‐eight patients had an isolated nodal recurrence (surveillance, 6%; CLND, 4%). In patients who received adjuvant treatment without undergoing prior CLND, all isolated nodal recurrences were resectable. On risk‐adjusted multivariable analyses, CLND was associated with improved isolated nodal RFS (hazard ratio HR, 0.36; 95% CI, 0.15‐0.88), but not all‐site RFS (HR, 0.68; 95% CI, 0.45‐1.02). Adjuvant therapy improved all‐site RFS (HR, 0.52; 95% CI, 0.47‐0.57). DSS and DMFS did not differ by nodal management or adjuvant treatment.
Conclusions
Active surveillance has been adopted for most SLN‐positive patients. At initial assessment, real‐world outcomes align with randomized trial findings, including in adjuvant therapy recipients.
Lay Summary
For patients with melanoma of the skin and microscopic spread to lymph nodes, monitoring with ultrasound is an alternative to surgically removing the remaining lymph nodes.
The authors studied adoption and real‐world outcomes of ultrasound monitoring in over 1000 patients treated at 21 centers worldwide, finding that most patients now have ultrasounds instead of surgery.
Although slightly more patients have cancer return in the lymph nodes with this strategy, typically, it can be removed with delayed surgery.
Compared with up‐front surgery, ultrasound monitoring results in the same overall risk of melanoma coming back at any location or of dying from melanoma.
In an international cohort of more than 1000 patients with sentinel node‐positive melanoma treated at 21 melanoma centers since the publication of landmark trials supporting active regional nodal basin surveillance using ultrasound as an alternative to completion lymph node dissection, there has been high adoption of active surveillance. Compared with patients who undergo completion lymph node dissection, those who undergo active surveillance have more nodal recurrences but comparable recurrence‐free and disease‐specific survival at this early assessment, including those who receive adjuvant therapy without undergoing prior completion lymph node dissection.
In sentinel lymph node (SLN)-positive melanoma, two randomized trials demonstrated equivalent melanoma-specific survival with nodal surveillance vs completion lymph node dissection (CLND). Patients ...with microsatellites, extranodal extension (ENE) in the SLN, or >3 positive SLNs constitute a high-risk group largely excluded from the randomized trials, for whom appropriate management remains unknown.
SLN-positive patients with any of the three high-risk features were identified from an international cohort. CLND patients were matched 1:1 with surveillance patients using propensity scores. Risk of any-site recurrence, SLN-basin–only recurrence, and melanoma-specific mortality were compared.
Among 1,154 SLN-positive patients, 166 had ENE, microsatellites, and/or >3 positive SLN. At 18.5 months median follow-up, 49% had recurrence (vs 26% in patients without high-risk features, p < 0.01). Among high-risk patients, 52 (31%) underwent CLND and 114 (69%) received surveillance. Fifty-one CLND patients were matched to 51 surveillance patients. The matched cohort was balanced on tumor, nodal, and adjuvant treatment factors. There were no significant differences in any-site recurrence (CLND 49%, surveillance 45%, p = 0.99), SLN-basin–only recurrence (CLND 6%, surveillance 14%, p = 0.20), or melanoma-specific mortality (CLND 14%, surveillance 12%, p = 0.86).
SLN-positive patients with microsatellites, ENE, or >3 positive SLN constitute a high-risk group with a 2-fold greater recurrence risk. For those managed with nodal surveillance, SLN-basin recurrences were more frequent, but all-site recurrence and melanoma-specific mortality were comparable to patients treated with CLND. Most recurrences were outside the SLN-basin, supporting use of nodal surveillance for SLN-positive patients with microsatellites, ENE, and/or >3 positive SLN.
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OBJECTIVESCompare mental health, stress, and well-being in the Swedish population as measured before and during the COVID-19 pandemic. METHODSRepeated cross-sectional design using data measured ...before (Jan-2019; n = 2791) and during (Oct/Nov-2020; n = 2926) COVID-19 pandemic in Swedish population-representative cohorts. Following constructs were measured: anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory-II), stress (Perceived Stress Scale-10 items), health-related quality of life (HRQOLFunctional Assessment of Cancer Therapy-General Population) and self-rated health (SRH) was assessed with a single-item question. RESULTSWhen adjusting for age, sex, education, and income there were significantly higher levels of anxiety (M̂ = 9.15 vs. 8.48, p < 0.01) and depression (M̂ = 3.64 vs. 3.30, p = 0.03), lower levels of stress (M̂ = 14.06 vs. 14.91, p < 0.001), but worsened HRQOL (M̂ = 76.40 vs. 77.92, p < 0.01) and SRH (M̂ = 6.91 vs. 7.20, p < 0.001), observed in 2020 compared to 2019. For the negative effects seen in anxiety, depression, HRQOL, and SRH, higher income and education had a protective effect. The decrease in stress was also correlated with higher income. CONCLUSIONSThe COVID-19 pandemic led to a small but significant worsening in mental health and well-being in the general Swedish population, where higher socioeconomic status seemed to have a protective effect.
Preclinical studies have suggested that epigenetic therapy could enhance immunogenicity of cancer cells. We report the results of the PEMDAC phase 2 clinical trial (n = 29; NCT02697630) where the ...HDAC inhibitor entinostat was combined with the PD-1 inhibitor pembrolizumab in patients with metastatic uveal melanoma (UM). The primary endpoint was objective response rate (ORR), and was met with an ORR of 14%. The clinical benefit rate at 18 weeks was 28%, median progression free survival was 2.1 months and the median overall survival was 13.4 months. Toxicities were manageable, and there were no treatment-related deaths. Objective responses and/or prolonged survival were seen in patients with BAP1 wildtype tumors, and in one patient with an iris melanoma that exhibited a UV signature. Longer survival also correlated with low baseline ctDNA levels or LDH. In conclusion, HDAC inhibition and anti-PD1 immunotherapy results in durable responses in a subset of patients with metastatic UM.Trial registration ClinicalTrials.gov registration number: NCT02697630 (registered 3 March 2016). EudraCT registration number: 2016-002114-50.
No review has used a meta-analytic approach to estimate common odds ratios (ORs) for the effect of acute use of alcohol (AUA) on suicide attempts. We aim to report the results of the first ...meta-analysis of controlled epidemiological studies on AUA and suicide attempt.
The English-language literature on Medline, PsycINFO and Google Scholar was searched for original articles and critical review on AUA and suicide attempt (period 1996-2015). Studies had to report an OR estimate for this association. Common ORs and 95% confidence intervals (CIs) from random effects in meta-analyses for any AUA and two levels of alcohol use on suicide attempt were calculated.
In all, seven studies provided OR estimates for the likelihood of suicide attempt by AUA, compared with those who did not drink alcohol. Studies used case-control (n 3) and case-crossover designs (n 4). Meta-analysis revealed a common OR of 6.97 (95% CI 4.77-10.17) for any AUA. Using four studies, 'low levels of acute drinking' resulted in an OR of 2.71 (95% CI 1.56-4.71) and 'high levels' had an OR of 37.18 (95% CI 17.38-79.53).
AUA is associated with increased likelihood of a suicide attempt, particularly at high doses. Such data should be incorporated into estimates of the burden of disease associated with alcohol use, which are currently limited by a consideration of only alcohol's chronic effects. Future research should focus on the mechanisms through which AUA confers risk for attempt.
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