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Background and Purpose: In this study, we conducted a population-based retrospective audit of heart doses for high-risk breast cancer (BC) over a nine-year period in patients treated with adjuvant CT-based radiotherapy in a comprehensive and homogenized national BC cohort. Additionally, this serves as a demonstration of performing large scale audits with consistent delineations created by an auto-segmentation tool., Materials and Methods: High-risk BC patients treated with adjuvant radiotherapy in the period 2008-2016 from all seven radiotherapy centres in Denmark were included. A homogenized cohort was created using an inhouse developed auto-segmentation tool. The homogenized cohort volume and planned doses (mean heart dose (MHD), V20Gy and V40Gy) were evaluated. Volumes and dose metrics were compared for clinical and homogenized heart volumes., Results: Among 6925 patients, 5589(81 %) had a clinical heart delineation. The median delineated heart volume increased from 531.9 ml (2008) to 638.5 ml (2016) (p < 0.01). The median MHD for the homogenized cohort was 1.58 Gy (2008-2016) with an overall decreasing trend, 2.14 Gy in left- and 1.08 Gy in right-sided patients. The median MHD in the clinically delineated hearts was 0.01 Gy lower than the planned median MHD in the homogenized cohort., Conclusion: During 2008-2016 the planned heart dose has been low across the population. A volume increase was observed in the clinically delineated hearts, however the median MHD in the homogenized cohort was low, with 1.58 Gy. The study demonstrated the possibilities for full population-based and consistent dose audit by using auto-segmentation tools., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Diagnostic and therapeutic management of patients with head and neck squamous cell carcinoma of unknown primary (HNSCCUP) remains a challenge. The aim of the present phase IV study was to assess adherence to the current Danish guidelines and evaluate the treatment outcome in HNSCCUP patients., Materials and Methods: Prospectively collected data in the DAHANCA database from patients treated between 2014 and 2020 was evaluated. The median follow-up was 6.7 years. Treatment included definitive neck dissection (dND), primary (chemo-)radiotherapy ((C-)RT), neck dissection (ND) followed by postoperative (C-)RT (ND + (C-)PORT). Outcome were reported as five-year estimates of loco-regional failure (LRF), ultimate LRF (ULRF), disease specific mortality (DSM), overall survival (OS), and toxicity scores ≥ 3., Results: A total of 288 patients were treated, of which 254 (88 %) received treatment with curative intent and were eligible for adherence assessment. These were allocated to dND (n = 60), (C-)RT (n = 81) and ND + (C-)PORT (n = 113). The HPV/p16 status was known in 95 % of patients with 109 (43 %) positive cases. The 5-year LRF, DSM, and OS for patients treated with curative intent was 22 %, 15 % and 73 %, and in patients with p16 positive disease 16 %, 5 %, and 85 %. The overall guideline adherence was 76 % (192/254). In the adherent group the LRF, ULRF, DSM, and OS were 22 %, 11 %, 16 %, and 73 %, respectively., Conclusion: The study revealed good treatment outcome measures in HNSCCUP patients subject to the Danish guidelines, comparable to other head and neck cancer patients. The observed guideline-deviations did not affect outcome., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Malignant pleural effusion (MPE) is common in individuals with cancer and typically reflects advanced disease. Most cases are symptomatic, with dyspnea and pain having a severe effect on the patient's quality of life (QOL). The management of MPE aims to relieve symptoms, improve QOL, prevent repeated pleural interventions, and minimize hospital admissions. Common treatments for MPE that provide symptomatic relief include thoracentesis, chemical (talc) pleurodesis, or indwelling pleural catheters (IPCs). Talc pleurodesis and IPCs are the mainstay of treatment but represent very different treatment strategies: talc pleurodesis is an inpatient procedure, whereas IPCs are an ambulatory strategy. Given their similar efficacy, treatment decisions in MPE are often determined by other factors, such as the patient's clinical characteristics, individual treatment goals, and preferences for hospital-based or home-based care. We provide a summary of the evidence for different interventions for treating MPE and compare recommendations from the major American, European, British, and Spanish guidelines regarding when to consider each treatment. We highlight specific challenging treatment scenarios and key clinical considerations that may influence treatment decisions for different patients. There are barriers to accessing and receiving evidence-based care. Patients with symptomatic MPE would benefit from early referral from oncology teams to pleural services. We provide best practice recommendations for optimal referral and coordination of care to ensure that patients receive maximum benefits from their interventions.

Purpose: Remote symptom monitoring of patients with cancer has previously shown potential for improving clinical outcomes. This study aimed to evaluate the effects of remote symptom monitoring in patients with lung cancer after palliative induction treatment., Methods: In a Danish multicenter randomized controlled trial, patients were randomly assigned 1:1 to remote symptom monitoring (intervention arm) added to standard of care versus standard of care (control arm). Key eligibility criteria were stage III-IV lung cancer (small cell lung cancer and non-small cell lung cancer), Eastern Cooperative Oncology Group performance status ≤2, and no sign of disease progression after initial induction treatment. Patients in the intervention arm completed a weekly electronic questionnaire, assessing 14 common symptoms related to lung cancer. When a patient reported a severity exceeding a predefined threshold, the patient was subsequently contacted by phone to address potential clinical needs. Symptom monitoring was discontinued after progression. The primary outcome was overall survival (OS). Secondary measures included assessment of health-related quality of life (HRQoL)., Results: Of 494 randomly assigned patients, 240 were assigned to the intervention arm and 254 were assigned to the control arm. At a median follow-up of 3.5 years, symptom monitoring did not significantly improve OS compared with standard care (hazard ratio [HR], 0.93 [95% CI, 0.75 to 1.16]; P = .53). Exploratory subgroup analyses indicated improved survival for patients treated with carboplatin/vinorelbine (HR, 0.67 [95% CI, 0.45 to 0.98]; P = .04) and in departments with previous implementation of patient-reported outcomes (HR, 0.66 [95% CI, 0.44 to 0.98]; P = .04). HRQoL analyses did not reveal clinically meaningful effects., Conclusion: In the Danish health care system, remote symptom monitoring did not improve OS but led to modest improvements in HRQoL for patients with advanced lung cancer.

Introduction: Observational studies have shown that more educated people are at lower risk of developing type 2 diabetes (T2D). However, robust study designs are needed to investigate the likelihood that such a relationship is causal. This study used genetic instruments for education to estimate the effect of education on T2D using the Mendelian randomisation (MR) approach., Methods: Analyses have been conducted in the European Prospective Investigation into Cancer and Nutrition (EPIC)-InterAct study (more than 20 000 individuals), a case-cohort study of T2D nested in the EPIC cohort. Education was measured as Years of Education and Relative Index of Inequality. Prentice-weighted Cox models were performed to estimate the association between education and T2D. One-sample MR analyses investigated whether genetic predisposition towards longer education was associated with risk of T2D and investigated potential mediators of the association., Results: MR estimates indicated a risk reduction of about 15% for each year of longer education on the risk of developing T2D, confirming the protective role estimated by observational models (HR 0.96, 95% CI 0.95 to 0.96). MR analyses on putative mediators showed a significant role of education on body mass index, alcohol consumption, adherence to the Mediterranean diet and smoking habits., Conclusion: The results supported the hypothesis that higher education is a protective factor for the risk of developing T2D. Based on its position in the causal chain, education may be antecedent of other known risk factors for T2D including unhealthy behaviours. These findings reinforce evidence obtained through observational study designs and bridge the gap between correlation and causation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: This study aimed at training and validating a multi-institutional deep learning (DL) auto segmentation model for nodal clinical target volume (CTVn) in high-risk breast cancer (BC) patients with both training and validation dataset created with multi-institutional participation, with the overall aim of national clinical implementation in Denmark., Materials and Methods: A gold standard (GS) dataset and a high-quality training dataset were created by 21 BC delineation experts from all radiotherapy centres in Denmark. The delineations were created according to ESTRO consensus delineation guidelines. Four models were trained: One per laterality and extension of CTVn internal mammary nodes. The DL models were tested quantitatively in their own test-set and in relation to interobserver variation (IOV) in the GS dataset with geometrical metrics, such as the Dice Similarity Coefficient (DSC). A blinded qualitative evaluation was conducted with a national board, presented to both DL and manual delineations., Results: A median DSC > 0.7 was found for all, except the CTVn interpectoral node in one of the models. In the qualitative evaluation 'no corrections needed' were acquired for 297 (36 %) in the DL structures and 286 (34 %) for manual delineations. A higher rate of 'major corrections' and 'easier to start from scratch' was found in the manual delineations. The models performed within the IOV of an expert group, with two exceptions., Conclusion: DL models were developed on a national consensus cohort and performed on par with the IOV between BC experts and had a comparable or higher clinical acceptance than expert manual delineations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Neurofibromatosis type 1 (NF1) is a genetic condition characterized by various somatic manifestations and cognitive impairments, but the latter are sparsely described in adults. This study aimed at characterizing potential impairments of neurocognitive functions using neuropsychological tests as well as a self-report questionnaire., Methods: In a nationwide, population-based study including 103 adults with NF1 and 38 age- and gender-matched NF1-free comparisons, we used a comprehensive neurocognitive test battery to assess intelligence and visual short-term memory, immediate visuospatial recall, reaction time, sustained attention, motor speed, planning, planning time, working memory as well as multitasking and a questionnaire to assess executive functions. Descriptive statistics, multivariate analysis of variance (MANOVA), and general linear models with repeated measure analysis of variance (ANOVA) were used., Results: We observed a statistically significant difference in overall performance-based cognitive functioning. Adults with NF1 showed significant, moderate-to-severe impairments in intelligence, visual short-term memory, immediate visuospatial recall, sustained attention (p < 0.0001-0.002), and some executive functions (p = 0.008 - 0.001), whereas other cognitive functions (multitasking, reaction time, motor speed, spatial working memory, planning time, and planning efficacy as well as some self-reported executive functions) were unimpaired., Conclusions: This is the first study with a population-based sample of persons with NF1 and the results show impairments of intelligence and other cognitive functions. The pattern of both significant cognitive impairments and non-significantly different cognitive functions suggests a cognitive profile of selective rather than generalized cognitive deficits in NF1., Competing Interests: Declarations. Ethics approval and consent to participate: This study followed the ethical principles in the Declaration of Helsinki. Informed written consent were obtained from all participants. Permissions were obtained from the Institutional Review Board (IRB) at the Danish Cancer Society Research Center, the local Institutional Review Board, and the Research Board of the Department of Defense US Army under Award No. W81XWH-14-1-0054. The data collection procedure was approved by the Danish Health Data Authority. Further, the NF1-program was registered at the Danish Cancer Society Research Centers archive (2018-DCRC-0012). Consent for publication: Not applicable. Conflict of interest: The authors do not have any conflict of interest to declare., (© 2024. The Author(s).)

Introduction: Nasopharyngeal carcinoma (NPC) is a rare disease and most studies have therefore been conducted in endemic areas. The aim of this study was to describe epidemiology and treatment outcomes of NPC in a population-based, non-endemic setting., Material and Methods: Patients with NPC diagnosed in Denmark from 2000 to 2018 were identified in the Danish Head and Neck Cancer Study Group (DAHANCA) database. Clinical records were reviewed to obtain missing data and confirm outcome, histological subtypes, Epstein-Barr virus (EBV)-status, prognostic factors, and treatment., Results: NPC was identified in 394 patients corresponding to age-standardized incidence rates of 0.5 and 0.2 per 100,000 in men and women, respectively. The 5-year overall (OS) and disease-specific survival (DSS) were 56 and 66%. In multivariate analysis, stage, smoking, and histology affected both OS and DSS, as patients with undifferentiated carcinomas had superior outcomes. Tumor EBV-status was determined in 221 patients, of whom 160 (72%) tested positive. EBV-positivity was associated with an improved OS in univariate analysis, but not after adjustment for relevant clinical factors., Interpretation: NPC is a rare malignancy in Denmark, and three in four patients have EBV-associated tumors. Tumor histology, smoking status, and stage, but not EBV-status, had independent prognostic impact on survival.

Background: Given their antioxidative stress, anti-allergic, anti-inflammatory, and immune-modulating effects, flavonoids are hypothesized to play a role in preventing chronic obstructive pulmonary disease (COPD) and asthma., Objectives: This cohort study aimed to examine associations between flavonoid intake and COPD, asthma, and lung function., Methods: Among 119,466 participants of the UK Biobank, median [interquartile range] age of 60 [53, 65] y, we estimated intakes of flavonoids, flavonoid-rich foods, and a flavodiet score from 24-h diet assessments. Prospective associations with both incident COPD and asthma and cross-sectional associations with measures of lung function [%predicted forced expiratory volume in 1s (FEV 1 ); and FEV 1 /forced vital capacity (FVC)] were examined using multivariable-adjusted Cox proportional hazards and linear regression models, respectively. We investigated mediation by inflammation--represented by the INFLA score--and stratified analyses by smoking status., Results: Compared with low intakes, moderate intakes of total flavonoids, flavonols, theaflavins + thearubigins, and flavanones, and moderate-to-high intakes of flavanol monomers, proanthocyanidins, anthocyanins, flavones, and the flavodiet score were associated with up to an 18% lower risk of incident COPD {e.g., [hazard ratio (95% confidence interval) for total flavonoids: 0.83 (0.75, 0.92)]} but not incident asthma. Furthermore, compared with low intakes, higher intakes of all flavonoid subclasses (except theaflavins + thearubigins), and the flavodiet score were associated with better percent predicted FEV 1 baseline. Associations were most apparent in ever (current or former) smokers. Flavonoid intakes were inversely associated with the INFLA score, which appeared to mediate 11%-14% of the association between intakes of proanthocyanidins and flavones and incident COPD., Conclusions: Moderate-to-high flavonoid intakes were associated with a lower risk of COPD and better lung function, particularly among ever smokers. Promoting intakes of healthy flavonoid-rich foods, namely, tea, apples, and berries, may improve respiratory health and lower COPD risk, particularly in individuals with a smoking history., Competing Interests: Conflict of interest AC acts as an advisor to the United States Highbush Blueberry Council (USHBC) grant committee and has received funding from them for a randomized controlled trial and population-based work. BHP consults for MaxBiocare, a company engaged in micronutrient research and related commercial activities. All other authors report no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The primary analysis of the DBCG 07-READ trial reported in 2017 provided evidence of no overall benefit from adjuvant anthracyclines in patients with early TOP2A normal breast cancer in disease-free survival (DFS), distant disease-free survival (DDFS), or overall survival (OS). We performed a protocol-scheduled analysis of DDFS, DFS, and OS on the basis of 10-year follow-up. Full details on incident heart failure (HF) and second cancers were presented. Patients in the intention-to-treat population assigned to epirubicin and cyclophosphamide followed by docetaxel (EC-D) had longer DDFS (adjusted hazard ratio [HR], 0.79 [95% CI, 0.64 to 0.98]; P = .03) and DFS (HR Adjusted , 0.83 [95% CI, 0.69 to 0.99]; P = .04) than patients assigned to docetaxel and cyclophosphamide (DC). There was no statistically significant difference in mortality rates. The 10-year cumulative risk of HF was 2.1% (95% CI, 1.4 to 3.3) with EC-D and 1.1% (95% CI, 0.6 to 2.0) with DC (HR Unadjusted , 2.12 [95% CI, 1.03 to 4.35]; P = .04). In conclusion, anthracycline followed by docetaxel improved outcome compared with DC in patients with TOP2A normal early breast cancer, and no clinical value of TOP2A testing was shown. The risk of HF was doubled in patients receiving anthracycline; however, overall, the risk of HF was low.

Objective: Determine participants' satisfaction with rehabilitation following total laryngectomy (TL) and investigate associations between dysphagia, voice problems, and possible explanatory variables., Methods: 172 Danish and Swedish participants having received a TL 1.6-18.1 years ago for laryngeal/hypopharyngeal cancer answered a questionnaire regarding satisfaction with rehabilitation following TL and the V-RQOL, MDADI, and HADS questionnaires., Results: 85% and 75% were satisfied with the help received from their local hospital and municipality, respectively. 22%, 78%, and 65% indicated having not received any vocal, swallow, or olfactory rehabilitation, respectively. MDADI mean score was 77.5, V-RQOL was 62.8 and the HADS questionnaire indicated that possible depression or anxiety was present in 16% and 20% of participants, respectively. Multivariate analysis found the following variables to be associated with dysphagia; more voice problems, higher depression score, higher anxiety score, and being treated and rehabilitated in Denmark vs. in Sweden. Furthermore, multivariate analysis found the following variables to be associated with voice problems; more problems with dysphagia and higher depression score., Conclusion: We found that the majority of participants were satisfied with the received rehabilitation but that a large proportion reported having no dysphagia or olfactory rehabilitation. We found that voice problems, dysphagia, and depression after TL are tightly linked, and therefore suggest that medical personnel in contact with TL patients should be aware of possible psychological late effects. We found that being treated and rehabilitated in Sweden, vs. in Denmark, was associated with a better swallow outcome and we suggest additional centralization of rehabilitation in especially Denmark., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Both adherence rates to pulmonary rehabilitation (PR) programmes and long-term attendance in exercise training after PR remain a challenge. In our previous randomised controlled trial (RCT), effects were positively associated with a dose-response pattern, regardless of whether PR contained conventional physical exercise training (PExT) or Singing for Lung Health (SLH) as a training modality within a 10 weeks' PR programme for chronic obstructive pulmonary disease (COPD). However, long-term status of this RCT cohort remains unknown. In this study, we investigated whether current status (=attendance in supervised exercise training or a lung choir and scoring in quality of life (QoL)) was related to initial PR completion, randomisation, or adherence., Methods: We collected data via telephone, using a researcher-developed questionnaire on current self-reported attendance in supervised exercise training or a lung choir and on perceived benefits of the initial RCT intervention. Additionally, we used COPD-validated questionnaires (primarily: QoL (measure: St George's Respiratory Questionnaire; SGRQ)., Results: In 2023 (i.e., mean/median 4.7 years after initial PR), surviving participants were contacted ( n  = 196; 73% of 270), and 160 (82% of 196) were included. Out of the included participants, 30 (19%) had not completed initial PR. Compared to the initial PR-completers, non-completers reported less current attendance in exercise training or lung choir (24% vs. 46%, p  = 0.03) but SGRQ scores were comparable. Yet, those who attended exercise training or lung choir at present ( n  = 66/160; 41% out of 160) reported better QoL score than those with no current attendance (SGRQ; Attending: 39.9 ± 15.4; Not attending: 43.1 ± 16.7; p  = 0.02). Neither having had SLH instead of PExT, nor adherence level during initial PR, was related to current attendance or to QoL scores., Conclusion: This study indicates that long-term self-reported attendance and current QoL scores are positively related to initial completion of a PR programme. Surprisingly, neither initial PR content (PExT or SLH) nor initial PR adherence was related to long-term outcomes. We suggest that future PR programmes include special attention to those who do not complete PR to support long-term attendance and QoL status., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Kaasgaard, Bodtger, Skou, Clift, Hilberg, Rasmussen and Løkke.)

Background: Before administration of myelosuppressive chemotherapy, complete blood counts (CBC) collected at the hospital/nursing stations are evaluated to avoid severe bone marrow suppression. This maintains disease fixation which often reduces their quality of life. This mixed-method study examined at home self-testing of CBC, the test quality, and the effects on patients' mental well-being., Methods: Patients with breast cancer receiving chemotherapy were recruited and trained to perform capillary finger prick CBC testing at home using the HemoScreen Point-of-Care instrument and to upload the test results to the hospital's IT system subsequently. A venous reference CBC sample was taken and tested at the hospital on the day of self-testing. Semi-structured interviews with open-ended components were performed to investigate the user experience and the impact of self-testing on the patients' everyday lives., Results: Thirty-nine patients completed the self-testing education using the HemoScreen instrument. Eight patients withdrew, while the remaining 31 patients performed 161 home tests (2-11 tests per patient) over a 4-month period. The test results compared well with the venous reference CBCs except for platelet counts (correlation coefficient 0.26). Qualitative interviews with nine of the 31 patients emphasized that the patients were comfortable using the self-testing instrument and becoming an active partner in their own treatment., Interpretation: CBC self-testing at home produced clinically valid hemoglobin and white blood cell counts with the added benefit that the patients became active partners in their own treatment course, which was of great importance for the patients and increased their wellbeing.

Background: Approximately onethird of cancer survivors encounter challenges reintegrating into the workforce, often experiencing involuntary unemployment and/or partial or full work disability following diagnosis and treatment. Returning to paid employment presents evident challenges due to uncertainties regarding work ability, perceived employer discrimination, and a lack of support, thereby risking social exclusion. However, interventions addressing return to paid employment among unemployed and/or work-disabled cancer survivors are scarce. Here, we describe the protocol of a randomized controlled trial (RCT), including a process and economic evaluation, evaluating the effectiveness and cost-effectiveness of the PLACES (unemPLoyed cAnCEr survivors Support) intervention aimed at supporting unemployed and/or work-disabled cancer survivors returning to paid employment., Methods: A two-armed RCT with a 12-month follow-up period will be conducted. Eligible participants: (1) are of working age (18-65 years), (2) are diagnosed with cancer between 6 months and 10 years ago, (3) are unemployed and/or partially or fully work-disabled, (4) have completed cancer treatment, and (5) are seeking paid employment and are motivated to initiate work immediately. Participants will primarily be identified through the Dutch Social Security Agency and the Netherlands Cancer Registry and recruited via healthcare professionals. Participants randomly allocated to the intervention group (n = 82) will receive the PLACES intervention: a tailored supported employment intervention based on the principles of Individual Placement and Support (IPS). This includes support in seeking, returning to, and maintaining paid employment. Participants allocated to the control group (n = 82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after 3 (T1), 6 (T2), and 12 (T3) months of follow-up. The primary outcome is paid employment [yes/no]. Secondary outcomes are time until paid employment, change in working hours, work ability, quality of (working) life, and self-efficacy regarding return to work. Additionally, process and economic evaluations will be conducted., Discussion: We hypothesize that the PLACES intervention will be effective in obtaining paid employment, enhancing work ability, and improving quality of life. In addition, we expect the intervention to be cost-effective. If proven effective and cost-effective, actions should be taken to implement the intervention in usual care., Trial Registration: NCT06028048., (© 2024. The Author(s).)

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background and Purpose: As preparation for a national randomized study comparing proton radiotherapy to photon radiotherapy, DAHANCA 35, we performed a non-randomized pilot study to investigate patient selection, logistics, planning, and treatment delivery. With the present study, as a comprehensive safety analysis, we want to compare toxicity during and up to two months after therapy to a historically matched group of patients treated with photon radiotherapy., Materials and Methods: 62 patients treated with protons were matched to 124 patients who received photon treatment outside a protocol. Available data were retrieved from the DAHANCA database. Patients were matched on treatment centre, concurrent chemotherapy, tumour site, stage, p16 status for oropharynx cancers. Selection of patients for proton therapy was based on comparative treatment plans with a NTCP reduction for dysphagia and xerostomia at six months., Results: Baseline characteristics between groups were well balanced, except for the type of drug used concurrently; more photon patients received Carboplatin (21.2 % vs 5.8 %, p = 0.01). Proton therapy was associated with significantly less weight loss at the end of treatment, mean weight loss of 3 % for protons and 5 % for photons (p < 0.001). There were more grade 3 skin reactions and grade 3 mucositis after proton treatment compared with photons at the end of treatment, Risk Ratio (RR) 1.9 (95 % CI: 1.01-3.5, p = 0.04) and RR 1.5 (95 % CI: 1.3-1.7, p < 0.001), respectively. All differences resolved at follow up two months after treatment. There were no significant differences between groups on opioid use, use of feeding tubes, or hospitalization during the observation period., Conclusion: Proton treatment resulted in excess objective mucositis and dermatitis, which was transient and did not seem to negatively influence weight or treatment compliance and intensity. Selection bias was likely especially since NTCP models were used for selection of proton treatment and photon treated patients were matched manually. We are currently including patients in a randomized controlled trial., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology.)

Introduction: Arts and health practice and research has expanded rapidly since the turn of the millennium. A World Health Organization scoping review of a large body of evidence claims positive health benefits from arts participation and makes recommendations for policy and implementation of arts for health initiatives. A more recent scoping review (CultureForHealth) also claims that current evidence is sufficient to form recommendations for policy and practice. However, scoping reviews of arts and health research-without critical appraisal of included studies-do not provide a sound basis for recommendations on the wider implantation of healthcare interventions., Methods: We performed a detailed assessment of 18 Randomised Controlled Trials (RCTs) on arts-based interventions included in Section 1 of the CultureForHealth report using the Joanna Briggs Institute Critical Appraisal Tool for RCTs (2023)., Results: The 18 RCTs included demonstrated considerable risks of bias regarding internal and statistical conclusion validity. Moreover, the trials are substantially heterogeneous with respect to settings, health-issues, interventions, and outcomes, which limits their external validity, reliability, and generalisability., Conclusions: The absence of a critical appraisal of studies included in the CultureForHealth report leads to an overinterpretation and overstatement of the health outcomes of arts-based interventions. As such, the CultureForHealth review is not a suitable foundation for policy recommendations, nor for formulating guidance on implementation of arts-based interventions for health., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Kaasgaard, Grebosz-Haring, Davies, Musgrave, Shriraam, McCrary and Clift.)

Introduction: Treatment planning using a five-millimetre geometrical margin from GTV to high-dose CTV (CTV1) has been used in DAHANCA treatment centres since 2013. We aimed to evaluate changes in CTV1 volumes, local control (LC), and recurrence pattern after the implementation of five-millimetre geometrical margins nationally., Materials and Methods: 1,948 patients with pharyngeal, and laryngeal squamous cell carcinomas completed definitive IMRT-based treatment in 2010-2012 and 2013-2015 in three centres. The patient-specific margin was calculated as median surface distance from primary tumour GTV (GTV-T) to CTV1. Radiologically verified local recurrences were analysed using a centre of mass (COM) of the delineated recurrence volume, measuring the shortest distance between COM to GTV-T and CTV1 boundaries., Results: Median GTV-CTV1 was 0.9 (0.0-0.97) and 0.47 cm (0.4-0.5) for 2010-2012 and 2013-2015, respectively. Median CTV1 changed in three centres from 76, 28, 42 cm 3 to 61, 53, 62 cm 3 for 2010-2012 and 2013-2015, respectively. Local failures occurred at 247 patients during first three years after radiotherapy. The 3-year LC rate for 2010-2012 and 2013-2015 was 0.84 and 0.87 (p = 0.06). Out of 146 radiology-verified analysable local recurrences, 102 (69.9%) were inside the CTV1. In 74.6% and 91% of cases, the LRs were covered by 95% isodose in 2010-2012 and 2013-2015, respectively., Conclusion: DAHANCA radiotherapy guidelines based on a geometrically generated isotropic CTV1 margin led to less variation in treatment volumes and between centres than previous guidelines. The transition towards consensus GTV-CTV1 margins did not influence local tumour control. The majority of local recurrences were inside CTV1 and covered by the prescription dose., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background and Purpose: Calcium electroporation (CaEP) involves injecting calcium into tumour tissues and using electrical pulses to create membrane pores that induce cell death. This study assesses resultant immune responses and histopathological changes in patients with cutaneous metastases., Patients/materials and Methods: The aimed cohort comprised 24 patients with metastases exceeding 5 mm. Tumours were treated once with CaEP (day 0) or twice (day 28). Biopsies were performed on days 0 and 2, with additional samples on days 7, 28, 30, 35, 60, and 90 if multiple tumours were treated. The primary endpoint was the change in tumour-infiltrating lymphocytes (TILs) two days post-treatment, with secondary endpoints evaluating local and systemic immune responses via histopathological analysis of immune markers, necrosis, and inflammation., Results: Seventeen patients, with metastases primarily from breast cancer (14 patients), but also lung cancer (1), melanoma (1), and urothelial cancer (1), completed the study. Of the 49 lesions treated, no significant changes in TIL count or PD-L1 expression were observed. However, there was substantial necrosis and a decrease in FOXP3-expression (p = 0.0025) noted, with a slight increase in CD4+ cells but no changes in CD3, CD8, or CD20 expressions. Notably, four patients showed reduced tumour invasiveness, including one case of an abscopal response., Interpretation: This exploratory study indicates that CaEP can be an effective anti-tumour therapy potentially enhancing immunity. Significant necrosis and decreased regulatory lymphocytes were observed, although TIL count remained unchanged. Several patients exhibited clinical signs of immune response following treatment.

Background: The optimal management for spontaneous pneumothorax (SP) remains contentious, with various proposed approaches. This joint clinical practice guideline from the ERS, EACTS and ESTS societies provides evidence-based recommendations for the management of SP., Methods: This multidisciplinary Task Force addressed 12 key clinical questions on the management of pneumothorax, using ERS methodology for guideline development. Systematic searches were performed in MEDLINE and Embase. Evidence was synthesised by conducting meta-analyses, if possible, or narratively. Certainty of evidence was rated with GRADE (Grading of Recommendations, Assessment, Development and Evaluations). The Evidence to Decision framework was used to decide on the direction and strength of the recommendations., Results: The panel makes a conditional recommendation for conservative care of minimally symptomatic patients with primary spontaneous pneumothorax (PSP) who are clinically stable. We make a strong recommendation for needle aspiration over chest tube drain for initial PSP treatment. We make a conditional recommendation for ambulatory management for initial PSP treatment. We make a conditional recommendation for early surgical intervention for the initial treatment of PSP in patients who prioritise recurrence prevention. The panel makes a conditional recommendation for autologous blood patch in secondary SP patients with persistent air leak (PAL). The panel could not make recommendations for other interventions, including bronchial valves, suction, pleurodesis in addition to surgical resection or type of surgical pleurodesis., Conclusions: With this international guideline, the ERS, EACTS and ESTS societies provide clinical practice recommendations for SP management. We highlight evidence gaps for the management of PAL and recurrence prevention, with research recommendations made., Competing Interests: Conflict of interest: R. Hallifax has received consulting fees from Rocket Medical UK and Cook Medical, and honoraria for educational talks from AstraZeneca. M. Keijzers has received consulting fees from Philips. Y.C.G. Lee received drainage kits from Rocket Medical PLC for patients participating in clinical trials. P. Licht has received personal honoraria from Ethicon and Johnson & Johnson. N. Maskell has received consulting fees and device support for clinical trials from Rocket Medical UK and BD. B. Nagavci acted as ERS methodologist. E. Roessner has received consultancy fees from Rivolution, lecture fees from Siemens Healthineers and AstraZeneca, and was Thoracic Domain chair, Council member and Task Force member of the Solitary Pulmonary Nodules Task Force for EACTS. N. Rahman has received consulting fees Rocket Medical UK and Cook Medical, and has received device support for clinical trials from Rocket Medical UK. P. Van Schil has received personal payments from BMS and Roche, institutional payment from Janssen, MSD and AstraZeneca, and is the treasurer of BACTS (Belgian Association for Cardiothoracic Surgery) and president-elect for IASLC (International Association for the Study of Lung Cancer). D. Waller has received lecture fees from Pulmonx and Medtronic. T. Walles has received a grant (WA 1649/5-2) for clinical study on surgical therapy for treatment of primary pneumothorax from the German Research Foundation, and is an assessor (unpaid) for the German Society of Thoracic Surgery. The remaining authors have no potential conflicts of interest to disclose., (This article has been co-published with permission in the European Journal of Cardio-Thoracic Surgery and in the European Respiratory Journal. Copyright ©The Author(s) 2024. Published by European Respiratory Society. All rights reserved. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article. For reproduction rights and permissions contact permissions@ersnet.org.)

Background: Wearables that measure vital parameters can be potential tools for monitoring patients at home during cancer treatment. One type of wearable is a smart T-shirt with embedded sensors. Initially, smart T-shirts were designed to aid athletes in their performance analyses. Recently however, researchers have been investigating the use of smart T-shirts as supportive tools in health care. In general, the knowledge on the use of wearables for symptom monitoring during cancer treatment is limited, and consensus and awareness about compliance or adherence are lacking., Objectives: The aim of this study was to evaluate adherence to and experiences with using a smart T-shirt for the home monitoring of biometric sensor data among adolescent and young adult patients undergoing cancer treatment during a 2-week period., Methods: This study was a prospective, single-cohort, mixed methods feasibility study. The inclusion criteria were patients aged 18 to 39 years and those who were receiving treatment at Copenhagen University Hospital - Rigshospitalet, Denmark. Consenting patients were asked to wear the Chronolife smart T-shirt for a period of 2 weeks. The smart T-shirt had multiple sensors and electrodes, which engendered the following six measurements: electrocardiogram (ECG) measurements, thoracic respiration, abdominal respiration, thoracic impedance, physical activity (steps), and skin temperature. The primary end point was adherence, which was defined as a wear time of >8 hours per day. The patient experience was investigated via individual, semistructured telephone interviews and a paper questionnaire., Results: A total of 10 patients were included. The number of days with wear times of >8 hours during the study period (14 d) varied from 0 to 6 (mean 2 d). Further, 3 patients had a mean wear time of >8 hours during each of their days with data registration. The number of days with any data registration ranged from 0 to 10 (mean 6.4 d). The thematic analysis of interviews pointed to the following three main themes: (1) the smart T-shirt is cool but does not fit patients with cancer, (2) the technology limits the use of the smart T-shirt, and (3) the monitoring of data increases the feeling of safety. Results from the questionnaire showed that the patients generally had confidence in the device., Conclusions: Although the primary end point was not reached, the patients' experiences with using the smart T-shirt resulted in the knowledge that patients acknowledged the need for new technologies that improve supportive cancer care. The patients were positive when asked to wear the smart T-shirt. However, technical and practical challenges in using the device resulted in low adherence. Although wearables might have potential for home monitoring, the present technology is immature for clinical use., (© Emma Balch Steen-Olsen, Helle Pappot, Maiken Hjerming, Signe Hanghoej, Cecilie Holländer-Mieritz. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org).)

Competing Interests: We declare no competing interests.

Background: This study evaluates the validity of the information in the Danish Lung Cancer Registry (DLCR). Since 2000, the DLCR has been a tool for monitoring interventions and outcome of all Danish lung cancer patients with the intent to streamline and improve treatment and survival. The DLCR receives information from the Danish Patient Registries in addition to clinical information from the treating physicians. In the year 2022, more than 50 papers have been published using DLCR as a data source. However, the DLCR has not previously been validated., Methods: A random sample of 1000 patients diagnosed with non-small cell lung cancer from 2014 to 2016 and recorded in the DLCR were included for validation. Medical records were reviewed and were considered as the "gold standard" to which data listed in the DLCR were compared., Results: Information was retrieved from medical charts for all patients. Agreement on stage at diagnosis was 90.1 % (95 % CI 88.0-91.9) and on date of diagnoses was 93.8 (95 % CI 92.1-93.2). Agreement on smoking status in pack years (+/- 10 pack years) was 91.2 % (95 % CI 88.6-93.2). The positive predictive value of treatment intent was 87.4 (95 % CI 85.1-89.6)., Conclusion: The data in the DLCR are complete, detailed and accurate. The comparison of data from the DLCR with the medical records revealed overall high validity of the data in the registry., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Research in Denmark indicates that approximately 30% of people with confirmed COVID-19 infection experience at least one physical symptom 6-12 months after the acute infection. The lived experiences of undergoing prolonged recovery processes and how these processes unfold need further attention., Aim: To contribute in-depth knowledge about recovery, as experienced over time by people living with the post COVID-19 condition., Methods: Within a qualitative research design, nine women and six men were interviewed. Ten of them gave a follow-up interview. Prompt cards and participant-generated photographs were included. A phenomenological-hermeneutic approach inspired by Ricoeur's theory of interpretation guided the data analysis., Findings: Living with long-term health problems associated with the post COVID-19 condition involved recovery processes where participants struggled with reduced capacity, new unpredictability and uncertainty in everyday life. Participants continuously searched for improvement and aimed for regaining former health and well-being. Lack of knowledge, acknowledgement and support made it difficult to find clear directions for improvement. Participants created a protective shield and struggled, often jointly with family and friends, to cope with bodily, cognitive, emotional, existential and social challenges. Over time, some participants realised that they might not be able to fully return to their earlier habitus. However, some of them gained a new foothold and sense of hope for the future., Conclusion: This study provides in-depth insight into the experience of changing and open-ended recovery processes while living with the post COVID-19 condition. Over time, some participants learned to rebuild their lives, adapting to their reduced capacities. Future care and rehabilitation models for these patients must address the complex and challenging nature of recovery processes associated with living with post-COVID-19 condition., (© 2023 The Authors. Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.)

Background and Purpose: Hippocampal-sparing (HS) is a method that can potentially reduce late cognitive complications for pediatric medulloblastoma (MB) patients treated with craniospinal proton therapy (PT). The aim of this study was to investigate robustness and dosimetric plan verification of pencil beam scanning HS PT., Materials and Methods: HS and non-HS PT plans for the whole brain part of craniospinal treatment were created for 15 pediatric MB patients. A robust evaluation of the plans was performed. Plans were recalculated in a water phantom and measured field-by-field using an ion chamber detector at depths corresponding to the central part of hippocampi. All HS and non-HS fields were measured with the standard resolution of the detector and in addition 16 HS fields were measured with high resolution. Measured and planned dose distributions were compared using gamma evaluation., Results: The median mean hippocampus dose was reduced from 22.9 Gy (RBE) to 8.9 Gy (RBE), while keeping CTV V 95% above 95 % for all nominal HS plans. HS plans were relatively robust regarding hippocampus mean dose, however, less robust regarding target coverage and maximum dose compared to non-HS plans. For standard resolution measurements, median pass rates were 99.7 % for HS and 99.5 % for non-HS plans (p < 0.001). For high-resolution measurements, median pass rates were 100 % in the hippocampus region and 98.2 % in the surrounding region., Conclusions: A substantial reduction of dose in the hippocampus region appeared feasible. Dosimetric accuracy of HS plans was comparable to non-HS plans and agreed well with planned dose distribution in the hippocampus region., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Per Munck af Rosenschöld: Research Agreement: Accuray Inc, US., (© 2024 The Authors.)

Proton radiotherapy offers a dosimetric advantage compared to photon therapy in sparing normal tissue, but the clinical evidence for toxicity reductions in the treatment of head and neck cancer is limited. The Danish Head and Neck Cancer Group (DAHANCA) has initiated the DAHANCA 35 randomised trial to clarify the value of proton therapy (NCT04607694). The DAHANCA 35 trial is performed in an enriched population of patients selected by an anticipated benefit of proton therapy to reduce the risk of late dysphagia or xerostomia based on normal tissue complication probability (NTCP) modelling. We present our considerations on the trial design and a test of the selection procedure conducted before initiating the randomised study., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Objective: Patients with incurable cancer should receive general palliative care according to their needs, as provided through collaboration between hospital departments, municipalities, and general practices and as outlined in national guidelines. However, the implementation of general palliative care in Denmark has been inadequate. This study aimed to investigate the healthcare professionals' (HCPs') perceptions on barriers to and facilitators of the implementation of the Danish National Guideline (NG) for general palliative care., Methods: This descriptive, qualitative study was guided by the Consolidated Framework for Implementation Research (CFIR). Qualitative focus group and individual interviews were conducted with 23 HCPs. The interview guide, coding, analysis, and reporting of findings were developed within the CFIR framework., Results: The main barriers to implementing NG were as follows: lack of knowledge about the NG, lack of an implementation plan, and insufficient communication and collaboration across sectors. Important facilitators were as follows: HCP motivation to meet palliative care needs, HCPs with special functions taking responsibility for incorporating NG into local guidelines, and the role of district nurses specialised in palliative care as opinion leaders providing security and continuity for the HCPs working in palliative care., Conclusions: To address the needs of patients with incurable cancer, greater efforts are required on implementing general palliative care. Although HCPs in our setting were motivated to improve NG implementation, financial resources and strategies are necessary to ensure sufficient knowledge uptake and accommodate identified barriers in order to translate the NG into practice., (© 2023 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.)

Background: Parents who lose a child are at increased risk of impaired mental health, which may negatively affect their work ability. The aims of this study were to examine the risk for reduced labor market affiliation in parents who lost a child with cancer compared to a matched parent cohort, and factors associated with the bereaved parents' labor market affiliation., Methods: We conducted a nationwide population-based cohort study using Danish registry data. We followed bereaved parents (n = 1609) whose child died with cancer at age less than 30 during 1992-2020, and a matched, population-based sample of parents (n = 15,188) of children with no history of childhood cancer. Cox proportional hazard models and fractional logit models were performed separately for mothers and fathers., Results: Cancer-bereaved mothers had an overall increased risk of long-term sick leave (hazard ratio [HR] = 1.62; 95% confidence interval [CI]: 1.48-1.77), unemployment (HR = 1.53; CI: 1.37-1.70), and lower odds of working in the first 2 years following the loss (odds ratio [OR] = 0.44; CI: 0.39-0.49), while bereaved fathers had lower odds of working (OR = 0.65; CI: 0.53-0.79), and increased risk of permanently reduced work ability (HR = 1.29; 95% CI: 1.01-1.66), compared to the matched cohort of parents of cancer-free children. Younger parental age, lower education, and being a single parent were identified as the main determinants of the bereaved parents' reduced labor market affiliation., Conclusions: Cancer-bereaved parents are at increased risk of reduced labor market affiliation, compared with a matched, population-based sample of parents. Certain groups of bereaved parents may be at particularly high risk, and targeted bereavement interventions are warranted., (© 2023 Wiley Periodicals LLC.)

Introduction: Proton treatment can potentially spare patients with H&N cancer for substantial treatment-related toxicities. The current study investigated the reproducibility of a decentralised model-based selection of patients for a proton treatment study when the selection plans were compared to the clinical treatment plans performed at the proton centre., Methods: Sixty-three patients were selected for proton treatment in the six Danish Head and Neck Cancer (DAHANCA) centres. The patients were selected based on normal tissue complication probability (NTCP) estimated from local photon and proton treatment plans, which showed a ΔNTCP greater than 5%-point for either grade 2 + dysphagia or grade 2 + xerostomia at six months. The selection plans were compared to the clinical treatment plans performed at the proton centre., Results: Of the 63 patients, 49 and 25 were selected based on an estimated benefit in risk of dysphagia and xerostomia, respectively. Eleven patients had a potential gain in both toxicities. The mean ΔNTCP changed from the local selection plan comparison to the clinical comparison from 6.9 to 5.3 %-points (p = 0.01) and 7.3 to 4.9 %-points (p = 0.03) for dysphagia and xerostomia, respectively. Volume differences in both CTV and OAR could add to the loss in ΔNTCP. 61 of the 63 clinical plans had a positive ΔNTCP, and 38 had a ΔNTCP of 5%-points for at least one of the two endpoints., Conclusion: A local treatment plan comparison can be used to select candidates for proton treatment. The local comparative proton plan overestimates the potential benefit of the clinical proton plan. Continuous quality assurance of the delineation procedures and planning is crucial in the subsequent randomised clinical trial setting., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: A new primary cancer is a serious late effect of a pre-existing cancer diagnosis, and can be attributed to hereditary cancer syndromes, immune or hormonal factors, cancer treatment, or modifiable lifestyle or environmental factors. We investigated the absolute and relative incidence of second primary cancers in a large cohort of Danish cancer survivors. Furthermore, we examined the association between alcohol-related, smoking-related, virus-related, and hormone-related first and second primary cancers., Methods: In this retrospective cohort study, we identified a cohort of Danish adults (aged ≥40 years) diagnosed with cancer from Jan 1, 1997, to Dec 31, 2014 and alive 1 year after diagnosis. Follow-up was from date of first cancer diagnosis and lasted up to 24 years, ending on Dec 31, 2020. Cohort identification and information on second primary cancers was obtained from the Danish Cancer Registry, and comorbidity and sociodemographic information was obtained from Danish population-based registries. Overall, and for 27 cancer types, cumulative incidence functions and Cox proportional hazard regression models were used to estimate the incidence of second primary cancer and death, and hazard ratios (HRs) and 95% CIs of second primary cancer adjusted for sex, age and year of diagnosis, cohabitation status, income, and comorbidity., Findings: 457 334 Danish adults were included in our study (230 150 [50·3%] male individuals and 227 184 [49·7%] female individuals; median age at diagnosis 68·3 years, IQR 59·7-76·6; median follow-up 3·6 years, IQR 0·6-9·3). The cumulative incidence of second primary cancer increased over time from 6·3% (95% CI 6·2-6·4) 5 years after diagnosis to 10·5% (10·4-10·6) 10 years after diagnosis and to 13·5% (13·4-13·7) 15 years after diagnosis. The highest cumulative incidence of second primary cancer 10 years after diagnosis was observed in survivors of cancers in the larynx (21·8%, 20·5-23·1), oropharynx and oral cavity (19·5%, 18·7-20·3), and bladder and urinary tract (18·5%, 18·0-19·0). Survivors of cancers related to alcohol (HR 1·09, 95% CI 1·06-1·13), smoking (1·73, 1·68-1·78), diet high in red or processed meat (1·32, 1·24-1·39), or virus (1·23, 1·13-1·35) were at increased risk of developing a second cancer with the same aetiology, whereas having had a hormone-related first cancer was associated with lower risk of a second hormone-related cancer (0·77, 0·73-0·81)., Interpretation: Our results could help optimise prevention efforts targeting modifiable risk factors to reduce risk of developing a second primary cancer., Funding: Nordic Cancer Union and The Health Foundation (Helsefonden)., Competing Interests: Declaration of interests CJ received honoraria for lectures (Sanofi, Pfizer, Astellas, Janssen). TKK, EAWA, GU, SBL, PEB, JFW, MB, and SOD declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

We developed the Navigate intervention to improve survival among vulnerable lung cancer patients. In this intervention-only study, we examined feasibility in terms of recruitment, retention, attendance, adherence, and acceptability to specify adjustments to study procedures and intervention components prior to a randomized trial. The Navigate intervention includes nurse navigation, patient-reported outcomes, and physical exercise. Patients ≥ 18 years old, diagnosed with non-small cell lung cancer at any stage, with performance status ≤ 2, eligible for cancer treatment and vulnerable according to a screening instrument were included. The recruitment goal of eligible patients was 40% while the retention goal was 85%. The predefined cut-offs for sufficient attendance and adherence were ≥ 75%. Acceptability was evaluated by semi-structured interviews with participants, nurse navigators, and physiotherapists. Seventeen (56%) out of 30 screened patients were considered vulnerable and eligible for the study, 14 (82%) accepted participation, and 3 (21%) were subsequently excluded due to ineligibility, leaving 11 patients. Four patients dropped out (36%) and four patients died (36%) during follow-up and 3 (27%) were retained. All 11 patients participated in nurse sessions (mean 16, range 1-36) with 88% attendance and dialogue tools being applied in 68% of sessions. Ninety-one percent of patients responded to PROs (mean of 9 PROs, range 1-24) with 76% of the PRO questionnaires used (attendance) and 100% adherence (completion of all questions in PRO questionnaires), and 55% participated in exercise sessions with 58% attendance and 85% adherence. We identified important barriers primarily related to transportation, but overall acceptability was high. The Navigate intervention was feasible with high participation, acceptability and satisfactory adherence. Retention and exercise attendance were low, which resulted in adjustments.Trial registration: The feasibility study was initiated prior to the multicenter randomized controlled trial registered by ClinicalTrials.gov (number: NCT05053997; date 23/09/2021)., (© 2023. The Author(s).)

Introduction: Many studies using Patient-reported outcomes (PRO) data have been conducted to monitor symptoms and health-related quality of life during follow-up after cancer treatment. However new ways of using (e)PROs have emerged. We aimed to explore the Danish landscape of the use of PRO in a research setting, where PRO is used actively in cancer patients undergoing treatment, and give an overview of how it is embraced by patients and clinicians., Methods and Materials: A literature search was performed in June 2023, using the keywords Denmark, cancer, and patient-reported outcomes. An expert on literature searches identified the search terms, and double screening was performed at both abstract and screening levels and full-text stage. The software tool Covidence was used., Results: 467 articles were retrieved and 19 studies were included. They described the type of ePRO instrument used and the application of active ePRO i.e. a dialogue tool in the clinical encounter, release of alerts to clinicians, and enhancement of self-management. Finally, a development in the use of active ePROs over time is elucidated and we show how it is embraced by patients and clinicians., Conclusion: This mini-review gives an overview of how ePRO solutions are tested in oncological research in Denmark and embraced by patients and clinicians. ePRO solutions in a Danish setting seem well-suited for self-management. However, if more impact is warranted, clinicians need to engage in reviewing and using ePROs. Moreover, for successful implementation, the integration of ePROs in electronic health records must be supported by IT specialists and management., (© 2023 The Authors.)

Background: Patients with detectable ctDNA after radical-intent treatment of metastatic spread from colorectal cancer (mCRC) have a very high risk of recurrence, which may be prevented with intensified adjuvant chemotherapy (aCTh). In the OPTIMISE study, we investigate ctDNA-guided aCTh after radical-intent treatment of mCRC. Here we present results from the preplanned interim analysis., Material and Methods: The study is an open-label 1:1 randomized clinical trial comparing ctDNA-guided aCTh against standard of care (SOC), with a run-in phase investigating feasibility measures. Key inclusion criteria; radical-intent treatment for mCRC and clinically eligible for triple-agent chemotherapy. Patients underwent a PET-CT scan before randomization. ctDNA analyses of plasma samples were done by ddPCR, detecting CRC-specific mutations and methylation of the NPY gene. In the ctDNA-guided arm, ctDNA positivity led to an escalation strategy with triple-agent chemotherapy, and conversely ctDNA negativity led to a de-escalation strategy by shared-decision making. Patients randomized to the standard arm were treated according to SOC. Feasibility measures for the run-in phase were; the inclusion of 30 patients over 12 months in two Danish hospitals, compliance with randomization >80%, rate of PET-CT-positive findings <20%, and eligibility for triple-agent chemotherapy >80%., Results: Thirty-two patients were included. The rate of PET-CT-positive cases was 22% ( n  = 7/32). Ninety-seven percent of the patients were randomized. Fourteen patients were randomly assigned to SOC and sixteen to ctDNA-guided adjuvant treatment and follow-up. All analyses of baseline plasma samples in the ctDNA-guided arm passed the quality control, and 19% were ctDNA positive. The median time to result was three working days. All ctDNA-positive patients were eligible for triple-agent chemotherapy., Conclusion: The study was proven to be feasible and continues in the planned large-scale phase II trial. Results from the OPTIMISE study will potentially optimize the adjuvant treatment of patients undergoing radical-intent treatment of mCRC, thereby improving survival and reducing chemotherapy-related toxicity.

We have mapped a locus on chromosome 7p22.3-7p15.3 spanning a 22.4 Mb region for ulcerative colitis (UC) by whole genome linkage analyses of a large Danish family. The family represent three generations with UC segregating as an autosomal dominant trait with variable expressivity. The whole-genome scan resulted in a logarithm of odds score (LOD score) of Z = 3.31, and a whole genome sequencing (WGS) of two affected excluded disease-causing mutations in the protein coding genes. Two rare heterozygote variants, rs182281985:G>A and rs541426369:G>A, both with low allele frequencies (MAF A:0.0001, gnomAD ver3.1.2), were found in clusters of ChiP-seq transcription factors binding sites close to the AHR (aryl hydrocarbon receptor) gene and the UC associated SNP rs1077773:G>A. Testing the two SNPs in a promoter reporter assay for regulatory activity revealed that rs182281985:G>A influenced the AHR promoter. These results suggest a regulatory region that include rs182281985:G>A close to the UC GWAS SNP rs1077773:G>A and further demonstrate evidence that the AHR gene on the 7p-tel region is a candidate susceptible gene for UC., (© 2023. The Author(s), under exclusive licence to European Society of Human Genetics.)

Introduction: Both quantitative and molecular changes in ctDNA can hold important information when treating metastatic colorectal cancer (mCRC), but its clinical utility is yet to be established. Before conducting a large-scale randomized trial, it is essential to test feasibility. This study investigates whether ctDNA is feasible for detecting patients who will benefit from treatment with epidermal growth factor receptor inhibitors and the prognostic value of circulating tumor DNA (ctDNA) response., Materials and Methods: Patients with mCRC, who were considered for systemic palliative treatment and were eligible for ctDNA analysis. Mutational testing on cell-free DNA (cfDNA) was done by ddPCR. ctDNA response from baseline to the third treatment cycle was evaluated in patients with detectable ctDNA at baseline. ctDNA maximum response was defined as undetectable ctDNA at the third treatment cycle, ctDNA partial response as any decrease in the ctDNA level, and ctDNA progression as any increase in the ctDNA level., Results: Forty-nine patients were included. The time to test results for mutational testing on cfDNA was significantly shorter than on tumor tissue (p < .001). Progression-free survival were 11.2 months (reference group), 7.5 months (HR = 10.7, p= .02), and 4.6 months (HR = 11.4, p= .02) in patients with ctDNA maximum response, partial response, and progression, respectively. Overall survival was 31.2 months (reference group), 15.2 months (HR = 4.1, p= .03), and 9.0 months (HR = 2.6, p= .03) in patients with ctDNA maximum response, partial response, and progression, respectively., Conclusion: Pretreatment mutational testing on cfDNA in daily clinic is feasible and can be applied in randomized clinical trials evaluating the clinical utility of ctDNA. Early dynamics in ctDNA during systemic treatment hold prognostic value., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: This study investigates the association between socioeconomic position (SEP) and health-related quality of life (HRQoL) in a cross-sectional cohort among cancer survivors and compares with cancer-free people., Methods: Survivors of colorectal, hematological, gynecological, prostate, thyroid cancer, and melanoma diagnosed 2000-2014 were identified in the PROFILES registry, and an age- and sex-matched cancer-free population were identified in the CentER panel. HRQoL, education, and comorbidity were self-reported. Street-level income and clinical factors were obtained from Statistics Netherlands and the Netherlands Cancer Registry. Multivariable logistic regression was used to examine associations of SEP (measured by education and income) and impaired HRQoL among cancer survivors and the cancer-free population, adjusting for age, sex, and time since diagnosis., Results: We included 6693 cancer survivors and 565 cancer-free people. Cancer survivors with low versus medium SEP more frequently reported impaired HRQoL (odds ratio (OR) range for all HRQoL outcomes, 1.06-1.78 for short education and 0.94-1.56 for low income). Survivors with high compared to medium SEP reported impaired HRQoL less frequently (OR range for all HRQoL outcomes, 0.46-0.81 for short education and 0.60-0.84 for low income). The association between SEP and HRQoL was similar in the matched cancer-free population., Conclusion: Low SEP was associated with impaired HRQoL in both cancer survivors and cancer-free people., Implications for Cancer Survivors: Targeted care is warranted for cancer survivors with impaired HRQoL, especially among those with low SEP., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: As magnetic resonance imaging (MRI) becomes increasingly integrated into radiotherapy (RT) for enhanced treatment planning and adaptation, the inherent geometric distortion in acquired MR images pose a potential challenge to treatment accuracy. This study aimed to evaluate the geometric distortion levels in the clinical MRI protocols used across Danish RT centers and discuss influence of specific sequence parameters. Based on the variety in geometric performance across centers, we assess if harmonization of MRI sequences is a relevant measure., Materials and Methods: Nine centers participated with 12 MRI scanners and MRI-Linacs (MRL). Using a travelling phantom approach, a reference MRI sequence was used to assess variation in baseline distortion level between scanners. The phantom was also scanned with local clinical MRI sequences for brain, head/neck (H/N), abdomen, and pelvis. The influence of echo time, receiver bandwidth, image weighting, and 2D/3D acquisition was investigated., Results: We found a large variation in geometric accuracy across 93 clinical sequences examined, exceeding the baseline variation found between MRI scanners ( σ  = 0.22 mm), except for abdominal sequences where the variation was lower. Brain and abdominal sequences showed lowest distortion levels ([0.22, 2.26] mm), and a large variation in performance was found for H/N and pelvic sequences ([0.19, 4.07] mm). Post hoc analyses revealed that distortion levels decreased with increasing bandwidth and a less clear increase in distortion levels with increasing echo time. 3D MRI sequences had lower distortion levels than 2D (median of 1.10 and 2.10 mm, respectively), and in DWI sequences, the echo-planar imaging read-out resulted in highest distortion levels., Conclusion: There is a large variation in the geometric distortion levels of clinical MRI sequences across Danish RT centers, and between anatomical sites. The large variation observed makes harmonization of MRI sequences across institutions and adoption of practices from well-performing anatomical sites, a relevant measure within RT.

Background: In the Danish Head and Neck Cancer Group (DAHANCA) 35 trial, patients are selected for proton treatment based on simulated reductions of Normal Tissue Complication Probability (NTCP) for proton compared to photon treatment at the referring departments. After inclusion in the trial, immobilization, scanning, contouring and planning are repeated at the national proton centre. The new contours could result in reduced expected NTCP gain of the proton plan, resulting in a loss of validity in the selection process. The present study evaluates if contour consistency can be improved by having access to AI (Artificial Intelligence) based contours., Materials and Methods: The 63 patients in the DAHANCA 35 pilot trial had a CT from the local DAHANCA centre and one from the proton centre. A nationally validated convolutional neural network, based on nnU-Net, was used to contour OARs on both scans for each patient. Using deformable image registration, local AI and oncologist contours were transferred to the proton centre scans for comparison. Consistency was calculated with the Dice Similarity Coefficient (DSC) and Mean Surface Distance (MSD), comparing contours from AI to AI and oncologist to oncologist, respectively. Two NTCP models were applied to calculate NTCP for xerostomia and dysphagia., Results: The AI contours showed significantly better consistency than the contours by oncologists. The median and interquartile range of DSC was 0.85 [0.78 - 0.90] and 0.68 [0.51 - 0.80] for AI and oncologist contours, respectively. The median and interquartile range of MSD was 0.9 mm [0.7 - 1.1] mm and 1.9 mm [1.5 - 2.6] mm for AI and oncologist contours, respectively. There was no significant difference in Δ NTCP., Conclusions: The study showed that OAR contours made by the AI algorithm were more consistent than those made by oncologists. No significant impact on the Δ NTCP calculations could be discerned.

Importance: Since bilateral simultaneous postoperative endophthalmitis (BSPOE) after immediate sequential bilateral cataract surgery (ISBCS) can be devastating for the patient, evaluating such cases in depth is important to maintaining patient safety., Objective: To evaluate whether a systemic breach of sterility was associated with an outbreak of BSPOE after ISBCSs performed on the same day at a single community-based eye clinic., Design, Setting, and Participants: This retrospective case series included all patients diagnosed with BSPOE at ophthalmology departments in Denmark following an infectious outbreak after ISBCSs performed at a single community-based eye clinic in December 2022., Exposure: Bilateral simultaneous postoperative endophthalmitis acquired after ISBCS., Main Outcome and Measures: Patient recovery from BSPOE after ISBCS was evaluated based on clinical and microbiological reports., Results: A woman aged 71 years, a man aged 84 years, and a woman aged 79 years consecutively presented with symptoms of endophthalmitis at regional eye departments 4 to 8 days after ISBCS performed on the same date at the same eye clinic. Five of 6 infected eyes underwent vitrectomy, and all eyes received an intravitreous injection of antibiotics. The same strain of Staphylococcus epidermidis was isolated in 4 of 5 eyes that underwent vitrectomy. Contamination of viscoelastics was ruled out with repeated cultures. One eye was eviscerated due to phthisis. In another patient, the final visual acuity of the eye most severely affected was 20/63 Snellen equivalents. Visual acuity of the remaining eyes recovered to 20/25 (3 eyes in 2 patients) and 20/20 (1 eye) Snellen equivalents., Conclusions and Relevance: The finding of the same strain of S epidermidis in all patient cultures suggests a systemic breach of sterility at the clinic on the day of ISBCS. The outcome of these cases emphasizes the need to adhere to a strict surgical methodology and sterile principles during ISBCS.

Background: Multimodal prehabilitation is a promising adjunct to the current surgical treatment pathway for colorectal cancer patients to further improve postoperative outcomes, especially for high-risk patients with low functional capacity. The aim of the present study was to test the effect of prehabilitation on immediate postoperative recovery., Method: The study was designed as a RCT with two arms (intervention and control). The intervention consisted of 4 weeks of multimodal prehabilitation, with supervised physical training, nutritional support and medical optimization. The control group received standard of care. A total of 40 patients with colorectal cancer (WHO performance status I or II) undergoing elective surgery with curative intent were included. The primary outcome was postoperative recovery within the first 3 postoperative days, measured by Quality of Recovery-15, a validated questionnaire with a scoring range between 0 and 150 and a minimal clinically relevant difference of 8., Results: In total, 36 patients were analysed with 16 in the intervention group and 20 in the control group. The mean age of the included patients was 79 years. The overall treatment effect associated with the intervention was a 21.9 (95% c.i. 4.5-39.3) higher quality of recovery-15 score during the first 3 postoperative days compared to control, well above the minimal clinically relevant difference., Conclusion: Four weeks of multimodal prehabilitation prior to elective curative intended colorectal cancer surgery in patients with WHO performance status I or II was associated with a clinically relevant improvement in postoperative recovery.Registration number: NCT04167436 (http://www.clinicaltrials.gov)., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Background: The socioeconomic differences in survival are pronounced for patients diagnosed with head and neck cancer; disease stage at diagnosis is suggested to be a main driver of this association. This nationwide, population-based study investigates socioeconomic differences in the pre-diagnostic interval and disease stage at diagnosis., Material and Methods: Information on patient-reported symptoms, symptom onset and disease-specific factors was obtained from the nationwide population-based Danish Head and Neck Cancer Group (DAHANCA) database for patients diagnosed with head and neck squamous cell carcinoma between 2008 and 2019 in Denmark. Socioeconomic position (SEP) was measured by individual-level education, income and cohabitation status obtained from administrative registers. Socioeconomic differences in the interval from symptom onset to diagnosis were investigated in general linear models with 95% confidence intervals (CIs); overall and by subsite, symptom and comorbidity score. Consultation patterns prior to diagnosis were examined using methods for change-point detection. Associations with advanced-stage disease were estimated in logistic regression models., Results: Patients with low, medium and high SEP had a similar interval from patient-reported symptom onset to diagnosis of 10 weeks. Although this interval varied according to primary symptom and anatomical subsite, no apparent socioeconomic differences were observed within these subgroups. Aligned with the patient-reported symptom onset, a distinct increase in consultation rates was observed at 9 weeks (95% CI [7.3; 10.7]) for patients with low SEP and 7 weeks (95% CI [4.8; 9.2]) for patients with high SEP, with overlapping CIs. Patients with low compared to high SEP had increased odds for advanced-stage glottic and oral cavity squamous cell carcinoma. For the remaining subsites the association varied according to SEP-indicator and TNM-edition., Conclusion: The interval from symptom onset to diagnosis and consultation patterns were similar across SEP groups. Still, socioeconomic differences in stage at diagnosis were observed for some - but not all - subsites.

Background: Chylothorax is an uncommon medical condition for which limited data are available regarding the contemporary aetiology, management and outcomes. The goal of this study was to better define these poorly characterised features., Methods: The medical records of adult patients diagnosed with chylothorax at 12 centres across Europe, America and South Africa from 2009-2021 were retrospectively reviewed. Descriptive and inferential statistics were performed., Results: 77 patients (median age 69 years, male to female ratio 1.5) were included. Subacute dyspnoea was the most typical presenting symptom (66%). The commonest cause of chylothorax was malignancy (68.8%), with lymphoma accounting for 62% of these cases. Other aetiologies were trauma (13%), inflammatory/miscellaneous conditions (11.7%) and idiopathic cases (6.5%). At the initial thoracentesis, the pleural fluid appeared milky in 73%, was exudative in 89% and exhibited triglyceride concentrations >100 mg·dL -1 in 88%. Lymphangiography/lymphoscintigraphy were rarely ordered (3%), and demonstration of chylomicrons in pleural fluid was never ascertained. 67% of patients required interventional pleural procedures. Dietary measures were infrequently followed (36%). No patient underwent thoracic duct ligation or embolisation. Morbidity included infections (18%), and thrombosis in malignant aetiologies (16%). The 1-year mortality was 47%. Pleural fluid protein >3.5 mg·dL -1 (sub-distribution hazard ratio (SHR) 4.346) or lactate dehydrogenase <500 U·L -1 (SHR 10.21) increased the likelihood of effusion resolution. Pleural fluid protein ≤3.5 mg·dL -1 (HR 4.047), bilateral effusions (HR 2.749) and a history of respiratory disease (HR 2.428) negatively influenced survival., Conclusion: Chylothoraces have a poor prognosis and most require pleural interventions. Despite the standard recommendations, lymphatic imaging is seldom used, nor are dietary restrictions followed., Competing Interests: Conflict of interest: J.M. Porcel has received consultancy fees from Becton Dickinson and Suministros Hospitalarios SA (SH Medical Group), and is an associate editor of this journal. Conflict of interest: The remaining authors declare that they have no relevant conflicts of interest., (Copyright ©The authors 2023.)

Objectives: To identify and investigate different cohorts of cancer patients' use of physical rehabilitation and specialised palliative care (SPC) services, focusing on patients with incurable cancer and the impact of social vulnerability., Methods: The sample originated from patients diagnosed during 2013-2018 and alive 1 January 2015. Use of physical rehabilitation and/or SPC units were identified from contacts registered in population-based administrative databases. Competing-risks regression models were applied to investigate disparities with regard to social vulnerability, disease duration, gender and age., Results: A total of 101 268 patients with cancer were included and 60 125 survived longer than 3 years after their diagnosis. Among the 41 143 patients, who died from cancer, 66%, survived less than 1 year, 23% survived from 1 to 2 years and 11% survived from 2 to 3 years. Contacts regarding physical rehabilitation services appeared in the entire cancer trajectory, whereas contacts regarding SPC showed a steep increase as time drew closer to death. The largest disparity was related to disease duration. Socially vulnerable patients had less contact with SPC, while a larger proportion of the socially vulnerable cancer survivors used rehabilitation, compared with the non-vulnerable patients., Conclusions: This study provides a previously unseen detailed overview of the use of physical rehabilitation and/or SPC among patients with incurable cancer. The services appeared to overlap at a group level in the cancer trajectory, emphasising the importance of awareness with regard to coordination and combination of the services. Disparities between socially vulnerable or non-vulnerable patients were identified., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Metastatic triple-negative breast cancer (mTNBC) is an aggressive subtype of breast cancer with poor survival. Currently, the literature lacks comprehensive real-world evidence on locally recurrent and mTNBC patients. To validate the optimal treatment for patients with mTNBC, real-world evidence in combination with data from clinical trials must be evaluated as complementary., Objectives: The objective of the study is to examine outcomes and treatment patterns of patients with advanced triple-negative breast cancer (TNBC) utilizing real-world data of patients from all oncology sites across Denmark., Design: This is a retrospective, non-interventional, multi-site, population-based observational study conducted across all oncology departments in Denmark., Methods: We included all women diagnosed with metastatic or locally recurrent TNBC from January 1, 2017, to December 31, 2019, using the national Danish Breast Cancer Group database. The primary endpoints were overall survival (OS) and progression-free survival (PFS) in the first to third treatment line., Results: The study included 243 women diagnosed with metastatic or recurrent TNBC. The median OS (mOS) was 11.6 months after the first line of treatment, 6.5 months after the second line, and 6.5 months after the third line. De novo mTNBC was associated with shorter OS (mOS: 8.3 vs 14.2 months), and those with a relapse within 18 months of primary diagnosis had shorter OS than those with a relapse after 18 months (mOS: 10.0 vs 18.2). In the first line, taxane was the preferred choice of treatment for patients with de novo mTNBC, whereas capecitabine was preferred for patients with recurrent TNBC., Conclusions: This real-world, nationwide study demonstrated poor OS among patients with metastatic or recurrent TNBC, with a mOS of 11.6 months (95% CI, 9.9-17.3). Patients who presented with de novo mTNBC or who had a relapse of their breast cancer within 18 months of primary diagnosis had shorter OS., Registration: The study was registered and approved by the Danish Capital Regions research overview (P-2021-605)., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TB: Institutional grants from Danish Cancer Society, Neye-fonden, Roche, Novartis, Samsung Bioepis, Pfizer, AstraZeneca, Merck Eisai, and Venture Oncology Personal; Invited Speaker: Pfizer; and Advisory Board: Merck. MJ: Institutional grants from Samsung Bioepis, Nanostring Technologies, and Venture Oncology. AK: Institutional grants from Roche and Venture Oncology Personal and Advisory Board: Novartis, AstraZeneca, MDS, Roche, Pfizer, and Eli Lilly Danmark A/S. Other authors had no conflict of interest to declare., (© The Author(s) 2023.)

Background: This study aimed at investigating the feasibility of developing a deep learning-based auto-segmentation model for the heart trained on clinical delineations., Material and Methods: This study included two different datasets. The first dataset contained clinical heart delineations from the DBCG RT Nation study (1,561 patients). The second dataset was smaller (114 patients), but with corrected heart delineations. Before training the model on the clinical delineations an outlier-detection was performed, to remove cases with gross deviations from the delineation guideline. No outlier detection was performed for the dataset with corrected heart delineations. Both models were trained with a 3D full resolution nnUNet. The models were evaluated with the dice similarity coefficient (DSC), 95% Hausdorff distance (HD95) and Mean Surface Distance (MSD). The difference between the models were tested with the Mann-Whitney U-test. The balance of dataset quantity versus quality was investigated, by stepwise reducing the cohort size for the model trained on clinical delineations., Results: During the outlier-detection 137 patients were excluded from the clinical cohort due to non-compliance with delineation guidelines. The model trained on the curated clinical cohort performed with a median DSC of 0.96 (IQR 0.94-0.96), median HD95 of 4.00 mm (IQR 3.00 mm-6.00 mm) and a median MSD of 1.49 mm (IQR 1.12 mm-2.02 mm). The model trained on the dedicated and corrected cohort performed with a median DSC of 0.95 (IQR 0.93-0.96), median HD95 of 5.65 mm (IQR 3.37 mm-8.62 mm) and median MSD of 1.63 mm (IQR 1.35 mm-2.11 mm). The difference between the two models were found non-significant for all metrics ( p  > 0.05). Reduction of cohort size showed no significant difference for all metrics ( p  > 0.05). However, with the smallest cohort size, a few outlier structures were found., Conclusions: This study demonstrated a deep learning-based auto-segmentation model trained on curated clinical delineations which performs on par with a model trained on dedicated delineations, making it easier to develop multi-institutional auto-segmentation models.

Background: In this study we present the Tracking Accessory 3 (TA3) as an alternative to the commercial gating block (GB) surrogate for the Varian Truebeam™ gating system (TGS). The TGS requires three visible reflectors to track the surrogate, presenting an opportunity for a surrogate to be made with less material and thus smaller dosimetric footprint than the commercial four reflector model., Materials and Methods: Relative dose and depth dose profiles below the TA3 and the GB were measured with radiosensitive film. Accuracy and reproducibility of the detected motion amplitude for three TA3s and one GB were determined using a respiratory phantom with surrogate to determine the camera's tracking volume. Clinical performance was evaluated prospectively in 10 breast cancer patients treated with deep inspiration breath hold monitored with TA3 and compared to previously published results. Non-parametric statistics were applied to test for significance., Results and Conclusions: Surface doses were increased up to 94% and 187% for the TA3 and GB, respectively, compared to no surrogate. The surface area influenced by at least 25% increase in dose was 12 cm 2 and 105 cm 2 for the TA3 and GB, respectively. The water equivalent thickness of the surrogates was found to be 1 mm for the TA3 and 3 mm for GB. The difference in measured amplitude were <0.2 mm for TA3 compared to the GB. The TA3s and GB were detected at all extremes of the clinically relevant tracking volume of the TGS. Clinical performance showed no significant differences. The TA3 caused less surface dose increase compared to the commercial GB. In the tested range all surrogates measured motion amplitude within 0.2 mm of reference value, which is not a clinically relevant difference. The TA3 showed no significant differences in clinical performance to similarly positioned surrogates.

Background: Previously, many radiotherapy (RT) trials were based on a few selected dose measures. Many research questions, however, rely on access to the complete dose information. To support such access, a national RT plan database was created. The system focuses on data security, ease of use, and re-use of data. This article reports on the development and structure, and the functionality and experience of this national database., Methods and Materials: A system based on the DICOM-RT standard, DcmCollab, was implemented with direct connections to all Danish RT centres. Data is segregated into any number of collaboration projects. User access to the system is provided through a web interface. The database has a finely defined access permission model to support legal requirements., Results: Currently, data for more than 14,000 patients have been submitted to the system, and more than 50 research projects are registered. The system is used for data collection, trial quality assurance, and audit data set generation.Users reported that the process of submitting data, waiting for it to be processed, and then manually attaching it to a project was resource intensive. This was accommodated with the introduction of triggering features, eliminating much of the need for users to manage data manually. Many other features, including structure name mapping, RT plan viewer, and the Audit Tool were developed based on user input., Conclusion: The DcmCollab system has provided an efficient means to collect and access complete datasets for multi-centre RT research. This stands in contrast with previous methods of collecting RT data in multi-centre settings, where only singular data points were manually reported. To accommodate the evolving legal environment, DcmCollab has been defined as a 'data processor', meaning that it is a tool for other research projects to use rather than a research project in and of itself.