MR-guided stereotactic radiotherapy of infra-diaphragmatic oligometastases: Evaluation of toxicity and dosimetric parameters.

BACKGROUND AND PURPOSE: The SOFT trial is a prospective, multicenter, phase 2 trial investigating magnetic resonance (MR)-guided stereotactic ablative radiotherapy (SABR) for abdominal, soft tissue metastases in patients with oligometastatic disease (OMD) (clinicaltrials.gov ID NCT04407897). We present the primary endpoint analysis of 1-year treatment-related toxicity (TRAE). MATERIALS AND METHODS: Patients with up to five oligometastases from non-hematological cancers were eligible for inclusion. A risk-adapted strategy prioritized fixed organs at risk (OAR) constraints over target coverage. Fractionation schemes were 45-67.5 Gy in 3-8 fractions. The primary endpoint was grade ≥ 4 TRAE within 12 months post-SABR. The association between the risk of gastrointestinal (GI) toxicity and clinical and dosimetric parameters was tested using a normal tissue complication probability model. RESULTS: We included 121 patients with 147 oligometastatic targets, mainly located in the liver (41 %), lymph nodes (35 %), or adrenal glands (14 %). Nearly half of all targets (48 %, n = 71) were within 10 mm of a radiosensitive OAR. No grade 4 or 5 TRAEs, 3.5 % grade 3 TRAEs, and 43.7 % grade 2 TRAEs were reported within the first year of follow-up. We found a significant association between grade ≥ 2 GI toxicity and the parameters GI OAR D0.1cc, D1cc, and D20cc. CONCLUSION: In this phase II study of MR-guided SABR of oligometastases in the infra-diaphragmatic region, we found a low incidence of toxicity despite half of the lesions being within 10 mm of a radiosensitive OAR. GI OAR D0.1cc, D1cc, and D20cc were associated with grade ≥ 2 GI toxicity.

Patient-reported outcomes used actively in cancer patients undergoing antineoplastic treatment: A mini-review of the Danish landscape.

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.

Using video consultations for clinical assessment and decision of treatment readiness before chemotherapy: A mixed-methods study among patients with gastrointestinal cancer and oncology nurses.

Objective: To investigate the feasibility of clinical assessment and decision of treatment readiness before chemotherapy using video consultations, as perceived by gastrointestinal cancer patients and oncology nurses. In addition, to estimate reductions in travel time for patients and environmental carbon dioxide (CO2) emissions. Methods: In a mixed-method study, patients with gastrointestinal cancer who participated in at least one video consultation during April-October 2019 completed a questionnaire on socioeconomic status, time and kilometers saved on travel. Kilometers saved were converted into reduced CO2 emissions. Descriptive statistics were used for analysis. Patients (n = 15) participated in semi-structured individual interviews, and five oncology nurses participated in a focus group interview. Results: A total of 84/119 patients (71%) consented to video consultation and responded to the questionnaire. 69% were male, with a mean age of 66 years. For 46% of patients, a video consultation saved more than an hour of travel time. Avoiding a median travel distance of 120 km per patient (range, 2-450 km) reduced CO2 emissions by 7018 lb. Video consultations had other positive effects on patients, including avoiding waiting rooms, having more energy, and experiencing more focused interactions with nurses. Technical issues occurred rarely. Nurses found technical issues more troublesome, sometimes precluding complete assessments. They reported a need to rethink nursing practice to effectively provide care during video consultations. Conclusions: Video consultations reduced CO2 emissions. In addition, they were beneficial for patients with gastrointestinal cancer. However, providing an optimal clinical assessment and decision of treatment readiness before chemotherapy requires testing patient equipment, technical skills and new oncology nursing competencies.

Development and results of a patient-reported treatment experience questionnaire on a 1.5 T MR-Linac.

INTRODUCTION: With the implementation of new radiotherapy technology, it is imperative that patient experience is investigated alongside efficacy and outcomes. This paper presents the development of a specifically designed validated questionnaire and a first report of international multi-institutional preliminary patient experience of MRI-guided adaptive radiotherapy (MRgART) on the 1.5 T MR-Linac (MRL). METHODS: A patient experience questionnaire was developed and validated before being distributed to the Elekta MRL Consortium, to gather first patient-reported experience from participating centres worldwide. The final version of the questionnaire contains 18 questions covering a range of themes and was scored on a Likert scale of 0-3. Responses were post-processed so that a score of 0 represents a negative response and 3 represents the most favourable response. These results were analysed for patient-reported experience of treatment on the MRL. Results were also analysed for internal consistency of the questionnaire using Chronbach's Alpha and the questionnaire contents were validated for relevance using content validity indexes (CVI). RESULTS: 170 responses were received from five centres, representing patients with a wide range of tumour treatment sites from four different countries. MRgART was well tolerated with an 84% favourable response across all questions and respondents. When analysed by theme, all reported the highest percentage of results in the favourable categories (2 and 3). Internal consistency in the questionnaire was high (Cronbach's α = 0.8) and the item-level CVI for each question was 0.78 or above and the Scale-level CVI was 0.93, representing relevant content. CONCLUSION: The developed questionnaire has been validated as relevant and appropriate for use in reporting experience of patients undergoing treatment on the MRL. The overall patient-reported experience and satisfaction from multiple centres within the Elekta MRL Consortium was consistently high. These results can reinforce user confidence in continuing to expand and develop MRL use in adaptive radiotherapy.

Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - A Danish intra-patient randomized multicentre study.

BACKGROUND AND PURPOSE: Radiodermatitis is a well-known toxicity of radiotherapy and barrier film has been shown to reduce the severity of radiodermatitis. We have validated prior findings in a Danish cohort, using a similar barrier film and patient reported outcomes. MATERIALS AND METHODS: 101 Danish breast cancer patients were included at three radiotherapy centres. Based on randomization either the lateral or medial part of their chest was covered by Mepitel film; making the patients their own control. The primary endpoint was patient reported symptoms and experience. A secondary endpoint was radiotherapy staff evaluation of dermatitis. RESULTS: Within the skin area covered by film, the patients reported a statistical significant lower level of pain (p < .001), itching (p = 0.005), burning sensation (p = 0.005) as well as edema (p = 0.017) and reduced sensitivity (p < .001). Most patients (76%) would have preferred film on the entire treatment area (p < 0.001) and Mepitel Film as a standard treatment option (84%) (p < 0.001). Patients treated after mastectomy had a significantly lower severity of radiation-induced dermatitis with film at the end of RT compared to standard care (p = 0.005). However, in the blinded staff evaluation, no significant differences were found at follow-up. CONCLUSIONS: Patients reported reduced symptoms from the skin with Mepitel Film and the majority would have preferred film as a standard offer to cover their entire treatment area. Especially women treated after mastectomy had a significantly lower level of radiodermatitis and preferred the film over standard care.

Predictors of continuous tobacco smoking in a clinical cohort study of Danish laryngeal cancer patients smoking before treated with radiotherapy.

BACKGROUND: Many cancer patients who are smokers when starting cancer therapy continue smoking despite evidence of tobacco smoking as a risk factor for poor treatment response and secondary primary cancers. Small samples and inconsistent results in previous studies warrant further research to identify predictors of being a continuous smoker during and after radiotherapy. MATERIAL AND METHODS: In the clinical database of the Danish Head and Neck Cancer Group (DAHANCA), we identified 1455 patients diagnosed with laryngeal cancer between 2000 and 2010, who were all smokers at date of diagnosis and treated with primary radiotherapy. Information on the socio-economic characteristics of the study cohort was obtained from Statistics Denmark the year prior to diagnosis. Logistic regression analyses were applied. RESULTS: In the cohort of laryngeal cancer patients smoking before starting radiotherapy, 50% still smoked one year after radiotherapy similar to the percentage of smokers during treatment. Being younger than 60 years (OR 1.39, 95% CI 1.00-1.91), commenced smoking before the age of 15 (OR 1.77, 95% CI 1.32-2.38), having a poor WHO Performance status (OR 3.09, 95% CI 1.71-5.61), low income (OR 2.21, 95% CI 1.23-3.98) and living alone (OR 1.56, 95% CI 1.13-2.14) were associated with increased risk of continuous smoking during treatment. Similar findings were found two months and one year after radiotherapy, however, no association with living alone (OR 1.08, 95% CI 0.73-1.59) at the one-year follow-up. Tumor stage and the average number of cigarettes smoked per day before radiotherapy were not associated with being a continuous smoker. CONCLUSION: Younger patients, who had an early smoking initiation, a poor performance status, low income and lived alone, were most likely to continue smoking. Continuous smoking was not related to the extent of disease.