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Background: Robust optimization has been suggested as an approach to reduce the irradiated volume in lung Stereotactic Body Radiation Therapy (SBRT). We performed a retrospective planning study to investigate the potential benefits over Planning Target Volume (PTV)-based planning. Material and methods: Thirty-nine patients had additional plans using robust optimization with 5-mm isocenter shifts of the Gross Tumor Volume (GTV) created in addition to the PTV-based plan used for treatment. The optimization included the mid-position phase and the extreme breathing phases of the 4D-CT planning scan. The plans were compared for tumor coverage, isodose volumes, and doses to Organs At Risk (OAR). Additionally, we evaluated both plans with respect to observed tumor motion using the peak tumor motion seen on the planning scan and cone-beam CTs. Results: Statistically significant reductions in irradiated isodose volumes and doses to OAR were achieved with robust optimization, while preserving tumor dose. The reductions were largest for the low-dose volumes and reductions up to 188 ccm was observed. The robust evaluation based on observed peak tumor motion showed comparable target doses between the two planning methods. Accumulated mean GTVdose was increased by a median of 4.46 Gy and a non-significant increase of 100 Monitor Units (MU) was seen in the robust optimized plans. Interpretation: The robust plans required more time to prepare, and while it might not be a feasible planning strategy for all lung SBRT patients, we suggest it might be useful for selected patients.

Background Radiotherapy of breast cancer can be associated with dermatitis. Grade ≥2 radiation dermatitis can be painful and impair the patients’ quality of life. To reduce the risk of this complication, patients have to perform skin care several times each day. This may require a considerable level of compliance. This randomized DAI-BREAC trial investigates whether a mobile application reminding the patients four times per day to perform skin care (reminder app) will contribute to reduction of grade ≥2 radiation dermatitis. Methods This multinational, randomized, active-controlled, parallel-group, multicenter trial compares standard skin care supported by a reminder app (Arm A) versus standard skin care alone (Arm B) regarding grade ≥2 radiation dermatitis in patients receiving adjuvant radiotherapy for breast cancer. The effect of the app will be considered clinically relevant, if the rate of grade ≥2 radiation dermatitis is reduced from 25.4% (rate identified in a preceding study) to 15%. A total of 134 patients per arm including drop-outs are required. Secondary aims include pain (visual analogue scale), patient satisfaction with the app (questionnaire), impact of the app on the use of health technology (questionnaire), and benefit from support (coaching) by staff members regarding the use of the app (questionnaire). Discussion If the reminder app contributes to a decrease of grade ≥2 radiation dermatitis in patients irradiated for breast cancer, it will likely become a useful instrument for these patients. Trial registration Clinicaltrials.gov (NCT06483477; URL: https://clinicaltrials.gov/show/NCT06483477 ). Registered on 1st of July, 2024. First patient was included in December 2024.

IntroductionPatient engagement is continuously being promoted by patients as well as politicians and healthcare professionals. One way of increasing patient engagement is by using shared decision-making (SDM), which is a joint effort of clinicians and patients making decisions together.When planning stereotactic body radiation therapy (SBRT) for a lung tumour located close to the thoracic wall, there are conflicting interests between (1) delivering the highest possible dose to obtain local tumour control and (2) reducing the dose to the thoracic wall to decrease the risk of chest wall pain and rib fractures following treatment. The radiation oncologist often makes the choice of dose without any engagement of the patient. We believe that the patients should be engaged in such a decision.To explore this matter, we have designed a randomised trial, ‘SDM Lung SBRT’, for which we present our study protocol with a special focus on a patient decision aid (PtDA), which is being tested in this trial.Methods and analysisThis study includes patients with a lung tumour located ≤1 cm from the thoracic wall. Patients are randomised to have the primary consultation with or without use of the PtDA. Treatment options are a radiation dose of either 66 Gray (Gy) in three fractions, 45 Gy in three fractions or no treatment. The primary outcome is patient engagement in decision-making measured by the validated observer-rated OPTION-12 score. Secondary outcomes are patient-reported outcomes, quality of life and side effects following treatment.Ethics and disseminationAll patients give informed consent to participate. According to Danish legislation, ethical approval is not required for this study as studies using questionnaires, observations or other non-biological studies are not considered interventions according to the Committee Act. Results from this study will be presented at scientific meetings and published in English peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT04940936).

Background/Objectives: Radiation therapy is a common treatment modality for non-small-cell and small-cell lung cancer that can be associated with considerable side effects, mainly reactions of healthy tissues in the radiation field. Radiation therapy may lead to significant fatigue, which can potentially be mitigated by maintaining or increasing physical activity during treatment. Since achieving this goal may be a challenge for patients, they may benefit from a mobile application reminding them daily to perform a predefined number of steps. Such a reminder app will be investigated prospectively in a phase 2 trial. The current APART-LUNG study (NCT07380815) is a mandatory study for designing the prospective trial. Methods: The main objective of the APART-LUNG (exploratory non-interventional) study is to report patterns of physical activity during radiation therapy for lung cancer patients and generate hypotheses based on our findings. Our primary endpoint is the within-patient difference in weekly average steps per wear hour of the smartphone (week 5 minus week 1 of radiation therapy), and our secondary aim is to estimate differences in operational measures (wear time of the smartphone) between week 5 and week 1. The sample size of approximately 20 patients (full analysis set) allows us to detect a moderate-to-large standardized within-patient difference and is driven by feasibility and the intent to obtain preliminary estimates of effect size and variability. The results of the APART-LUNG study will be very important for appropriately designing a phase 2 trial.

Survival scores facilitate personalized cancer treatment. Due to demographic changes, very elderly patients are more prevalent than in the past. A score was developed in 94 patients aged ≥ 80 years undergoing whole-brain radiotherapy for brain metastases. Dose fractionation, treatment period, age, sex, performance score (ECOG-PS), tumor type, count of lesions, metastases outside the brain, and interval tumor diagnosis to radiotherapy were retrospectively evaluated. Independent predictors of survival were used for the score. Based on individual scoring points obtained from 3-month survival rates, prognostic groups were designed. Additionally, the score was compared to an existing tool developed in patients ≥ 65 years. ECOG-PS, count of lesions, and extra-cranial metastases were independent prognostic factors. Three groups were created (7, 10, and 13–16 points) with 3-month survival of 6%, 25%, and 67% (p < 0.001), respectively. Positive predictive values (PPVs) regarding death ≤ 3 and survival ≥ 3 months were 94% and 67% (new score) vs. 96% and 48% (existing tool), respectively. PPVs for survival ≥1 and ≥2 months were 88% and 79% vs. 63% and 58%, respectively. Both tools were accurate in predicting death ≤2, ≤3, and ≤6 months. The new score was more precise regarding death ≤1 month and survival (all time periods) and appeared preferable. However, it still needs to be validated.

Many patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increased urinary toxicity. Therefore, it is important to maintain bladder volumes greater than 200 ml during as many radiation fractions as possible. Several studies investigated drinking protocols, where patients were asked to drink a certain amount of water prior to radiotherapy sessions. This may require considerable discipline from the patients, who are predominantly older adults. Adherence to a drinking protocol may be facilitated by a mobile app that reminds patients to drink water prior to each radiation session. This study investigates the effect of such an app on bladder filling status in patients with prostate cancer undergoing external beam radiotherapy (EBRT) alone. The primary goal of this study is to evaluate the impact of an app that reminds patients irradiated for prostate cancer to drink 300 ml of water prior to each radiotherapy session on the number of fractions with bladder volumes <200 ml during the radiotherapy course. This ongoing phase 2 aims to recruit 28 patients treated with EBRT alone for nonmetastatic prostate cancer. Radiotherapy will be administered using normo-fractionation, with doses ranging from 70 to 80 Gy in 35 to 40 fractions of 2 Gy, preferably with volumetric-modulated arc therapy (VMAT). Treatment volumes include the prostate with or without the seminal vesicles. Recruitment for this trial will start in March 2025 and is planned to be completed in October 2026. The study is scheduled to conclude in December 2026. This trial is the first to evaluate the impact of a reminder app on the number of radiotherapy fractions with bladder volumes <200 ml in patients undergoing irradiation for localized prostate cancer. Clinicaltrials.gov NCT06653751; https://clinicaltrials.gov/show/NCT06653751. PRR1-10.2196/68179.

Background/Objectives: During radiotherapy for prostate cancer, the risk of radiation cystitis is increased if the volume of the bladder is small. According to previous studies, it is important that bladder volumes are ≥200 mL. Drinking protocols may be helpful in this context. Adherence to such protocols can be challenging, and may be improved by an app reminding patients before each session of radiotherapy to drink a certain amount of water. Our prospective phase 2 trial (REFILL-PAC-HYPO, NCT06784115) evaluates the impact of a reminder app on bladder filling in prostate cancer patients treated with hypo-fractionated radiotherapy. Methods: Twenty-seven patients need to be recruited for the REFILL-PAC-HYPO trial. Radiotherapy, preferably with volumetric-modulated arc therapy, uses hypo-fractionation with 20 × 3.0 Gy over four weeks. An app reminds patients to drink water (300 mL) 45 min before each session of hypo-fractionated irradiation. On the last day of their treatment, patients are asked about their satisfaction with the app. In the case of a dissatisfaction rate of >20%, the app requires modifications. If this rate is >40%, the app is considered not useful. Additionally, patients are asked about the impact of their participation in the trial and using the app on their general attitude towards health technology. Furthermore, the phase 2 cohort is compared to a historical control group treated with hypo-fractionated radiotherapy during recent years but not supported by an app. The REFILL-PAC-HYPO trial will contribute to identifying the potential value of a reminder app for bladder filling during hypo-fractionated radiotherapy for prostate cancer.

We investigated the impact of 2-[18F]FDG-PET/CT on detection rate (DR) of the primary tumor and survival in patients with suspected cancer of unknown primary tumor (CUP), comparing it to the conventional diagnostic imaging method, CT. Patients who received a tentative CUP diagnosis at Odense University Hospital from 2014–2017 were included. Patients receiving a 2-[18F]FDG-PET/CT were assigned to the 2-[18F]FDG-PET/CT group and patients receiving a CT only to the CT group. DR was calculated as the proportion of true positive findings of 2-[18F]FDG-PET/CT and CT scans, separately, using biopsy of the primary tumor, autopsy, or clinical decision as reference standard. Survival analyses included Kaplan–Meier estimates and Cox proportional hazards regression adjusted for age, sex, treatment, and propensity score. We included 193 patients. Of these, 159 were in the 2-[18F]FDG-PET/CT group and 34 were in the CT group. DR was 36.5% in the 2-[18F]FDG-PET/CT group and 17.6% in the CT group, respectively (p = 0.012). Median survival was 7.4 (95% CI 0.4–98.7) months in the 2-[18F]FDG-PET/CT group and 3.8 (95% CI 0.2–98.1) in the CT group. Survival analysis showed a crude hazard ratio of 0.63 (p = 0.024) and an adjusted hazard ratio of 0.68 (p = 0.087) for the 2-[18F]FDG-PET/CT group compared with CT. This study found a significantly higher DR of the primary tumor in suspected CUP patients using 2-[18F]FDG-PET/CT compared with patients receiving only CT, with possible immense clinical importance. No significant difference in survival was found, although a possible tendency towards longer survival in the 2-[18F]FDG-PET/CT group was observed.

Patients receiving systemic treatment for non-small cell lung cancer (NSCLC) may experience significant fatigue leading to decrease in physical activity. An app reminding them to reach a pre-defined daily step count may be useful. The APACHIE-01 trial aimed to investigate step counts during systemic treatment and form the basis of a complimentary prospective trial testing a reminder app. Primary endpoint was the mean step count per week during the first three cycles of systemic treatment (weeks three, six, and nine) in relation to the pre-treatment step count (baseline). Recruitment of the required 38 patients with advanced NSCLC should be completed within four months. Since only three patients were included during this period, the trial was stopped prematurely. Given the very small sample size, analyses were descriptive and exploratory in nature. Mean weekly step counts at baseline were 2,451, 7,250, and 4,877 steps (mean value=4,859±2,400 steps; timepoint A). Mean values during weeks three (timepoint B), six (timepoint C), and nine (timepoint D) were 3,114±2,568, 2,837±750, and 1,224±44 (only two patients available) steps, respectively. Comparisons of mean step counts revealed numerical decreases, particularly between timepoints A and D. It was unexpectedly difficult to recruit patients for the APACHIE-01 trial. Given the very low number of participants, the results of the APACHIE-01 trial can only serve for descriptive orientation. The decrease of the mean step count may justify further exploratory investigations during systemic treatment and support the idea of an app reminding NSCLC patients to walk a pre-defined number of steps per day.

Very elderly patients irradiated for bone metastases likely benefit from individualized treatments. A specific survival score was created for this group and compared to existing instruments. Ninety-six patients aged 80+ irradiated for bone metastases were retrospectively evaluated. Dose-fractionation regimen plus twelve characteristics were evaluated for survival. In the Cox regression model, performance status and tumor type were significant and used for the score, which included three groups (5-7, 8-12, and 14 points) with 6-month survival rates of 15%, 52%, and 90%. Positive predictive values (PPVs) regarding death ≤6 months were 85% (new score), 100% (previous 65+ score), and 84% (previous score for any age). The new instrument and the 65+ score were also very accurate regarding survival. Since PPV regarding death was calculated from only four patients for the 65+ score, this PPV may be less conclusive than that for the new instrument. The new score appears useful for patients aged 80+ irradiated for bone metastases.