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Background/aim: Patients who receive radiotherapy (RT) may experience significant distress. This study investigated distress scores during RT for a variety of malignancies., Patients and Methods: Distress thermometers (scores of 0-10 points) were completed by 927 patients at baseline and end of RT. Six characteristics were evaluated for changes of distress scores including age, sex, Karnofsky performance score (KPS), tumor type, intent of treatment, and previous RT., Results: Mean distress scores were 4.9 (±2.7) at baseline and 4.6 (±2.7) at the end of RT; mean change was -0.3 (±2.8) points. On univariable analysis, increased distress (≥2 points) was significantly associated with KPS 90-100 (p<0.001) and curative intent (p=0.040). Trends were found for age ≤64 years (p=0.062), head-and-neck cancer (p=0.076), and no prior RT (p=0.055). In patients with baseline scores ≤5 points, deterioration rates were 30-47%., Conclusion: Psychological support should be offered to all patients undergoing RT. This would benefit particularly patients with risk factors for increased distress., (Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: 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., Patients and Methods: Ninety-six patients aged 80+ irradiated for bone metastases were retrospectively evaluated. Dose-fractionation regimen plus twelve characteristics were evaluated for survival., Results: 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., Conclusion: The new score appears useful for patients aged 80+ irradiated for bone metastases., (Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Many cancer patients receive radiotherapy, which may cause distress. This pilot study evaluated distress levels before and after radiotherapy to contribute to the design of a prospective trial., Patients and Methods: Two-hundred patients completed distress thermometers before and after radiotherapy. Distress levels ranged from 0 (no distress) to 10 (maximum distress). Five characteristics were retrospectively analyzed regarding changes of distress including age, sex, performance score, tumor type, previous radiotherapy, and treatment intention. Additional analyses were performed for elderly (>65 years) and non-elderly (≤65 years) patients., Results: In all patients and both age groups, median pre-radiotherapy and post-radiotherapy distress levels were 5 (0-10) vs. 4 (0-10) points. Mean changes of distress levels were -0.5 (±2.6) points in all, -0.4 (±2.5) in elderly, and -0.7 (±2.8) in non-elderly patients. Changes were significantly associated with tumor type in all (p=0.049) and elderly (p=0.025) patients., Conclusion: Future studies investigating distress levels in patients receiving radiotherapy should consider age and tumor type., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

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.

Survival scores are important for personalized treatment of bone metastases. Elderly patients are considered a separate group. Therefore, a specific score was developed for these patients. Elderly patients (≥65 years) irradiated for bone metastases were randomly assigned to the test (n = 174) or validation (n = 174) cohorts. Thirteen factors were retrospectively analyzed for survival. Factors showing significance (p < 0.05) or a trend (p < 0.06) in the multivariate analysis were used for the score. Based on 6-month survival rates, prognostic groups were formed. The score was compared to an existing tool developed in patients of any age. In the multivariate analysis, performance score, tumor type, and visceral metastases showed significance and gender was a trend. Three groups were designed (17, 18−25 and 27−28 points) with 6-month survival rates of 0%, 51%, and 100%. In the validation cohort, these rates were 9%, 55%, and 86%. Comparisons of prognostic groups between both cohorts did not reveal significant differences. In the test cohort, positive predictive values regarding death ≤6 and survival ≥6 months were 100% with the new score vs. 80% and 88% with the existing tool. The new score was more accurate demonstrating the importance of specific scores for elderly patients.

Background: Radiotherapy of head-and-neck cancer (SCCHN) is often associated with acute toxicity. In a previous trial, daily reminders by staff members to perform skin care resulted in less dermatitis. This randomized trial investigated whether a mobile application can replace these reminders., Methods: Patients were stratified according to tumor site, treatment and center. Fifty-three patients were eligible for per-protocol-set (25 with, 28 without app). Primary endpoint was grade ≥ 2 dermatitis until 60 Gy. Secondary endpoints included dermatitis grade ≥ 2 until end of radiotherapy (EOT), dermatitis grade ≥ 3, and mucositis grade ≥ 2 and ≥ 3., Results: After an interim analysis, the study was terminated (delayed and slow accrual). Until 60 Gy, grade ≥ 2 dermatitis rates were 72% with vs. 82% without app (p = 0.38), grade ≥ 3 dermatitis rates 20% vs. 11% (p = 0.45). Until EOT, grade ≥ 2 and ≥ 3 dermatitis rates were 72% vs. 86% (p = 0.22) and 24% vs. 18% (p = 0.58). Until 60 Gy, grade ≥ 2 and ≥ 3 mucositis rates were 76% vs. 82% (p = 0.58) and 20% vs. 36% (p = 0.20). Until EOT, corresponding mucositis rates were 76% vs. 82% (p = 0.58) and 28% vs. 43% (p = 0.26)., Conclusion: Given the limitations of this trial, the reminder app led to non-significant reduction of grade ≥ 2 dermatitis, grade ≥ 2 mucositis and ≥ 3 mucositis. Additional studies are required to define the value of reminder apps during radiotherapy for SCCHN., (© 2022. The Author(s).)

Background/aim: Little is known regarding seizures during radiotherapy for brain tumors. This prospective study investigated seizure activity in patients irradiated for high-grade gliomas., Patients and Methods: Using a seizure diary, progression of seizure activity was evaluated in 22 patients receiving chemoradiation for grade III (n=1) or IV (n=21) gliomas. Progression was defined as increased frequency of any and/or generalized seizures (>50%) or increased anti-epileptic medication (≥25%). Patients' satisfaction with the diary was assessed using a questionnaire (six scales of 1-7 points). Uni- and multivariable analyses were performed including baseline seizure activity, age, sex, resection, tumor site, performance score, and history of epilepsy/seizures., Results: Ten patients (45%) experienced progression of seizure activity during their radiotherapy course, mainly due to increased seizure frequency (nine patients=41%). Mean values of patients' satisfaction scores ranged between 3.92 and 4.92 points., Conclusion: Radiotherapy of high-grade gliomas can increase seizure activity. Patients require close monitoring to initiate or adjust anti-epileptic medication., (Copyright © 2022, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Organ-sparing treatment is increasingly used for bladder cancer, particularly for patients with significant comorbidities or advanced age. The upcoming treatment can cause distress and sleep disturbances. This study investigated pre-radiotherapy sleep disturbances in these patients., Patients and Methods: Twenty-two patients with bladder cancer scheduled for local or loco-regional radiotherapy were retrospectively evaluated. Sixteen characteristics were analyzed for sleep disturbances including age, sex, performance score, comorbidities, previous malignancy, distress score, emotional problems, physical problems, treatment situation, treatment intent, current primary tumor and nodal stage, distant metastasis, treatment volume, concurrent chemotherapy, and Coronavirus Disease 2019 pandemic., Results: Eleven patients (50.0%) reported sleep disturbances that were significantly associated with distress scores ≥5 (p=0.035). Trends were found for age ≤75 years (p=0.183), ≥2 emotional problems (p=0.183), ≥5 physical problems (p=0.064), and distant metastasis (p=0.090)., Conclusion: Half of the patients reported pre-radiotherapy sleep disturbances. Risk factors facilitate identification of patients requiring psychological support., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Many patients with locally advanced cancer of the esophagus or esophagogastric junction receive definitive or neoadjuvant radiochemotherapy. Patient anticipation of this treatment can cause or aggravate distress and sleep disorders. This study aimed to identify the prevalence of sleep disorders and risk factors., Patients and Methods: Thirty-eight patients assigned to radio-chemotherapy were retrospectively evaluated for pre-treatment sleep disorders. Investigated characteristics included age; sex; performance score; comorbidity index; previous malignancies; family history; distress score; emotional, physical or practical problems; tumor site; histology and grading; tumor stage; planned treatment; and relation to 2019 Coronavirus pandemic., Results: Sleep problems were reported by 15 patients (39.5%). Significant associations were found for higher distress scores (p=0.016) and greater numbers of emotional problems (p<0.0001). A trend was observed for greater numbers of physical problems (p=0.176)., Conclusion: The prevalence of sleep problems was high. Risk factors were found that can help identify patients requiring psychological support already prior to radio-chemotherapy., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Upcoming radiotherapy may cause distress and sleep disorders (SDO). This prospective interventional trial investigated SDO during a course of radiotherapy for breast cancer., Patients and Methods: Fifty patients were eligible. The primary endpoint was improvement of SDO after 15 fractions. Additional endpoints included SDO after 5 fractions and at the end of radiotherapy (EOT). Additional characteristics were analysed including use of smartphones/tablets, age, body mass index, performance score, comorbidity score, surgery, distress score, and emotional/ physical/practical problems., Results: After 15 fractions, 38% of patients reported improvement of SDO (p<0.0001). Improvement rates were 22% after 5 fractions (p=0.003) and 39% at EOT (p<0.0001). Moreover, a significant association was observed for lower distress score after 5 fractions., Conclusion: Improvement of SDO occurred more often than expected, most likely due to habituation to radiotherapy. Since SDO did not improve in the majority of patients, timely psychological support should be offered to all patients., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Many patients with malignant gliomas are scheduled for radiochemotherapy, which may cause emotional distress associated with sleep problems. This study aimed to determine the prevalence of such sleep problems in these patients and identify risk factors., Patients and Methods: Fifty-seven patients scheduled for radiochemotherapy for grade II-IV gliomas were retrospectively investigated for pre-treatment sleep problems. Fifteen characteristics were evaluated including temporal relation to COVID-19 pandemic, age, gender, performance status, comorbidity, (family) history of malignancies, distress score, emotional problems, physical problems, practical problems, involved sites, glioma grade, upfront surgery, and corticosteroids., Results: Nineteen patients stated pre-treatment sleep problems (prevalence=66.7%). Significant associations with sleep problems were found for female gender (p=0.023), presence of emotional problems (p=0.006), and ≥4 physical problems (p<0.001). A trend was found for distress scores ≥5 (p=0.077)., Conclusion: The prevalence of sleep problems was high. Risk factors were determined that can be used to identify patients who likely benefit from psychological support., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Most breast cancer patients with non-metastatic disease receive adjuvant local or loco-regional radiotherapy. To be scheduled for irradiation may cause distress and fears that can lead to sleep disorders. Few reports focused on sleep problems in patients assigned to radiotherapy. This study evaluates the course of sleep disorders during adjuvant radiotherapy for primary breast cancer and potential risk factors including the use of smartphones or tablets at bedtime., Methods: The main goal is the evaluation of sleep disorders prior to radiotherapy and after 15 fractions of radiotherapy. A potential effect of habituation to the procedure of radiotherapy can be assumed that will likely lead to improvement (decrease) of sleep disorders. Improvement of sleep disorders (compared to baseline before radiotherapy) is defined as decrease of the severity of sleep disorders by ≥2 points on a patient self-rating scale (0 = no problems; 10 = maximum problems) or decrease of distress caused by sleep disorders by ≥2 points on a self-rating scale (0 = no distress; 10 = maximum distress) or reduction of the dose of sleeping drugs by ≥25%. Additional endpoints include sleep disorders after 5 fractions and at the end of radiotherapy. Moreover, potential risk factors including the use of smartphones or tablets at bedtime are evaluated. Fifty-one patients (48 plus potential drop-outs) are required. With this sample size, a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance, if the rate of patients with improvement of sleep disorders is 25% (rate under the alternative hypothesis) and assuming that a decrease of ≤10% has to be judged as a random, non-causal change in this uncontrolled study setting (null hypothesis)., Discussion: If a decrease of sleep disorders during the course of radiotherapy is shown, this aspect should be included in the pre-radiotherapy consent discussion with the patients. Moreover, identification of additional risk factors will likely lead to earlier psychological support. If the use of smartphones or tablets at bedtime is a risk factor, patients should be advised to change this behavior., Trial Registration: clinicaltrials.gov (NCT04879264; URL: https://clinicaltrials.gov/show/NCT04879264 ); registered on 7th of May, 2021., (© 2021. The Author(s).)

Background/aim: A considerable number of patients with lung cancer are scheduled for definitive or adjuvant radiotherapy. Prevalence and potential risk factors of pre-radiotherapy sleep disturbances were evaluated., Patients and Methods: Nineteen factors were retrospectively investigated for associations with pre-radiotherapy sleep disturbances in 77 lung cancer patients. Factors included COVID-19 pandemic; age; gender; performance score; comorbidity index; history of another malignancy; distress score; number of emotional, physical or practical problems; patient's request for psychological support; histology; tumor stage; upfront surgery; chemotherapy; and type of radiotherapy., Results: Thirty-one patients (40.3%) reported sleep disturbances that were significantly associated with distress score 6-10 (p=0.019), ≥2 emotional problems (p=0.001), ≥5 physical problems (p<0.001), and request for psychological support (p=0.006). Trends were found for female gender (p=0.064) and stereotactic body radiation therapy (p=0.057)., Conclusion: Many lung cancer patients assigned to radiotherapy reported sleep disturbances. Risk factors can be used to identify patients in need of psychological support already before treatment., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Many patients with prostate cancer receive definitive or adjuvant radiotherapy. This study aimed to identify the frequency of sleep disturbances and corresponding risk factors prior to radiation treatment., Patients and Methods: Data of 48 patients assigned to local or loco-regional irradiation for prostate cancer were retrospectively analyzed for pre-radiotherapy sleep disturbances. Fifteen characteristics were analyzed including age, performance status, comorbidity, history of previous malignancy, distress score, (emotional, physical or practical) problems, prostate-specific antigen, primary tumor stage, Gleason-score, upfront androgen deprivation therapy (ADT), treatment volume, brachytherapy, and COVID-19 pandemic., Results: Pre-radiotherapy sleep disturbances were reported by 20.8% of patients and significantly associated with distress scores ≥4 (p<0.0001) and ≥3 physical problems (p=0.0001). Trends were found for Karnofsky performance score ≤80 (p=0.095), Gleason score 7b-9 (p=0.079), and ADT (p=0.067)., Conclusion: Pre-radiotherapy sleep disturbances were less common in prostate cancer patients than in other cancer patients. Risk factors were identified that can help identify patients requiring psychological support prior to radiotherapy., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Many patients with head-and-neck cancer are scheduled for irradiation. This study was performed to determine the frequency of and risk factors for pre-radiotherapy sleep disturbances in these patients., Patients and Methods: A total of 103 patients with head-and-neck cancer scheduled for radiotherapy were included in this retrospective study. Eighteen characteristics were evaluated including timing of start of radiotherapy relative to COVID-19 pandemic; age; gender; Karnofsky performance score; Charlson comorbidity index; history of another malignancy; family history of malignancy; distress score; number of emotional, physical or practical problems; request for psychological support; tumor site and stage; upfront surgery; planned chemotherapy; and brachytherapy boost., Results: The frequency of pre-radiotherapy sleep disturbances was 42.7%. This was significantly associated with age ≤63 years (p=0.049), Karnofsky performance score ≤80 (p=0.002), Charlson comorbidity index ≥3 (p=0.005), history of another malignancy (p=0.012), emotional (p=0.001) or physical (p<0.001) problems, and request for psychological support (p=0.002)., Conclusion: Sleep disturbances were frequent in patients assigned to radiotherapy of head-and-neck cancer. Recognizing risk factors for sleep disturbance helps identify patients requiring psychological support., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Being scheduled for radiotherapy can cause emotional distress. This study aimed to identify risk factors in 338 patients assigned to radiotherapy for breast cancer., Patients and Methods: Nineteen potential risk factors including the COVID-19 pandemic were investigated for associations with the six emotional problems included in the National Comprehensive Cancer Network Distress Thermometer., Results: Worry and fears were significantly associated with age ≤60 years; sadness with age and Karnofsky performance score (KPS) <90; depression with KPS and Charlson Comorbidity Index ≥3; loss of interest with KPS. Trends were found for associations between sadness and additional breast cancer/DCIS, Charlson Index and chemotherapy; between depression and additional breast cancer/DCIS, treatment volume and nodal stage N1-3; between nervousness and additional breast cancer/DCIS, mastectomy and triple-negativity; between loss of interest and Charlson Index, family history of breast cancer/DCIS, invasive cancer, chemotherapy, and treatment volume. The COVID-19 pandemic did not increase emotional problems., Conclusion: Several risk factors for emotional problems were identified. Patients with such factors should receive psychological support well before radiotherapy., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Radiotherapy and radiochemotherapy are common treatments for rectal and anal cancer. Anticipation of treatment may cause distress and sleep disorders. This study aimed to identify risk factors for sleep disorders., Patients and Methods: In 42 patients with rectal or anal cancer scheduled for radiotherapy, 16 characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, gender, performance score, comorbidity, patient's or family history of additional cancer/melanoma, distress score, emotional/physical/practical problems, tumor site and stage, surgery and relation to COVID-19 pandemic., Results: Overall prevalence of pre-radiotherapy sleep disorders was 42.9%. Sleep disorders were significantly associated with Karnofsky performance score 60-80 (p=0.044), Charlson comorbidity index ≥3 (p=0.0012), distress score 6-10 (p=0.00012), and more emotional (p=0.0012), physical (p=0.0004) or practical (p=0.033) problems. A trend was found for female gender (p=0.061)., Conclusion: Sleep disorders were common in patients with rectal or anal cancer scheduled for radiotherapy. Risk factors can help identify patients requiring psychooncological support already prior to the start of radiotherapy., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Many patients with gynecological malignancies receive postoperative radiotherapy, which can lead to fear and sleep disorders. We aimed to identify the prevalence of and risk factors for sleep disorders., Patients and Methods: Sixty-two patients assigned to radiotherapy for gynecological malignancies were retrospectively evaluated. Seventeen characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, Karnofsky performance score, Charlson comorbidity index, history of additional malignancy, family history of gynecological cancer, distress score, emotional, physical or practical problems, tumor site/stage; chemotherapy, treatment volume, brachytherapy, and the COVID-19 pandemic., Results: The prevalence of pre-radiotherapy sleep disorders was 46.8%. Sleep disorders were significantly associated with Charlson comorbidity index ≥3 (p=0.012), greater number of physical problems (p<0.0001), and advanced primary tumor stage (p=0.005). A trend was found for greater number of emotional problems (p=0.075)., Conclusion: Pre-radiotherapy sleep disorders are common in patients with gynecological malignancies, particularly in those with specific risk factors. Patients should be offered early psychological support., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: The anticipation of radiotherapy can cause distress and sleep disorders, which may be aggravated by the COVID-19 pandemic. This study investigated sleep disorders in a large cohort of patients with breast cancer before and during the pandemic., Patients and Methods: Twenty-three characteristics were retrospectively analyzed for associations with pre-radiotherapy sleep disorders in 338 patients. Moreover, 163 patients presenting before and 175 patients presenting during the COVID-19 pandemic were compared for sleep disorders., Results: Sleep disorders were significantly associated with age ≤60 years (p=0.006); high distress score (p<0.0001); more emotional (p<0.0001), physical (p<0.0001) or practical (p<0.0001) problems; psycho-oncological need (p<0.0001); invasive cancer (p=0.003); chemotherapy (p<0.001); and hormonal therapy (p=0.006). Sleep disorders were similarly common in both groups (prior to vs. during the pandemic: 40% vs. 45%, p=0.38)., Conclusion: Although additional significant risk factors for sleep disorders were identified, the COVID-19 pandemic appeared to have no significant impact on sleep disorders in patients scheduled for irradiation of breast cancer., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Most patients with breast cancer are assigned to radiotherapy, which may cause fears leading to sleep disorders. Very few data are available regarding the prevalence of sleep disorders and corresponding risk factors., Patients and Methods: Data of 175 patients with breast cancer presenting for adjuvant radiotherapy were retrospectively analyzed. Twenty-three patient and tumor characteristics were investigated for associations with pre-radiotherapy sleep disorders., Results: Seventy-eight patients (44.6%) stated sleep disorders prior to radiotherapy. These were significantly associated with higher distress score (p<0.0001); greater number of emotional (p<0.0001), physical (p<0.0001) or practical problems (p<0.001); and request for psycho-oncological support (p<0.001). Trends were found for worse performance status (p=0.062) and higher comorbidity index (p=0.059)., Conclusion: Sleep disorders prior to radiotherapy for breast cancer are common. This applies particularly to patients with risk factors including distress due to emotional, physical or practical problems. These patients should be offered psycho-oncological support as soon as possible., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Gliomas are often associated with symptoms including seizures. Most patients with high-grade gliomas are treated with radiotherapy or radio-chemotherapy. Since irradiation causes inflammation, it may initially aggravate symptoms. Studies focusing on seizure activity during radiotherapy for gliomas are not available. Such knowledge may improve patient monitoring and anti-epileptic treatment. This study evaluates seizure activity during radiotherapy for high-grade gliomas., Methods: The primary objective this prospective interventional study is the evaluation of seizure activity during a course of radiotherapy for high-grade gliomas. Progression of seizure activity is defined as increased frequency of seizures by > 50%, increased severity of seizures, or initiation/increase by ≥25% of anti-epileptic medication. Seizure frequency up to 6 weeks following radiotherapy and electroencephalography activity typical for epilepsy will also be evaluated. Patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, they will document number (and type) of seizures and anti-epileptic medication. Once a week, the findings of the diary are checked and discussed with a neurologist to initiate or adjust anti-epileptic medication, if necessary. Patients complete a questionnaire regarding their satisfaction with the seizure diary. If the dissatisfaction rate is > 40%, the seizure diary will be considered not suitable for the investigated indication. Thirty-five patients (32 patients plus drop-outs) should be enrolled. With this sample size, a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance, if the rate of patients with progression of seizure activity is 30% (rate under the alternative hypothesis), assuming a 'natural' background progression-rate of 10% without radiotherapy (null hypothesis)., Discussion: If an increase in seizure activity during a course of radiotherapy for high-grade glioma occurs, the findings of this study may pave the way for a larger prospective trial and will likely lead to closer patient monitoring and better anti-epileptic treatment., Trial Registration: clinicaltrials.gov ( NCT04552756 ); registered on 16th of September, 2020.

Background/aim: Previously, we identified predictors of survival after irradiation of grade II-IV cerebral gliomas. In this supplementary analysis, survival was calculated in a more appropriate way than the original study., Patients and Methods: Ten factors were re-evaluated for survival in patients of the original study including pre-radiotherapy seizures. In the original study, survival was calculated from the end of the last radiotherapy course (primary or re-irradiation). After re-review, this approach was considered inappropriate. Survival should have always been calculated from the first radiotherapy course, as done in this supplementary analysis., Results: On multivariate analysis, WHO-grade II (p=0.006) and upfront resection (p=0.001) were associated with better survival. Unifocal glioma was significant on univariate analysis (p=0.001), where a trend could be identified for age ≤59 years (p=0.057) and seizures (p=0.060)., Conclusion: The findings of this supplementary analysis regarding the identification of prognostic factors for survival agree with the results of the original study., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Seizures can be the initial symptom of brain metastases. This study investigated pre-treatment seizures in patients with a single lesion., Patients and Methods: Pre-operative seizures were analyzed in 104 patients with a single brain metastasis receiving resection plus whole-brain irradiation and a boost. Prevalence of seizures, risk factors and associations with survival (OS) were evaluated., Results: Thirty patients (34.6%) had seizures prior to neurosurgery. Significant associations between seizures and investigated characteristics were not found. However, age ≤61 years showed a trend (p=0.117) for increased incidence of seizures. Time from diagnosis of malignancy until neurosurgery >12 months was significantly associated with improved OS on univariate analysis (p=0.003). Trends for a positive association with OS were found for no seizures (p=0.054), female gender (p=0.066) and breast cancer (p=0.098). On multivariate analysis, time until neurosurgery >12 months was independently associated (p=0.019) with better OS, and seizures showed a trend (p=0.119) for improved OS., Conclusions: Considering the high prevalence of seizures in this cohort, regular screening and monitoring of these patients appears reasonable. This applies particularly to patients aged ≤61 years., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Seizures impair patients' quality of life. The prognostic role of pre-treatment seizures in patients with 1-3 cerebral metastases receiving local therapies plus whole-brain radiotherapy (WBRT) was investigated., Patients and Methods: In 249 patients, prevalence, risk factors and associations of pre-treatment seizures with survival were retrospectively evaluated. Age, gender, performance score, tumor type, number of lesions, extra-cerebral metastases, and time from tumor diagnosis to treatment of cerebral metastasis were analyzed for associations with seizures. These characteristics and pre-treatment seizures were also analyzed for associations with survival., Results: The prevalence of pre-treatment seizures was 24.1%. Trends for associations were found between seizures and gender or performance score. On multivariate analysis, age (p=0.008), performance score (p=0.004), tumor type (p<0.001) and extra-cerebral metastasis (p<0.001) were significantly associated with survival., Conclusion: Seizures were comparably common prior to local therapies plus WBRT for cerebral metastases. No factor was found to be significantly associated with seizures, and seizures were not associated with survival., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Pneumonitis is a possible side effect of radiotherapy for lung cancer. Since it can occur up to several months following treatment, symptoms may not be associated with previous radiotherapy, and pneumonitis can become severe before diagnosed. This study aimed to develop a symptom-based scoring system to contribute to earlier detection of radiation pneumonitis requiring medical intervention (grade ≥ 2)., Methods: Patients irradiated for lung cancer complete a paper-based questionnaire (symptom-based score) during and up to 24 weeks following radiotherapy. Patients rate symptoms potentially associated with pneumonitis, and scoring points are assigned to severity of these symptoms. Sum scores are used to identify radiation pneumonitis. If radiation pneumonitis is suspected, patients undergo standard diagnostic procedures. If grade ≥ 2 pneumonitis is confirmed, medical intervention is indicated. The discriminative power of the score will be assessed by calculating the area under the receiver operating characteristic curve (AUC). If statistical significance of the AUC is reached, the optimal sum score to predict radiation pneumonitis will be established, which is defined as a cut-off value with sensitivity ≥90% and specificity ≥80%. Assuming a ratio between patients without and with pneumonitis of 3.63, a sample size of 93 patients is required in the full analysis set to yield statistical significance at the level of 5% with a power of 90% if the AUC under the alternative hypothesis is at least 0.9. Considering potential drop-outs, 98 patients should be recruited. If > 20% of patients are not satisfied with the score, modification is required. If the dissatisfaction rate is > 40%, the score is considered not useful. In 10 patients, functionality of a mobile application will be tested in addition to the paper-based questionnaire., Discussion: If an optimal cut-off score resulting in sufficiently high sensitivity and specificity can be identified and the development of a symptom-based scoring system is successful, this tool will contribute to better identification of patients experiencing pneumonitis after radiotherapy for lung cancer., Trial Registration: Clinicaltrials.gov ( NCT04335409 ); registered on 2nd of April, 2020.

Background/aim: Seizures represent a common manifestation of gliomas. This study evaluated the prevalence of pre-radiotherapy seizures, potential risk factors and associations with survival., Patients and Methods: Eight factors were analyzed in 222 patients for associations with seizures including number, size and location of glioma, World Health Organization (WHO) grade, performance score, gender, age and upfront resection. These factors plus pre-radiotherapy symptoms and seizures were assessed for survival., Results: Prevalence of pre-radiotherapy seizures was 29.3%. A significant correlation was found for grade II (p=0.002), trends for age ≤59 years (p=0.123) and lack of upfront resection (p=0.113). Unifocal gliomas (p<0.001), grade II (p=0.045) and upfront resection (p<0.001) showed significant associations with survival (univariate analyses). A trend was found for seizures (p=0.075) and age ≤59 years (p=0.091). In the multivariate analysis, grade II (p=0.002) and upfront resection (p=0.004) maintained significance; unifocal gliomas showed a trend (p=0.062)., Conclusion: Pre-radiotherapy seizures appeared to be correlated with WHO grade, age and lack of upfront resection, and with better survival., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Seizures are a serious condition for patients with brain metastases. Prevalence, risk factors and a potential association of seizures with survival prior to whole-brain irradiation (WBI) for cerebral metastases were retrospectively investigated., Patients and Methods: In 1,934 patients, the prevalence of pre-treatment seizures (pre-WBI) was determined. Seven pre-treatment characteristics were evaluated for associations with seizures. Ten characteristics including pre-treatment symptoms (none vs. seizures only vs. seizures+others vs. others only) and seizures (yes vs. no) were analyzed for survival., Results: In 251 patients (13.0%), pre-treatment seizures were documented. The occurrence of seizures was significantly associated with 1-3 brain metastases and lack of extra-cerebral spread. On multivariate analysis, age, gender, performance score, number of metastases and extra-cerebral spread were significantly associated with survival; pre-treatment symptoms and seizures showed associations on univariate but not on multivariate analyses., Conclusion: Few brain metastases and lack of extra-cerebral spread were independent risk factors for pre-treatment seizures. Seizures appeared positively associated with survival., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Seizures represent a major problem for patients with brain metastases. This study evaluated the role of seizures in patients receiving single-fraction radiosurgery (SRS) or multi-fraction stereotactic radiotherapy (FSRT)., Patients and Methods: This retrospective study included 195 patients receiving SRS (n=164) or FSRT (n=31) alone for one to three brain metastases. The prevalence of pre-SRS/FSRT seizures and correlations with pre-treatment factors were investigated. These factors plus pre-SRS/FSRT seizures were assessed in regard to survival., Results: Thirty-three patients had pre-SRS/FSRT seizures (prevalence=16.9%). Seizures were significantly correlated with age ≤61 years. Trends were observed for seizures being more frequent in those with NSCLC and those without extra-cranial metastatic spread. On multivariate analysis, significant associations with improved survival were found for Karnofsky performance score ≥80%, breast cancer, and an interval from diagnosis of malignant disease to SRS/FSRT ≥21 months., Conclusion: Younger age, NSCLC and absence of extra-cranial spread appeared to be risk factors for seizures prior to SRS/FSRT. Having seizures prior to SRS/FSRT showed no association with survival., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients' prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients., Methods: This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade ≥ 3 at 60 Gy and both grade ≥ 2 and grade ≥ 3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rates of grade ≥ 2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%., Discussion: If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients with head-and-neck cancer during radiotherapy., Trial Registration: clinicaltrials.gov (NCT04110977). Registered on September 27, 2019. First patient is planned to be included in December 2019.