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.
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).
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.
clinicaltrials.gov (NCT04879264; URL: https://clinicaltrials.gov/show/NCT04879264 ); registered on 7th of May, 2021.
Patients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free ...survival (LPFS) and overall survival (OS).
This prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5% of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33% higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks.
If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.
Clinicaltrials.gov NCT04043156. Registered 30-07-2019.
To create and validate scoring systems for intracerebral control (IC) and overall survival (OS) of patients irradiated for brain metastases.
In this study, 1,797 patients were randomly assigned to ...the test (n = 1,198) or the validation group (n = 599). Two scoring systems were developed, one for IC and another for OS. The scores included prognostic factors found significant on multivariate analyses. Age, performance status, extracerebral metastases, interval tumor diagnosis to RT, and number of brain metastases were associated with OS. Tumor type, performance status, interval, and number of brain metastases were associated with IC. The score for each factor was determined by dividing the 6-month IC or OS rate (given in percent) by 10. The total score represented the sum of the scores for each factor. The score groups of the test group were compared with the corresponding score groups of the validation group.
In the test group, 6-month IC rates were 17% for 14-18 points, 49% for 19-23 points, and 77% for 24-27 points (p < 0.0001). IC rates in the validation group were 19%, 52%, and 77%, respectively (p < 0.0001). In the test group, 6-month OS rates were 9% for 15-19 points, 41% for 20-25 points, and 78% for 26-30 points (p < 0.0001). OS rates in the validation group were 7%, 39%, and 79%, respectively (p < 0.0001).
Patients irradiated for brain metastases can be given scores to estimate OS and IC. IC and OS rates of the validation group were similar to the test group demonstrating the validity and reproducibility of both scores.
Background Previous survival scores for breast cancer patients with cerebral metastases were developed in cohorts receiving heterogeneous treatments, which could have introduced selection biases. A ...new instrument (WBRT-30-BC) was created from 170 patients receiving whole-brain radiotherapy (WBRT) alone with 30 Gy in 10 fractions. Methods Characteristics showing significant associations (p < 0.05) with overall survival (OS) or a trend (p < 0.08) on multivariate analysis were used for the WBRT-30-BC. For each characteristic, 6-month OS rates were divided by 10. These scoring points were added for each patient (patient scores). The WBRT-30-BC was compared to the diagnosis- specific graded prognostic assessment (DS-GPA) classification and Rades-Score for breast cancer regarding positive predictive values (PPVs) to identify patients dying within 6 months and patients surviving at least 6 months following WBRT. Results On multivariate analysis, Karnofsky performance score (KPS) was significant (risk ratio RR: 2.45, p < 0.001). In addition, extra-cerebral metastatic disease (RR: 1.52, p = 0.071) and time between breast cancer diagnosis and WBRT (RR: 1.37, p = 0.070) showed a trend. Based on these three characteristics, four predictive groups were designed: 7-9, 10-12, 13-15 and 16 points. Six-month OS rates were 8%, 41%, 68% and 100% (p < 0.001). PPVs to identify patients dying within 6 months were 92% (WBRT-30-BC), 84% (DS-GPA) and 92% (Rades-Score). PPVs to identify patients surviving for at least 6 months were 100% (WBRT-30-BC), 74% (DS-GPA) and 68% (Rades-Score). Conclusions The WBRT-30-BC appeared very accurate in predicting death ≤ 6 months and survival ≥ 6 months of breast cancer patients receiving WBRT. It was superior to previous instruments in predicting survival ≥ 6 months.
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.
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.
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).
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.
Background/Aim: Personalization of the treatment of brain metastases considering patient’s overall survival (OS) prognosis is gaining importance. This study was conducted to develop an OS score ...particularly for patients receiving local therapies for single brain metastasis from gynecological malignancies. Patients and Methods: In 11 patients, the following factors were retrospectively analyzed for associations with OS: Age, Karnofsky performance score (KPS), tumor type, extra-cranial metastatic sites, and time from diagnosis of gynecological malignancy to treatment of brain metastasis. Factors showing at least a strong trend were used for the score. Results: A KPS of 80-90% resulted in a significantly better OS than a KPS of 50-70% (p=0.008). Absence of extra-cranial metastases showed a strong trend (p=0.052). For the score, the following points were used: KPS 50-70%=0, KPS 80-90%=1, presence of extra-cranial metastatic sites=0, absence=1. Patients’ scores were 0, 1 or 2 points. OS rates at both 6 and 12 months were 0%, 67% and 100%, respectively (p=0.020). Conclusion: This specific score can be used to estimate OS in patients receiving local therapies for single brain metastasis from gynecological malignancies and personalize their care.
Background/Aim: Treatment for elderly patients with few brain metastases is controversial. A score was generated to predict distant brain metastases (DBMs) after stereotactic radiosurgery (SRS) or ...fractionated stereotactic radiotherapy (FSRT). Patients and Methods: Ten characteristics were retrospectively analyzed for freedom from new DBMs in 104 elderly patients receiving SRS or FSRT alone for 1-3 brain metastases. Characteristics that were significant or showed a trend on multivariate analysis were used for the score. Results: On multivariate analysis, favorable histology (p=0.026) and single brain metastasis (p=0.006) showed significant associations with freedom from DBMs. A trend was found for supra-tentorial location only (p=0.065). Three groups were designed, 10-14, 16-20 and 21-25 points, with 6-month rates of freedom from DBMs of 10%, 54% and 95%, respectively (p<0.0001). Positive predictive values to predict DBMs and freedom from DBMs at 6 months were 91% and 94%. Conclusion: This new score provided high accuracy in predicting DBMs and freedom from DBMs.
The use of stereotactic radiosurgery (SRS) alone has become popular for treating patients with a limited number of brain metastases. In very few patients, the primary tumor leading to cerebral spread ...is unknown. This study investigated the role of SRS for this rare situation.
Eight patients with 1-2 brain metastases from cancer of unknown primary (CUP) received SRS alone (median dose 20 Gy). Five clinical factors were evaluated for association with local control of the irradiated lesions, freedom from new cerebral lesions and survival.
Six-month and 12-month survival rates were 63% and 63%, respectively. Improved survival was associated with male gender and only one cerebral lesion. Local control rates at 6 and 12 months were 100%. Six-month rate of freedom from new cerebral lesions was 86%.
SRS appeared effective and resulted in promising local control and survival rates in patients with 1-2 brain metastases from CUP.
To design a tool to predict the probability of new cerebral lesions after stereotactic radiosurgery/radiotherapy for patients with 1-3 brain metastases from colorectal cancer.
In 21 patients, nine ...factors were evaluated for freedom from new brain metastases, namely age, gender, Karnofsky performance score (KPS), tumor type, number, maximum total diameter of all lesions and sites of cerebral lesions, extra-cranial metastases, and time from cancer diagnosis to irradiation.
Freedom from new lesions was positively associated with KPS of 90-100 (p=0.013); maximum total diameter ≤15 mm showed a trend for positive association (p=0.09). Points were assigned as: KPS 70-80=1 point, KPS 90-100=2 points, maximum diameter ≤15 mm=2 points and maximum diameter >15 mm=1 point. Six-month rates of freedom from new lesions were 29%, 45% and 100% for those with total scores of 2, 3 and 4 points, respectively, with corresponding 12-month rates of 0%, 45% and 100% (p=0.027).
This study identified three risk groups regarding new brain metastases after stereotactic irradiation. Patients with 2 points could benefit from additional whole-brain radiotherapy.
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