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Clinical Research in Cardiology :... Nov 2020Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown.
METHODS/DESIGN
In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first 30 days after radiosurgery. Secondary endpoints are the assessment of VT burden, reduction of implantable cardioverter defibrillator (ICD) interventions [shock, anti-tachycardia pacing (ATP)], mid-term side effects and quality-of-life (QoL) in the first year after radiosurgery. The planned sample size is 20 patients with the goal of demonstrating safety and feasibility of cardiac radiosurgery in ≥ 70% of the patients. Quality assurance is provided by initial contouring and planning benchmark studies, joint multi-center treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.
DISCUSSION
RAVENTA will be the first study to provide the initial robust multi-center multi-platform prospective data on the therapeutic value of cardiac radiosurgery for ventricular tachycardia.
TRIAL REGISTRATION NUMBER
NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.
Topics: Catheter Ablation; Feasibility Studies; Female; Germany; Humans; Male; Prospective Studies; Quality of Life; Radiosurgery; Tachycardia, Ventricular; Treatment Outcome
PubMed: 32306083
DOI: 10.1007/s00392-020-01650-9 -
Neurology India 2020Cushing's disease is caused by a pituitary tumor causing increased production of adrenocorticotropic hormone, which leads to chronic hypersecretion of cortisol through... (Review)
Review
Cushing's disease is caused by a pituitary tumor causing increased production of adrenocorticotropic hormone, which leads to chronic hypersecretion of cortisol through adrenal cortices. Endoscopic trans-sphenoidal adenomectomy is the first choice of treatment with greatest efficiency for the treatment of the disease. However, in the absence of remission or recurrence of hypercortisolism after neurosurgical resection (adenomectomy), as well as in cases when surgical intervention cannot be carried due to medical contraindications to surgical intervention, radiation treatment is used as an alternative or adjoining therapy. In this literature review the efficiency of different radiation techniques (the conventional and the modern techniques), as well as possible complications of modern methods of radiosurgery and radiotherapy have been looked for.
Topics: Humans; Pituitary ACTH Hypersecretion; Proton Therapy; Radiosurgery; Treatment Outcome
PubMed: 32611903
DOI: 10.4103/0028-3886.287663 -
Chinese Clinical Oncology Apr 2022To provide a review of the current status of predictive nomograms and brain metastasis velocity (BMV) in the prognostication of brain metastasis outcomes. (Review)
Review
OBJECTIVE
To provide a review of the current status of predictive nomograms and brain metastasis velocity (BMV) in the prognostication of brain metastasis outcomes.
BACKGROUND
Statistical analyses have been used for many years in an attempt to predict clinical outcomes of brain metastasis patients. Such models have attempted to predict such endpoints as survival and which patients would most benefit from stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT).
METHODS
This narrative review includes documents the history of statistical models and nomograms through the stage migration of the brain metastasis population from a population with large symptomatic brain metastases to the modern population with small asymptomatic metastases found on surveillance imaging. It also tells the history of the derivation and validation of BMV, a recently identified biomarker for survival and neurologic death in the brain metastasis population treated with SRS.
CONCLUSIONS
Statistical models predicting brain metastasis behavior continue to evolve with the changing landscape of systemic therapy and the more aggressive use of SRS. Previous models with ultimately need to integrate biologic data and will continue to be updated.
Topics: Brain Neoplasms; Cranial Irradiation; Humans; Nomograms; Prognosis; Radiosurgery; Retrospective Studies
PubMed: 34775780
DOI: 10.21037/cco-21-102 -
The British Journal of Radiology May 2021We aimed at describing and assessing the quality of reporting in all published prospective trials about radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). (Review)
Review
OBJECTIVES
We aimed at describing and assessing the quality of reporting in all published prospective trials about radiosurgery (SRS) and stereotactic body radiotherapy (SBRT).
METHODS
The Medline database was searched for. The reporting of study design, patients' and radiotherapy characteristics, previous and concurrent cancer treatments, acute and late toxicities and assessment of quality of life were collected.
RESULTS
114 articles - published between 1989 and 2019 - were analysed. 21 trials were randomised (18.4%). Randomisation information was unavailable in 59.6% of the publications. Data about randomisation, ITT analysis and whether the study was multicentre or not, had been significantly less reported during the 2010-2019 publication period than before (respectively 29.4% 57.4% ( < 0.001), 20.6% 57.4% ( < 0.001), 48.5% 68.1% ( < 0.001). 89.5% of the articles reported the number of included patients. Information about radiation total dose was available in 86% of cases and dose fraction in 78.1%. Regarding the method of dose prescription, the prescription isodose was the most reported information (58.8%). The reporting of radiotherapy characteristics did not improve during the 2010 s-2019s. Acute and late high-grade toxicity was reported in 37.7 and 30.7%, respectively. Their reporting decreased in recent period, especially for all-grade late toxicities ( = 0.044).
CONCLUSION
It seems necessary to meet stricter specifications to improve the quality of reporting.
ADVANCES IN KNOWLEDGE
Our work results in one of the rare analyses of radiosurgery and SBRT publications. Literature must include necessary information to first, ensure treatments can be compared and reproduced and secondly, to permit to decide on new standards of care.
Topics: Clinical Trials, Phase III as Topic; Humans; Multicenter Studies as Topic; Neoplasms; Prospective Studies; Publishing; Quality of Life; Radiosurgery; Radiotherapy Dosage; Randomized Controlled Trials as Topic; Time Factors
PubMed: 33861141
DOI: 10.1259/bjr.20200115 -
Current Oncology (Toronto, Ont.) Jul 2023Stereotactic body radiotherapy (SBRT) has emerged as a technique to treat oligoprogressive sites among patients with breast cancer who are otherwise doing well on... (Review)
Review
Stereotactic body radiotherapy (SBRT) has emerged as a technique to treat oligoprogressive sites among patients with breast cancer who are otherwise doing well on systemic therapy. This study systematically reviewed the efficacy and safety of SBRT in the setting of oligoprogressive breast cancer. A literature search was conducted in the MEDLINE database. Studies regarding SBRT and oligoprogressive breast cancer were included. Key outcomes of interest were toxicity, local control, progression, and overall survival. From 863 references, five retrospective single-center cohort studies were identified. All studies included patients with both oligometastatic and oligoprogressive disease; 112 patients with oligoprogressive breast cancer were identified across these studies. Patient age ranged from 22 to 84, with a median of 55 years of age. Most patients had hormone-receptor-positive and HER2-negative disease. SBRT doses varied from 24 to 60 Gy in 1-10 fractions based on the location/size of the lesion. Forty toxicity events were reported, of which the majority ( = 25, 62.5%) were grade 1-2 events. Among 15 patients who received SBRT concurrently with a CDK4/6 inhibitor, 37.5% of patients experienced grade 3-5 toxicities. Progression-free and overall survival ranged from 17 to 57% and 62 to 91%, respectively. There are limited data on the role of SBRT in oligoprogressive breast cancer, and prospective evaluation of this strategy is awaited to inform its safety and efficacy.
Topics: Humans; Young Adult; Adult; Middle Aged; Aged; Aged, 80 and over; Female; Radiosurgery; Retrospective Studies; Breast Neoplasms
PubMed: 37504365
DOI: 10.3390/curroncol30070505 -
BMC Cancer Oct 2023Brain metastases are the most common intracranial tumours. Variation exists in the use of stereotactic radiosurgery for patients with 10 or more brain metastases.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Brain metastases are the most common intracranial tumours. Variation exists in the use of stereotactic radiosurgery for patients with 10 or more brain metastases. Concerns include an increasing number of brain metastases being associated with poor survival, the lack of prospective, randomised data and an increased risk of toxicity.
METHODS
We performed a systematic review and meta-analysis to assess overall survival of patients with ten or more brain metastases treated with stereotactic radiosurgery as primary therapy. The search strings were applied to MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL). Log hazard ratios and standard errors were estimated from each included study. A random-effects meta-analysis using the DerSimonian and Laird method was applied using the derived log hazard ratios and standard errors on studies which included a control group.
RESULTS
15 studies were included for systematic review. 12 studies were used for pooled analysis for overall survival at set time points, with a predicted 12 month survival of 20-40%. The random-effects meta-analysis in five studies of overall survival comparing ten or greater metastases against control showed statistically worse overall survival in the 10 + metastases group (1.10, 95% confidence interval 1.03-1.18, p-value = < 0.01, I = 6%). A funnel plot showed no evidence of bias. There was insufficient information for a meta-analysis of toxicity.
DISCUSSION
Overall survival outcomes of patients with ten or more brain metastases treated with SRS is acceptable and should not be a deterrent for its use. There is a lack of prospective data and insufficient real-world data to draw conclusions on toxicity.
PROSPERO ID
CRD42021246115.
Topics: Humans; Radiosurgery; Cranial Irradiation; Brain Neoplasms; Combined Modality Therapy; Proportional Hazards Models; Retrospective Studies
PubMed: 37858075
DOI: 10.1186/s12885-023-11452-7 -
Journal of Cancer Research and Clinical... Jan 2023Meningioma is a common type of benign tumor that can be managed in several ways, ranging from close observation, surgical resection, and various types of radiation. We... (Review)
Review
PURPOSE
Meningioma is a common type of benign tumor that can be managed in several ways, ranging from close observation, surgical resection, and various types of radiation. We present here results from a 10 year experience treating meningiomas with a hypofractionated approach.
MATERIALS AND METHODS
To define the rate of tumor control and factors associated with the relief of symptoms and radiation-related complications after radiosurgery and hypofractionated radiosurgery for patients with imaging-defined intracranial meningiomas. We reviewed the charts of 48 patients treated with stereotactic radiosurgery (SRS) or hypofractionated stereotactic radiotherapy (SRT) from 2002 to 2018. A total of 37 (82%) patients had WHO Grade 1 disease, and 11 (22%) had Grade 2. Outcomes that were analyzed included local control rates and the rate and grade of any reported toxicity.
RESULTS
Only 36 patients with 38 lesions, who underwent the follow-up regime, were enrolled in the retrospective analysis. The follow-up mean was 40 months (12-120 months). 25/34 patients had surgery before the radiotherapy. Sixteen underwent SRS with a median dose of 13, 5, and 20 received hypofractionated SBRT with a median dose of 26.9 (22-45 Gy) in median six fractions (5-13 fractions). Local control at 2 and 5 years for all patients was 90 and 70%, respectively. No patient suffered from toxicity > 2 CTC. 21/36 patients showed stable disease, while 8/36 patients showed partial Remission. 7/36 developed recurrent meningioma (five in-field), only one patient with grade 1 meningioma, in a median of 22 months (13-48 months).
CONCLUSION
SFRT was superior to SRS for local control in our analysis of Grade I meningiomas. This might be due to a tendency for higher EQD2 in the PTV with SFRT compared to SRS, which was reduced to avoid brain necrosis in large PTVs. Therefore, SFRT appears preferable for typical meningioma PTVs.
Topics: Humans; Meningioma; Radiosurgery; Meningeal Neoplasms; Retrospective Studies; Radiation Dose Hypofractionation; Follow-Up Studies; Neoplasm Recurrence, Local; Particle Accelerators; Treatment Outcome
PubMed: 36307558
DOI: 10.1007/s00432-022-04450-y -
Frontiers in Immunology 2023Radiotherapy is one of the standard treatments for brain metastases (BM). Over the past years, the introduction of immunotherapy as routine treatment for solid tumors... (Review)
Review
INTRODUCTION
Radiotherapy is one of the standard treatments for brain metastases (BM). Over the past years, the introduction of immunotherapy as routine treatment for solid tumors has forced investigators to review and evaluate how it would interact with radiation. Radiation and Immunotherapy have shown a synergic effect activating the host's immune system and enhancing treatment response. The combinatory effect on BM is currently under investigation.
METHODS
Data published on Pubmed to determine toxicity, survival, treatment characteristics and timing on the combination of radiotherapy and immunotherapy for the treatment of BM has been reviewed.
RESULTS
Mostly retrospective reviews report an improvement of intracranial progression free survival (iPFS) when combining radioimmunotherapy for BM patients. Two systematic reviews and meta-analysis and one phase II prospective trial also report a benefit on iPFS without an increase of toxicity. Among the published literature, the definition of concurrency is heterogeneous, being one month or even narrowed intervals correlated to better clinical outcomes. Toxicity due to concurrent radioimmunotherapy, specifically symptomatic radionecrosis, is also directly analyzed and reported to be low, similar to the toxicity rates secondary to stereotactic radiosurgery alone.
CONCLUSION
Radiation combined with immunotherapy has shown in predominantly retrospective reviews a synergic effect on the treatment of BM. The concurrent combination of radioimmunotherapy is a feasible therapeutic strategy and seems to improve clinical outcomes, especially iPFS, when delivered within <30 days. Larger prospective and randomized studies are needed to establish reliable outcomes, best delivery strategies and toxicity profile.
Topics: Humans; Brain Neoplasms; Immunotherapy; Prospective Studies; Radiosurgery; Retrospective Studies
PubMed: 37915576
DOI: 10.3389/fimmu.2023.1236398 -
Cancer Reports (Hoboken, N.J.) Jul 2023Clinical trials evaluating immune checkpoint inhibition (ICI) in recurrent high-grade gliomas (rHGG) report 7%-20% 6-month progression-free survival (PFS), while...
BACKGROUND
Clinical trials evaluating immune checkpoint inhibition (ICI) in recurrent high-grade gliomas (rHGG) report 7%-20% 6-month progression-free survival (PFS), while re-irradiation demonstrates 28%-39% 6-month PFS.
AIMS
We evaluate outcomes of patients treated with ICI and concurrent re-irradiation utilizing stereotactic body radiotherapy/fractionated stereotactic radiosurgery (SBRT) compared to ICI monotherapy.
METHODS AND RESULTS
Patients ≥18-years-old with rHGG (WHO grade III and IV) receiving ICI + SBRT or ICI monotherapy between January 1, 2016 and January 1, 2019 were included. Adverse events, 6-month PFS and overall survival (OS) were assessed. Log-rank tests were used to evaluate PFS and OS. Histogram analyses of apparent diffusion coefficient maps and dynamic contrast-enhanced magnetic resonance perfusion metrics were performed. Twenty-one patients with rHGG (ICI + SBRT: 16; ICI: 5) were included. The ICI + SBRT and ICI groups received a mean 7.25 and 6.2 ICI cycles, respectively. There were five grade 1, one grade 2 and no grade 3-5 AEs in the ICI + SBRT group, and four grade 1 and no grade 2-5 AEs in the ICI group. Median PFS was 2.85 and 1 month for the ICI + SBRT and ICI groups; median OS was 7 and 6 months among ICI + SBRT and ICI groups, respectively. There were significant differences in pre and posttreatment tumor volume in the cohort (12.35 vs. 20.51; p = .03), but not between treatment groups.
CONCLUSIONS
In this heavily pretreated cohort, ICI with re-irradiation utilizing SBRT was well tolerated. Prospective studies are warranted to evaluate potential therapeutic benefits to re-irradiation with ICI + SBRT in rHGG.
Topics: Humans; Adolescent; Radiosurgery; Re-Irradiation; Glioma; Progression-Free Survival; Immunotherapy
PubMed: 36750401
DOI: 10.1002/cnr2.1788 -
Practical Radiation Oncology 2022To determine safety and efficacy of postoperative spine stereotactic body radiation therapy (SBRT) in the published literature, and to present practice recommendations... (Meta-Analysis)
Meta-Analysis
PURPOSE
To determine safety and efficacy of postoperative spine stereotactic body radiation therapy (SBRT) in the published literature, and to present practice recommendations on behalf of the International Stereotactic Radiosurgery Society.
METHODS AND MATERIALS
A systematic review of the literature was performed, specific to postoperative spine SBRT, using PubMed and Embase databases. A meta-analysis for 1-year local control (LC), overall survival (OS), and vertebral compression fracture probability was conducted.
RESULTS
The literature search revealed 251 potentially relevant articles after duplicates were removed. Of these 56 were reviewed in-depth for eligibility and 12 met all the inclusion criteria for analysis. 7 studies were retrospective, 2 prospective observational and 3 were prospective phase 1 and 2 clinical trials. Outcomes for a total of 461 patients and 499 spinal segments were reported. Ten studies used a magnetic resonance imaging (MRI) scan fused to computed tomography (CT) simulation for treatment planning, and 2 investigations reported on all patients receiving a CT-myelogram at the time of planning. Meta-analysis for 1 year LC and OS was 88.9% and 57%, respectively. The crude reported vertebral compression fracture rate was 5.6%. One case of myelopathy was described in a patient with a previously irradiated spinal segment. One patient developed an esophageal fistula requiring surgical repair.
CONCLUSIONS
Postoperative spine SBRT delivers a high 1-year LC with acceptably low toxicity. Patients who may benefit from this include those with oligometastatic disease, radioresistant histology, paraspinal masses, or those with a history of prior irradiation to the affected spinal segment. The International Stereotactic Radiosurgery Society recommends a minimum interval of 8 to 14 days after invasive surgery before simulation for SBRT, with initiation of radiation therapy within 4 weeks of surgery. An MRI fused to the planning CT, or the use of a CT-myelogram, are necessary for target and organ-at-risk delineation. A planning organ-at-risk volume (PRV) of 1.5 to 2 mm for the spinal cord is advised.
Topics: Fractures, Compression; Humans; Observational Studies as Topic; Practice Guidelines as Topic; Prospective Studies; Radiosurgery; Retrospective Studies; Spinal Fractures; Spinal Neoplasms; Treatment Outcome
PubMed: 34673275
DOI: 10.1016/j.prro.2021.10.004