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Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study.

ABSTRACT: BACKGROUND: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). METHODS/DESIGN: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. DISCUSSION: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. TRIAL REGISTRATION:Clinicaltrials.gov NCT04043156. Registered 30-07-2019.

SUBMITTER: Rades D

PROVIDER: S-EPMC6884857 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study.

Rades Dirk D Hansen Olfred O Jensen Lars Henrik LH Dziggel Liesa L Staackmann Christian C Doemer Claudia C Cacicedo Jon J Conde-Moreno Antonio J AJ Segedin Barbara B Ciervide-Jurio Raquel R Rubio-Rodriguez Carmen C Perez-Romasanta Luis A LA Alvarez-Gracia Ana A Dennis Kristopher K Ferrer-Albiach Carlos C Navarro-Martin Arturo A Lopez-Campos Fernando F Jankarashvili Natalia N Janssen Stefan S Olbrich Denise D Holländer Niels Henrik NH

BMC cancer 20191129 1

<h4>Background</h4>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).<h4>Methods/design</h4>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 progres ...[more]

PMID: 31783816

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Project description:For metastatic spinal cord compression (MSCC), conventional radiotherapy with 10?×?3 Gy in 2 weeks results in better local progression-free survival (LPFS) than 5?×?4 Gy in 1 week. Since patients with MSCC are often significantly impaired, an overall treatment time of 1 week would be preferable if resulting in similar outcomes as longer programs. This may be achieved with 5?×?5 Gy in 1 week, since the biologically effective dose is similar to 10?×?3 Gy. It can be expected that 5?×?5 Gy (like 10?×?3) Gy results in better LPFS than 5?×?4 Gy in 1 week.This phase 2 study investigates LPFS after high-precision RT with 5?×?5 Gy in 1 week. LPFS is defined as freedom from both progression of motor deficits during RT and new or progressive motor deficits dur to an in-field recurrence of MSCC following RT. Considering the tolerance dose of the spinal cord, 5?×?5 Gy can be safely administered with high-precision radiotherapy such as volumetric modulated arc therapy (VMAT) or stereotactic body radiotherapy (SBRT). Maximum dose to the spinal cord should not exceed 101.5% of the prescribed dose to keep the risk of radiation myelopathy below 0.03%. Primary endpoint is LPFS at 6 months following radiotherapy; secondary endpoints include motor function/ability to walk, sensory function, sphincter dysfunction, LPFS directly and 1 and 3 months following radiotherapy, overall survival, pain relief, quality of life and toxicity. Follow-up visits will be performed directly and at 1, 3 and 6 months following radiotherapy. After completion of this phase 2 study, patients will be compared to a historical control group receiving conventional radiotherapy with 5?×?4 Gy in 1 week. Forty-four patients will be included assuming 5?×?5 Gy will provide the same benefit in LPFS when compared to 5?×?4 Gy as reported for 10?×?3 Gy.If superiority regarding LPFS is shown for high-precision radiotherapy with 5?×?5 Gy when compared to conventional radiotherapy with 5?×?4 Gy, patients with MSCC would benefit from 5?×?5 Gy, since high LPFS rates could be achieved with 1 week of radiotherapy instead of 2 weeks (10?×?3 Gy).clinicaltrials.gov NCT03070431 . Registered 27 February 2017.

Project description:BackgroundMetastatic epidural spinal cord compression (MESCC) is a devastating complication of advanced cancer. A deep learning (DL) model for automated MESCC classification on MRI could aid earlier diagnosis and referral.PurposeTo develop a DL model for automated classification of MESCC on MRI.Materials and methodsPatients with known MESCC diagnosed on MRI between September 2007 and September 2017 were eligible. MRI studies with instrumentation, suboptimal image quality, and non-thoracic regions were excluded. Axial T2-weighted images were utilized. The internal dataset split was 82% and 18% for training/validation and test sets, respectively. External testing was also performed. Internal training/validation data were labeled using the Bilsky MESCC classification by a musculoskeletal radiologist (10-year experience) and a neuroradiologist (5-year experience). These labels were used to train a DL model utilizing a prototypical convolutional neural network. Internal and external test sets were labeled by the musculoskeletal radiologist as the reference standard. For assessment of DL model performance and interobserver variability, test sets were labeled independently by the neuroradiologist (5-year experience), a spine surgeon (5-year experience), and a radiation oncologist (11-year experience). Inter-rater agreement (Gwet's kappa) and sensitivity/specificity were calculated.ResultsOverall, 215 MRI spine studies were analyzed [164 patients, mean age = 62 ± 12(SD)] with 177 (82%) for training/validation and 38 (18%) for internal testing. For internal testing, the DL model and specialists all showed almost perfect agreement (kappas = 0.92-0.98, p < 0.001) for dichotomous Bilsky classification (low versus high grade) compared to the reference standard. Similar performance was seen for external testing on a set of 32 MRI spines with the DL model and specialists all showing almost perfect agreement (kappas = 0.94-0.95, p < 0.001) compared to the reference standard.ConclusionA DL model showed comparable agreement to a subspecialist radiologist and clinical specialists for the classification of malignant epidural spinal cord compression and could optimize earlier diagnosis and surgical referral.

Project description:Simple Summary Metastatic epidural spinal cord compression (MESCC) is a disastrous complication of advanced malignancy, and early diagnosis is important to prevent irreversible neurological injury. MRI is the mainstay of diagnosis for MESCC, but it is expensive, and routine screening of asymptomatic patients is not feasible. Staging CT studies are performed routinely as part of the cancer diagnosis and represent an opportunity for earlier diagnosis and treatment planning. In this study, we trained deep learning models for automatic MESCC classification on staging CT studies using spine MRI and manual radiologist labels as the reference standard. On a test set, the DL models showed almost-perfect interobserver agreement for the classification of CT spine images into normal, low, and high-grade MESCC, with kappas ranging from 0.873–0.911 (p < 0.001). The DL models (lowest κ = 0.873, 95% CI 0.858–0.887) also showed superior interobserver agreement compared to two radiologists, including a specialist (κ = 0.820, 95% CI 0.803–0.837) and general radiologist (κ = 0.726, 95% CI 0.706–0.747), both p < 0.001. Abstract Background: Metastatic epidural spinal cord compression (MESCC) is a disastrous complication of advanced malignancy. Deep learning (DL) models for automatic MESCC classification on staging CT were developed to aid earlier diagnosis. Methods: This retrospective study included 444 CT staging studies from 185 patients with suspected MESCC who underwent MRI spine studies within 60 days of the CT studies. The DL model training/validation dataset consisted of 316/358 (88%) and the test set of 42/358 (12%) CT studies. Training/validation and test datasets were labeled in consensus by two subspecialized radiologists (6 and 11-years-experience) using the MRI studies as the reference standard. Test sets were labeled by the developed DL models and four radiologists (2–7 years of experience) for comparison. Results: DL models showed almost-perfect interobserver agreement for classification of CT spine images into normal, low, and high-grade MESCC, with kappas ranging from 0.873–0.911 (p < 0.001). The DL models (lowest κ = 0.873, 95% CI 0.858–0.887) also showed superior interobserver agreement compared to two of the four radiologists for three-class classification, including a specialist (κ = 0.820, 95% CI 0.803–0.837) and general radiologist (κ = 0.726, 95% CI 0.706–0.747), both p < 0.001. Conclusion: DL models for the MESCC classification on a CT showed comparable to superior interobserver agreement to radiologists and could be used to aid earlier diagnosis.

Dataset Information

Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study.

Publications

Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study.

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