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Abstract
BackgroundPatients 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/designThis 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.DiscussionIf 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 registrationClinicaltrials.gov NCT04043156. Registered 30-07-2019.
Highlights
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)
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
The characteristics to be recorded to allow a comparison with the historical control group include age, gender, primary tumor type, interval between tumor diagnosis and MSCC, number of vertebrae affected by MSCC, additional bone or visceral metastases, time developing motor deficits, preradiotherapy ambulatory status, and performance status according to the Eastern Cooperative Oncology Group (ECOG) [7]
Summary
Despite an increasing use of upfront decompressive surgery in addition to radiotherapy, the majority of patients with MSCC still receive radiotherapy alone [3, 4, 15, 16]. One important question is whether outcomes of radiotherapy for MSCC in patients with favorable survival prognoses can be further increased with radiation doses beyond 40Gy. LPFS is an important endpoint, since a lack of response to radiotherapy and an in-field recurrence of MSCC associated with neurologic deficits must be considered serious for the patients. The previous randomized trials of radiotherapy for MSCC that were not limited to patients with favorable prognoses did not show a benefit for higher doses with respect to improvement of motor function, which is important for patients with poor or intermediate survival prognoses who likely will not live long enough to experience a local recurrence of MSCC [25,26,27,28,29].
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