Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1–2 trial

Abstract

Summary Background This study investigated the clinical benefit of using hypofractionated stereotactic body radiotherapy (SBRT) to manage spinal metastases in patients with cancer and to reduce cancer-related symptoms. Methods Cancer patients (n=149) with mechanically stable, non–cord-compressing, spinal metastases (n=166) were treated by SBRT in a phase I/II study. Patients received a total dose of 27–30 Gy, typically in three fractions. Symptoms were measured repeatedly by the Brief Pain Inventory (BPI) and the M. D. Anderson Symptom Inventory (MDASI). The primary endpoint was to establish the safety, feasibility, and efficacy of using a CT-on-Rails or Trilogy Stereotactic Spine Radiation Therapy system to treat spinal and paraspinal tumors and to document pain relief and toxicity associated with such treatment. Symptom outcomes were estimated according to protocol using descriptive analysis and ordinal regression modeling. This is the final report for the completed enrollment and follow-up. Findings The median follow-up time was 15·9 (interquartile range 9·5–30·3) months and the mean was 20·9 (SD=17·1) months. The actuarial tumor progression-free survival rates at one year and two years post-SBRT were 80·5% and 72·4%, respectively. Patients reported significant MDASI pain reduction (p=0·00003) during the six months post-SBRT. Patients reporting no pain from bone metastases on the BPI increased from 39/149 (26·2%) before SBRT to 55/102 (53·9%) six months post-SBRT (p<0·0001). BPI pain reduction from baseline to four weeks post-SBRT was clinically meaningful (effect size=0·47, p<0·01). These improvements were accompanied by significant reduction in opioid use during the six months post-SBRT (p<0·05) and a significant reduction in MDASI symptom interference with daily life (p<0·01).. Only a few instances of nonneurological grade 3 toxicities occurred (one report each of nausea, vomiting, diarrhea, fatigue, dysphagia, neck pain, diaphoresis, two reports of pain associated with severe tongue edema and trismus, and 3 reports of noncardiac chest pain). No grade 4 toxicities occurred. Interpretation SBRT is an effective primary or salvage treatment of mechanically stable spinal metastasis. Significant reduction in patient-reported pain and other symptoms was evident six months post-SBRT, along with satisfactory progression-free survival and no late spinal cord toxicities.

Stereotactic Radiosurgery for the Treatment of Primary and Metastatic Spinal Sarcomas

“…[22][23][24][25][26] This questionnaire has also been used in the study of SRS-induced vertebral fractures, metastatic bone disease, and sarcoma resections. [27][28][29] Patients rate their worst, current, and average pain at the time of BPI collection (each ranging from 0 to 10) at the treatment site of interest. 30 ''Current'' pain at the time of BPI collection during clinical follow-up was used to evaluate pain relief and symptomatic failure after SRS.…”

Local treatments for metastases of renal cell carcinoma: a systematic review

“…CRT is fractionated radiotherapy primarily applied to treat painful metastases, whereas SBRT, like SRS, delivers high-dose single-fraction or multi-fraction radiation. 14 Until now, no systematic review on the outcome of diff erent local treatment options for metastases from renal cell carcinoma has been done, and there is a need to identify potential benefi ts of such an approach. Therefore, in this systematic review, we aimed to address the question of whether integration of local treatment of metastases into the management of metastatic renal cell carcinoma is benefi cial and, if so, what the best treatment modalities are.…”

The use of spine stereotactic radiosurgery for oligometastatic disease

“…13,23,31 In addition, it has proven to be an effective salvage tool in patients who have progressive spinal metastases who have received prior radiation. 11,13,31 abbreviationS CI = confidence interval; CTV = clinical treatment volume; DFS = disease-free survival; Dmax = dose maximum; Dmin = dose minimum; EBRT = external beam radiation therapy; GI = gastrointestinal; GTV = gross tumor volume; HR = hazard ratio; KPS = Karnofsky Performance Scale; OS = overall survival; SSRS = spine stereotactic radiosurgery; STMFS = systemic therapy modification-free survival. obJective The authors investigated the outcomes following spine stereotactic radiosurgery (SSRS) for patients with oligometastatic disease of the spine.…”

“…It appears to lead to improved tumor control and pain control rates compared with conventionally dosed palliative EBRT, especially for radioresistant histologies, although there has not been any randomized evidence to date. 13,23,31 In addition, it has proven to be an effective salvage tool in patients who have progressive spinal metastases who have received prior radiation. 11,13,31 abbreviationS CI = confidence interval; CTV = clinical treatment volume; DFS = disease-free survival; Dmax = dose maximum; Dmin = dose minimum; EBRT = external beam radiation therapy; GI = gastrointestinal; GTV = gross tumor volume; HR = hazard ratio; KPS = Karnofsky Performance Scale; OS = overall survival; SSRS = spine stereotactic radiosurgery; STMFS = systemic therapy modification-free survival.…”