Pain Response After Stereotactic Body Radiation Therapy Versus Conventional Radiation Therapy in Patients With Bone Metastases—A Phase 2 Randomized Controlled Trial Within a Prospective Cohort

Abstract

Pain response after conventional external beam radiation therapy (cRT) in patients with painful bone metastases is observed in 60% to 70% of patients. The aim of the VERTICAL trial was to investigate whether stereotactic body radiation therapy (SBRT) improves pain response. Methods and Materials: This single-center, phase 2, randomized controlled trial was conducted within the PRESENT cohort, which consists of patients referred for radiation therapy of bone metastases to our tertiary center. Cohort participants with painful bone metastases who gave broad informed consent for randomization were randomly assigned to cRT or SBRT. Only patients in the intervention arm received information about the trial and were offered SBRT (1 Â 18 Gy, 3 Â 10 Gy, or 5 Â 7 Gy), which they could accept or refuse. Patients who refused SBRT underwent standard cRT (1 Â 8 Gy, 5 Â 4 Gy, or 10 Â 3 Gy). Patients in the control arm were not informed. Primary endpoint was pain response at 3 months after radiation therapy.

Hypofractionated radiation therapy as palliative management for symptomatic and local control of advanced thoracic malignancies

“…Higher rates of pain response have also been corroborated in non-spine bone metastasis treated with SBRT compared to MFRT (14). In contrast, other studies showed in localized spine metastases that pain control was not improved following SBRT (15,16). This study presents the first evaluation of the efficacy of SBRT for palliation of intra-thoracic tumors.…”

“…Most literature assessing the efficacy of SBRT has been in the curative or oligometastatic setting (4)(5)(6)(7)(8)(9)(10)(11)(12). In the realm of spinal and bone metastases, recent studies have assessed the role of SBRT in the palliative setting with overall mixed results in pain relief (13)(14)(15)(16)(17). However, no studies have yet explored the role of palliative SBRT in thoracic malignancies.…”

Response assessment after stereotactic body radiation therapy for spine and non-spine bone metastases: results from a single institutional study

“…Furthermore, there was a significant association between single fraction SBRT and the development of pseudo-progression [ 26 ]. The so far published randomized trials comparing SBRT versus conventional radiotherapy have not reported the rates of pseudo-progression [ 12 , 27 , 28 ]. The SPINO group defined any new or progressive tumor within the epidural space as local progression [ 13 ], but we have recently published a case report showing clear epidural involvement on radiological images after spine SBRT, yet histologically without tumor cells in the epidural space [ 29 ].…”

“…However, as they chose the single fraction SBRT with 24 Gy, the rates of new pathological fracture were high in that study, with 8.7% and 27.8% at 3 and 6 months respectively [ 12 ]. Another randomized phase 2 trial from the Netherlands compared SBRT versus conventional radiotherapy for bone metastases using different fractionations [ 28 ]. SBRT group did not show significant pain improvement, but because of selective dropout, this trial was underpowered to detect the difference in pain response [ 28 ].…”

Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial

“…Using this design, the intervention study is performed within a prospective cohort. Compared to conventional RCTs, the TwiCs design can lead to more efficient patient recruitment, generalizability of results may be improved, and TwiCs allows evaluation of patients' acceptability of the intervention [14][15][16][17].…”