Abstract
BACKGROUND: Radiation therapy (RT) offers pain relief for patients with symptomatic spine metastases. This study compares pain response and quality of life (QOL) between conventional RT or RT and radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA). METHODS: This single-center, prospective, randomized phase 2 trial (NCT04375891) enrolled patients with spine metastasis (T5-L5, with 1-2 index sites amenable to RFA) and a minimum Numeric Pain Rating Scale (NPRS) of 5. After stratifying by tumor type (radioresistant vs. radiosensitive), patients were randomized (1:2) to RT or RT+RFA/PVA. The primary endpoint was 3-month pain response. Secondary endpoints included rapidity and duration of pain response, adverse events, and QOL measures. RESULTS: The study terminated after enrolling and randomizing 63 patients (79% of planned accrual; 21 RT alone, 42 RT+RFA/PVA). The median baseline NPRS was 10 (interquartile range [IQR] 8-10) for RT and 9 (7.5-10) for RT+RFA/PVA. The primary endpoint of pain control 3 months after treatment was similar between the RT and RT+RFA/PVA arms (50% vs. 48%, P = .92). Complete pain response rates at 3 months were also similar in the RT and RT+RFA/PVA arms (17% vs. 21%, P = .77). The 3-month median NPRS reduction was -4 (IQR, -6 to -1) in both the RT and the RT+RFA/PVA arms. Secondary efficacy endpoints and toxicity rates were comparable. Overall QOL measures including FACT-G, BPI, and EQ-5D scores were also similar between the two treatment arms. CONCLUSIONS: The addition of RFA/PVA to conventional RT for patients with symptomatic spine metastases did not improve pain control or QOL measures at 3 months.