Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for painful spine metastasis: A phase 2 randomized controlled trial.

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.