TY - JOUR
T1 - Radiation therapy (RT) alone versus RT plus radiofrequency ablation/vertebral augmentation for painful spine metastasis
T2 - a phase 2 randomized controlled trial
AU - Kotecha, Rupesh
AU - Gal, Omer
AU - Appel, Haley
AU - Carolina Avendano, Maria
AU - Pimentel, Antoinette M
AU - Starosciak, Amy K
AU - Rubens, Muni
AU - Roy, Mukesh
AU - Perche, Dilanis
AU - Pow-Sang, Cristina I
AU - Milosevic, Fabiana
AU - Cruz, Ramon F
AU - Kudryashev, Alex
AU - Hall, Matthew D
AU - Botero, Ana
AU - Mehta, Minesh P
AU - Sporrer, Justin M
AU - Schiro, Brian J
N1 - © The Author(s) 2025. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected].
PY - 2025/10/7
Y1 - 2025/10/7
N2 - 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=0.92). Complete pain response rates at 3 months were also similar in the RT and RT+RFA/PVA arms (17% vs. 21%, p=0.77). 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.
AB - 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=0.92). Complete pain response rates at 3 months were also similar in the RT and RT+RFA/PVA arms (17% vs. 21%, p=0.77). 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.
U2 - 10.1093/neuonc/noaf231
DO - 10.1093/neuonc/noaf231
M3 - Article
C2 - 41056433
SN - 1522-8517
JO - Neuro-Oncology
JF - Neuro-Oncology
ER -