300 - Radiation Therapy Alone vs. Radiation Therapy Plus Radiofrequency Ablation/Vertebral Augmentation for Painful Spine Metastasis: A Randomized Controlled Trial
Presenter(s)
R. Kotecha1, O. Gal2, H. Appel2, M. C. Avendano2, A. M. Pimentel2, A. K. Starosciak2, M. Rubens3, M. Roy4, D. Perche1, C. I. Pow-Sang2, F. Milosevic2, R. Cruz2, A. Kudryashev2, M. D. Hall2, A. C. Botero5, M. P. Mehta2, J. Sporrer6, and B. Schiro7; 1Miami Cancer Institute, Baptist Health South Florida, Miami, FL, 2Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, 3Department of Biostatistics, Miami Cancer Institute, Miami, FL, 4Department of Biostatistics, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, 5Miami Cancer Institute Baptist Health South Florida, Miami, FL, 6Miami Neuroscience Institute, Baptist Health South Florida, Miami, FL, 7Miami Cardiac and Vascular Institute, Baptist Health South Florida, Miami, FL
Purpose/Objective(s): External beam radiation therapy (EBRT) offers modest pain relief for patients with symptomatic spine metastases; efforts to improve upon this with image-guided thermal ablative approaches remain understudied. This study aimed to prospectively compare pain response rates and corresponding quality of life (QoL) between EBRT alone and EBRT + radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA).
Materials/Methods: In this single-center, prospective, randomized phase 2 trial we enrolled patients with spine metastasis from T5-L5, with 1-2 index sites amenable to RFA and a minimum Numeric Pain Rating Scale (NPRS) of 5. Patients were stratified according to tumor type (radioresistant vs. radiosensitive) and randomly assigned in a 1:2 ratio to receive either EBRT (20-30 Gy in 5-10 fractions) alone or with the addition of RFA/PVA (RFA/PVA arm). The primary endpoint was 3-month pain response (complete or partial), defined as a reduction in the worst NPRS score of =3 points from baseline at the index sites. Adverse events and patient-reported QoL measures were secondary objectives.
Results: The study was terminated early due to a futility analysis after enrolling and randomizing 63 patients (79% of planned accrual; 21 EBRT, 42 RFA/PVA). The median age was 68 (interquartile range [IQR] IQR: 61-77), 65% were female, 70% ECOG 1, and 60% Hispanic. The median baseline NPRS was 10 (IQR: 8-10) for EBRT alone and 9 (7.5-10) for the RFA/PVA arm. The primary endpoint of pain response 3 months after treatment was similar between EBRT alone and RFA/PVA arms (50.0% vs. 48.3%, p-value= 0.92). Complete pain response rates at 3 months were also similar between the EBRT alone arm and the RFA/PVA arm (16.7% vs. 20.7%, p-value =0.77). The median 3-month NPRS reduction was -4 (IQR: -6 to -1) in both treatment arms. Adverse events were comparable between the arms, as were QoL measures including FACT-G, BPI, and EQ-5D scores.
Conclusion: The routine addition of RFA/PVA to EBRT for spine metastases did not improve pain control or quality of life measures, as assessed by patient reported pain impact, health utility, and overall quality of life in this diverse patient population.