Premium
Dose‐intensified hypofractionated stereotactic body radiation therapy for painful spinal metastases: Results of a phase 2 study
Author(s) -
Guckenberger Matthias,
Sweeney Reinhart A.,
Hawkins Maria,
Belderbos Jose,
Andratschke Nicolaus,
Ahmed Merina,
Madani Indira,
Mantel Frederick,
Steigerwald Sabrina,
Flentje Michael
Publication year - 2018
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.31294
Subject(s) - medicine , confidence interval , quality of life (healthcare) , radiosurgery , brief pain inventory , dose fractionation , visual analogue scale , radiation therapy , surgery , physical therapy , chronic pain , nursing
BACKGROUND The objective of this study was to prospectively evaluate dose‐intensified hypofractionated stereotactic body radiation therapy (SBRT) in patients with painful spinal metastases in a multicenter, single‐arm, phase 2 study. METHODS Patients with 2 or fewer distinct, noncontiguous, painful, mechanically stable, unirradiated spinal metastases from a solid tumor with a Karnofsky performance status ≥ 60 were eligible. Patients with a long (Mizumoto score ≤ 4) or intermediate overall survival expectancy (Mizumoto score = 5‐9) received 48.5 Gy in 10 fractions or 35 Gy in 5 fractions, respectively, with SBRT. The primary outcome was the overall (complete and partial) pain response as measured with international consensus guidelines 3 months after SBRT. RESULTS There were 57 patients enrolled between 2012 and 2015, and 54 of these patients with 60 painful vertebral metastases were analyzed. The 3‐month pain response was evaluated in 42 patients (47 lesions). An overall pain response was observed in 41 lesions (87%), and the pain response remained stable for at least 12 months. The mean maximum pain scores on a visual analogue scale significantly improved from the baseline of 6.1 (standard deviation, 2.5) to 2.0 (standard deviation, 2.3) 3 months after treatment ( P < .001). The 5‐level EuroQol 5‐Dimension Questionnaire quality‐of‐life (QOL) dimensions (self‐reported mobility, usual activities, and pain/discomfort) significantly improved from the baseline to 3 months after treatment. The 12‐month overall survival and local control rates were 61.4% (95% confidence interval [CI], 48%‐74.8%) and 85.9% (95% CI, 76.7%‐95%), respectively. Grade 3 toxicity was limited to acute pain in 1 patient (2%). No patient experienced radiation‐induced myelopathy. Six patients (11%) developed progressive vertebral compression fractures (VCFs), and 8 patients (15%) developed new VCFs. CONCLUSIONS Dose‐intensified SBRT achieved durable local metastasis control and resulted in pronounced and long‐term pain responses and improved QOL. Cancer 2018;124:2001‐9 . © 2018 American Cancer Society .