Patient-Reported Outcomes-Secondary Analysis of the SCORE-2 Trial Comparing 4 Gy x 5 to 3 Gy x 10 for Metastatic Epidural Spinal Cord Compression

Autor: Rades D, Segedin B, Conde-Moreno A, Ferrer-Albiach C, Metz M, Polat B, Badakhshi H, Schreiber A, Nitsche M, Cacicedo J, Schild S
Rok vydání: 2019
Zdroj: INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
r-FHPC. Repositorio Institucional de Producción Científica de la Fundación del Hospital Provincial de Castellón
instname
ISSN: 0360-3016
Popis: Purpose: To compare 4 Gy x 5 (1 week) to 3 Gy x 10 (2 weeks) in relieving pain and distress in patients with metastatic epidural spinal cord compression (MESCC). Methods and Materials: The randomized SCORE-2 trial compared 4 Gy x 5 (n = 101) to 3 Gy x 10 (n = 102) for MESCC. In this additional analysis, these regimens were compared for their effect in relieving pain and distress. Distress was evaluated with the distress-thermometer (0 = no distress, 10 = extreme distress) and pain on a linear scale (0 = no pain, 10 = worst pain). Relief of distress was defined as decrease of >= 2 points; complete and partial pain relief were defined as achieving a score of 0 points and a decrease >= 2 points, respectively, without increase of analgesic use. This prospective secondary analysis of the SCORE-2 trial aimed to show that 4 Gy x 5 was not inferior to 3 Gy x 10 regarding distress and pain relief. Analyses were performed using the unconditional test of noninferiority for binomial differences based on restricted maximum likelihood estimates (noninferiority margin: -20%). Evaluations were performed before, directly after, and 1, 3, and 6 months after radiation therapy. (ClinicalTrials.gov: NCT02189473). Results: At baseline, median distress scores were 8 (2-10) points in the 4 Gy x 5 group and 8 (2-10) points in the 3 Gy x 10 group. At 1 month, distress relief rates were 58.1% (43/74) and 62.7% (47/75) (difference: -4.6%; 95% confidence interval, -20.0% to +11.1%; P = .025). At baseline, median pain scores were 7 (2-10) and 7 (2-10) points, respectively. At 1 month, complete pain relief rates were 23.5% (16/68) versus 20.0% (14/70) (difference, +3.5%; 95% confidence interval, -10.4% to +17.5%; P < .001), and overall pain relief rates were 52.9% (36/68) versus 57.1% (40/70) (difference, -4.2%; 95% confidence interval, -20.5% to +12.3%; P = .029). Distress and pain relief rates after 4 Gy x 5 were largely comparable to 3 Gy x 10 at all time points. Associated 95% confidence intervals did not point toward any relevant differences. Conclusions: In patients with MESCC and poor to intermediate survival prognoses, 4 Gy x 5 appeared noninferior to 3 Gy x 10 regarding pain and distress relief. (C) 2019 Elsevier Inc. All rights reserved.
Databáze: OpenAIRE
Externí odkaz: