TY - JOUR
T1 - Dexamethasone for the Prevention of a Pain Flare After Palliative Radiation Therapy for Painful Bone Metastases
T2 - The Multicenter Double-Blind Placebo-Controlled 3-Armed Randomized Dutch DEXA Study
AU - van der Linden, Yvette M.
AU - Westhoff, Paulien G.
AU - Stellato, Rebecca K.
AU - van Baardwijk, Angela
AU - de Vries, Kim
AU - Ong, Francisca
AU - Wiggenraad, Ruud
AU - Bakri, Bonnie
AU - Wester, Gerda
AU - de Pree, Ilse
AU - van Veelen, Lieneke
AU - Budiharto, Tom
AU - Schippers, Maaike
AU - Reyners, Anna K. L.
AU - de Graeff, Alexander
N1 - Funding Information:
This work was supported in part by the Dutch Cancer Society (KWF grant 2009-4595 ) and the Netherlands Organisation for Health Research and Development (ZonMW grant 1151.0009 ). The funders had no role in study design, data collection, data analyses, data interpretation, or report writing.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/11/1
Y1 - 2020/11/1
N2 - Purpose: After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF.Methods and Materials: This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF.Results: From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar.Conclusions: There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5. (C) 2020 Elsevier Inc. All rights reserved.
AB - Purpose: After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF.Methods and Materials: This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF.Results: From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar.Conclusions: There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5. (C) 2020 Elsevier Inc. All rights reserved.
KW - CANCER-PATIENTS
KW - RADIOTHERAPY
KW - PROPHYLAXIS
KW - QUESTIONNAIRE
U2 - 10.1016/j.ijrobp.2020.05.007
DO - 10.1016/j.ijrobp.2020.05.007
M3 - Article
C2 - 32446951
SN - 0360-3016
VL - 108
SP - 546
EP - 553
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 3
ER -