TY - JOUR
T1 - Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients with Predominantly Nonspine Bone Metastases
T2 - A Randomized Phase 2 Trial
AU - Nguyen, Quynh Nhu
AU - Chun, Stephen G.
AU - Chow, Edward
AU - Komaki, Ritsuko
AU - Liao, Zhongxing
AU - Zacharia, Rensi
AU - Szeto, Bill K.
AU - Welsh, James W.
AU - Hahn, Stephen M.
AU - Fuller, C. David
AU - Moon, Bryan S.
AU - Bird, Justin E.
AU - Satcher, Robert
AU - Lin, Patrick P.
AU - Jeter, Melenda
AU - O'Reilly, Michael S.
AU - Lewis, Valerae O.
N1 - Publisher Copyright:
© 2019 American Medical Association. All rights reserved.
PY - 2019/6
Y1 - 2019/6
N2 - Importance: Consensus is lacking as to the optimal radiotherapy dose and fractionation schedule for treating bone metastases. Objective: To assess the relative efficacy of high-dose, single-fraction stereotactic body radiotherapy (SBRT) vs standard multifraction radiotherapy (MFRT) for alleviation of pain in patients with mostly nonspine bone metastases. Design, Setting, and Participants: This prospective, randomized, single-institution phase 2 noninferiority trial conducted at a tertiary cancer care center enrolled 160 patients with radiologically confirmed painful bone metastases from September 19, 2014, through June 19, 2018. Patients were randomly assigned in a 1:1 ratio to receive either single-fraction SBRT (12 Gy for ≥4-cm lesions or 16 Gy for <4-cm lesions) or MFRT to 30 Gy in 10 fractions. Main Outcomes and Measures: The primary end point was pain response, defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (≥2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. We hypothesized that SBRT was noninferior to MFRT. Results: In this phase 2 noninferiority trial of 96 men and 64 women (mean [SD] age, 62.4 [10.4] years), 81 patients received SBRT and 79 received MFRT. Among evaluable patients who received treatment per protocol, the single-fraction group had more pain responders than the MFRT group (complete response + partial response) at 2 weeks (34 of 55 [62%] vs 19 of 52 [36%]) (P =.01), 3 months (31 of 43 [72%] vs 17 of 35 [49%]) (P =.03), and 9 months (17 of 22 [77%] vs 12 of 26 [46%]) (P =.03). No differences were found in treatment-related toxic effects or quality-of-life scores after SBRT vs MFRT; local control rates at 1 and 2 years were higher in patients receiving single-fraction SBRT. Conclusions and Relevance: Delivering high-dose, single-fraction SBRT seems to be an effective treatment option for patients with painful bone metastases. Among evaluable patients, SBRT had higher rates of pain response (complete response + partial response) than did MFRT and thus should be considered for patients expected to have relatively long survival. Trial Registration: ClinicalTrials.gov identifier: NCT02163226.
AB - Importance: Consensus is lacking as to the optimal radiotherapy dose and fractionation schedule for treating bone metastases. Objective: To assess the relative efficacy of high-dose, single-fraction stereotactic body radiotherapy (SBRT) vs standard multifraction radiotherapy (MFRT) for alleviation of pain in patients with mostly nonspine bone metastases. Design, Setting, and Participants: This prospective, randomized, single-institution phase 2 noninferiority trial conducted at a tertiary cancer care center enrolled 160 patients with radiologically confirmed painful bone metastases from September 19, 2014, through June 19, 2018. Patients were randomly assigned in a 1:1 ratio to receive either single-fraction SBRT (12 Gy for ≥4-cm lesions or 16 Gy for <4-cm lesions) or MFRT to 30 Gy in 10 fractions. Main Outcomes and Measures: The primary end point was pain response, defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (≥2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. We hypothesized that SBRT was noninferior to MFRT. Results: In this phase 2 noninferiority trial of 96 men and 64 women (mean [SD] age, 62.4 [10.4] years), 81 patients received SBRT and 79 received MFRT. Among evaluable patients who received treatment per protocol, the single-fraction group had more pain responders than the MFRT group (complete response + partial response) at 2 weeks (34 of 55 [62%] vs 19 of 52 [36%]) (P =.01), 3 months (31 of 43 [72%] vs 17 of 35 [49%]) (P =.03), and 9 months (17 of 22 [77%] vs 12 of 26 [46%]) (P =.03). No differences were found in treatment-related toxic effects or quality-of-life scores after SBRT vs MFRT; local control rates at 1 and 2 years were higher in patients receiving single-fraction SBRT. Conclusions and Relevance: Delivering high-dose, single-fraction SBRT seems to be an effective treatment option for patients with painful bone metastases. Among evaluable patients, SBRT had higher rates of pain response (complete response + partial response) than did MFRT and thus should be considered for patients expected to have relatively long survival. Trial Registration: ClinicalTrials.gov identifier: NCT02163226.
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U2 - 10.1001/jamaoncol.2019.0192
DO - 10.1001/jamaoncol.2019.0192
M3 - Article
C2 - 31021390
AN - SCOPUS:85065320588
SN - 2374-2437
VL - 5
SP - 872
EP - 878
JO - JAMA Oncology
JF - JAMA Oncology
IS - 6
ER -