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.
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.
Authors: Gillian Bedard; Rachel McDonald; Ian Poon; Darby Erler; Hany Soliman; Patrick Cheung; Hans Chung; William Chu; Andrew Loblaw; Edward Chow; Arjun Sahgal Journal: Ann Palliat Med Date: 2016-01
Authors: Darby Erler; Drew Brotherston; Arjun Sahgal; Patrick Cheung; Andrew Loblaw; William Chu; Hany Soliman; Hans Chung; Alex Kiss; Edward Chow; Ian Poon Journal: Radiother Oncol Date: 2018-04-26 Impact factor: 6.280
Authors: Edward Chow; Peter Hoskin; Gunita Mitera; Liang Zeng; Stephen Lutz; Daniel Roos; Carol Hahn; Yvette van der Linden; William Hartsell; Eshwar Kumar Journal: Int J Radiat Oncol Biol Phys Date: 2011-04-12 Impact factor: 7.038
Authors: Laurent M Grignon; Mark J Jameson; Lucy Hynds Karnell; Alan J Christensen; Gerry F Funk Journal: Arch Otolaryngol Head Neck Surg Date: 2007-05
Authors: Patricia Mae G Santos; Kaitlyn Lapen; Zhigang Zhang; Stephanie Lobaugh; C Jillian Tsai; T Jonathan Yang; Justin E Bekelman; Erin F Gillespie Journal: Int J Radiat Oncol Biol Phys Date: 2020-11-12 Impact factor: 7.038
Authors: Yilin Cao; Gregory C Stachelek; Wei Fu; Daniel Y Song; Russell K Hales; K Ranh Voong; Jeffrey J Meyer; Harry Quon; Chen Hu; Kristin J Redmond Journal: J Radiosurg SBRT Date: 2021
Authors: Michael F Gensheimer; Sonya Aggarwal; Kathryn R K Benson; Justin N Carter; A Solomon Henry; Douglas J Wood; Scott G Soltys; Steven Hancock; Erqi Pollom; Nigam H Shah; Daniel T Chang Journal: J Am Med Inform Assoc Date: 2021-06-12 Impact factor: 4.497
Authors: Christopher L Tinkle; Charu Singh; Shane Lloyd; Yian Guo; Yimei Li; Alberto S Pappo; Steven G DuBois; John T Lucas; Daphne A Haas-Kogan; Stephanie A Terezakis; Steve E Braunstein; Matthew J Krasin Journal: Int J Radiat Oncol Biol Phys Date: 2020-11-28 Impact factor: 7.038
Authors: Mansoor M Aman; Ammar Mahmoud; Timothy Deer; Dawood Sayed; Jonathan M Hagedorn; Shane E Brogan; Vinita Singh; Amitabh Gulati; Natalie Strand; Jacqueline Weisbein; Johnathan H Goree; Fangfang Xing; Ali Valimahomed; Daniel J Pak; Antonios El Helou; Priyanka Ghosh; Krishna Shah; Vishal Patel; Alexander Escobar; Keith Schmidt; Jay Shah; Vishal Varshney; William Rosenberg; Sanjeet Narang Journal: J Pain Res Date: 2021-07-16 Impact factor: 3.133