Objective:The SHARON (Short course RadiatiON therapy for palliative treatment) Bone trial is a phase III randomized non-inferiority multicentric study comparing symptom relief for complicated bone metastases (BMs) achieved through hypofractionated accelerated palliative radiotherapy (RT) to a standard RT regimen.Methods: Eligible participants were adults with ECOG PS ≤ 3 who were referred for palliative RT for painful BMs. Patients were assigned to receive either 30 Gy delivered in 10 daily fractions or 20 Gy in 4 fractions over two consecutive days. The primary outcome was pain relief one month post-treatment. Pain relief and adverse events were also evaluated at 2, 3, 6, and 12 months after RT. This trial was registered at clinicaltrials.gov (NCT03503682).Results:Between February 2018 and November 2021, 83 patients were enrolled (30 Gy: 41; 20 Gy: 42). In the standard RT group, five patients did not complete the prescribed RT, while none in the experimental arm discontinued treatment (p= 0.026). Due to early mortality, the primary endpoint was evaluable in 73 patients (35 and 38 in the standard and experimental arms, respectively). The rate of complete pain response at one month was 22.9% and 28.9% in the 30 Gy and 20 Gy arms, respectively (p: 0.571). The overall pain response rates, which included complete and partial responses, were 74.3% and 78.9% in the 30 Gy and 20 Gy arms, respectively (p= 0.638), when considering at least a 2-point reduction in the numerical rating scale. In both arms, 4.8% of patients experienced Grade >2 toxicity.Conclusions: Administering 20 Gy in four fractions twice a day is non-inferior to the standard 30 Gy delivered in 10 fractions for pain relief in the context of complicated BMs. Furthermore, this regimen demonstrated comparable safety in terms of acute toxicity, with a lower incidence of definitive interruptions of radiotherapy.
目的：SHARON（姑息治疗短程放射疗法）骨转移试验是一项III期随机非劣效性多中心研究，旨在比较大分割加速姑息放疗（RT）与标准放疗方案对复杂性骨转移（BMs）症状缓解的效果。 方法：符合入组标准的参与者为ECOG PS评分≤3、因疼痛性骨转移需接受姑息放疗的成年患者。患者被随机分配接受两种方案：30 Gy分10次每日照射，或20 Gy分4次在连续两天内完成照射。主要结局指标为治疗后一个月的疼痛缓解情况。疼痛缓解及不良事件也在放疗后2、3、6和12个月进行评估。本试验已在ClinicalTrials.gov注册（注册号：NCT03503682）。 结果：2018年2月至2021年11月期间，共纳入83例患者（30 Gy组：41例；20 Gy组：42例）。标准放疗组中有5例患者未完成规定放疗，而试验组无患者中断治疗（p=0.026）。由于早期死亡，主要终点可在73例患者中评估（标准组35例，试验组38例）。一个月时，30 Gy组和20 Gy组的完全疼痛缓解率分别为22.9%和28.9%（p=0.571）。当考虑数字评分量表至少降低2分时，30 Gy组和20 Gy组的总体疼痛缓解率（包括完全和部分缓解）分别为74.3%和78.9%（p=0.638）。两组中均有4.8%的患者出现>2级毒性反应。 结论：对于复杂性骨转移的疼痛缓解，每日两次、总剂量20 Gy分4次照射的方案不劣于标准30 Gy分10次照射的方案。此外，该方案在急性毒性方面表现出相当的安全性，且确定性放疗中断的发生率更低。
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