A randomized phase III trial of denosumab before curettage for giant cell tumor of bone. JCOG1610
A randomized phase III trial of denosumab before curettage for giant cell tumor of bone. JCOG1610
复制标题
一项在骨巨细胞瘤刮除术前使用狄诺塞麦的随机 III 期试验。
DOI：
10.1093/jjco/hyac071
复制
发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Ozaki T.
中科院分区：
文献类型：
--
作者：
Urakawa H;Nagano A;Machida R;Tanaka K;Kataoka T;Sekino Y;Nishida Y;Takahashi M;Kunisada T;Kawano M;Yoshida Y;Takagi T;Sato K;Hiruma T;Hatano H;Tsukushi S;Sakamoto A;Akisue T;Hiraoka K;Ozaki T.
JCOG1610（随机对照III期试验）的目的是证实术前denosumab对骨巨细胞瘤患者刮除配合局部辅助治疗的优越性，且术后不可能出现较大骨缺损。方法主要终点为无复发生存期，总样本量为106例。患者收益开始于2017年10月。然而，由于患者累积不良，根据数据和安全监测委员会的建议，该项目于2020年12月终止。现在，我们报告在本研究中获得的描述性结果。结果截至2020年12月终止时，日本13家机构共登记了18例患者。11例患者被分配到A组（刮痧和辅助局部治疗），7例患者被分配到B组（术前denosumab，刮痧和辅助局部治疗）。中位随访时间为1.6年（范围：0.5-2.8年）。除一例患者手术前发生病理性骨折外，A组所有患者均完成了方案治疗。B组所有患者术前均接受5个疗程的denosumab治疗。A组和B组1年无复发生存率分别为90.0%（95%可信区间：473 - 98.5）和100%(100-100)，2年无复发生存率分别为60.0%（19.0-85.5）和62.5%(14.2-89.3)[风险比（95%可信区间）：1.51(0.24-9.41)]。结论在无复发生存方面，对于术后无较大骨缺损的骨巨细胞瘤患者，术前denosumab无优势。
ObjectivesThe aim of JCOG1610 (randomized controlled phase III trial) was to confirm the superiority of preoperative denosumab to curettage with adjuvant local therapy for patients with giant cell tumor of bone without possible post-operative large bone defect.MethodsThe primary endpoint was relapse-free survival and the total sample size was set at 106 patients. Patient accrual began in October 2017. However, the accrual was terminated in December 2020 due to a recommendation from the Data and Safety Monitoring Committee because of poor patient accrual. Now, we report the descriptive results obtained in this study.ResultsA total of 18 patients had been registered from 13 Japanese institutions at the time of termination on December 2020. Eleven patients were assigned to Arm A (curettage and adjuvant local therapy) and 7 to Arm B (preoperative denosumab, curettage and adjuvant local therapy). Median follow-up period was 1.6 (range: 0.5–2.8) years. Protocol treatment was completed in all but one patient in Arm A who had a pathological fracture before surgery. All patients in Arm B were treated with five courses of preoperative denosumab. Relapse-free survival proportions in Arm A and B were 90.0% (95% confidence interval: 47.3–98.5) and 100% (100–100) at 1 year, and 60.0% (19.0–85.5) and 62.5% (14.2–89.3) at 2 years, respectively [hazard ratio (95% confidence interval): 1.51 (0.24–9.41)].ConclusionIn terms of relapse-free survival, the superiority of preoperative denosumab was not observed in patients with giant cell tumor of bone without possible post-operative large bone defect.