地诺单抗联合手术治疗骶骨骨巨细胞瘤效果分析

Effect of denosumab combined with surgery on sacral giant cell tumor

目的 评估骶骨骨巨细胞瘤（GCTB）患者在术前、术后接受地诺单抗治疗后疗效及骶神经功能的改善情况.方法 回顾性分析2014年4月至2016年7月北京大学人民医院骨与软组织肿瘤治疗中心收治的30例骶骨GCTB患者临床资料,根据地诺单抗的用药时机分为对照组（10例）、术后用药组（9例）和新辅助治疗组（11例）.所有接受地诺单抗治疗的患者每4周接受120mg地诺单抗皮下注射,第8天和第15天增加2次负荷剂量.结果 对照组中3例（3/10）术后复发,术后用药组无复发（0/9）,新辅助治疗组3例（3/11）术后复发.3组无事件生存率比较,差异无统计学意义（P=0.133）.新辅助治疗组用药后依据实体瘤的疗效评价标准（RECIST 1.1）评估,客观反应率为63.6%（7/11）.新辅助治疗组中5例患者术前应用地诺单抗后疼痛明显改善（骶神经功能评分下降≥2分）,同时大小便困难、失禁及麻木感减轻,4例术前留置尿管的患者中2例使用地诺单抗后拔除尿管.结论 地诺单抗可缓解骶神经压迫造成的疼痛和大小便障碍,新辅助用药方式可部分减少术中出血,但手术清除肿瘤仍为治疗骶骨GCTB的基本手段.

Objective To evaluate the clinical benefits of denosumab in treatment of sacral giant cell tumor of bone（GCTB） when used preoperatively or postoperatively along with surgery, and to analysis the improvement of sacral nerve function. Methods Thirty patients diagnosed as sacral GCTB in Musculoskeletal Tumor Center of Peking University People＆#39;s Hospital from April 2014 to July 2016 were divided into control group （10 cases）, post-operative group （9 cases）, and neoadjuvant group （11 cases）. Patients in the post-operative and neoadjuvant group were treated with 120 mg of subcutaneous denosumab every 4 weeks with loading doses on days 8 and 15 of the first cycle. Results Three patients in the control cohort 1 had recurrence （3/10）, no recurrence occurred in the post-operative group （0/9）, and 3 patients in the neoadjuvant group had recurrence（3/11）.There were no significant differences in event-free survival（EFS） among the three groups （P = 0.133）. The objective response rate （OTR） was 63.6 % （7/11） in the neoadjuvant group based on the RECIST 1.1 criteria for evaluating the efficacy of solid tumors. Five cases had significant pain improvement （defined 2 points improved） and had much better bladder and bowel functions. Four patients were able to have their indwelling catheters removed after neoadjuvant denosumab treatment. Conclusions Neoadjuvant therapy with denosumab can relieve the symptoms and neurologic deficits caused by nerve compression and can diminish the intraoperative blood loss. Surgical removal of the tumor is still the basic treatment of sacral GCTB.