[摘 要] 目的：探讨白蛋白结合型紫杉醇联合PD-1抑制剂用于治疗一线化疗失败的骨与软组织肉瘤的疗效及安全性。方 法：回顾性分析北京积水潭医院骨肿瘤科2017年8月至2020年8月收治的一线化疗失败的晚期骨与软组织肉瘤患者。患者接受 白蛋白结合型紫杉醇（125~140 mg/m2，第1天和第8天）与PD-1抑制剂（信迪利单抗或特瑞普利单抗，每21 d一次）联合治疗。每 2个治疗周期评估1次疗效，按RECIST 1.1标准评估肿瘤疗效，按NCI-CTCAE5.0标准评估不良反应。结果：共20名患者纳入研 究，完成1至8个治疗周期，中位治疗周期数为3个。所有患者均可评估疗效，完全缓解4例（20%），部分缓解0例，稳定9例 （45%），疾病进展7例（35%）。客观缓解率（ORR）为20%，疾病控制率（DCR）为65%。中位无进展生存期（PFS）为3.0个月。治疗 期间主要不良反应包括2级白细胞减少（40%）、1-2级神经毒性反应（20%），以及2级甲状腺功能减退（10%）。结论：白蛋白结合 型紫杉醇联合PD-1抑制剂治疗为一线化疗失败的晚期骨与软组织肉瘤患者提供了一种潜在的治疗选择，其不良反应可控，值得 开展更大样本的前瞻性研究进一步验证其疗效。

[Abstract] Objective: To investigate the efficacy and safety of albumin-binding paclitaxel combined with PD-1 inhibitor in the treatment of bone and soft tissue sarcomas after first-line chemotherapy failure. Methods: This retrospective study analyzed patients with advanced bone and soft tissue sarcomas who failed first-line chemotherapy and were treated at the Department of Orthopedic Oncology of Beijing Jishuitan Hospital between August 2017 and August 2020. Patients received combined treatment with albumin binding paclitaxel (125-140 mg/m2 on days 1 and 8) and anti-PD-1 therapy (sintilimab or toripalimab, every 21 days). Efficacy was evaluated every two treatment cycles according to the RECIST 1.1 criteria and adverse reactions were assessed using the NCI-CTC5.0 criteria. Results: A total of 20 patients who completed between 1 to 8 cycles of treatment with a median of 3 cycles were included in the study. All patients were evaluable for responses: 4 patients (20%) achieved complete remission; no partial remissions were observed; 9 patients (45%) had stable disease, and 7 patients (35%) had disease progression. The overall response rate (ORR) was 20%, and the disease control rate (DCR) was 65%. The median progression-free survival (PFS) was 3.0 months. The main adverse reactions during treatment included Grade 2 leukopenia (40%), Grade 1-2 neurotoxicity (20%), and Grade 2 hypothyroidism (10.0%). Conclusion: The combination therapy of albumin-binding paclitaxel and PD-1 inhibitor offers a potential treatment option for patients with advanced bone and soft tissue sarcomas who have failed first-line chemotherapy. The adverse reactions are manageable, and this regimen merits prospective studies with larger samples to further verify its efficacy.

[基金项目] 北京积水潭医院“学科新星”（No. XKXX2018013）