目的： 探讨抗PD-1单抗联合化疗及抗血管生成药物治疗晚期黑色素瘤的疗效和安全性。 方法： 收集2020年4月至2021年6月在北京大学肿瘤医院接受抗PD-1单抗联合化疗药物替莫唑胺±顺铂、白蛋白结合型紫杉醇及抗血管生成药物贝伐珠单抗治疗的14例（男6、女8例）不可切除的晚期黑色素瘤患者的临床资料。主要研究终点为无进展生存期（PFS），次要终点为客观有效率（ORR）、疾病控制率（DCR）、总生存期（OS）及安全性数据（CTCAE 5.0标准）。 结果： 14例晚期黑色素瘤患者均纳入生存分析，中位随访时间为5.50个月（95% CI: 0~13.12个月），中位PFS为7.43个月（95% CI: 3.07~11.79个月），中位OS为13.50个月（95% CI: 5.19~21.81个月），中位起效时间为1.5个月；ORR为28.6%（4例均为部分缓解），DCR为85.7%；不良反应多为1~2级。结论： 抗PD-1单抗联合化疗及抗血管生成药物治疗在晚期黑色素患者中显示出初步的有效性及良好的安全性，此可能为晚期黑色素瘤的联合治疗策略提供了新思路。

Objective: To investigate the efficacy and safety of anti-PD-1 antibody combined with chemotherapy and anti-angiogenic drugs in the treatment of advanced melanoma. Methods: The clinical data of 14 patients (6 males and 8 females) with unresectable advanced melanoma who received anti-PD-1 antibody combined with chemotherapy (temozolomide±cisplatin, albumin bound paclitaxel) and anti-angiogenic drug (bevacizumab) in Peking University Cancer Hospital from April 2020 to June 2021 were collected. The primary endpoint was the progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety data (CTCAE 5.0). Results: All of the 14 patients with advanced melanoma were included in the survival analysis. The median follow-up time was 5.50 months (95% CI: 0-13.12 months). The median PFS was 7.43 months (95% CI: 3.07-11.79 months), and the median OS was 13.50 months (95% CI: 5.19-21.81 months). The median onset time was 1.5 months. The ORR was 28.6% (all the 4 patients were in partial remission) and the DCR was 85.7%. The adverse events were almost grade 1-2. Conclusion: Chemotherapy combined with anti-PD-1 antibody and anti-angiogenic drug showed certain efficacy and safety in patients with advanced melanoma, which might provide new ideas for the combined treatment of advanced melanoma.

R739.5; R730.5; R730.7

国家自然科学基金资助项目（No. 81972562）；北京市属医院科研培育项目（No.PX2017042，No.PX2021046）；北京市医院管理中心“青苗”计划专项经费资助项目（No.QML20181101）