Department of Orthopaedics, Henan Provincial People's Hospital, Department of Orthopaedics of Central China Fuwai Hospital,Central China Fuwai Hospital of Zhengzhou University, No. 1, Fuwai Avenue, Zhengdong New District, Zhengzhou, 450003, China.
Department of Oral and Maxillofacial Surgery, The First Affiliated Hospital, Sun Yat-sen University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China.
BMC Cancer. 2021 Feb 2;21(1):108. doi: 10.1186/s12885-021-07843-3.
Currently, the choice of treatment for individuals with metastatic soft tissue sarcomas (MSTS) presents a significant challenge to clinicians. The aim of this retrospective study was to assess the efficacy and safety of nivolumab plus ipilimumab (NPI) versus nivolumab alone (NIV) in individuals with treatment-naive programmed death-ligand 1 (PD-L1) positive MSTS.
Prospectively maintained databases were reviewed from 2013 to 2018 to assess individuals with treatment-naive PD-L1 MSTS who received NPI (nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks) or NIV (3 mg/kg every 2 weeks) until disease progression, withdrawal, unendurable [AEs], or death. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS).
The median follow-up was 16.0 months (IQR 14.4-18.5) after targeted intervention. The median OS was 12.2 months (95% confidence interval [CI], 6.1-13.7) and 9.2 months (95% CI, 4.2-11.5) for the NPI and NIV groups, respectively (hazard ratio [HR] 0.49, 95% CI, 0.33-0.73; p=0.0002); the median PFS was 4.1 months (95% CI, 3.2-4.5) and 2.2 months (95% CI, 1.1-3.4) for the NPI and NIV groups, respectively (HR 0.51, 95% CI, 0.36-0.71; p< 0.0001). Key grade 3-5 AEs occurred more frequently in the NPI group than in the NIV group (94 [72.9%] for NPI vs. 35 [27.1%], p< 0.001).
For treatment-naive PD-L1 positive MSTS, NPI seems to be less tolerated but has a greater survival advantage than NIV as the primary therapy.
目前，转移性软组织肉瘤（MSTS）患者的治疗选择对临床医生来说是一个巨大的挑战。本回顾性研究旨在评估纳武单抗联合伊匹单抗（NPI）与纳武单抗单药（NIV）治疗初治程序性死亡配体 1（PD-L1）阳性 MSTS 的疗效和安全性。
从 2013 年至 2018 年，前瞻性维护的数据库进行了审查，以评估接受 NPI（纳武单抗 3mg/kg 和伊匹单抗 1mg/kg，每 3 周一次，共 4 次，随后纳武单抗 3mg/kg，每 2 周一次）或 NIV（3mg/kg，每 2 周一次）治疗的初治 PD-L1 MSTS 患者，直至疾病进展、退出、无法耐受[不良反应]或死亡。主要终点是总生存期（OS）和无进展生存期（PFS）。
靶向治疗后中位随访时间为 16.0 个月（IQR 14.4-18.5）。NPI 和 NIV 组的中位 OS 分别为 12.2 个月（95%CI 6.1-13.7）和 9.2 个月（95%CI 4.2-11.5）（风险比[HR]0.49，95%CI 0.33-0.73；p=0.0002）；NPI 和 NIV 组的中位 PFS 分别为 4.1 个月（95%CI 3.2-4.5）和 2.2 个月（95%CI 1.1-3.4）（HR 0.51，95%CI 0.36-0.71；p<0.0001）。NPI 组比 NIV 组更常发生 3-5 级关键不良反应（94 [72.9%] vs. 35 [27.1%]，p<0.001）。
对于初治 PD-L1 阳性 MSTS，NPI 的耐受性较差，但作为一线治疗的生存获益大于 NIV。
