Sun Xin, Xu Jie, Xie Lu, Guo Wei
Department of Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, 100044, People's Republic of China.
Int J Gen Med. 2022 Sep 28;15:7581-7591. doi: 10.2147/IJGM.S379269. eCollection 2022.
This study was to investigate the effectiveness and tolerability of anlotinib plus PD-1 inhibitors for patients with previously treated metastatic soft tissue sarcoma (STS).
Patients with previously treated metastatic STS who were administered with anlotinib plus PD-1 inhibitors in clinical practice were included for analysis retrospectively. All the common subtypes of advanced STS were appropriate for analysis. Efficacy of the regimen was assessed according to the change of target lesion radiologically, and all the patients were followed up regularly. Safety profile during the combination administration was recorded and documented specifically. Clinical significance according to different STS subtypes was analyzed accordingly.
From September 2018 to January 2022, a total of 32 patients with previously treated metastatic STS who received anlotinib plus PD-1 blockades were screened for the analysis in this study. The best overall response during the combination administration indicated that partial response was observed in 11 patients, stable disease was noted in 16 patients and progressive disease was found in 6 patients, yielding an objective response rate (ORR) of 34.4% (95% CI: 18.6-53.2%) and a disease control rate (DCR) of 84.4% (95% CI: 67.2-94.7%). Furthermore, the median PFS of 32 patients with metastatic STS was 7.6 months (95% CI: 3.31-11.89) and the median OS was 14.9 months (95% CI: 8.36-21.44). Besides, adverse reactions related to the treatment during anlotinib plus PD-1 inhibitors administration were observed in 29 patients (90.6%), of whom, a total of 13 patients (40.6%) were deemed as grade 3-4 adverse reactions and no grade 5 adverse reaction was found. Specifically, the most common adverse reactions were fatigue, hypertension, hand-foot syndrome, diarrhea and dermal toxicity.
Anlotinib plus PD-1 inhibitors demonstrated durable and promising efficacy and tolerable safety for patients with metastatic STS in real world. Further prospective clinical trials were warranted to validate the feasibility of anlotinib plus PD-1 blockades clinically.
本研究旨在探讨安罗替尼联合PD-1抑制剂治疗既往接受过治疗的转移性软组织肉瘤（STS）患者的有效性和耐受性。
回顾性分析临床实践中接受安罗替尼联合PD-1抑制剂治疗的既往接受过治疗的转移性STS患者。所有晚期STS的常见亚型均适合分析。根据目标病灶的影像学变化评估该方案的疗效，并对所有患者进行定期随访。具体记录并记录联合给药期间的安全性。据此分析不同STS亚型的临床意义。
2018年9月至2022年1月，本研究共筛选出32例既往接受过治疗的转移性STS患者，这些患者接受了安罗替尼联合PD-1阻断治疗。联合给药期间的最佳总体反应表明，11例患者观察到部分缓解，16例患者疾病稳定，6例患者疾病进展，客观缓解率（ORR）为34.4%（95%CI：18.6-53.2%），疾病控制率（DCR）为84.4%（95%CI：67.2-94.7%）。此外，32例转移性STS患者的中位无进展生存期为7.6个月（95%CI：3.31-11.89），中位总生存期为14.9个月（95%CI：8.36-21.44）。此外，29例患者（90.6%）在安罗替尼联合PD-1抑制剂给药期间观察到与治疗相关的不良反应，其中共有13例患者（40.6%）被判定为3-4级不良反应，未发现5级不良反应。具体而言，最常见的不良反应为疲劳、高血压、手足综合征、腹泻和皮肤毒性。
在现实世界中，安罗替尼联合PD-1抑制剂对转移性STS患者显示出持久且有前景的疗效和可耐受的安全性。有必要进行进一步的前瞻性临床试验以在临床上验证安罗替尼联合PD-1阻断治疗的可行性。
