School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, 211198, China.
Nanjing Medical University, Nanjing, 211166, China.
J Cancer Res Clin Oncol. 2023 Jul;149(7):3895-3903. doi: 10.1007/s00432-022-04297-3. Epub 2022 Aug 26.
The aim of this retrospective study is to evaluate the impact on efficacy and safety between epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) alone and in combination with Shenqi Fuzheng injection (SFI) in patients with advanced NSCLC harboring epidermal growth factor receptor (EGFR) activating mutations.
Retrospectively, information of 88 patients receiving EGFR-TKIs as first-line targeted treatment or in combination with SFI in the Affiliated Drum Tower Hospital of Nanjing University Medical College and the Affiliated Cancer Hospital of Anhui University of Science and Technology was collected. The primary endpoint was to assess progression-free survival (PFS) and safety of EGFR-TKIs alone or in combination with SFI.
Between January 2016 and December 2019, a total of 88 patients were enrolled in this research, including 50 cases in the EGFR-TKIs single agent therapy group and 38 cases in the SFI combined with EGFR-TKIs targeted-therapy group. The median PFS (mPFS) of monotherapy group was 10.50 months (95%CI 9.81-11.19), and 14.30 months (95%CI 10.22-18.38) in the combination therapy group. Compared to the single EGFR-TKIs administration, combinational regimen with SFI exhibited a lower incidence of rash and diarrhea in patients and was even better tolerated.
SFI combined with the first-generation EGFR-TKIs are more efficient, can prominently prolong the PFS and attenuate the adverse reactions in patients with advanced NSCLC with EGFR-sensitive mutations.
本回顾性研究旨在评估表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）单药治疗与联合参芪扶正注射液（SFI）治疗表皮生长因子受体（EGFR）激活突变的晚期非小细胞肺癌（NSCLC）患者的疗效和安全性。
回顾性收集南京鼓楼医院和安徽医科大学附属肿瘤医院 88 例接受 EGFR-TKIs 一线靶向治疗或联合 SFI 治疗的患者资料。主要终点是评估 EGFR-TKIs 单药或联合 SFI 的无进展生存期（PFS）和安全性。
2016 年 1 月至 2019 年 12 月，共纳入 88 例患者，其中 EGFR-TKIs 单药治疗组 50 例，SFI 联合 EGFR-TKIs 靶向治疗组 38 例。单药组中位 PFS（mPFS）为 10.50 个月（95%CI 9.81-11.19），联合组为 14.30 个月（95%CI 10.22-18.38）。与单药 EGFR-TKIs 相比，联合 SFI 治疗组皮疹和腹泻的发生率较低，患者耐受性更好。
SFI 联合第一代 EGFR-TKIs 治疗 EGFR 敏感突变的晚期 NSCLC 患者更有效，可显著延长 PFS，减轻不良反应。
