Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
Graduate Schools, University of South China, Hengyang, Hunan, China.
Cancer Med. 2019 Apr;8(4):1434-1441. doi: 10.1002/cam4.2014. Epub 2019 Feb 14.
This real-world study is conducted to evaluate the efficacy and safety of recombinant human endostatin (rh-endostatin) combined with chemotherapy as first-line treatment for non-driver genes mutation non-small cell lung cancer (NSCLC) patients, and establish evidence-based optimal regimen for rh-endostatin.
Using propensity score matching (cut-off: 0.01), 88 patients were eligible for our study, 34 of which received platinum-based chemotherapy alone (chemotherapy group), 54 patients received platinum-based chemotherapy plus rh-endostatin (rh-endostatin group). Among those 54 patients in the rh-endostatin group, 27 patients received rh-endostatin administered at 7.5 mg/m from day 1 to day 14 (rh-endostatin 14d group), and the other 27 patients were administered at 15 mg/m from day 1 to day 7 (rh-endostatin 7d group). The primary endpoint was progression-free survival (PFS) and secondary endpoints were overall survival (OS), overall response rate (ORR), disease control rate (DCR), and safety.
There were no differences in clinic characteristics among 3 groups. Compared with chemotherapy group, rh-endostatin group improved PFS and OS significantly. The median PFS was 6 months vs 4.5 months (P = 0.047), and median OS was 20 months vs 10 months (P < 0.001). The ORR was 33.3% vs 20.6% (P = 0.197) and DCR was 83.3% vs 64.7% (P = 0.046) in the rh-endostatin group and chemotherapy group, respectively. The comparisons between the rh-endostatin 7d and 14d groups revealed a significant improvement in PFS for the rh-endostatin 7d group (P = 0.044), but no significant differences in OS (P = 0.111), ORR (P = 0.074), or DCR (P = 0.234). The incidences of grade 3 and 4 adverse events were similar among 3 groups.
Chemotherapy combined with rh-endostatin was more effective than chemotherapy alone for non-driver gene mutation NSCLC patients. The administration of rh-endostatin for 7 days at 15 mg/m was non-inferior to 14 days at 7.5 mg/m in prolonging patients' PFS. Further evaluation should be conducted before its application in clinical work.
本研究旨在评估重组人血管内皮抑制素（rh-endostatin）联合化疗作为非驱动基因突变非小细胞肺癌（NSCLC）患者一线治疗的疗效和安全性，并为 rh-endostatin 建立基于证据的最佳治疗方案。
采用倾向性评分匹配（截止值：0.01），纳入 88 例符合条件的患者，其中 34 例接受铂类化疗（化疗组），54 例接受铂类化疗联合 rh-endostatin（rh-endostatin 组）。在 rh-endostatin 组的 54 例患者中，27 例患者接受 rh-endostatin 7.5mg/m2 治疗（rh-endostatin 14d 组），27 例患者接受 rh-endostatin 15mg/m2 治疗（rh-endostatin 7d 组）。主要终点为无进展生存期（PFS），次要终点为总生存期（OS）、总缓解率（ORR）、疾病控制率（DCR）和安全性。
3 组患者的临床特征无差异。与化疗组相比，rh-endostatin 组 PFS 和 OS 显著改善。rh-endostatin 组中位 PFS 为 6 个月，化疗组为 4.5 个月（P=0.047），中位 OS 分别为 20 个月和 10 个月（P<0.001）。rh-endostatin 组和化疗组的 ORR 分别为 33.3%和 20.6%（P=0.197），DCR 分别为 83.3%和 64.7%（P=0.046）。rh-endostatin 7d 组和 rh-endostatin 14d 组比较，rh-endostatin 7d 组 PFS 显著改善（P=0.044），但 OS（P=0.111）、ORR（P=0.074）和 DCR（P=0.234）差异无统计学意义。3 组不良反应发生率相似。
与化疗相比，化疗联合 rh-endostatin 治疗非驱动基因突变 NSCLC 患者更有效。rh-endostatin 以 15mg/m2 治疗 7 天与以 7.5mg/m2 治疗 14 天在延长患者 PFS 方面非劣效。在临床应用前，还需进一步评估。
