| Summary: | Abstract Aims 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. Patients and Methods 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/m2 from day 1 to day 14 (rh‐endostatin 14d group), and the other 27 patients were administered at 15 mg/m2 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. Results 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. Conclusion 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/m2 was non‐inferior to 14 days at 7.5 mg/m2 in prolonging patients’ PFS. Further evaluation should be conducted before its application in clinical work.
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