Real-world outcomes of various regimens of recombinant human endostatin combined with chemotherapy in non-driver gene mutation advanced non-small cell lung cancer.

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/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.

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/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.