Efficacy and safety of recombinant human endostatin combined with gemcitabine and carboplatin as first-line treatment of advanced NSCLC with liver metastases / 肿瘤

ABSTRACT

Objective: To compare the efficacy and safety of GC (gemcitabine plus carboplatin) regimen combined with recombinant human endostatin (rh-endostatin) and GC regimen alone in the first-line treatment of advanced non-small cell lung cancer (NSCLC) with liver metastases. Methods: The clinical and pathological data of patients with advanced NSCLC and liver metastases, who were diagnosed from October 2013 to July 2017 in Hunan Cancer Hospital and treated with rh-endostatin combined with GC regimen or GC regimen alone as the firstline treatment, were retrospectively analyzed. A total of 94 patients were enrolled, including 46 cases in combination group and 48 cases in chemotherapy group. All patients received at least 2 cycles of treatment (21 days per cycle). Objective response rate (ORR), progressionfree survival (PFS), overall survival (OS), and adverse events were observed and compared between the two groups. Results: After 2 cycles of treatment, the ORR in the combination group and the chemotherapy group were 27.1% and 10.9%, respectively; while the ORR in the combination group was significantly higher than that in the chemotherapy group (P = 0.046). Subgroup analysis showed that the patients in adenocarcinoma subgroup could benefit more from the combination treatment (combination group vs chemotherapy group 35.0% vs 11.1%, P = 0.048). The median PFS time was 4.5 months and 3.4 months in the combination group and the chemotherapy group, respectively; while the median OS time was 7 months and 6 months in the two groups, respectively; so the PFS and OS in the combination group were significantly prolonged (both P < 0.001). In the patients receiving 4 or more cycles of treatment, the survival benefit of combination therapy was more significant as compared with the chemotherapy group (PFS 7 months vs 4 months, P < 0.001; OS 10 months vs 6 months, P < 0.001). The main adverse reactions in the two groups were nausea, vomiting and myelosuppression, in which myelosuppression was mainly caused by leukopenia and neutropenia. Conclusion: Compared with the chemotherapy alone, rh-endostatin combined with GC regiment as the first-line treatment can significantly improve the median PFS, median OS and ORR in the patients with advanced NSCLC and liver metastases, and has good safety and clinical application prospects.