Abstract

ABSTRACT Purpose Recombinant human endostatin is a novel inhibitor of tumor angiogenesis. Previous studies have indicated that Recombinant human endostatin (endostar) plus vinorelbine-cisplatin chemotherapy could improve objective response rates (ORR) and time to progression (TTP) of advanced non-small cell lung cancer (NSCLC) patients with decreased toxicity. The purpose of this study was to retrospectively compare the efficacy and safety of NP chemotherapy plus endostar with NP alone as first-line therapy in stage IIIB/IV non-small cell lung cancer. Methods We reviewed the records of 65 previously untreated Chinese patients with stage IIIB/IV NSCLC who were treated with NP chemotherapy plus endostar or NP alone between January 2005 and December 2010 at The First Hospital of China Medical University. Vinorelbine (25mg/m2) was administered on days 1 and 8, cisplatin(75mg/m2) was administered on day 1, and endostar (7.5mg/m2) was administered on days 1-14. Treatments were repeated every 3 weeks for a maximum of 6 cycles. The best tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). The adverse events were defined by NCI-CTC 3.0 criteria. Univariate and multivariate analyses were performed using the SPSS 20.0 software. Results The median age of patients was 58 years (range, 34–77 years). Our main results are as follows: Addition of endostar to standard NP chemotherapy significantly reduced the risks of disease progression and death. The median progression-free survival of the NP plus endostar group and NP group were 7.4 months and 5.5 months (P= 0.042). The median overall survival of the NP plus endostar group and NP group were 17.6 months and 12.6 months (P = 0.046). There was no statistical difference in objective response rates and disease control rates between the two groups. The incidence of grade 3/4 hematologic adverse events was higher in NP plus endostar group (48.5% vs 21.9%, P = 0.025) but tolerable. Conclusion This study demonstrated that the addition of endostar to the NP regimen is an effective treatment option with an acceptable increase in hematologic toxicity in previously untreated patients with stage IIIB/IV non-small cell lung cancer. Disclosure All authors have declared no conflicts of interest.

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