A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Paclitaxel-Carboplatin Alone or with Endostar for Advanced Non-small Cell Lung Cancer

Abstract

In previously untreated, advanced NSCLC patients, treatment with TC plus endostar seemed to improve ORR. However, the differences in PFS or OS between the two groups were not statistically significant. Treatment with TC plus endostar exhibited a good safety profile.

Efficacy and safety of rh‐endostatin (Endostar) combined with pemetrexed/cisplatin followed by rh‐endostatin plus pemetrexed maintenance in non‐small cell lung cancer: A retrospective comparison with standard chemotherapy

“…Regarding safety, the adverse event profile of rh‐endostatin in this study was consistent with previous studies, without unexpected safety concerns 15, 16, 17, 18, 19, 20. Adding rh‐endostatin to pemetrexed/cisplatin did not increase the incidence of drug‐related or grade 3/4 adverse events, suggesting that toxicity is related to chemotherapy.…”

“…It was approved in 2006 as a component combined with vinorelbine/cisplatin for the treatment of NSCLC. Previous studies have evaluated the efficacy and safety of the combination of rh‐endostatin and platinum‐based doublet chemotherapy; however, limited data is available on the combination of rh‐endostatin and pemetrexed‐based first‐line and maintenance therapy 17, 18, 19, 20…”

“…The addition of rh‐endostatin was associated with prolonged time‐to‐progression when compared to chemotherapy alone (5.7–6.6 vs. 3.2–3.7 months) for the treatment of NSCLC patients, regardless of histological subtypes or the presence of previous treatment 17, 18, 19. On the contrary, no PFS benefit was shown in a multicenter phase 2 study in which 126 previously untreated advanced‐stage NSCLC patients were enrolled and randomized to receive rh‐endostatin plus paclitaxel/carboplatin or paclitaxel/carboplatin 20. Despite a numerical prolongation of survival, there was no statistically significant difference in PFS (7.1 vs. 6.3 months, respectively; P = 0.522) or OS (17.6 vs. 15.8 months, respectively; P = 0.696) between the groups.…”

Endostatin Has ATPase Activity, Which Mediates Its Antiangiogenic and Antitumor Activities

“…Endostatin, as an endogenous antiangiogenic inhibitor (1), exhibits potent antitumor activities in various mouse models (2) and receives CFDA (China Food and Drug Administration) approval as a new drug for the treatment of non-small cell lung cancer (NSCLC) patients in clinic (3). This drug is widely used in China and shows profound clinical efficacy (4)(5)(6). Accumulating evidence demonstrates that the N-terminal integrity and correct folding are essential to guarantee the structural stability and biological functions of endostatin (7,8).…”

Salvage Therapy of Gemcitabine Plus Endostar Significantly Improves Progression-free Survival (PFS) with Platinum-resistant Recurrent Epithelial Ovarian Cancer

“…Endostar combining with chemoradiotherapy could improve the early outcome of the advanced cervical cancer, and adverse effects were not encountered (Ke et al, 2012). TC plus endostar seemed to improve ORR (39.3% vs. 23.0%) with a good safety profile in previous untreated advanced NSCLC, compared with TC alone (Han et al, 2011). Endostar suppressed proliferation and triggered cell death in HepG2 cells by autophagy induction in a dose-dependent manner, and the findings provided mechanistic insight into endostar action (Wu et al, 2008).…”