ABSTRACT: Angiogenesis plays fundamentally critical roles in solid-tumor pathogenesis, growth, invasion and metastasis. Endostatin, one of the most potent anti-angiogenic factors, was first isolated in Folkman's lab in 1997, and was reported to dramatically shrink tumor blood formation. But its insoluble and unstable nature coupled with the high cost of synthesizing the endostatin protein doomed it for clinical cancer treatment. Intrigued by Folkman's pioneering discoveries, Chinese scientists found a way to refold the protein, making it cost-effective to manufacture a recombinant human endostatin, a soluble and stable form of endostatin. A number of clinical studies have demonstrated the significant survival benefit of rh-endostatin in treating late stage non-small-cell lung carcinoma (NSCLC) and, as a result, rh-endostatin (Endostar®) was approved by the State Food and Drug Administration of China (CFDA) in September of 2005 as a treatment option for NSCLC. Since then, increasing bodies of clinical data and experience have been obtained from a variety of other different cancers, such as small cell lung cancer, NSCLC in other settings, including malignant serous effusion, melanoma, colon cancer, gastric cancer, breast cancer, nasopharyngeal cancers, and others. This review aims at summarizing current clinical data of rh-endostatin including its survival benefits, optimized dosages, routes of administration, recommended duration and frequency of treatment, predictive biomarkers, and its safety profile in lung cancers as well as other cancers.
