地诺单抗的效果好吗？

It is mainly used to treat cancer bone metastasis. On May 28, 2010, the European Commission approved this product to be used to treat postmenopausal women with osteoporosis and hormone suppression-related bone loss in prostate cancer patients. It is also used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. Later, the FDA approved this product for use in postmenopausal women with osteoporosis who are at high risk of fractures. It can help reduce the incidence of vertebral, non-vertebral and hip fractures in postmenopausal women with osteoporosis. Is denosumab treatment effective?

In 2015, The Lancet published the preliminary results of the randomized double-blind placebo-controlled phase III study (ABCSG-18) of the Austrian Breast and Colorectal Cancer Research Group (ABCSG), which showed that using denosumab as an adjuvant drug for AI therapy can significantly reduce clinical SREs. On February 19, 2019, Lancet oncology published the ABCSG-18 disease-free survival results online.

In this multicenter, prospective, double-blind, placebo-controlled phase 3 trial, conducted at 58 sites in Austria and Sweden, from December 18, 2006, to July 22, 2013, a total of 3425 patients with early-stage HR-positive postmenopausal, non-metastatic breast cancer who had completed their initial adjuvant treatment pathway (surgery, radiotherapy, chemotherapy, or combination therapy) and were receiving adjuvant AI therapy were enrolled. Patients were allocated on a 1:1 basis, with 1711 patients assigned to the denosumab group and 1709 patients assigned to the placebo group (an additional 5 patients withdrew their consent), receiving subcutaneous injections of denosumab (60 mg) or matching placebo every 6 months during aromatase inhibitor treatment.

The study concluded that aromatase inhibitor therapy is a safe and effective adjuvant treatment for postmenopausal patients with hormone receptor-positive early breast cancer.