In a nutshell
This phase II clinical trial examined the safety and efficacy of adding a drug called rh-endostatin (Endostar) to chemotherapy in breast cancer patients.
Cancer cells need blood supply in order to grow. As cancer grows, it forms its own blood vessels, a process called angiogenesis. Therefore, anti-angiogenesis therapies, which stop the formation of new blood vessels, are getting increased attention as a new cancer treatments. Recombinant human (rh)-endostatin is an anti-angiogenesis drug that has also been shown to inhibit the growth of some cancer cells. Previous studies have found that adding rh-endostatin to chemotherapy treatments increased the response rates (assessed by tumor shrinkage) and disease progression rates (the time between treatment and disease worsening) in lung cancer, without additional side effects. The aim of this trial was to evaluate whether adding rh-endostatin to chemotherapy is safe and has any benefits as treatment for breast cancer patients.
Methods & findings
This study included 64 patients with stage II and III breast cancer (cancer that has spread to the lymph nodes). Before surgery to remove the cancer, patients were assigned to receive every 3 weeks, either chemotherapy alone (docetaxel and epirubicin or DE), or chemotherapy plus rh-endostatin (DErh). The main parameters evaluated, after 3 cycles of treatment, were response rate (defined as tumor shrinkage after treatment), or whether the disease remained stable (no change in tumor size) or progressed (an increase in tumor size or spreading of the cancer), as well as side effects and patients’ quality of life.
Results showed that response rate was significantly higher in the DErh group (90.9%) compared to the DE group (67.7%). The researchers also found a higher response rate in women before menopause (100% versus 46.3%) and in women who were still fully mobile and active (94.4% versus 66.7%). Side effects occurred in 81.2% of patients treated with DErh and in 79.3% of patients treated with DE alone. However, most side effects were mild or moderate and did not have significant effects on patients’ quality of life in both groups.
The bottom line
In conclusion, rh-endostatin added to DE chemotherapy is a safe and effective treatment before surgery for breast cancer patients.
The fine print
However, this was only a phase II clinical trial that included only a small number of patients. Further clinical trials on larger groups of participants are expected to fully evaluate the risks and benefits of adding rh-endostatin to chemotherapy as treatment for breast cancer.
Published By :
May 21, 2013
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