Experimental Breast Cancer Drug Seems Safe, Effective for Advanced Disease
Preliminary results look promising, experts say.
In an early trial, an experimental breast cancer drug stopped disease growth and shrank tumors by more than 30 percent in some patients.
The pill, bemaciclib, was safe and well-tolerated by women with breast cancer that had spread, or metastasized, to other parts of the body, according to the results of this phase 1 trial.
This is a novel oral treatment for patients with metastatic breast cancer.
If these results are replicated in future trials, it's conceivable that the pill might extend survival for women with terminal breast cancer, experts suggested.
The drug was particularly effective for the most common type of breast cancer, called hormone receptor-positive breast cancer. In this type of cancer, cancer cells grow in response to signals from the hormones estrogen and/or progesterone.
The study included more than 130 women. Overall, half of them had cancer growth controlled and 25 percent had shrinkage of their tumors.
Unlike standard cancer drugs, this is a twice-daily pill that allows women to go on with their daily lives. In contrast, other cancer drugs are given intravenously at a hospital or doctor's office. Another difference is that bemaciclib is a targeted therapy, a newer type of drug that is better able to identify and attack specific cells.
The results show that it can be given safely over a long period of time, and patients are able to go on with their routine activities and have a good quality of life.
Side effects of the drug include diarrhea, nausea and vomiting. For study participants, most of these problems were mild or moderate, expert said.
Metastatic breast cancer is generally incurable. Goals of therapy include maintaining quality of life while administering effective therapy.
Expert hopes bemaciclib and other new drugs will make a difference in the treatment of advanced breast cancer.
For the study, the researchers tested the drug on 132 women with breast cancer. Forty-seven of them with metastatic cancer had tried as many as seven other drugs before bemaciclib.
The women took bemaciclib pills twice daily for 28 days.
Thirty-six of the 47 patients with metastatic breast cancer had hormone receptor-positive disease, the researchers noted. Nine of the 47 patients had a partial response, and 24 of the 47 patients saw the growth of their cancer stopped.
Among the metastatic breast cancer group, 11 patients had their cancer progress despite treatment, the researchers said.
Among women with hormone receptor-positive breast cancer, 81 percent had a complete response, partial response or stable disease, and their cancer didn't progress for an average of nine months, the study found. For study participants overall, progression-free survival was nearly 6 months.
The trial lasted 28 days, but women who benefited from the drug could continue on it in 28 day cycles as long as they continued to benefit. Eighteen of the hormone receptor-positive breast cancer patients are still being treated with bemaciclib.
For hormone receptor-positive breast cancer, doctors often use anti-estrogen therapies. However, tumor cells stop responding to these drugs, so alternatives are often needed.
Bemaciclib's trial results are very exciting and confirm that developing this class of drugs is very promising for patients with advanced breast cancer.
Source: HealthDay News
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