Herceptin能提高晚期乳腺癌存活率
http://www.100md.com
2001年3月15日
NEW YORK (Reuters Health) - The breast cancer drug Herceptin (trastuzumab) improves the survival odds of women with advanced breast cancer that has spread beyond the breast, researchers report.
But the drug increases the risk of serious heart problems, particularly when it is prescribed in combination with certain chemotherapeutic drugs, the investigators found.
Herceptin is a monoclonal antibody, meaning that it binds to one specific protein, HER2, which helps regulate cell growth. Overexpression of HER2, a sign of more aggressive cancer, occurs in about 25% to 30% of breast tumors.
, 百拇医药
In 1998, the US Food and Drug Administration (news - web sites) approved the drug as a treatment for certain women with metastatic breast cancer, or cancer that has spread beyond the breast and underarm lymph nodes.
In the new study, Dr. Dennis J. Slamon, of the University of California at Los Angeles, and colleagues evaluated the safety and effectiveness of the drug when used in combination with chemotherapy to treat metastatic breast cancer in women with HER2-positive tumors. None of the women had received chemotherapy to treat the advanced cancer, although some had undergone chemotherapy when cancer was still confined to the breast.
, 百拇医药
The researchers randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive chemotherapy along with Herceptin. The type of chemotherapy varied depending on each woman's previous treatment.
Women treated with Herceptin tended to fare better than those who received only chemotherapy, Slamon and his colleagues report in the March 15th issue of The New England Journal of Medicine (news - web sites). The 1-year death rate was significantly lower in women taking Herceptin than in those in the chemotherapy-only group, 22% versus 33%. Survival time was also greater in the Herceptin group, with women living an average of about 25 months compared with about 20 months in the standard chemotherapy group.
, 百拇医药
``We found that trastuzumab-based combination therapy was effective in that it reduced the relative risk of death by 20% at a median follow-up of 30 months,'' Slamon and his colleagues write. The addition of a single drug has rarely shown such benefits for the treatment of metastatic breast cancer, they note.
``It's exciting to have a new treatment for women with advanced (breast) cancer,'' Dr. Jeffrey Abrams, of the National Cancer Institute (news - web sites) (NCI) in Bethesda, Maryland, told Reuters Health in an interview. He estimated that about 20% of women with advanced breast cancer have HER2-positive tumors.
, 百拇医药
Despite the apparent benefits of Herceptin, however, the drug did cause several side effects. Most serious were the effects of the drug on the heart. When one patient had a stroke, and another experienced chest pain, Salmon's team took a closer look at all cases of heart problems that occurred during the study.
The rate of heart dysfunction, which included heart failure, ranged from 8% to 27% depending on the type of chemotherapy used. The highest rate of cardiac problems occurred in patients taking Herceptin and the anthracycline-cyclophosphamide chemotherapy combination.
, http://www.100md.com
Since the prognosis for women with HER2-positive metastatic breast cancer is ``extremely poor'' without treatment, the cardiac risks of Herceptin have to be weighed against the drug's potential benefits, according to the researchers. However, Salmon's team urges a ``cautious approach'' in prescribing Herceptin to women who are currently or have previously been treated with anthracyclines.
The NCI's Abrams agreed on the need for caution in prescribing Herceptin, but he went a step further, stating that the drug should not be prescribed with anthracycline, since the combination causes ``unacceptable'' side effects.
, http://www.100md.com
The next step in studying Herceptin, according to Abrams, is to see whether the drug works as an adjuvant therapy, which is given in addition to primary therapy to destroy any lingering cancer cells. Two NCI-supported trials are testing the drug in combination with chemotherapy in women whose cancer has not spread past the underarm lymph nodes.
The study was funded by Genentech, and several of the researchers are past or current employees of the California-based company or have had a financial or advisory relationship to it.
SOURCE: The New England Journal of Medicine 2001;344:783-792., 百拇医药
But the drug increases the risk of serious heart problems, particularly when it is prescribed in combination with certain chemotherapeutic drugs, the investigators found.
Herceptin is a monoclonal antibody, meaning that it binds to one specific protein, HER2, which helps regulate cell growth. Overexpression of HER2, a sign of more aggressive cancer, occurs in about 25% to 30% of breast tumors.
, 百拇医药
In 1998, the US Food and Drug Administration (news - web sites) approved the drug as a treatment for certain women with metastatic breast cancer, or cancer that has spread beyond the breast and underarm lymph nodes.
In the new study, Dr. Dennis J. Slamon, of the University of California at Los Angeles, and colleagues evaluated the safety and effectiveness of the drug when used in combination with chemotherapy to treat metastatic breast cancer in women with HER2-positive tumors. None of the women had received chemotherapy to treat the advanced cancer, although some had undergone chemotherapy when cancer was still confined to the breast.
, 百拇医药
The researchers randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive chemotherapy along with Herceptin. The type of chemotherapy varied depending on each woman's previous treatment.
Women treated with Herceptin tended to fare better than those who received only chemotherapy, Slamon and his colleagues report in the March 15th issue of The New England Journal of Medicine (news - web sites). The 1-year death rate was significantly lower in women taking Herceptin than in those in the chemotherapy-only group, 22% versus 33%. Survival time was also greater in the Herceptin group, with women living an average of about 25 months compared with about 20 months in the standard chemotherapy group.
, 百拇医药
``We found that trastuzumab-based combination therapy was effective in that it reduced the relative risk of death by 20% at a median follow-up of 30 months,'' Slamon and his colleagues write. The addition of a single drug has rarely shown such benefits for the treatment of metastatic breast cancer, they note.
``It's exciting to have a new treatment for women with advanced (breast) cancer,'' Dr. Jeffrey Abrams, of the National Cancer Institute (news - web sites) (NCI) in Bethesda, Maryland, told Reuters Health in an interview. He estimated that about 20% of women with advanced breast cancer have HER2-positive tumors.
, 百拇医药
Despite the apparent benefits of Herceptin, however, the drug did cause several side effects. Most serious were the effects of the drug on the heart. When one patient had a stroke, and another experienced chest pain, Salmon's team took a closer look at all cases of heart problems that occurred during the study.
The rate of heart dysfunction, which included heart failure, ranged from 8% to 27% depending on the type of chemotherapy used. The highest rate of cardiac problems occurred in patients taking Herceptin and the anthracycline-cyclophosphamide chemotherapy combination.
, http://www.100md.com
Since the prognosis for women with HER2-positive metastatic breast cancer is ``extremely poor'' without treatment, the cardiac risks of Herceptin have to be weighed against the drug's potential benefits, according to the researchers. However, Salmon's team urges a ``cautious approach'' in prescribing Herceptin to women who are currently or have previously been treated with anthracyclines.
The NCI's Abrams agreed on the need for caution in prescribing Herceptin, but he went a step further, stating that the drug should not be prescribed with anthracycline, since the combination causes ``unacceptable'' side effects.
, http://www.100md.com
The next step in studying Herceptin, according to Abrams, is to see whether the drug works as an adjuvant therapy, which is given in addition to primary therapy to destroy any lingering cancer cells. Two NCI-supported trials are testing the drug in combination with chemotherapy in women whose cancer has not spread past the underarm lymph nodes.
The study was funded by Genentech, and several of the researchers are past or current employees of the California-based company or have had a financial or advisory relationship to it.
SOURCE: The New England Journal of Medicine 2001;344:783-792., 百拇医药