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Herceptin targets cancer cells that "overexpress," or make too much of, a protein called HER-2 or erb B2, which is found on the surface of cancer cells. Herceptin slows or stops the growth of these cells. Herceptin is used only to treat cancers that overexpress the HER-2 protein.
Approximately 25 to 30 percent of breast cancers overexpress HER-2. These tumors tend to grow faster and are generally more likely to recur (come back) than tumors that do not overproduce HER-2.
The amount of HER-2 protein in the tumor is measured in the laboratory using a scale from 0 (negative) to 3+ (strongly positive). The result helps the doctor determine whether a patient might benefit from treatment with Herceptin. Patients whose tumors are strongly positive for HER-2 protein overexpression (a score of 3+ on the laboratory test) are more likely to benefit. There is no evidence of benefit in patients whose tumors do not overexpress HER-2 (a score of 0 or 1+ on the laboratory test).
Herceptin is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of metastatic breast cancer (breast cancer
that has spread to other parts of the body). Herceptin can be
given by itself or along with chemotherapy.
Researchers continue to study Herceptin in clinical trials
(research studies with people) (see questions 6 and 7). These
studies can show whether new treatments are more or less effective
than standard ones and how the side effects compare.
3. What are some of the common side effects of Herceptin?
Side effects that most commonly occur during the first treatment
with Herceptin include fever and/or chills. Other possible side
effects include pain, weakness, nausea, vomiting, diarrhea,
headaches, difficulty breathing, and rashes. These side effects
generally become less severe after the first treatment with
Herceptin.
Patients who receive Herceptin along with chemotherapy may
experience side effects that are different from those of patients
who take Herceptin by itself. Patients should discuss any concerns
about the side effects of treatment with their doctor. The doctor
may be able to make suggestions for managing side effects.
4. Can Herceptin cause any serious side effects?
Herceptin may also cause allergic reactions that can be severe or life-threatening. These reactions can involve a drop in blood pressure, shortness of breath, rashes, and wheezing. These reactions may be more common in patients who already have breathing difficulties or lung disease. Because of these potentially life-threatening side effects, patients are evaluated carefully for any heart or lung problems before starting treatment and are monitored closely during treatment. Patients who develop any problems during or after treatment should call the doctor immediately or go to the nearest emergency care facility.
The safety and effectiveness of Herceptin were studied in two
clinical trials with women whose metastatic breast cancers
produced excess amounts of HER2. In one clinical trial, women
received either Herceptin and chemotherapy or chemotherapy alone.
The women who received Herceptin and chemotherapy had slower tumor
growth, greater reduction in tumor size, and longer survival than
the women who received chemotherapy alone. In another trial, women
received Herceptin by itself. In 14 percent of these women, the
tumor got smaller or disappeared. Scientists continue to study the
safety and effectiveness of Herceptin in clinical trials (see
questions 6 and 7).
6. Is Herceptin being studied to treat nonmetastatic breast cancer?
Yes. The National Cancer Institute (NCI) is sponsoring two large, multicenter phase III clinical trials of Herceptin as adjuvant therapy to treat node-positive breast cancer; this is breast cancer that has spread to the lymph nodes under the arm (regional lymph nodes), but not to other parts of the body. These trials will take place in hospitals and cancer centers around the country. Adjuvant therapy is treatment given in addition to the primary therapy to kill any cancer cells that may have spread, even if the spread cannot be detected by radiologic or laboratory tests.
Patients who are interested in receiving Herceptin as adjuvant
therapy for breast cancer should consider participating in a
clinical trial. For more information about these and other
clinical trials, patients and doctors may call the Cancer
Information Service (CIS) (see below) or visit the NCIs Web site
at Http: //cancer.gov on the Internet.
7. Is Herceptin under study for cancers other than breast cancer?
Yes. Herceptin is also being studied in clinical trials for other
types of cancer, including osteosarcoma (a type of bone
cancer) and cancers of the lung, pancreas, salivary gland,
colon, prostate, endometrium (lining of the
uterus), and bladder. Some patients with these types of
cancer have tumors that overexpress the HER2 protein. These
patients will be possible candidates for clinical trials with
Herceptin.
Researchers are exploring the use of Herceptin by itself and in
combination with anticancer drugs. They are also investigating the
use of Herceptin with other types of cancer treatment.
This fact sheet was reviewed on 2/14/02
You may want more information for yourself, your family, and your doctor. The following National Cancer Institute (NCI) services are available to help you.
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Provides accurate, up-to-date information on cancer to patients and their families, health professionals, and the general public. Information specialists translate the latest scientific information into understandable language and respond in English, Spanish, or on TTY equipment.
Http: //cancer.gov - Cancer.gov is the NCI s primary web site and provides immediate access to critical cancer information and resources. It contains material for health professionals, patients, and the public, including information from PDQ about cancer treatment, screening, prevention, genetics, supportive care, and clinical trials, and CANCERLIT, a bibliographic database. Cancer.gov also includes information on understanding trials, deciding whether to participate in trials, finding specific trials, plus research news and other resources.
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