Herceptin medication for cancer treatment, breast and stomach cancer therapy and prevention, side effects
November 22 2015 by
Ray Sahelian, M.D.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). In the United States there are an estimated 213, 000 new cases of breast cancer and about 41,000 related deaths each year. Approximately 25 percent of women with breast cancer will have tumors that produce excessive amounts of HER2 protein.

2014
Herceptin is the best drug treatment for a type of breast cancer called HER2-positive and should remain the standard of care for that type of tumor, according to new findings from a long-term clinical trial. Mayo Clinic, news release, Sept. 29, 2014.

2010
Britain's health cost watchdog has recommended the National Health Service should pay for Roche's cancer drug in some cases for patients where stomach cancer has spread. Herceptin only works in cancer patients whose tumors have high levels of a protein called human epidermal growth factor receptor 2, or HER2, and is not suitable for others.

2009 - Herceptin reduces the risk of death for certain stomach cancer patients by 26 percent compared with chemotherapy alone. Dr. Richard Schilsky, president of the American Society of Clinical Oncology, says high amounts of the HER-2 receptor are found in up to a quarter of patients with stomach cancer. "This is the first phase III study to report improved overall survival with a personalized, targeted treatment for gastric cancer," said Dr. Eric Van Cutsem, professor at the University Hospital Gasthuisberg in Leuven, Belgium, and lead author of the study. Median overall survival was 13 months in the Herceptin plus chemotherapy group compared with 11 months in the standard chemotherapy group. The treatment was generally well tolerated and there were no unexpected side effects. The rate of symptomatic congestive heart failure was similar between the two groups.

2007 - Herceptin is a prescription medication approved in Europe for the treatment of advanced breast cancer in combination with hormonal therapy. Herceptin was approved for the treatment of postmenopausal patients with HER2 and hormone receptor positive metastatic breast cancer. Genentech is a unit of Roche Holding AG.

2007 - Adding Herceptin to chemotherapy before surgery eradicates tumors more effectively in women with inflammatory breast cancer than chemotherapy alone.

FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
2006 - The U. S. Food and Drug Administration (FDA) expanded the approved use of this biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin. Now its approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery. Herceptin should only be prescribed for women diagnosed with HER2 positive breast cancer. The two studies leading to this new approved indication were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trials group. Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005. Due to positive results, the National Cancer Institute, a part of the National Institutes of Health, ended the studies early. The results showed that women who received Herceptin combined with chemotherapy had fewer relapses (return of breast cancer) for up to three years after surgery. The estimated three-year disease-free rates were 87 percent in women receiving Herceptin and chemotherapy and 75 percent in those receiving chemotherapy alone. It is too soon to know whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.

Herceptin side effects, danger
The most serious side effect of Herceptin is heart failure (weakening of the heart muscle) that requires medical treatment. Due to the risk of Herceptin side effect of heart disease, only certain patients should receive the drug, including:

JAMA Oncol. 2015. Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer. Trastuzumab is a life-saving therapy but is associated with symptomatic and asymptomatic left ventricular ejection fraction (LVEF) decline. We report the cardiac toxic effects of a nonanthracycline and trastuzumab-based treatment for patients with early-stage human epidermal growth factor receptor 2 (ERBB2, formerly HER2 or HER2/neu)-positive breast cancer. Cardiac toxic effects from paclitaxel with trastuzumab, manifesting as grade 3 or 4 LVSD or asymptomatic LVEF decline, were low. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year, and our findings suggest that LVEF monitoring during trastuzumab therapy without anthracyclines could be simplified for many individuals.

J Am Soc Echocardiogr. 2014 Feb 14. Doxorubicin and Trastuzumab Regimen Induces Biventricular Failure in Mice.

Only patients whose tumors are HER2 Positive
Patients who do not have heart failure or weak heart muscle (cardiomyopathy). Patients must be screened for heart function before beginning and during Herceptin treatment. Less common but serious side effects include infusion reactions (chills, fever, shortness of breath) that rarely are accompanied by lung problems, low white blood counts, and low red blood cell counts.

Herceptin (trastuzumab) is manufactured by the drug company Genentech, Inc, San Francisco, CA. In England, the high cost of treating cancer patients with expensive drugs like Herceptin could mean hospitals cutting treatment for other patients if no extra funding is available. Hospitals in England and Wales were told earlier this year they should offer the breast cancer drug Herceptin to suitable patients in the early stage of the disease. But the drug's high cost -- 20,000 pounds per patient a year -- means cuts may have to be made elsewhere, doctors wrote in the British Medical Journal.

Emails
Q. My wife has breast cancer and she is under chemo and herceptin treatment ( she is HER2 positive). This treatment helped shrink the tumour in her breast and now we are going for lumpectomy to remove the tumour. Would Inositol hexaphosphate (IP6) help her in reducing the chances of reoccurance ?
   A. Don't know for sure. See IP6 for more info on this nutrient.

How is herceptin administered?
   It is given by injection. It is an antibody-based drug designed to target tumor cells and spare normal cells, unlike chemotherapy, which is toxic throughout the body.