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When
combined with standard chemotherapy, the drug Herceptin
(generic name, trastuzumab) significantly increases the chances of survival for some women
with advanced breast cancer, according to a newly
published study. Approximately 25% to 30% of advanced (metastatic) breast cancer patients
carry extra copies of the HER2 gene (also written
HER2/neu), which usually signals aggressive cancers. Herceptin targets this cancer and
results in fewer deaths from breast cancer. However, Herceptin does increase the risk of
serious heart problems, and patients need to be
monitored by physicians for potential complications.
In the study, Dennis J. Slamon, MD, PhD and his colleagues randomly assigned 469
advanced breast cancer patients to receive standard chemotherapy alone or chemotherapy
with Herceptin. All of the patients had tested positive for HER2 gene overexpression and
thus were candidates for Herceptin. Depending on the patients’ previous treatment,
the chemotherapy regimens given in the trial were:
- AC regimen: an anthracycline—either Adriamycin
(generic name, doxorubicin) or Ellence (generic
name, epirubicin)—and Cytoxan (generic name, cyclophospamide)
with or without Herceptin
- Taxol (generic name, paclitaxel) with or without
Herceptin
After one year, Dr. Slamon and his colleagues observed fewer deaths among the women who
took Herceptin: only 22% of the women who took Herceptin died after one year compared with
33% of the women who did not take Herceptin.
"The study by Slamon et al. is a landmark trial…. This is the beginning of an
important new era in cancer treatment since many more targeted therapies are now
undergoing clinical evaluation," wrote Elizabeth A. Eisenhauer, MD, in an
accompanying editorial in The New England Journal of Medicine. The average
survival time was also greater among the women who took Herceptin: 25 months compared to
20 months among the women who did not take Herceptin.
While the results of the study show that Herceptin can be beneficial for women with
advanced breast cancer, the researchers did find that serious heart problems
(cardiotoxicity) can also occur. Cardiac dysfunction occurred in 27% of the women on
Herceptin who also took the AC chemotherapy regimen, and in 8% of the women who took
Herceptin with Taxol. "Although the cardiotoxicity was potentially severe and, in
some cases, life-threatening, the symptoms generally improved with standard medical
management," wrote Dr. Slamon and his colleagues. Thus, patients who take Herceptin
should be monitored by physicians for heart problems.
The most common side effects of Herceptin include:
- Fever and chills
- Weakness
- Nausea or vomiting
In rare cases, women may have serious adverse reactions to Herceptin, including
allergic shock and respiratory distress. These reactions were not observed in clinical
trials prior to drug approval by the U.S. Food and Drug Administration (FDA) in 1998, but
warning labels have been amended since then to include these possible effects. Herceptin
is currently FDA approved to treat advanced (metastatic) breast cancer patients who carry
extra copies of the HER2 gene. While Herceptin has been approved to be used in conjunction
with Taxol, it is not approved for use with the AC chemotherapy regimen outside of
clinical trials. Researchers are currently planning four large clinical trials to
determine whether Herceptin is helpful for early-stage breast cancers. The trials will
enroll more than 10,000 patients at 800 sites worldwide.
Metastatic breast cancer is the most advanced form of breast cancer, in which cancer
cells have spread out of the breast to invade other areas of the body, such as the bone,
liver or lung. The approach to treating advanced breast cancer focuses largely on
relieving cancer symptoms and extending survival time. Promising new research, including
this most recent study with Herceptin, is giving advanced breast cancer patients more
treatment options.
Additional Resources and References
- The study, "Use of Chemotherapy Plus a Monoclonal Antibody Against HER2 for
Metastatic Breast Cancer That Overexpresses HER2," is published in the March 15, 2001
issue of The New England Journal of Medicine. An abstract of the study is available
at http://www.nejm.org/content/2001/0344/0011/0783.asp
- The accompanying editorial by Elizabeth A. Eisenhauer, MD, "From the Molecule to
the Clinic—Inhibiting HER2 to Treat Breast Cancer," is published in the March
15, 2001 issue of The New England Journal of Medicine. The editorial is available
at http://www.nejm.org/content/2001/0344/0011/0841.asp
- The March 14, 2001 Genentech, Inc. news release, "Study Published in New England
Journal of Medicine Demonstrates Herceptin with Chemotherapy Increases Median Survival in
Women with Metastatic Breast Cancer," is available at http://www.gene.com/news/2001/20010314-140439.html
- To learn more about Herceptin, please visit http://www.imaginis.com/breasthealth/herceptin.asp
- To search for clinical trials with Herceptin, http://www.imaginis.com/breasthealth/links/clinical_trails.asp
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