Treatment with a combination of chemotherapy drugs improves survival and should be recommended for most women with localized breast cancer, according to a consensus panel convened by the National Institutes of Health. The panel also recommended hormonal therapy for women whose tumors have estrogen receptors, and radiation therapy for women who have had mastectomies and who are at high risk for recurrence of cancer.
These and other recommendations emerged from
a 3-day NIH Consensus Development Conference on Adjuvant Therapy for Breast
Cancer held November 1-3, 2000 at the NIH in Bethesda, Md. Adjuvant therapy treatments
used in addition to surgery to kill cancer cells that may have begun to spread
to other organs includes chemotherapy and hormonal therapy, typically tamoxifen.
In addition to these systemic therapies, radiation therapy is sometimes used
as a local adjuvant treatment to help destroy breast cancer cells that have
spread to nearby tissues.
"Clinical trials over the past ten years have contributed
an enormous amount of new information about adjuvant therapies," said panel
chair Patricia Eifel, M.D., Professor of Radiation Oncology at M.D. Anderson
Cancer Center in Houston. "Women with breast cancer have more treatment options
and a better chance of surviving their disease than ever before. At the same
time, making treatment decisions has become a more complex process for them
and their physicians due to a growing list of effective options."
brought together national and international experts to clarify, for clinicians,
patients, and the general public, key questions regarding the selection of
treatments, quality of life, and new research directions in adjuvant therapy.
Dr. Eifel and her colleagues noted that decisions about the choice of adjuvant
therapy should be based on age, tumor size, presence or absence of hormone
receptors, presence or absence of cancerous lymph nodes, and other generally
accepted factors. New technologies and molecular markers hold potential but
require further study.
Hormonal therapy was recommended by the panel for women
whose breast tumors contain estrogen receptors, regardless of age, menopausal
status, tumor size, or whether the cancer has spread to nearby lymph nodes.
Five years of tamoxifen is currently the standard adjuvant hormonal therapy.
The panel noted that no data support the use of tamoxifen for longer than
five years outside of a clinical trial but that this is an important area
for investigation. The panel emphasized that hormonal therapy is not indicated
for women whose tumors do not have hormone receptors. The panel recommended
chemotherapy with a combination of drugs for most pre- and post-menopausal
women regardless of lymph node involvement or estrogen receptor status. Including
anthracycline drugs as part of chemotherapy regimens produces a small but
statistically significant survival advantage over regimens that do not contain
anthracyclines. However, there are not enough data to support the routine
use of taxanes or dose-intensive chemotherapy.
Women who have undergone mastectomy
and who have four or more cancerous lymph nodes or an advanced primary tumor
benefit from post-surgical radiation, the panel concluded. The panel added
that it is unclear whether women with one to three cancerous lymph nodes benefit
from radiation therapy and that this question should be tested in a randomized
Adjuvant treatments often involve serious short- and long-term
side effects such as premature menopause, weight gain, mild memory loss, and
fatigue. The panel recommended that selected trials of adjuvant therapy include
quality-of-life measures. It emphasized that long term follow-up of women
in these trials is important to fully understand the effects of adjuvant therapies.
It also endorsed continued development of decision-making tools to help patients
and their physicians weigh the risks and benefits of adjuvant treatments.
Among its other recommendations for future research, the panel called for
carefully designed studies of:
- combined hormonal therapy
- hormonal therapy versus chemotherapy in premenopausal women whose tumors
have estrogen receptors
- high dose chemotherapy
- factors that predict the effectiveness of treatments in individual patients
- new drugs, including trastuzumab and bisphosphonates
- radiation techniques that reduce the dose to normal tissue such as the
heart and lungs
- the effectiveness and side effects of adjuvant therapies in women older
The National Cancer Institute and the NIH Office of Medical Applications
of Research sponsored the conference. Cosponsors included the National Institute
of Nursing Research and the NIH Office of Research on Women's Health.
The full NIH Consensus Statement on Adjuvant Therapy for Breast Cancer is
available by calling 1-888-NIH-CONSENSUS (1-888-644-2667) or by visiting the
NIH Consensus Development Program Web site at http://consensus.nih.gov. (The
panel's draft statement will be posted to the Web by the evening of November
The consensus statement is the report of an independent panel and is not
a policy statement of the NIH or the Federal Government. The NIH Consensus
Development Program was established in 1977 to resolve in an unbiased manner
controversial topics in medicine. To date, NIH has conducted 113 such conferences
addressing a wide range of controversial medical issues important to health
care providers, patients, and the general public.