The treatment of lobular carcinoma in situ (LCIS) is somewhat controversial. LCIS is thought to be an indicator for an increased risk of developing invasive breast cancer, but may not be a direct precursor to invasive breast cancer. This abnormality is generally widely distributed throughout the breast and frequently occurs in both breasts simultaneously.
A variety of factors ultimately influence a patient's decision to receive treatment of cancer. The purpose of receiving cancer treatment may be to improve symptoms through local control of the cancer, increase a patient's chance of cure, or prolong a patient's survival. The potential benefits of receiving cancer treatment must be carefully balanced with the potential risks of receiving cancer treatment.
The following is a general overview of the treatment of LCIS. Circumstances unique to your situation and prognostic factors of your cancer may ultimately influence how these general treatment principles are applied. The information on this Web site is intended to help educate you about your treatment options and to facilitate a mutual or shared decision-making process with your treating cancer physician.
Most new treatments are developed in clinical trials. Clinical trials are studies that evaluate the effectiveness of new drugs or treatment strategies. The development of more effective cancer treatments requires that new and innovative therapies be evaluated with cancer patients. Participation in a clinical trial may offer access to better treatments and advance the existing knowledge about treatment of this cancer. Clinical trials are available for most stages of cancer. Patients who are interested in participating in a clinical trial should discuss the risks and benefits of clinical trials with their physician. To ensure that you are receiving the optimal treatment of your cancer, it is important to stay informed and follow the cancer news in order to learn about new treatments and the results of clinical trials.
From long-term retrospective studies, it is estimated that approximately 25% of patients with LCIS will develop invasive breast cancer within 25 years of diagnosis. Thus, this diagnosis is being used to identify patients at high risk of subsequently developing invasive breast cancer. Current approaches for management of LCIS include surgical removal of the LCIS or treatment with anti-estrogens to reduce the risk of developing invasive cancer.
Observation is a generally accepted form of management for patients with LCIS. Many patients have received no further treatment following initial surgical removal of LCIS for diagnosis. In one study, researchers from the National Surgical Adjuvant Breast and Bowel Project (NSABP) evaluated 182 patients with LCIS. With a 5-year follow-up, the risk of developing invasive breast cancer after excisional biopsy alone was 3.3%, with 2.2% involving the same breast as the biopsy and 1.1% involving the opposite breast. Patients who choose observation require yearly examinations and follow-up biopsies as indicated. Although mammograms are relatively insensitive for the detection of invasive lobular breast cancer, they should probably be performed annually. Women with LCIS may also consider periodic examinations with CT or MRI scans in addition to a mammography.
Because of the observation that women with breast cancer treated with Nolvadex® had a lower risk of developing a new breast cancer in their unaffected breast, many doctors felt that Nolvadex® may actually be able to prevent breast cancer from occurring. Several clinical studies have been ongoing around the world to determine whether Nolvadex® can prevent the development of breast cancer in high-risk women. In May of 1998, the results of the National Cancer Institute clinical study evaluating Nolvadex® were presented. The primary objective of this clinical study was to determine whether Nolvadex® could decrease the number of breast cancers and thereby decrease the number of women dying from breast cancer. Other goals of the study were to determine whether Nolvadex® could also decrease the number of heart attacks and bone fractures, as well as determine whether Nolvadex® has any detrimental side effects.
Women aged 35-59 at high risk of developing breast cancer and all women over the age of 60 years were eligible to participate in this clinical study. A total of 13,388 women were enrolled on the clinical study and the average duration of follow-up is 3.6 years. Half of the patients enrolled in this clinical study were treated with Nolvadex® for 5 years and half of the patients received placebo (no Nolvadex®). Eighty-five women treated with Nolvadex® have developed invasive breast cancer, compared to 154 women treated with placebo, representing a 45% reduction in the development of breast cancer. In patients with LCIS, the incidence of invasive breast cancer was reduced 56% by the administration of Nolvadex®. Nolvadex® reduced the risk of estrogen receptor-positive invasive breast cancer by 69%, but had no effect on the incidence of estrogen receptor-negative tumors. Women treated with Nolvadex® also experienced a significant reduction in hip fractures; however, no reduction in the development of heart attacks has yet been observed.
On the other hand, women treated with Nolvadex® were more likely to develop endometrial cancer of the uterus. In this clinical study, 33 women treated with Nolvadex® developed an endometrial cancer, compared to only 14 women treated with placebo. All of the cancers occurring in the Nolvadex® treated group were early stage I cancers. Women treated with Nolvadex® were also more likely to develop blood clots, with 17 women treated with Nolvadex® developing pulmonary emboli, compared to 6 treated with placebo and 30 women treated with Nolvadex® developing blood clots of the deep veins of the legs, compared to 19 treated with placebo. Women treated with Nolvadex® were more likely to need cataract surgery, which occurred in 201 women treated with Nolvadex®, compared to 129 treated with placebo. Based on the results of this clinical study, the Food and Drug Administration concluded that Nolvadex® should be approved for reducing the risk of breast cancer in women at high risk of developing breast cancer. Additional follow-up and the results of other clinical studies will further clarify the role of Nolvadex® and other hormonal therapies in the prevention of breast cancer. All patients with LCIS may want to consider treatment intervention with Nolvadex® or other anti-estrogens.
Significant progress has been made in understanding the role of preventative therapy. This progress has resulted from the willingness of thousands of women and doctors to participate in clinical studies. There are several ongoing areas of clinical research evaluating hormonal therapies for the prevention and treatment of breast cancer. Active areas of investigation include, but are not limited to, the following:
Novel Anti-estrogens: Evaluating the duration of Nolvadex® therapy required for the optimal prevention of breast cancer is ongoing as are clinical studies evaluating a class of hormonal drugs known as selective estrogen receptor modulators. Selective estrogen receptor modulators are thought to have positive effects on bones and factors affecting cardiovascular disease and anti-estrogen effects on breast cancer without increasing the risk of uterine cancer.
Bilateral Prophylactic Mastectomy: A bilateral prophylactic mastectomy involves the preventive removal of both breasts. This is an effective method of preventing invasive breast cancer in patients with LCIS. This option is only considered if the patient insists that the risk of developing carcinoma must be totally excluded. Reconstructive surgery may be used immediately or subsequent to mastectomy. However, most physicians and patients consider this a drastic approach and it is not usually recommended given the relatively good results of observation and treatment with Nolvadex®.