BREAST CANCER

Breast cancer is the second leading cause of cancer deaths in women today (after lung cancer) and is the most common cancer among women, excluding non-melanoma skin cancers. According to the American Cancer Society, about 1.3 million women worldwide will be diagnosed with breast cancer annually, and about 465,000 will die from the disease.

Breast cancer either begins in the cells of the lobules, which are the milk-producing glands, or the ducts, the passages that drain milk from the lobules to the nipple. Less commonly, breast cancer can begin in the stromal tissues, which include the fatty and fibrous connective tissues of the breast.

Over time, cancer cells can invade nearby healthy breast tissue and make their way into the underarm lymph nodes, small organs that filter out foreign substances in the body. If cancer cells get into the lymph nodes, they then have a pathway into other parts of the body. The breast cancer’s stage refers to how far the cancer cells have spread beyond the original tumor to other parts of the body.

Stage 0 cancer refers to cancer in the breast duct only; Stage 1 is defined as: cancer of 2 centimeters or less and is confined to the breast (lymph nodes are clear); Stage 2 indicates spread to lymph nodes under the arms (axillary lymph nodes); Stage III is further spread to lymph nodes around the breast, neck, chest wall and under the arms and Stage IV is spread to distant sites like the bones (metastatic cancer).

Breast cancer is caused by a genetic abnormality (a “mistake” in the genetic material). However, only 5-10% of cancers are due to an abnormality inherited from a patient’s parents. About 90% of breast cancers are due to genetic abnormalities that happen as a result of the aging process, presence of lifestyle-related risk factors and potentially from carcinogens in the environment.

The chance of a woman living in the United States to develop breast cancer over her lifetime is about 1 in 8 (about 13%). In 2009, an estimated 192,370 new cases of invasive breast cancer were expected to be diagnosed in women in the U.S., along with 62,280 new cases of non-invasive (in situ) breast cancer. About 60,000 women in the U.S. died in 2010 from breast cancer. For women in the U.S., breast cancer death rates are higher than those for any other cancer besides lung cancer. Besides skin cancer, breast cancer is the most commonly diagnosed cancer among U.S. women. More than 1 in 4 cancers in women are breast cancer. A woman’s risk of breast cancer approximately doubles if she has a first-degree relative (mother, sister, daughter) who has been diagnosed with breast cancer. About 20-30% of women diagnosed with breast cancer have a family history of breast cancer. About 5-10% of breast cancers are caused by gene mutations inherited from one’s mother or father. Women with these mutations have up to an 80% risk of developing breast cancer during their lifetime, and they often are diagnosed at a younger age (before age 50). An increased ovarian cancer risk is also associated with these genetic mutations.

Several risk factors have been identified for developing breast cancer. Being overweight is associated with increased risk of breast cancer, especially for women after menopause. Fat tissue is the body’s main source of estrogen after menopause, when the ovaries stop producing the hormone. Having more fat tissue means having higher estrogen levels, which can increase breast cancer risk.

Diet is a suspected risk factor for many types of cancer, including breast cancer, but studies have yet to show for sure which types of foods increase risk. It’s a good idea to restrict sources of red meat and other animal fats (including dairy fat in cheese, milk, and ice cream), because they may contain hormones, other growth factors, antibiotics, and pesticides. Some researchers believe that eating too much cholesterol and other fats are risk factors for cancer, and studies show that eating a lot of red and/or processed meats is associated with a higher risk of breast cancer. A low-fat diet rich in fruits and vegetables is generally recommended.

Evidence is growing that exercise can reduce breast cancer risk. The American Cancer Society recommends engaging in 45-60 minutes of physical exercise 5 or more days a week.

Studies have shown that breast cancer risk increases with the amount of alcohol a woman drinks. Alcohol can limit the liver’s ability to control blood levels of the hormone estrogen, which in turn can increase risk.

Smoking is associated with a small increase in breast cancer risk.

Because the female hormone estrogen stimulates breast cell growth, exposure to estrogen over long periods of time, without any breaks, can increase the risk of breast cancer. This includes taking combined hormone replacement therapy (estrogen and progesterone; HRT) for several years or more, or taking estrogen alone for more than 10 years.

Using oral contraceptives (birth control pills) appears to slightly increase a woman’s risk for breast cancer, but only for a limited period of time. Women who stopped using oral contraceptives more than 10 years ago do not appear to have any increased breast cancer risk.

Women with a first-degree relative (mother, daughter, sister) who has had breast cancer, or with multiple relatives affected by breast or ovarian cancer (especially before they turned age 50), are at higher risk of getting breast cancer.

If someone has already been diagnosed with breast cancer, the risk of developing it again, either in the same breast or the other breast, is higher than those who never had the disease.

White women are slightly more likely to develop breast cancer than are African American women. Asian, Hispanic, and Native American women have a lower risk of developing and dying from breast cancer.

Having radiation therapy to the chest area as a child or young adult as treatment for another cancer significantly increases breast cancer risk. The increase in risk seems to be highest if the radiation was given while the breasts were still developing (during the teen years).

Because the female hormone estrogen stimulates breast cell growth, exposure to estrogen over long periods of time, without any breaks, can increase the risk of breast cancer, such as: starting menstruation (monthly periods) at a young age (before age 12); going through menopause (end of monthly cycles) at a late age (after 55) and exposure to estrogens in the environment (such as hormones in meat or pesticides such as DDT, which produce estrogen-like substances when broken down by the body)

Pregnancy and breastfeeding reduce the overall number of menstrual cycles in a woman’s lifetime, and this appears to reduce future breast cancer risk. Women who have never had a full-term pregnancy, or had their first full-term pregnancy after age 30, have an increased risk of breast cancer. For women who do have children, breastfeeding may slightly lower their breast cancer risk, especially if they continue breastfeeding for 1 1/2 to 2 years. For many women, however, breastfeeding for this long is neither possible nor practical.

Women who took a medication called diethylstilbestrol (DES), used to prevent miscarriage from the 1940s through the 1960s, have a slightly increased risk of breast cancer. Women whose mothers took DES during pregnancy may have a higher risk of breast cancer as well.

Standard treatments for breast cancer include surgery, chemotherapy, radiation and hormonal therapy. Surgical options include lumpectomy, mastectomy and lymph node removal. Lumpectomy is reserved for smaller, early stage tumors and is usually followed by 5-7 weeks of radiation. Recurrences in the same breast occur about 10% of the time, but can frequently be successfully managed with mastectomy with or without non-surgical treatments.

Mastectomy options include simple, modified total and radical procedures depending on the stage of the cancer and involvement of local tissues. Radiation treatment usually follows if: the tumor is larger than 5 centimeters; the tissue removed during mastectomy does not have clear margins; cancer cells are found in 4 or more lymph nodes and/or the cancer occurred in a number of locations within the breast.

Chemotherapy may be indicated for both early and late-stage cancers. Chemotherapy is used after surgery to remove the breast cancer to get rid of any cancer cells that may be left behind and to reduce the risk of the cancer coming back. In some cases, chemotherapy may be used before surgery to shrink the tumor so less tissue needs to be removed. Chemotherapy is almost always recommended if there is cancer in the lymph nodes, regardless of tumor size or menopausal status. Doctors recommend more aggressive treatments for premenopausal women diagnosed with invasive breast cancer. Breast cancer in premenopausal women tends to be more aggressive, so chemotherapy is often part of the treatment plan. Chemotherapy may be recommended for some women diagnosed with early-stage breast cancer if the cancer is hormone-receptor-negative and HER2-positive. Both of these characteristics are associated with cancer that is more aggressive. The Oncotype DX test may help some women diagnosed with estrogen-receptor-positive breast cancer and their doctors decide if the cancer is likely to come back and if chemotherapy would offer benefits. Chemotherapy usually is NOT recommended for non-invasive, in situ, Stage 0 cancers because they have very little risk of spreading to other parts of the body.

Radiation therapy has an important role in treating all stages of breast cancer because it is effective and relatively safe. It may be appropriate for people with stage 0 through stage III breast cancer after lumpectomy or mastectomy. Radiation can also be very helpful to people with stage IV cancer that has spread to other parts of the body.

Radiation therapy is recommended to most people who have lumpectomy. Radiation attempts to destroy any cancer cells that may have been left in the breast after the tumor was removed.

Radiation therapy may be recommended after mastectomy to destroy any breast calls that may remain at the mastectomy site. During breast removal, it's difficult to take out every cell of breast tissue, especially the tissue behind the skin in front of the breast or back along the muscle behind the breast. Usually any leftover breast cells are normal. But because it's possible for some breast cancer cells to linger, there is a risk of recurrence in the area where the breast was.

Hormonal therapy medicines are whole-body (systemic) treatment for hormone-receptor-positive breast cancers. Hormone receptors are like ears on breast cells that listen to signals from hormones. These signals "turn on" growth in cells that have receptors.  About 80% of breast cancers are estrogen-receptor positive. About 65% of estrogen-receptor-positive breast cancers are also progesterone-receptor-positive. About 13% of breast cancers are estrogen-receptor-positive and progesterone-receptor-negative. About 2% of breast cancers are estrogen-receptor-negative and progesterone-receptor-positive.

If a cancer has receptors for either estrogen or progesterone, it's considered hormone-receptor-positive.

Hormonal therapy medicines can be used to: lower the risk of early-stage hormone-receptor-positive breast cancer coming back; lower the risk of hormone-receptor-positive breast cancer in women who are at high risk but haven't been diagnosed with breast cancer or help shrink or slow the growth of advanced-stage or metastatic hormone-receptor-positive breast cancers.

Immunotherapy is gaining acceptance in the treatment of breast cancer. Two monoclonal antibody treatments are currently available for clinical use. Herceptin (chemical name: trastuzumab) works against HER2-positive breast cancers by blocking the ability of the cancer cells to receive chemical signals that tell the cells to grow. Avastin (chemical name: bevacizumab) works by blocking the growth of new blood vessels that cancer cells depend on to grow and function. As with most cancers, studies indicate that immune mechanisms are important in the prevention and control of breast cancer cells. Of particular importance are Natural Killer (NK) cells. The presence of cancer itself, along with treatment modalities like surgery, chemotherapy and radiation decrease NK function and number. Clinical trials are ongoing to assess the therapeutic efficacy of NK cell infusions and activators.

Treatment regimens have improved breast cancer outcomes, but the therapies themselves can result in significant toxicity and side-effects. Mastectomies result in disfigurement and there can be post-operative complications, loss of upper limb mobility and edema of the arms from lymph node dissections. Chemotherapy can result in nausea, vomiting, diarrhea, hair loss, infections, neuropathy, malaise and other constitutional symptoms as well as bone marrow suppression. The drugs decrease immune system function, which may have negative ramifications on tumor cell suppression. Radiation can cause significant dysfunction and scarring of underlying tissues as well as skin changes. The list of side-effects from hormonal therapy is long: osteoporosis, nausea, vomiting, headaches, bone and joint pain, malaise, insomnia and hot flashes among others that are drug-specific. Herceptin can cause flu-like symptoms. Tykarb can cause vomiting, fatigue and diarrhea. Avastin can cause high blood pressure and increased bleeding.

5-year survival rates depend upon the stage or disease, and the averages are summarized below:

In addition, longer survival rates for all stages of cancer have been calculated:

Enercel^® activates intra- and extracellular energy pathways of tissues throughout the body. Its physiologic effects are systemic. The energy enhancement in the tissues results in improved function, health, metabolism and resistance to infection, stress and tumorigenesis.  Once the energy of cells is normalized, particularly in the immune system, their health is restored and they are able to carry on their normal activities.  Furthermore, since all tissues in a local area are affected in this way, homeostasis not just of cells, but between cells as well, is restored.  When cells have sufficient and regulated energy, their function is improved.

NK cells may be important in limiting breast cancer growth and metastases. Multiple studies have shown that Enercel^® is a potent activator of NK cell function. In addition, Enercel^® showed benefit in an animal model of rat mammary (breast) gland cancer. Escalating IM Enercel^® doses up to 1 ml/day for 10 days were assessed. After 10 days, the animals showed a clear improvement in their general wellness as manifested by greater mobility, friskiness and an increase in body weight as compared to placebo-treated controls. Tumor growth was arrested, and sometimes regressed, in a high proportion of lesions in the treated rats. Some tumors developed a characteristic central lesion consistent with tumor breakdown on histopathological specimens. Statistical evaluation demonstrated that the survival of the test animals was significantly greater than that of the controls (p <0.01). The clinical and pathologic benefits of Enercel^® were dose-dependent. There was no difference in end points between animals treated with low-dose (0.05 ml/day) Enercel^® than in untreated controls. Thus, Enercel^® treatment was beneficial in a rat model of induced mammary tumors in a dose-dependent fashion. All but the lowest dose was successful. Tumor regression, improved clinical signs and greater survival were observed in treated animals compared to no response in placebo-treated ones.

Enercel^® was shown in a clinical trial to be beneficial in late-stage pancreatic carcinoma. Eighty-seven patients with stage III or IV pancreatic cancer were enrolled in this trial. A questionnaire was devised to measure selective aspects of quality of life.  A survival curve was analyzed; and group follow-up was for twelve months. Daily doses of Enercel^® 4 cc IM were administered during the entire study period. Sublingual and oral doses were also added for an additional 2.5 cc administered in four daily doses. A significant, beneficial effect was noted on several clinical parameters:  pain, appetite, nausea and vomiting, emotional state and physical function. Compared with historical controls with this stage and type of cancer, 1-year survival was significantly improved. Sixty subjects were still alive at 1 year.  The results of this study revealed that patients with advanced pancreatic cancer treated for 1 year with Enercel^® had a significant improvement on selective aspects of quality of life and survival compared to historical controls.

Enercel^® has been beneficial in multiple patients with breast cancer. Improved quality of life, survival, decreased side-effects of chemotherapy, tumor regression and decreased metastases were all noted. These encouraging results have led to a studies planned for later in 2011 in a European country. They are, namely, “Randomized Open-Label Study of Enercel^® in Combination With Standard Therapy Versus Standard Therapy Alone in Stage I, II And III Breast Cancer” and “Open-Label Study of Enercel^® as Monotherapy in Treatment Naïve vs Treatment Experienced Stage IV Breast Cancer Patients. If your health care practitioner believes that immune system suppression and/or energy depletion plays a role in your breast cancer, then Enercel^® may be very beneficial for you.