Bayer’s Nexavar Wins FDA Approval for Liver Cancer Treatment

Posted by sara | Posted in Cancer, Liver | Posted on 03-03-2008

The FDA has approved Bayer HealthCare AG’s drug, Nexavar (sorafenib) in patients with hepatocellular carcinoma when the cancer can not be removed surgically. Hepatocellular carcinoma is a type of liver cancer.

Hepatocellular carcinoma accounts for 80-90% of all liver cancers. If it can’t be removed surgically, hepatocellular carcinoma is usually fatal within 3-6 months. The American Cancer Society estimates that there will be more than 19,000 new cases and nearly 17,000 deaths in 2007 from liver cancer and intrahepatic bile duct cancer in the U.S.

Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

FDA’s approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.

“In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn’t receive the drug,” said Robert Justice, M.D., director of FDA’s division of drug oncology products. “This is an important new treatment option for patients who are fighting this very difficult form of cancer.”

A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.

The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.

The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.

Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.

Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.

Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.

Evening Primrose Oil Fights Breast Cancer

Posted by david | Posted in Article, Others, Women | Posted on 29-03-2007

Gamma-linolenic acid (GLA), the essential omega-6 fat that is found in evening primrose, black currant seed, and borage oil, can inhibit the action of the cancer gene Her-2/neu. This gene is responsible for almost 30 percent of all breast cancers.

40-Fold Increase in Effectiveness

When cancer cells that overexpress the Her-2/neu gene are treated with GLA, it not only helps suppress the cancer-causing gene, but also causes up to a 40-fold increase in response to the drug Herceptin (trastuzumab), which is used as part of breast cancer treatment. GLA also selectively affects cancer cells without damaging normal cells.

Good News for Those With an Aggressive Form of Cancer

This is especially good news because patients who possess the Her-2/neu gene also typically have an aggressive form of the disease and a poor prognosis.

GLA is one of two essential fatty acids, which are necessary for the normal functioning and growth of cells, nerves, muscles and organs. GLA is present in evening primrose oil, borage oil, and black current seed oil, among other sources.

Journal of the National Cancer Institute November 2, 2005; 97(21): 1611-1615 EurekAlert November 1, 2005 Northwestern University November 2, 2005

Dr. Mercola’s Comment:GLA is a powerful nutritional tool that is commonly used to treat:

Inflammation
Arthritic pain
Eczema (atopic dermatitis)

Although GLA is an omega-6 fat, it is one of the only ones that many people seem to benefit from by takingit insupplement form. It is frequently the “secret” weapon in resolving eczema and many mystery rashes.

It is important to use GLA with a balanced amount of a high-quality omega-3 fish oil or, at this time of year, cod liver oil. They act synergistically to provide a potent anti-inflammatory combination.

If taken as a supplement, I personally prefer the ones made from evening primrose oil, but borage oil hasa higher concentration of GLA, which means you need fewer capsules, and it tends to be less expensive.

However, it has been my experience that many experts insist on using evening primrose oil, even though it is more expensive, as it seems to provide better overall results. This may be related to the fact that these oils are not pure GLA but also have other oils. Nervonic acid is present in borage oil and may contributeto its lack of benefit relative to evening primrose oil.

Since cancer, not heart disease, is now the leading cause of death for most of us, this is an important issue.If you are interested in radically reducing yourrisk of developing cancerI would recommend the following:

1. Control your insulin levels: Make certain that you limit your intake of processed foods and sugars as much as possible. When your insulin levels are increased you will inhibit the action of an enzyme (delta-6 desaturase) that actually allows your body to produce GLA.

2. Get appropriate amounts of animal-based omega-3 fats and make sure you use cod liver oil if you don’t have regular access to sun exposure.

3. Get appropriate exercise. One of the primary reasons exercise works is that it drives your insulin levels down. Controlling insulin levels is one of the most powerful ways to reduce your cancer risks.

4. Normalize your vitamin D levels with safe amounts of sun exposure. This works primarily by optimizing your vitamin D level. If you have regular access to sun exposure then you should use fish oil, not cod liver oil, as your primary source of omega-3 fats. Ideally, it would be best to monitor your vitamin D levels.

5. Eat according to your metabolic type. The potent anti-cancer effects of this principle are very much underappreciated. When we treat cancer patients in our clinic this is one of the most powerful anti-cancer strategies we have.

6. Have a tool to permanently erase the neurological short-circuiting that can activate cancer genes. Even the CDC states that 85 percent of disease is caused by emotions. It is likely that this factor may be more important than all the other physical ones listed here, so make sure this is addressed. Energy psychology seems to be one of the best approaches and my particular favorite tool, as you may know, is the Emotional Freedom Technique.

7. Only 25 percent of people eat enough vegetables, so by all means eat as many vegetables as you are comfortable with. Ideally, they should be fresh and organic. However, please understand that, frequently, fresh conventionally grown vegetables are healthier than organic ones that are older and wilted in the grocery store. They are certainly better than no vegetables at all, so don’t use that as an excuse. If you are a carb metabolic type you may need up to 300 percent more vegetables than a protein metabolic type.

8. Make sure you are not in the two-thirds of the population who are overweight, and maintain an ideal body weight.

9. Get enough high-quality sleep.

10. Reduce your exposure to environmental toxins like pesticides, household chemical cleaners, synthetic air fresheners and air pollution.

11. Boil, poach or steam your foods, rather than frying or charbroiling them.

Article Source: Health Guidance

Vitamin D Can Fight Breast Cancer

Posted by david | Posted in Article, Breast Cancer, Cancer, Health | Posted on 06-11-2006

Vitamin D Can Fight Breast Cancer

Vitamin D may help curb breast cancer progression, as per a research studypublished recently in the Journal of Clinical Pathology.

The authors, from Imperial College London, measured the levels of vitamin D in the blood serum of 279 women with invasive breast cancer. The disease was in its early stages in 204 of the women, and advanced in the remaining 75.

The results showed that women with early stage disease had significantly higher levels of vitamin D (15 to 184 mmol/litre) than the women in the advanced stages of the disease (16 to 146 mmol/litre).

The authors say that the exact reasons for the disparity are not clear, nor is it known whether the lowered levels of vitamin D among those with advanced disease are a cause or a consequence of the cancer itself. However, the researchers’ results, taken together with results from prior studies, lead them to think that lowered levels of vitamin D may promote the progression of the disease to its advanced stages.

Laboratory studies have shown that vitamin D stops cancer cells from dividing and enhances cancer cell death. Vitamin D sufficiency and exposure to sunlight has been shown to reduce the risk of developing breast cancer. The body produces its own vitamin D in the skin when it is exposed to sunlight. The vitamin is also found in certain foods, including eggs and fatty fish………

by: Janet

Ovarian Cancer Overview

Posted by david | Posted in Article, Cancer | Posted on 16-10-2006

Cancer occurs when cells undergo a transformation and begin to grow and multiply without normal controls. As the cells grow and multiply, they form masses called tumors. Cancer is dangerous because it overwhelms healthy cells by taking their space and the oxygen and nutrients they need to survive and function.

Ovarian cancer occurs when a tumor forms in one or both of a woman’s ovaries. The ovaries are a pair of small organs that produce and release ova, or human eggs. The ovaries also produce important hormones such as estrogen and progesterone. They are located in the lower abdomen (pelvis), on either side of the womb (uterus). Ova released by the ovaries travel through the fallopian tubes to the uterus, where they may or may not be fertilized by the male sperm.

Cancerous tumors are malignant. This means they spread to other tissues and organs. Not all tumors, however, are malignant.

In a process called metastasis, malignant tumors may encroach on and invade neighboring organs or lymph nodes, or they may enter the bloodstream and spread to remote organs such as the liver or lungs. Metastatic tumors are the most aggressive and serious of all tumors.

The type of cell that originated the abnormal growth determines the class of the ovarian tumors.

  • Epithelial tumors: These tumors arise from a layer of cells that surrounds the outside of the ovary called the germinal epithelium. About 70-80% of all ovarian cancers are epithelial. These are most common in women who have been through menopause (aged 45-70 years).
  • Stromal tumors: Stromal tumors develop from connective-tissue cells that help form the structure of the ovary and produce hormones. Usually, only one ovary is involved. These account for 5-10% of ovarian cancers. These tumors typically occur in women aged 40-60 years. Often, surgical removal of the tumor is the only treatment needed. If the tumor has spread, though, the woman needs chemotherapy.
  • Germ cell tumors: Tumors that arise from germ cells (cells that produce the egg) account for about 15% of all ovarian cancers. These tumors develop most often in young women (including teenaged girls). Although 90% of women with this type of cancer are successfully treated, many become permanently infertile.
  • Metastatic tumors: Only 5% of ovarian cancers have spread from other sites. The most common sites from which they spread are the colon (52%), breast (17%), stomach (10%), and pancreas (5%).
  • Within these main classes are many different subtypes of tumors.

Noncancerous (benign) ovarian masses include abscesses or infections, fibroids, cysts, polycystic ovaries, endometriosis-related masses, ectopic pregnancies, and others.

  • Of markedly enlarged ovarian masses (>4 cm) found in women who are still menstruating (have not been through menopause), about 20% are cancerous.
  • Of markedly enlarged masses found in women who have been through menopause, about 45-50% are cancerous.

The incidence of ovarian cancer varies greatly. Globally, Scandinavia, Israel, and North America have the highest rates. Developing countries and Japan have the lowest rates.

  • At least 15,000 women die each year from ovarian cancer.
  • The 5-year survival rate is greater than 75% if diagnosis of the cancer occurs before it has spread to other organs. However, the 5-year survival rate drops to 20% when the tumor has spread to the upper abdomen.
  • In the United States, about 1 in 56 women develops cancer of the ovary. More than 26,000 new cases are diagnosed each year.

Types of Breast Cancer

Posted by david | Posted in Article, Breast Cancer | Posted on 14-10-2006

In breast cancer, cancer cells in the breast tissue divide and grow in an uncontrolled manner. About 20% of breast cancers originate in the milk-producing glands, also called lobules. About 80% originate in the mammary ducts, the milk passages that connect the lobules and the nipple. Cancerous tumors in the breast usually grow very slowly. By the time one is large enough to be felt as a lump, it may have been growing for as long as ten years.

There are two kinds of breast cancer, invasive breast cancer and non-invasive carcinoma in situ.

Invasive breast cancer
Invasive breast cancer is the more serious of the two types. It occurs when abnormal cells from inside the lobules or ducts spread into the surrounding breast tissue. This enables the cancer to spread to the lymph nodes and, in advanced stages, to areas such as the liver, lungs, and bones.

A previous assumption was that breast cancer started as a very small tumor in the breast tissue and grew bigger. It eventually spread to nearby lymph nodes, and then to distant lymph nodes. Finally, it metastasized in other parts of the body. Now, doctors think that cancer cells can spread from the breast through the blood and lymphatic system at early stages of the disease, even though these spreading cancer cells do not always survive.

A phrase that you may hear from your doctor is the term ‘locally advanced’ breast cancer. This is usually refered to as cancer has not spread to another area in the body. However the following issues may have occurred:

  • The cancer in the breast may be bigger than 5 centimetres across
  • The cancer may have spread into the skin or muscle of the chest, or
  • There may be cancer in the lymph nodes under the arm

Locally advanced breast cancer can be any of the above or all of these issues listed. Locally advanced could mean either stage II or stage III breast cancer.

Breast Cancer: The Basics #chap.1

Posted by david | Posted in Article, Breast Cancer, Cancer | Posted on 13-10-2006

What is the breast?

The breast is a collection of glands and fatty tissue that lies between the skin and the chest wall. The glands inside the breast produce milk after a woman has a baby. Each gland is also called a lobule, and many lobules make up a lobe. There are 15 to 20 lobes in each breast. The milk gets to the nipple from the glands by way of tubes called ducts. The glands and ducts get bigger when a breast is filled with milk, but the tissue that is most responsible for the size and shape the breast is the fatty tissue. There are also blood vessels and lymph vessels in the breast. Lymph is a clear liquid waste product that gets drained out of the breast into lymph nodes. Lymph nodes are small, pea-sized pieces of tissue that filter and clean the lymph. Most lymph nodes that drain the breast are under the arm in what is called the axilla.

What is breast cancer?

Breast cancer happens when cells in the breast begin to grow out of control and can then invade nearby tissues or spread throughout the body. Large collections of this out of control tissue are called tumors. However, some tumors are not really cancer because they cannot spread or threaten someone’s life. These are called benign tumors. The tumors that can spread throughout the body or invade nearby tissues are considered cancer and are called malignant tumors. Theoretically, any of the types of tissue in the breast can form a cancer, but usually it comes from either the ducts or the glands. Because it may take months to years for a tumor to get large enough to feel in the breast, we screen for tumors with mammograms, which can sometimes see disease before we can feel it.

MRI Best To Detect Cancer Spread Into Breast Ducts

Posted by david | Posted in Article, Breast Cancer | Posted on 11-10-2006

MRI Best To Detect Cancer Spread Into Breast Ducts

MRI is better than MDCT for determining if and how far breast cancer has spread into the breast ducts and should be used before patients receive breast conserving treatment, a new study shows.

“Patients have a lower survival rate if their surgical margins are positive for tumor cells. A positive surgical margin is commonly the result of inadequate resection of the cancer’s intraductal component,” said Akiko Shimauchi, MD, at Tohoku University in Sendai, Miyagi, Japan. “Accurate preoperative diagnosis of the intraductal component allows the surgeon to achieve a cancer-free surgical margin,” she said.

The study included 69 patients with proven invasive cancer, 44 of which had an intraductal component, said Dr. Shimauchi. MRI correctly identified 33 of the 44 cases, while MDCT correctly identified 27. “MRI revealed the presence of the intraductal component with significantly higher sensitivity (75%) in comparison to MDCT (61%), Dr. Shimauchi said.

“The lesions that were missed by both examinations were the ductal extension type, i.e. the tumor included a dominant mass with an outward extension of cancer cells, with a relatively small ductal component,” said Dr. Shimauchi. MRI was better able to detect the smaller ductal components than MDCT.