Alternative therapies don’t help kids’ cancer stress

(Reuters Health) – Massage, humor therapy and relaxation don’t seem to make life much easier for children with cancer who go through stressful bone marrow transplants, disappointed researchers said Monday.

Earlier studies, while not clear-cut, had suggested alternative treatment might benefit some adult cancer survivors. Doing yoga, for instance, helped women sleep better and have more energy after breast cancer treatment. (See Reuters Health story of May 21, 2010)

“We believed that we had a therapy that was helpful,” said psychologist Sean Phipps, of St. Jude Children’s Research Hospital in Memphis, who led the government- and foundation-funded study.

But, he said, even state-of-the-art alternative treatment didn’t trump standard supportive care, which includes drugs for nausea and pain as well as psychosocial support for both child and parent.

Phipps said stem cell transplants, from the bone marrow or blood, are some of the toughest treatments for children with cancer. He said they often experience pain, have restricted diets, and are kept largely isolated due to a high risk of infections. “It’s not a picnic,” he said.

To test whether alternative treatment could take the edge off the stress, Phipps and colleagues randomly assigned 178 children to one of three groups. One group received only standard care; another also had massages and humor therapy; in the third group, parents also got massages and were taught how to be more relaxed around their kids.

Using a common measure of quality of life in patients undergoing aggressive treatments, the researchers then tested how the kids fared in each group.

“We failed to demonstrate that our interventions changed those outcomes,” said Phipps. One possible explanation is that standard care was already doing a good job of helping the children, he added, stressing that more research is needed.

Dr. K. Scott Baker, who directs the Survivorship Program at the Fred Hutchinson Cancer Research Center in Seattle, said he was surprised by the new findings, which are published in the journal Cancer.

While they don’t jibe with work in adults, he said in an e-mail to Reuters Health, “this study had a very rigorous study design. Many times what we perceive to be true, or of benefit, is not always the case.”

“There are things that they can do to make them feel better,” Phipps said. “You don’t have to sit back and be passive.”

SOURCE: link.reuters.com/fyr76m Cancer, online July 12, 2010.

APP Pharmaceuticals to Market Anastrozole Tablets in the U.S.

SCHAUMBURG, Ill.–(Business Wire)–
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today
that APP Pharmaceuticals will immediately begin marketing Anastrozole tablets in
the U.S., after the U.S. Food and Drug Administration granted approval to market
the breast cancer treatment medication to Fresenius Kabi Oncology Limited
(NSE:FKONCO) (BSE:532545). APP Pharmaceuticals and Fresenius Kabi Oncology
Limited are members of the Fresenius Kabi Group of companies. Anastrozole is
therapeutically equivalent to the reference-listed drug Arimidex, which is
currently marketed by the innovator AstraZeneca.

APP will market Anastrozole in 1 mg tablets. According to IMS data, 2009 sales
of the branded product in the United States were approximately $916.8 million,
with approximately 105 million tablets sold annually.

“The approval of Anastrozole further expands APP’s product portfolio in the
strategically important Oncology segment,” said John Ducker, president and chief
executive officer of APP Pharmaceuticals. “We are delighted to be able to offer
this important oral medication to new customers in the retail pharmacy channel.”

About Anastrozole

Anastrozole is approved for the adjuvant treatment of postmenopausal women with
hormone receptor-positive early breast cancer. It is also a first-line treatment
for postmenopausal women with hormone receptor-positive or hormone receptor
unknown locally advanced or metastatic breast cancer. In addition, Anastrozole
is used in the treatment of advanced breast cancer in postmenopausal women with
disease progression following tamoxifen therapy. Patients with estrogen
receptor-negative disease and patients who did not respond to previous tamoxifen
therapy rarely responded to Anastrozole.

About APP Pharmaceuticals, Inc.

APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that
develops, manufactures and markets injectable pharmaceutical products with a
primary focus on the oncology, anti-infective, anesthetic/analgesic and critical
care markets. The company offers one of the most comprehensive product
portfolios used in hospitals, long-term care facilities, alternate care sites
and clinics within North America and manufactures a comprehensive range of
dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly
owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on
September 10, 2008. For more information about APP Pharmaceuticals, Inc., please
visit the company`s Web site at www.APPpharma.com.

Fresenius Kabi Oncology Limited

Fresenius Kabi Oncology Limited is one of the leading companies for cancer
research and anti-cancer products. Leveraging the global outreach through
integration with Fresenius Kabi, Fresenius Kabi Oncology Limited is benchmarking
oncology excellence with world class production, state-of-the-art manufacturing
and research & development facilities. Fresenius Kabi Oncology Limited has world
class expertise for the development and manufacturing of active pharmaceutical
ingredients, intermediates and oral & injectable finished dosage forms.

About Fresenius Kabi AG

Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in
Europe and in its most important countries of Latin America and Asia Pacific.
Fresenius Kabi`s core product range includes infusion solutions, blood volume
substitutes, I.V. drugs and parenteral nutrition, as well as products for
enteral nutrition. Furthermore, the company provides concepts for ambulatory
health care and is focused on managing and providing home therapies. With the
philosophy “caring for life” and a comprehensive product portfolio, the company
aims at improving the quality of life of critically and chronically ill patients
all over the world. In 2009, Fresenius Kabi achieved sales of EUR 3,086 million
and an operating profit of EUR 607 million. For more information visit the
company`s Web site at www.fresenius-kabi.com. Fresenius Kabi AG is a 100%
subsidiary of Fresenius SE.

Forward-Looking Statement

The statements contained in this news release that are not purely historical are
forward-looking statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended. Forward-looking statements in this news
release include statements regarding our expectations, beliefs, hopes, goals,
intentions, initiatives or strategies, including statements regarding the
demand, supply and distribution of our products. Because these forward-looking
statements involve risks and uncertainties, there are important factors that
could cause actual results to differ materially from those in the
forward-looking statements. Additional relevant information concerning risks are
discussed under the headings “Risk Factors” and “Management`s Discussion and
Analysis of Financial Condition and Results of Operations” in the Fresenius Kabi
Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2009
and other documents the company has filed with the Securities and Exchange
Commission.

The information contained in this news release is as of the date of this
release. Fresenius Kabi Pharmaceuticals Holding, Inc. does not assume any
obligation to update or revise these forward-looking statements to conform the
statement to actual results, new information, developments or changes in the
Company`s expectations.

1 2009 IMS Data

Arimidex is a registered trademark of AstraZeneca.

Investor and Media Inquiries
APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications
(847) 969-8026
dross@apppharma.com

Copyright Business Wire 2010

Simple genetic test may lead to more personalized breast cancer treatment

Washington, May 7 (ANI): US researchers say that a simple genetic test that uses just three genes is among the most effective means of classifying breast cancer into sub-types.

The findings are a significant step in bringing more personalized treatment into breast cancer, say researchers.

The study is based on the already well-established fact that breast cancer is not one biologically homogeneous disease, but it is composed of several molecular sub-types each of which is characterized by distinct gene expression profiles.

“It is these differences that explain, at least in part, why patients who have tumours that appear to be similar may experience completely different clinical outcomes such as prognosis and response to anticancer therapies,” said Benjamin Haibe-Kains from Dana-Farber Cancer Institute in Boston, USA.

“Thus, there is an urgent need for developing a robust tool to provide clinicians with guidance for classifying breast cancer molecular sub-types, which could then aid in making therapeutic decisions,” Haibe-Kains added.

Several research groups have already developed a range of different genetic ”fingerprints” they use to assign breast cancers into different sub-types, but questions have been raised about the reliability of these groupings.

To shed new light on this issue, Haibe-Kains and colleagues performed the largest comparative study to date of breast cancer sub-types, analyzing 32 publicly available gene expression datasets including more than 4600 breast cancer patients and six different classification models.

“We studied these models in terms of concordance and prognostic value and, for the first time, we estimated their robustness: that is, their capacity to assign the same tumours to the same molecular sub-types whatever the gene expression data used to fit this model,” Haibe-Kains said.

Two main classes of classification models have been published during the last decade: the Single Sample Predictor (SSP) and the Sub-type Classification Model (SCM). Over the years the list of genes used by these models have been refined, leading to the publication of six distinct classification models.

“Generally speaking, we found that SCMs yielded stronger concordance than SSPs. We also observed that SCMs, including a simple model that uses only three genes –ESR1, ERBB2 and AURKA– were significantly more robust than SSPs,” Haibe-Kains said.

By demonstrating the robustness of the SCM models, the new study is a significant step towards bringing these classification models into the clinic, Haibe-Kains said.

“The robustness of SCMs makes them promising candidates for an implementation into the clinic especially in the simplest form –that is, a model using only three genes,” Haibe-Kains added.

The findings were presented at the IMPAKT Breast Cancer Conference in Brussels, Belgium. (ANI)

‘Single shot’ breast cancer treatment to ward off radiotherapy ordeals

London, Mar 29 (ANI): A single half-hour “shot” treatment for breast cancer can now do away with a six-week course of tumour-destroying therapy, according to British doctors.

The radiotherapy treatment, which is for use in patients with early breast cancer after they have undergone surgery on the tumour, is showing positive results in early trials in patients.

The novel therapy is designed to kill remaining cancerous cells with a concentrated beam of radiation.

Currently, women with breast cancer undergo a five to six-week course of radiotherapy treatment after surgery, involving about 20 hospital visits.

The surgery is designed to conserve as much of the breast as possible, rather than a mastectomy where the whole breast is removed.

But the radiotherapy course can cause more general damage to the tissue and greater distortion to the breast.

The medics believe that, after the publication of trial data later this year, a single dose of intra-operative radiation therapy (IORT) could become more widely available and offer women a less gruelling and more cosmetically satisfactory outcome.

The procedure involves lowering a spherical applicator, ranging between a marble and a squash ball in size, into the tumour through the incision created during surgery while the patient is still under anaesthetic.

This applicator then gives out a uniform dose of low energy X-rays directly to the surrounding 2cm-deep area of the tumour bed.

The ten-year targeted intra-operative therapy trial aims to show that IORT is as safe and effective as a conventional course of radiotherapy.

Michael Baum, a British cancer specialist involved with the trial, said that the excitement surrounded the possibility that a one-shot treatment might be at least as effective and safe as conventional treatment.

Patients would then be able to move on to drug-based therapies, chemotherapy or hormonal therapy, as required.

Baum said that the portable machine, called the Intrabeam and manufactured by the Karl Zeiss Corporation in Germany, emits X-rays of a different quality to electron beam radiation, giving a different biological effect that “has the equivalent effect”.

“[The treatment] has a major complication of distorting the breast, and the breasts can end up different sizesIf this is shown to work [in the full trial results], many women will be spared six weeks of treatment going back and forth to the radiotherapy centre. Women would vote with their feet for this treatment,” Times Online quoted Baum as saying.

The study results will be presented at the American Society of Clinical Oncology conference. (ANI)

Cancer radiotherapy ups cardiovascular disease risk later in life

Washington, Mar 23 (ANI): Karolinska Institutet scientists have suggested that the sustained inflammation in the arteries brought on by changes in gene expression as a result of cancer radiotherapy could be the reason why so many people who survive their cancer diagnosis go on to develop cardiovascular disease later in life.

Epidemiological studies have shown that a course of radiotherapy increases the risk of cardiovascular disease in the same part of the body; for example, myocardial infarction after left-side breast cancer treatment, or stroke after the treatment of head and neck or brain tumours. Scientists know very little, however, about the biological causes of these serious side-effects, which often do not appear until many years following treatment.

“Studies have been hampered by the fact that the disease process is so slow,” says Martin Halle, researcher at Karolinska Institutet. “Cell studies and animal studies are best suited to the more immediate effects, and studies on human subjects have been ruled out for ethical reasons.”

By studying autografts that have been carried out after cancer, Halle and colleagues have now for the first time managed to study the long-term effects of radiotherapy on human blood vessels. This type of autograft involves the transplantation of skin, muscle or bone tissue from one part of a patient”s body to reconstruct defects that arise after the removal of a tumour in another, often irradiated, part. By harvesting biopsies from previously irradiated branches of the carotid arteries and non-irradiated arteries from grafts, the researchers have been able to compare the difference in global gene expression between irradiated and non-irradiated arteries from the same patient at the same time.

They found that the irradiated arteries showed signs of chronic inflammation and an increase in activity of Nuclear Factor- kappaB (NF-kappaB), a transcription factor known for playing a key part in the development of atherosclerosis. The greater inflammatory gene expression was visible for several years after irradiation, and might, the researchers believe, explain why cancer patients can suffer cardiovascular disease many years after radiotherapy.

“Hopefully, these findings will one day help medicine to mitigate the side effects by administering radiotherapy in combination with an anti-inflammatory treatment,” says Halle. (ANI)

Light therapy offers ‘non-invasive’ breast cancer treatment

London, June 30 (ANI): A British doctor is pioneering a groundbreaking treatment for breast cancer which uses light to target and kill tumours without the need for surgery.

Cancer surgeon Mo Keshtgar is adapting a form of light therapy for skin cancer to be used in breast cancer.

The treatment is known as photodynamic therapy (PDT). It uses tumour killing drugs which are injected into the body, latch onto the tumour and then are activated from outside using a laser, reports The Telegraph.

Its plus point is that it does not involve surgery and leaves healthy cells around the tumour unaffected.

Trials will be conducted at London’s Royal Free Hospital.

Keshtgar, who unveiled the technique at this year’s Royal Society Summer Science Exhibition, said: “The key appeal of photodynamic therapy is that it attacks and destroys cancer cells while retaining the viability of the surrounding normal cells.

“Breast cancer can be particularly traumatic, with more invasive treatments leaving physical and emotional scars. Our treatment will keep the structure of the connective tissue intact meaning the breast does not become deformed or lose shape.” (ANI)

Vitamin D ‘inhibits growth of breast cancer cells’

Washington, Feb 05 (ANI): In a new study, Calcitrol, the active form of vitamin D, has been found to induce a tumour suppressing protein that can inhibit the growth of breast cancer cells.

Prior to the current study, little was known about the factors that determine the effect of calcitrol on inhibiting breast cancer growth.

During the study, Sylvia Chistakos, Ph.D., of the UMDNJ-New Jersey Medical School and co-author Puneet Dhawan, Ph.D., examined the protein involved in the action that can reduce the growth of vitamin D in breast cancer cells.

“These results provide an important process in which the active form of vitamin D may work to reduce growth of breast cancer cells,” said Christakos.

“These studies provide a basis for the design of new anticancer agents that can target the protein as a candidate for breast cancer treatment,” she added.

The study was published in the recent issue of The Journal of Biological Chemistry. (ANI)

Scientists provide new insights into endometriosis

London, Jan 18 (ANI): Scientists from Northwestern University’s Feinberg School of Medicine have found vital clues that may help explain the cause of endometriosis.

Endometriosis is a chronic disease characterized by infertility and chronic pelvic pain during intercourse.

The study led by Serdar Bulun, M.D., George H. Gardner Professor of Clinical Gynecology at Northwestern University’s Feinberg School of Medicine, have discovered key epigenetic abnormalities in endometriosis and identified existing chemicals that now help treat it.

These abnormalities result from epigenetic defects that occur very early on during embryonic development and may be the result of early exposure to environmental toxins

One of the abnormalities he discovered is the presence of the enzyme aromatase — which produces estrogen — in endometriosis, the diseased tissue that exists on pelvic organs and mimics the uterine lining.

As a result, women with endometriosis have excessive estrogen in this abnormal tissue found on surfaces of pelvic organs such as the ovaries.

Bulun found the protein SF1 that produces aromatase, which is supposed to be shut down, is active in endometriosis.

“Estrogen is like fuel for fire in endometriosis. “It triggers the endometriosis and makes it grow fast,” Bulun said.

Bulun launched clinical trials in testing aromatase inhibitors — currently used in breast cancer treatment — for women with endometriosis.

The drug blocks estrogen formation and secondarily improves progesterone responsiveness.

“We came up with a new treatment of choice for post-menopausal women with endometriosis,” Bulun said. Moreover, treatment with an aromatase inhibitor is a very good option for premenopausal women with endometriosis not responding to existing treatments, he said.

Another molecular abnormality Bulun found is that women with endometriosis have a progesterone receptor that is inappropriately turned off.

In the absence of appropriate progesterone action, endometriosis tissue remains inflamed and continues to grow.

“This may be a disease that women are born with. Perhaps when a baby girl is born, it has already been determined that she is predisposed to have endometriosis,” Bulun said.

“Maybe research can now be directed toward the fetal origins of the disease and raise the awareness of how the disease develops,” he added.(ANI)