Posts Tagged ‘private’

Breast radiation trial provides more convenience, better compliance, lowered cost and patient outcomes on par with current treatment

These interim results of the 5-year Phase II clinical trial using the experimental regimen are being presented at the Breast Cancer Symposium 2014 in San Francisco by Anthony E. Dragun, M.D., vice chair and associate professor of radiation oncology at the University of Louisville.

Dragun, a radiation oncologist with University of Louisville Physicians, launched the trial three years ago at UofL’s James Graham Brown Cancer Center, a part of KentuckyOne Health and the only site offering the experimental regimen in the United States. A second KentuckyOne Health site is being planned, he said, and is expected to begin enrolling patients this autumn.

Reviewing data from Europe — the United Kingdom in particular — Dragun found an alternative to the currently standard daily radiation treatments prescribed to patients after a lumpectomy. Physicians in the U.K. and other European countries were reporting excellent results with a regimen of radiation administered once-weekly.

“Instead of daily treatments for 25-30 days, five to six treatments administered once each week were being used,” he said. “I thought this regimen would give our patients here in Kentucky a great deal of access and choice, so we developed the trial and launched it in 2011.”

Approximately 150 female patients have been enrolled in the trial thus far, he said. Patients undergoing a lumpectomy following diagnosis of breast cancer are given a choice of the current standard of daily radiation treatments or the option to enroll in the trial and receive treatment one time per week.

The radiation dosing has been calibrated to compensate for the change in how the treatments are administered, but no adverse effects have been seen, Dragun said. “The outcomes with once-weekly treatments are absolutely in line with what we see in daily breast irradiation,” he said. “The standard of care is maintained.”

Giving women the choice of how their treatment is administered means more women complete their treatment, he said. “Finding time for daily treatments for 6 weeks or more just isn’t possible for many women,” Dragun said. “Scheduling once-weekly treatments is much easier to fit into the busy lives our patients lead.

“We also see many patients who depend on public transportation or live in rural areas that are 30 miles or more from our center, and they have told us that they would not have been able to complete a traditional course of daily radiation treatment. Their only alternative would be a mastectomy,” he said.

Because radiation treatment is reimbursed on a per-treatment basis, Dragun said the overall cost is lowered. “We have reduced the number of treatments to about one-fourth to one-third of what the current daily treatment regimen is,” he said. “Medicare reimburses radiation costs on a per-treatment basis, and most private insurers do likewise.

“This means we’ve been able to reduce the cost by 50 to 60 percent without jeopardizing the quality of care.”

Dragun plans to enroll another 50 patients at the Louisville site and 30 at the future trial site. After the completion of this trial, he intends to expand into a multi-center Phase III trial at facilities in other states.

“We believe the once-weekly regimen such as this will become a standard option in the next decade,” he said.

source : http://www.sciencedaily.com/releases/2014/09/140904121041.htm

Preclinical development of tumor therapeutic agent begins

amcure, one of the partners of which is KIT, now plans to use the funds acquired for the further development of candidate agents identified by the team of Dr. Veronique Orian-Rousseau, KIT, for the treatment of metastatic tumors. The candidate substances bind specifically to a certain so-called isoform of the surface molecule CD44 and, thus, specifically interfere with central signal paths of tumor growth, while other types of cells remain unaffected. New formation of blood vessels supplying the tumor (angiogenesis) and migration of cancer cells and their invasion into other organs (development of metastases) are inhibited. “Data from animal tests reveal that our molecules do not only stop the growth of primary tumors, but may also prevent metastasis development and cause the regression of existing metastases,” says Dr. Alexandra Matzke, Chief Scientific Officer of amcure. The clinical studies that are to start in the next years will show whether these positive effects will also occur in human patients without any side effects.

The target molecule of amcure’s development candidates, CD44v6, plays a significant role for many types of tumors. It was discovered in the 1990s by Professor Helmut Ponta and his team at KIT. CD44 and its isoforms are increasingly considered significant factors for the spreading and formation of metastases. Blocking the receptor CD44v6 might open up opportunities for a wide-ranging application in tumor therapy.

“If these observations will be confirmed by clinical trials with patients, amcure can lay the foundation for treating tumors much more effectively and with far fewer side effects,” emphasizes Dr. Harald Poth, Senior Investment Manager of LBBW Venture Capital.

The next development steps will be funded by a consortium headed by LBBW Venture Capital, with participations from KfW, MBG Mittelst√§ndische Beteiligungsgesellschaft Baden-W√ľrttemberg, S-Kap Beteiligungen Pforzheim, BioM AG as well as private investors. In addition, the company receives funding by the Federal Ministry of Education and Research (BMBF) under the special program Spinnovator managed by Ascenion GmbH. The funds are so-called series A funds provided by venture capital investors to support growth of the young KIT spinoff in the next years. Prior to and during the establishment of the company, amcure was financed by its partner KIT and the Helmholtz Association as well as from federal funds.

“The consortium around LBBW Venture consists of experienced investors having extensive networks. We are happy to have convinced them of our development approach so that now the next steps in the preclinical and clinical stages can be financed,” says Dr. Matthias Klaften, Chief Executive Officer of amcure.

source : http://www.sciencedaily.com/releases/2014/08/140827091948.htm

Genetic testing of tumor is recommended for colorectal cancer patients

Universal Tumor Testing

Universal genetic testing of the tumors for evidence of mismatch repair (MMR) deficiency of newly diagnosed colorectal cancer patients is recommended for several reasons:

1. Use of clinical criteria and prediction models to identify patients with Lynch syndrome have less than optimal sensitivity and specificity.

2. It has been shown to be cost effective for the diagnosis of Lynch syndrome.

3. It has greater sensitivity for identification of Lynch syndrome compared with other strategies, including Bethesda guidelines, or a selective tumor testing strategy.

Genetic Counseling and Confirmatory Germline Genetic Testing

Individuals whose tumor shows evidence of MMR deficiency, have a known MMR gene mutation in the family, who meet clinical criteria for Lynch syndrome, or who have a personal risk of greater than or equal to 5 percent chance of Lynch syndrome based on prediction models should undergo a genetic evaluation for Lynch syndrome. Germline genetic testing has the following advantages:

1. It can confirm a diagnosis of Lynch syndrome in the patient.

2. It can determine the status of at-risk family members in families in which disease mutation has been found.

3. It can direct the management of affected and unaffected individuals.

Management of Lynch Syndrome

Patients with Lynch syndrome are at an increased risk of developing colorectal cancer, as well as cancers outside of the colon. The U.S. Multi-Society Task Force on Colorectal Cancer recommends that annual history, physical examination, and patient and family education regarding the risk of cancer should start between the ages of 20 and 25 years. In addition, the following recommendations are made for patients with or at risk of Lynch syndrome:

  • Colorectal cancer
    • Colonoscopy screening every one to two years beginning at ages 20 to 25, or two to five years younger than the youngest age of CRC diagnosis in the family, if the diagnosis was before the age of 25.
  • Endometrial cancer
    • Conduct pelvic exam screening and endometrial sampling annually starting between the ages of 30 and 35.
  • Ovarian cancer
    • Start annual transvaginal ultrasound screening at ages 30 to 35.
    • Hysterectomy and bilaterial salpingo-oophorectomy is recommended for women with Lynch syndrome at age 40 or after childbearing is complete.
  • Gastric cancer
    • Screen via endoscopy with gastric biopsy beginning at ages 30 to 35. Continue every two to three years based on patient risk factors.
  • Urinary cancer
    • Conduct annual urinalysis starting at ages 30 to 35.

Routine screening of the small intestine, pancreas, prostate and breasts are not recommended.

Treatment

There are two treatments recommended for patients affected with Lynch syndrome:

1. Removal of the large intestine: Colectomy with ileorectal anastomosis, which removes the large intestine and attaches the small intestine to the rectum, is the primary treatment for patients affected by Lynch syndrome who have colon cancer or precancerous colon polyps that cannot be removed by colonoscopy. Less extensive surgery can be considered for patients older than 60 to 65 years of age.

2. Aspirin therapy: There is growing evidence that the use of aspirin is beneficial in preventing cancer in Lynch syndrome patients. While the evidence is not conclusive, treatment of an individual patient with aspirin is a consideration after discussing patient-specific risks, benefits and uncertainties of treatment.

In the U.S., colorectal cancer is a major health problem — it is the second leading cause of cancer death, causing nearly 51,000 deaths each year. Environmental causes and inheritance play varying roles in different patients with colorectal cancer. About 20 to 30 percent of colorectal cancer patients appear to have a familial risk and a minority has a genetic mutation that contributed to the development of the disease.

The U.S. Multi-Society Task Force on Colorectal Cancer is composed of gastroenterology specialists with a special interest in colorectal cancer, representing the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy. Experts on Lynch syndrome from academia and private practice were invited authors of this guideline. Representatives of the Collaborative Group of the Americans on Inherited Colorectal Cancers and the American Society of Colon and Rectal Surgeons also reviewed the manuscript.

The consensus statement, “Guidelines on Genetic Evaluation and Management of Lynch Syndrome: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer,” is published in Gastroenterology, the official journal of the AGA Institute; American Journal of Gastroenterology, the official journal of ACG; Diseases of the Colon & Rectum, the official journal of ASCRS; and GIE: Gastrointestinal Endoscopy, the official journal of ASGE.

source : http://www.sciencedaily.com/releases/2014/08/140805132150.htm