The American Society for Gastrointestinal Endoscopy (ASGE) and the Pancreatic Cancer Action Network are teaming up this November to raise awareness about pancreatic cancer, educating patients about the disease and the resources that are available for them.

Pancreatic cancer is the fourth leading cause of cancer deaths in the U.S. In 2008, an estimated 37,680 Americans will be diagnosed with pancreatic cancer and 34,290 will die from the disease. Seventy-five percent of pancreatic cancer patients die within the first year of their diagnosis and only five percent survive more than five years. Unfortunately, it is one of the few cancers for which survival has not improved substantially over the past 25 years. Men are 20 percent more likely to get pancreatic cancer than women and the majority of cases occur in people over the age of 65. The incidence rate among African Americans is 40 to 50 percent higher than other ethnic groups.

“While the statistics on pancreatic cancer are sobering, it is important for patients to know that treatment does exist for pancreatic cancer. Clinical trials can provide important treatment options beyond what is currently available,” said Mark B. Pochapin, MD, chair of ASGE’s Public and Member Outreach Committee and member of the Pancreatic Cancer Action Network’s Medical Advisory Council. In addition, advanced technologies are allowing for the diagnosis of pancreatic cancer at earlier, more treatable stages.ASGE and the Pancreatic Cancer Action Network encourage patients and their families to become educated about the disease, to ask their doctor about treatments and to reach out for support. The organization’s Patient and Liaison Services program and Survivor Caregiver Network can be accessed at www.pancan.org to help patients diagnosed with this disease.

About Pancreatic Cancer

The pancreas is a gland deep in the abdomen, behind the stomach, that is part of the digestive and endocrine systems. The pancreas makes juices that help with digestion (enzymes) as well as important hormones such as insulin that control the level of sugar in the bloodstream. Pancreatic cancer is difficult to diagnose early, as the symptoms are often minor or non-existent until the tumor has extended outside the pancreas. Once outside the pancreas, the tumor invades a number of adjacent organs and is usually not amenable to surgical resection. There are no reliable early diagnostic tests for pancreatic cancer.

Scientific research is in the basic stages. Advancing pancreatic cancer research into the 21st century is dependent upon the increase of basic science research. Pancreatic cancer risk factors need to be identified and verified before research about prevention methods can begin. Recent research studies indicate that approximately 10 percent of pancreatic cancer cases are familial and another 30 percent are thought to result from cigarette smoking. Some other risk factors scientists are currently studying include: diabetes, chronic and hereditary pancreatitis (inflammation of the pancreas), obesity, physical activity, and diet.

“Screening for pancreatic cancer in relatives of affected people is not often done in the United States,” said Pochapin. “However, families with many cases of pancreatic cancer or close relatives of people who developed pancreatic cancer at an early age should seek the advice of a specialist such as a gastroenterologist or oncologist, as there are specific genetic syndromes that may increase susceptibility for pancreatic cancer.”

Symptoms and Detection

Since the pancreas is near the drainage tubes for bile and digestive enzymes, a mass in the pancreas can block the flow of these substances into the small intestine. This can cause the skin and eyes to turn yellow (jaundice) and the stool to turn pale. It can also cause pain, weight loss, nausea, vomiting, and itchy skin. The symptoms of pancreatic cancer can be confused with those of benign diseases such as arthritis (back pain), gallstones (jaundice) or chronic pancreatitis (pain, diarrhea, weight loss). Unfortunately, by the time most patients develop symptoms, the cancer is usually advanced and difficult to treat.

A variety of tests are used to detect and understand the extent or stage of the disease. It is important to detect pancreatic cancer at its earliest and most treatable stage. Precise staging helps determine what treatment course is best and what alternatives (such as participation in a clinical trial) might be appropriate.

After a physical examination and some basic blood tests, most patients get scanned with a CT (computerized tomography) or “CAT” scan. CT scans and MRI (magnetic resonance imaging) provide a detailed view of the pancreas and neighboring organs. A very important test, usually performed after a CT or MRI scan, is endoscopic ultrasound (EUS). EUS allows specially trained doctors known as endoscopists to obtain highly detailed pictures of the pancreas and to get a biopsy of any abnormalities seen. This type of biopsy is known as fine needle aspiration, or FNA. This technique uses a thin, flexible camera (combined with a tiny ultrasound device) that is passed gently through the mouth and into the stomach.
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Disparities in cervical cancer survival can be traced to differences in access to care for certain racial, ethnic and socioeconomic groups, according to a University of Miami Miller School of Medicine study of more than 5,300 Florida women. A team of researchers at the Miller School found that racial, ethnic and socioeconomic factors led to late-stage diagnosis and under-treatment of the disease, especially for women who are African-American or poor.

The results indicate that strategies that aim to reduce disparities in cervical cancer survival should be focused on improved screening and treatment. The findings are published online in CANCER, a peer-reviewed journal of the American Cancer Society.

Despite recent efforts to equalize care for all patients, disparities in cancer survival remain a considerable problem. Kathleen Brookfield, M.D., Ph.D. led a team of Miller School physicians and scientists who analyzed data from a large Florida cancer registry, in the hopes of pinpointing criteria that lead to the disparity. The researchers identified 5,367 residents diagnosed with invasive tumors of the cervix between 1998 and 2003.
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Under a ‘National Awareness and Early Diagnosis Initiative’ (NAEDI), launched by the Department of Health last week, work is already underway in the UK to improve public awareness and fast referral of cancer, with pilot schemes in 20 Primary Care Trusts (PCTs) run by the Improvement Foundation.

The Improvement Foundation is working with 20 PCTs in 60 specific communities. The first wave of the two-year programme will be completed in September 2009; the second wave continues until August 2010. Focused on early presentation of lung, breast and bowel cancer, the aim is to increase the number of people seeking advice, and encourage them to seek treatment earlier. As part of this the PCT teams identify and deliver locally-tailored ways of raising awareness about the risk factors and the benefits of earlier diagnosis.

There are two strands to the cancer programme:

- Work in the local communities to help educate and raise awareness of the symptoms of cancer, and when people should get in touch with their GP. The teams test ways of delivering health-related information in an understandable and acceptable way, to get people to present to their GP earlier.

- Working with GPs to improve early diagnosis in primary care and referral for investigation in accordance with best clinical practice.

Through this programme, the Improvement Foundation supports local people in deprived areas, raising their expectations and helping them to drive improvement in their own communities, working closely with local clinicians and voluntary agencies. Meetings are held in community centres, pubs, clubs, bingo halls and mosques. The aim is to get people to start talking about bowels and breasts and coughs, to find out what people know about cancer and to stimulate discussion.

The Improvement Foundation’s approach views local people as the key to understanding how their communities work. This programme is unique to the Improvement Foundation and is not being done anywhere else in the world.
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Breast cancer rates increased significantly in four Norwegian counties after women there began undergoing mammography every two years, according to a report in the November 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Rates among regularly screened women remained higher than rates among women of the same age who were screened only once after six years, suggesting that some of the cancers detected by mammography may have spontaneously regressed had they not been discovered and treated.

Throughout Europe, the start of screening mammography programs has been associated with increased incidence of breast cancer, according to background information in the article. “If all of these newly detected cancers were destined to progress and become clinically evident as women age, a fall in incidence among older women should soon follow,” the authors write. “The fact that this decrease is not evident raises the question: What is the natural history of these additional screen-detected cancers?”

Per-Henrik Zahl, M.D., Ph.D., of the Norwegian Institute of Public Health, Oslo, and colleagues examined breast cancer rates among 119,472 women age 50 to 64 who were all invited to participate in three rounds of screening mammograms between 1996 and 2001 as part of the Norwegian Breast Cancer Screening Program. They compared these to rates among a control group of 109,784 women age 50 to 64 in 1992, who would have been invited for screening if the program had existed at that time. Cancers were tracked for six years using a national registry, and at the end of that time all participants were invited to undergo a one-time screening to assess breast cancer prevalence.

As anticipated, breast cancer rates were higher among screened women than among the control group before the final prevalence screening. “Even after prevalence screening in controls, however, the cumulative incidence of invasive breast cancer remained 22 percent higher in the screened group,” the authors write. Of every 100,000 screened women, 1,909 had breast cancer during the six-year period, compared with 1,564 of every 100,000 in the control group. Screened women were more likely to have breast cancer at every age.

“Because the cumulative incidence among controls never reached that of the screened group, it appears that some breast cancers detected by repeated mammographic screening would not persist to be detectable by a single mammogram at the end of six years,” the authors write. “This raises the possibility that the natural course of some screen-detected invasive breast cancers is to spontaneously regress.”
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Inactivation of a specific protein associated with cancer development halts prostate tumor progression in animal model

Los Angeles, Calif. Nov. 24, 2008 California (USC) have found that inactivating a specific biomarker for aggressive prostate cancer blocks the development of prostate cancer in animal models.
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A coalition of European cancer specialists today called for major changes in the provision of emotional support for lung cancer patients. In conjunction with the International Psycho-Oncology Society, they issued a Mandate for Change, highlighting basic rights for patients in terms of their emotional wellbeing and quality of life.
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Dr Alexis Willett from Breakthrough Breast Cancer says:

“This research puts forward an interesting theory about breast cancer development. However, it is not currently possible to predict whether early changes picked up by breast screening will progress so treatment is usually offered to prevent breast cancer developing.
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The Russian regulatory body has approved YONDELIS® (trabectedin) for the treatment of soft tissue sarcoma in adults. This represents another approval for YONDELIS® for treatment soft tissue sarcoma (STS) following upon its approval in Europe in September 2007, which opens up new opportunities in markets with enormous growth potential. Under the licensing agreement with Ortho Biotech Products, L.P., PharmaMar will receive royalties on sales of YONDELIS® in Russia.

According to the licensing agreement, PharmaMar has rights to market the compound in Europe and Japan, while Ortho Biotech Products, L.P. has marketing rights for the product in the rest of the world.

YONDELIS® is currently being marketed in the European Union for the treatment of STS in adults after the failure of standard therapy. PharmaMar plans to submit a Marketing Authorization Application for YONDELIS for the treatment of ovarian cancer to the EMEA in December 2008.

YONDELIS® has been designated orphan drug for the treatment of STS and ovarian cancer in the European Union, United States and Switzerland. There are also 2 ongoing studies: A multicentre, phase III study of YONDELIS as a first-line therapy in patients with tumours bearing translocations, and a Phase II in children with recurrent rhabdomyosarcoma, Ewing sarcoma, and non-rabdomyosarcomatous STS.

YONDELIS is also being studied by PharmaMar as a treatment for high incidence and prevalence solid tumours such as prostate, breast, and lung cancer.
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NovoCure Ltd. presented results evaluating the Novo-TTF device in vitro and in a pilot clinical trial that showed the device enhanced the efficacy of standard chemotherapy (temozolomide) treatment in newly-diagnosed glioblastoma multiforme (GBM) patients. When used in combination with standard chemotherapy, the Novo-TTF, a non-invasive medical device that uses low intensity alternating electric fields to destroy cancer cells, enhanced the anti-tumor effects of standard chemotherapy, thus prolonging time to disease progression and extending survival.

This pilot trial, which was presented during the Society of Neuro-Oncology (SNO) annual meeting in Las Vegas, NV, showed that combination therapy prolonged time to disease progression by nearly 31 months and increased survival by more than 25 months compared to historical results of patients receiving standard chemotherapy alone. Patients in the study did not experience any device-related, systemic, adverse events. The in vitro study, which was also presented during the annual meeting, mirrored these effects when applying both treatments together to GBM cells in culture.

“The pilot study further demonstrated that the NovoTTF device can be applied over an extended period of time without significant toxicity. These results are promising as NovoCure continues to evaluate the use of the device in combination with standard-of-care chemotherapies,” said Eilon Kirson, MD, Medical Director, NovoCure Ltd. “This data adds to the growing body of evidence of Novo-TTF’s potential to enhance standard therapy and potentially improve patient outcomes.”

The Novo-TTF device disrupts cancer cell proliferation and tumor growth by generating low intensity, intermediate frequency, alternating electric fields within a tumor. These electric fields exert forces on polar structures within the dividing cancer cells that prevent tumor growth. In pre-clinical and clinical studies to date, the electric fields have shown no effect on non-dividing, healthy cells in the same region, suggesting that the device can treat cancer without harming surrounding tissue, unlike chemotherapies that are typically associated with high toxicity resulting in serious side effects. The Novo-TTF is currently an investigational medical device and is not yet FDA approved.
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Allos Therapeutics, Inc. (Nasdaq: ALTH), a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the Company’s novel antifolate, pralatrexate (PDX), for the treatment of patients with diffuse large B-cell lymphoma.

“We are pleased with this designation, which highlights the need for novel therapies to treat lymphoma,” said Paul L. Berns, President and Chief Executive Officer. “Pralatrexate previously received orphan drug designation from the FDA for the treatment of patients with T-cell lymphoma. This additional designation reinforces our intention to further evaluate pralatrexate as a potential treatment for patients with B-cell lymphoma.”

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the Orphan Drug Act, the FDA will not accept or approve other marketing applications from other sponsors to market the identical active moiety for the same therapeutic indication for a seven-year period once a designated orphan drug is approved for marketing. In addition to potential market exclusivity, orphan drug designation provides potential protocol assistance, advice on the conduct of clinical trials, tax credits for clinical research expenses, grant funding for research of rare disease treatments and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee for the drug’s sponsor.
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