12/16/2005 9:01:00 AM EST

Direct-to-consumer advertising promoting the use of erythropoietin to alleviate cancer-related fatigue fails to point out that the drug is only effective against fatigue caused by anemia. However, anemia is not a significant cause of fatigue in most cancer patients, according to a study in the December issue (Volume 8, Number 6) of Journal of Palliative Medicine, a peer-reviewed publication of Mary Ann Liebert, Inc., and the official journal of the American Academy of Hospice and Palliative Medicine. The paper is available free online at http://www.liebertonline.com/doi/pdf/10.1089/jpm.2005.8.1144

Fatigue is one of the most common and debilitating symptoms for patients with cancer, affecting as many as 80% of patients. It can be devastating–making even routine tasks like going to work, shopping, or doing daily chores exhausting. Fatigue can, in turn, lead to hopelessness and despair. Current direct-to-consumer advertising in the U.S. gives the mistaken impression that anemia is the only cause of fatigue from cancer and chemotherapy. Further, the ads give false hope, implying that a drug to treat anemia will make everything better.
(full story…)

Multigraph
A free service of the Prostate Cancer Research and Education Foundation

MultiGraphs can be simple or complicated. You can preview thumbnails of the two types available free from PCREF.

Sometimes it is useful to see a graphical picture of your medical history, correlating in time the history of your PSA and other data with your tests and treatments. A MultiGraph is a one-page summary of PSA and any other numerical data you may have, other test results, and treatment starts and stops.

There are two ways of getting your first MultiGraph:
1. Enter your data online
or
2. Create a chronological digest file ….

Sick and Vulnerable, Workers Fear for Health and Their Jobs - New York Times
This story is free online, requires free registration. All the stories in the series Being a Patient are archived, and free to read.

Excerpts below, my comments in italics.

By LISA BELKIN
Published: December 17, 2005

When Marty Domitrovich was first told that he had cancer, he was a 51-year-old sales executive, so successful that he had two goals: to reach $1 million in commissions and bonuses and to become chief executive of his company, where he had worked since his summers in college.

Before long, however, he could no longer travel, and on the bad days he did his work at home, lying on the couch and talking on the telephone.
When Shannon Abert was first told she had scleroderma, she was 35, and an employee is treated after crossing the stark line from worker to patient is broadly defined by legislation. But it is more specifically determined by things like the culture of a workplace and the sensitivity of a boss….

“The diagnosis is a crisis in itself,” said Carolyn Messner, an oncology social worker and director of education and training for cancer care in Manhattan. “The next crisis is telling people.”
(full story…)

As reported by the Indychannel.coml:

BLOOMINGTON, Ind. — Researchers in Indiana are searching for people who have recurrent prostate cancer. Doctors at the Indiana University School of Medicine are testing a procedure sing sound waves to zap malignant tissue without destroying healthy tissue. The procedure is done in the doctor’s office. Participants must be between the ages of 40 and 80 and have had radiation to treat prostate cancer.

Further information by calling (317) 278-3434.

What it means — Indiana University Cancer Center, Indianapolis, Indiana, 46202-52 is recruiting for a trial of Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer

Aim is to “Determine the ability of Sonablate to focus ultrasound waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with locally recurrent prostate cancer.”

Doctor in charge, Michael O. Koch, MD, Study Chair, Indiana University School of Medicine

A free, illustrated section in the journal NATURE

Insight: Angiogenesis Vol. 438, No. 7070 pp889-1050

Health News Article | Reuters.com
NEW YORK (Reuters Health) - A high lean body mass - calculated using an equation to determine body mass minus the fat — may lower the risk of prostate cancer, a new study indicates.

Prostate cancer is a hormone-related disease affected by a variety of other factors including genetics, age, ethnicity and family history. In the last few years, researchers started to suspect that body size might also affect the risk of prostate cancer, but research has provided conflicting results.

Most studies investigated body mass index, but this index includes lean and fat tissue, which may have different influences on the risk of cancer.

In an attempt to settle things, Dr. John S. Witte from the University of California, San Francisco,
(full story…)

News - UCI receives $9.5 million prostate cancer grant
UCI receives $9.5 million prostate cancer grant
Grant is among 10th largest received by the school.

By GARY ROBBINS
The Orange County Register

The federal government has awarded UC Irvine $9.5 million to develop a way to forecast the outcome of a person’s prostate cancer at the time they’re diagnosed, campus officials said today.

The grant is among the 10 largest in the university’s history and will be overseen by pathologist Dan Mercola, who will lead a team of scientists from UCI’s School of Medicine.

“The goal of the new study is to develop a ‘gene signature’ of prostate cancer for newly diagosed patients based on a tumor biopsy or blood examination,” UCI says in a news release. “This signature will let patients know if they have an aggressive form of cancer — allowing them to better understand their disease and make crucial decisions for appropriate early-stage treatment.”

Mercola said in the release, “We are aiming to meet a critical unmet need in prostate cancer treatment. Up to 30 perconet of men with prostate cancer do not need radical treatments like radiation or surgery, and this test will allow us to determine who these people are.”

psa-rising note: The money comes from NCI (National Cancer Institute) SPECS award:
http://www.cancer.gov/newscenter/pressreleases/SPECSawards

You’ve probably had your ‘flu shot. Have you ever had a pneumonia shot?

Pneumonia - a bacterial infection in the lungs - is a common complication from the flu. In addition to a flu shot every fall, it’s a good idea to get a shot of pneumococcal vaccine. Older people may require only one in a lifetime, but especially if you are a cancer patient, it’s good to know it can be repeated every 6 years.
(full story…)

MO’ MONEY: Matt Hernan, Adrian Hills, Andrew Campbell, Stuart Styles, Kingsley Baldwin and Brad Turner show off the moustaches they grew during November to raise money for research into prostate cancer.

Miners’ moustaches fund cancer research
Monday, 5 December 2005

BENDIGO Mining employees helped raise over $850 for research into Prostate Cancer by growing moustaches last month.
(full story…)

GPC Biotech completes enrolment in phase III trial for cancer drug Satraplatin
AFX News Limited/Forbes.com, 12.05.2005

MARTINSRIED, Germany (AFX) - GPC Biotech AG said it has completed the targeted enrolment of patients for its Phase III trial of the Satraplatin drug to treat hormone-refractory prostate cancer (HRPC).

The Germany biotech company said more than 200 clinical sites in fifteen countries have now accrued a total of 912 patients for the trial.

The trial, named SPARC (Satraplatin and Prednisone Against Refractory Cancer), is a double blind, randomised study that is assessing the safety and efficacy of Satraplatin in combination with prednisone as a second-line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).
(full story…)

New Study Suggests Artificial Sweetener Causes Cancer in Rats at Levels Currently Approved for Humans

Report in Environmental Health Perspectives calls for reevaluation of acceptable limits of aspartame consumption

November 17, 2005 [Research Triangle Park, NC] ] A statistically significant increase in the incidence of malignant tumors, lymphomas and leukemias in rats exposed to varying doses of aspartame appears to link the artificial sweetener to a high carcinogenicity rate, according to a study accepted for publication today by the peer-reviewed journal Environmental Health Perspectives (EHP).

The authors of the study, the first to demonstrate multipotential carcinogenic effects of aspartame administered to rats in feed, called for an “urgent reevaluation” of the current guidelines for the use and consumption of this compound.

“Our study has shown that aspartame is a multipotential carcinogenic compound whose carcinogenic effects are also evident at a daily dose of 20 milligrams per kilogram of body weight (mg/kg), notably less than the current acceptable daily intake for humans,” the authors write. Currently, the acceptable daily intake for humans is set at 50 mg/kg in the United States and 40 mg/kg in Europe.

Aspartame is the second most widely used artificial sweetener in the world. It is found in more than 6,000 products including carbonated and powdered soft drinks, hot chocolate, chewing gum, candy, desserts, yogurt, and tabletop sweeteners, as well as some pharmaceutical products like vitamins and sugar-free cough drops. More than 200 million people worldwide consume it. The sweetener has been used for more than 30 years, having first been approved by the FDA in 1974. Studies of the carcinogenicity of aspartame performed by its producers have been negative.

Researchers administered aspartame to Sprague-Dawley rats by adding it to a standard diet. They began studying the rats at 8 weeks of age and continued until the spontaneous death of each rat. Treatment groups received feed that contained concentrations of aspartame at dosages simulating human daily intakes of 5,000, 2,500, 500, 100, 20, and 4 mg/kg body weight. Groups consisted of 100 males and 100 females at each of the three highest dosages and 150 males and 150 females at all lower dosages and controls.

The experiment ended after the death of the last animal at 159 weeks. At spontaneous death, each animal underwent examination for microscopic changes in all organs and tissues, a process different from the aspartame studies conducted 30 years ago and one that was designed to allow aspartame to fully express any carcinogenic potential.

The treated animals showed extensive evidence of malignant cancers including lymphomas, leukemias, and tumors at multiple organ sites in both males and females. The authors speculate the increase in lymphomas and leukemias may be related to one of the metabolites in aspartame, namely methanol, which is metabolized in both rats and humans to formaldehyde. Both methanol and formaldehyde have shown links to lymphomas and leukemias in other long-term experiments by the same authors.

The current study included more animals over a longer period than earlier studies. “In our opinion, previous studies did not comply with today’s basic requirements for testing the carcinogenic potential of a physical or chemical agent, in particular concerning the number of rodents for each experimental group (40-86, compared to 100-150 in the current study) and the termination of previous studies at only 110 weeks of age of the animals,” the study authors wrote.

The authors of the study were Morando Soffritti, Fiorella Belpoggi, Davide Degli Esposti, Luca Lambertini, Eva Tibaldi, and Anna Rigano of the Cesare Maltoni Cancer Research Center, Oncology Ramazzini Foundation of Environmental and Environmental Sciences, Bologna, Italy. Funding for the research was provided by the Oncology Ramazzini Foundation of Environmental and Environmental Sciences, Bologna, Italy. The article is available free of charge at http://ehp.niehs.nih.gov/docs/2005/8711/abstract.html.

EHP is published by the National Institute of Environmental Health Sciences (NIEHS), part of the U.S. Department of Health and Human Services. EHP EHP is an Open Access journal. More information is available online at http://www.ehponline.org/. Brogan & Partners Convergence Marketing handles marketing and public relations for EHP, and is responsible for creation and distribution of this press release.

As reported, A Protein That Helps Maintain Vitamin E Levels Suppresses Prostate Cancer, University of Rochester Medical Center researchers have found a protein that helps prostate cancer cells retain vitamin E. This helps vitamin E to limit the growth of the cancer.

The protein, which they call alpha tocopherol associated protein, or TAP, suppresses growth of the cancer by disrupting an important signaling pathway in prostate cancer cells.

A reader asks, for men with prostate cancer would it help to take a high quality vitamin E pill?

We don’t really know. Last year a controversial study from Johns Hopkins found that, especially in older people, consumption of current maximum dose of vitamin E was associated with a higher death rate.

(full story…)

Our friend in Israel, Lenny Hirsch, has been fighting a lonely battle to try to get the health plan in his country to provide men with advanced prostate cancer a chance to receive Taxotere (docetaxel). Taxotere is the only chemotherapy drug so far proven to extend the lives of men with advanced metastatic prostate cancer. In Israel and in some European countries many men are not diagnosed until the disease has already spread outside the prostate — and then, as Lenny describes in his article “Sad Day,” they are not even able to receive chemotherapy.

Well, it’s no better in Scotland. Prostate cancer affects one in 15 men in Scotland. It is the UK’s most common form of male cancer and in the UK it has a much higher death rate than in the USA. It affects more than 30,000 UK men each year, killing 10,000 - at least one per hour. Now men in Scotland suffering from advanced prostate cancer have been told they cannot receive Taxotere.

“Men in Scotland with prostate cancer will not receive a life-prolonging drug on the NHS because it is too expensive,” BBC reports. They mean Taxotere.
(full story…)

Dendreon Announces FDA Grants Fast Track Status for Provenge

Earlier:
Dendreon’s Phase 3 Trial Shows Provenge Vaccine Extends Survival in Patients with Advanced Prostate Cancer Oct 28, 2004

Meanwhile in Europe:
Dendreon’s Second Randomized Phase 3 D9902A Trial of Provenge Extends Survival in Patients with Advanced Prostate Cancer

PARIS, FRANCE, October 31, 2005 – Dendreon Corporation (Nasdaq: DNDN) today announced that final results of its second Phase 3 study (D9902A) of PROVENGE® (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference. Researchers concluded that these results are consistent with the results from the Company’s first Phase 3 study (D9901). The Company recently announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.

“The combined data from the trials of PROVENGE versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, androgen-independent prostate cancer,” reported Celestia S. Higano, M.D., director and associate professor of the Genitourinary Oncology Clinical Research Group at the University of Washington, Seattle, who presented the data. “Given the favorable side effect profile, PROVENGE may provide a useful alternative for men prior to initiating chemotherapy.”
Study Results
(full story…)

NEW YORK (Reuters Health) Sept 12 - Treatment with vitamin C or ascorbate at high levels, which can be attained if administered intravenously, can selectively destroy cancer cells, new research indicates.
(full story…)

Prostate cancer patients are lobbying the FDA for approval of Abbot’s oral anti-cancer drug Xinlay (atrasentan), but the FDA is not impressed with the drug.

Abbott Laboratories Inc. did not provide clear evidence of effectiveness for Xinlay, U.S. Food and Drug Administration staff said in a preliminary report on Monday.

Studies of Xinlay also raised “serious cardiovascular safety issues,” the FDA staff said in a report posted on the FDA’s Web site.

In the only trial sufficient to evaluate for approval, Xinlay “does not demonstrate any clear evidence of clinical efficacy” in prostate cancer that has failed to respond to standard hormone therapy, the FDA staff report said.

Abbott, in a separate summary on the FDA Web site, said “the weight of evidence suggests that (Xinlay) provides measurable clinical benefit with a manageable safety profile.”

A panel of experts from outside the FDA is scheduled to decide Tuesday whether to recommend Xinlay for approval. The committee will consider the FDA staff comments, as well as arguments from Abbott.
(full story…)

FDA’s Oncologic Drugs Advisory Committe hearing in Washington, DC on Abbott Lab’s application for approval of Xinlay (Atrasentan) will be held Sept 13. Details for this and other drug applications scheduled for hearings on 13th and 14th, below.

Center: CDER

Date and time:
September 13, 2005, 8:00 a.m. - 5:00 p.m.
September 14, 2005, 8:00 a.m. - 5:00 p.m.

Location:
Holiday Inn
The Ballrooms
8120 Wisconsin Ave.
Bethesda, MD

Open Public Hearing: Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both
September 13 and 14, 2005.

Agenda:
On September 13, 2005, the committee will discuss the following: (1) new drug application (NDA) 21-491, proposed trade name XINLAY (atrasentan hydrochloride) Capsules, Abbott Laboratories, proposed indication for the treatment of men with metastatic hormone-refractory prostate cancer; and (2) NDA 21-743, S003, TARCEVA (erlotinib) TABLETS, OSI Pharmaceuticals Inc., proposed indication for the first-line treatment, in combination with gemcitabine, of patients with locally advanced, unresectable or metastatic
pancreatic cancer.

On September 14, 2005, the committee will discuss the following: (1) NDA 21-880, proposed trade name REVLIMID (lenalidomide), Celgene Corp., proposed indication for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; and (2) NDA 21-877, proposed trade name ARRANON (nelarabine) Injection, GlaxoSmithKline, proposed indication for the treatment of
patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed with, at least two chemotherapy regimens.

Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).

Procedure (Open Public Hearing):
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by September 2, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 2, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Johanna Clifford at 301-827-7001, at least 7 days in advance of the meeting.

Contact Person:
Johanna M. Clifford, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: [email protected]

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512542.

NPCC Suspends Regular Screenings, Lends Support to Hurricane Survivors
A big purple vehicle identified with the fight against cancer is now in the race to save lives in New Orleans.

The Drive Against Prostate Cancer, the world’s most successful mobile prostate cancer screening vehicle (over 35,000 tests in four years), has switched operations to help the survivors of Hurricane Katrina. Full Story “Upfront”

ASCO - Hurricane Katrina Message Board
Date: September 07, 2005, 01:48 AM
From: Physicians Relief Org.
Location: Baton Rouge, LA

We have four physicians in the area and can provide transportation for patients needing to reach oncology practices to continue ongoing treatment. Please call us at 434-227-6900 if the need arises.

The Drive Against Prostate Cancer is headed to Louisiana as soon as we get a
location from the command center. The vehicle will be used for general
medical care. We are doing what we can to help during the crisis. Prostate
Cancer Awareness Month is about saving lives, we are just doing it a little
differently this year. The next prostate cancer screening event with the
Drive will be at Cruisin’ for a Cure in California on September 23 and 24.

–Skip

Skip Lockwood
Executive Vice President and COO
National Prostate Cancer Coalition