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Body backs Sanofi’s Taxotere in prostate cancer

LONDON (Reuters) - A cost-effectiveness watchdog said on Friday it was provisionally recommending that Sanofi-Aventis SA’s chemotherapy drug Taxotere should be used to treat prostate cancer on the state health service.

A spokesman for the National Institute for Clinical Excellence said final guidance was likely to be issued around July next year, covering the use of the drug in men with advanced hormone refractory prostate cancer.

Until then, about 800 men in Scotland who could benefit from Taxoterer to releive pain and progression of advanced prostate cancer are on hold. Some of them may die waiting.
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Forbes has a story this month about a Cox-II inhibitor, Celebrex. While mostly used for arthritis pain, this drug is of high interest to cancer patients as a possible tumor inhibitor (for background on the cancer connection see
Cancer Patients … and Celebrex in Anti-Cancer Trials Nov 2004
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Dr. Zvi Fuks, a renowned radiation oncologist, is one of the principal developers of 3-D conformal radiation therapy, a system for delivering radiation that permits precise shaping and targeting of radiotherapy beams. He has worked for many years at MSKCC (memorial Sloan-Kettering Cancer Center).

Last month Dr. Fuks and a friend agreed to pay a total of $2.77 million to settle a lawsuit accusing them of insider trading in shares of a pharmaceutical company. The drug involved, ImClone’s Erbitux, was tested in clinical trials at MSKCC. A clinical trial of Erbitux for prostate cancer ran at MSKCC starting in 1996.
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Entrez PubMed
Cancer Biol Ther. 2006 Jan 25;5(1) [Epub ahead of print]
Corticosteroid-Induced Chemotherapy Resistance in Urological Cancers.

Zhang C, et al. Molecular Urooncology, German Cancer Research Center, Heidelberg, Germany.

Purpose: Glucocorticoids such as dexamethasone are widely used for medication of urological diseases, e.g., as cotreatment of advanced prostate cancer, to improve appetite, weight loss, fatigue, relieve bone pain, diminish ureteric obstruction, to reduce the production of adrenal androgens, as an antiemetic in patients undergoing chemo- and/or radiotherapy together with serving as “standard” therapy arm in randomized studies.

While the potent pro-apoptotic properties and the supportive effects of glucocorticoids to tumor therapy in lymphoid cells are well studied, the impact to growth of prostate and other urological carcinomas is unknown.

Methods: We isolated cells from surgical resections of 21 prostate tumors and measured apoptosis and viability in these primary cells and 17 established cell lines from human prostate, bladder, renal cell and testicular carcinomas.

Results: We found that dexamethasone induces resistance regarding exposure to several cytotoxic agents such as taxol, gemcitabine, cisplatin, 5-FU and gamma-irradiation in 86% of the freshly isolated prostate tumors and in 100% of the established urological cell lines.

No difference in dexamethasone-mediated protection was found in normal, benign and malignant prostate tumors.

Conclusions: These data show for the first time that dexamethasone induced therapy resistance in urological carcinomas is not the exception but a more common phenomenon and implicate that glucocorticoids may have two faces in cancer therapy, a beneficial and a dangerous one.

NOTE from psa-rising editor: This looks like a rather chilling early confirmation of a finding in breast cancer which we were concerned might apply also to prostate cancer. See:

Widely used anti-nausea drug, dexamethasone, may interfere with breast cancer chemotherapy

by J. Strax

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.
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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.
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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).
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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.
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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
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