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Archive for the ‘Provenge’ Category

NEW PROSTATE CANCER INFOLINK: Long-awaited advanced prostate cancer drug Provenge is a step closer to being available with news the manufacturing company has completed its full application to the FDA. READ MORE>


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WALL STREET JOURNAL: Dendreon Corp expects to file for marketing approval for advanced prostate cancer immunotherapy treatment Provenge in mid-November and hopes to get final FDA approval in the middle of next year. READ MORE>

NEW PROSTATE CANCER INFOLINK: It is worth remembering that Provenge is not a “drug” in any normal sense of the term. READ MORE>

Provenge is strictly a form of individual cell-based immunotherapy in which cells from the patient’s own body are extracted, modified, and then re-infused back into the patient.

Every single dose of Provenge therefore has to be individually created.

PROSTABLOG NZ: The pressure on NZ’s drug approval organisation, Pharmac, to fast-track Provenge to Kiwi patients is shaping to be another Herceptin debate.

In that case, it seems only a very loud and effective campaign by sufferers succeeded in getting the expensive breast cancer treatment past Pharmac’s drug subsidisation process.

If Provenge has to be individually manufactured for each patient, you can bet the doses will cost thousands of dollars.

Pharmac may be spared the dilemma beyond next year, since it seems the manufacturer will not be able to fulfill the demand in the US, let alone other countries.

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PROSTABLOG NZ: When global mainstream media reported the recent (partial) success of Dendreon drug company getting FDA approval for its new immunotherapy prostate cancer drug, Provenge, they didn’t mention how makers of a now-discredited rival drug may have delayed its path to chemist shops.

An “alternative” market investors’ website called Market Rap.com has just published a story by a former Wall Street Journal journalist that purports to reveal a murky background to what might be called – if it’s all, even partly, true – one of America’s biggest drug scandals.

It involves the US prostate Cancer Foundation (no relation to NZ’s) and its ubiquitous chairman, Michael Milken, who featured recently on the Larry King Live special about prostate cancer.

If you’ve got lots of time, READ MORE>

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WCVBTV5: Researchers are optimistic about Provenge, a new way of treating prostate cancer that would help the body’s own immune system to attack tumors once they have developed. Researchers at a number of institutions, including Beth Israel Deaconess Medical Center, are working on similar vaccine treatments. READ MORE>

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REUTERS: Dendreon Corp says it expects quick success for its Provenge prostate cancer treatment if it is approved by US regulators, with initial demand for the world’s first cancer vaccine exceeding supply. READ MORE>

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PUGET SOUND BUSINESS JOURNAL: The US drug company that is about to produce the world’s most promising immuno-therapy prostate cancer treatment – Provenge – has reported a second-quarter loss of $126.7 million. READ MORE>

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JULY 30: PR NEWSWIRE.COM: Oncologists expect to prescribe the new vaccine for advanced prostate cancer,  Provenge, to 54 percent of patients with asymptomatic hormone refractory metastatic prostate cancer. READ MORE>

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JULY 27: PUB MED: A trial involving men with hormone-refractory (advanced) prostate cancer who were  treated with Provenge (a cellular immunotherapy product called Sipuleucel-T) had a “survival benefit” and only modest side effects, say the Washington researchers. READ MORE>

The integrated results…demonstrate a survival benefit for patients treated with sipuleucel-T compared with those treated with placebo.

The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk-benefit ratio for sipuleucel-T in patients with advanced prostate cancer.

The most common adverse events associated with treatment were chills, pyrexia (fever), headache, asthenia (physical weakness), dyspnea (shortness of breath), vomiting, and tremor.

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JUNE 2; AQP: First there was surgery, then chemotherapy and radiation. Now, doctors have overcome 30 years of false starts and found success with a fourth way to fight cancer: using the body’s natural defender, the immune system. READ MORE>

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MAY 22: PROSTABLOG NZ:  How many questions did you ask your doctor when you got the news you have prostate cancer? A dozen? More?

I can’t remember now, even though it was less than six months ago, but I’m guessing it would barely have broken double figures, even by the time I was on my third visit to the urologist.

Did you know there are at least 28 queries you should probably make, and another 22 if you’re looking at brachytherapy?

I know this from an excellent new book on prostate cancer just published by the Michael Dattoli and his colleagues in Florida – The Dattoli Blue Ribbon Prostate Cancer Solution:  How to survive and thrive without surgery (February, 2009).

DattoliBk 1It’s a 260-page manual on the latest techniques for treating prostate cancer, most of it written by Dattoli, whose pen portrait in the back says he is “a board-certified oncologist with more than 20 years of brachytherapy experience and has performed thousands of prostate implant procedures…a noted author and speaker in this complex field of medicine.”

Aha, perhaps I hear you say:  he’s biased towards radiotherapy and hence the tilt at surgery in the book title.

Maybe. I’m hardly in a position to judge, being merely a humble prostate patient, although one who has done a fair bit of journalistic investigation into the topic during recent recovery “downtime”.

This book seems to me to be very thorough in its examination of prostate treatments, research, survival and success rates, issues and dilemmas, and refers to every branch of the burgeoning field of treatment I’ve so far come across.

The case he puts for radiotherapy/brachytherapy and combined drug treatments (if needed), in the second half of the book, seems convincing to me.

Essentially, he’s saying that advances in radiotherapy equipment and techniques make its use so accurate and effective that people with aggressive tumours and/or cancer that’s got out of the prostate box are better served by his approaches than surgery or some of the many experimental but unproven (long-term) therapies now on offer (in the US, anyway).

The book reinforces for me how crucial it is to discover prostate cancer at the earliest possible time, since it is one version of cancer that can conceivably be “cured” when discovered at its least developed and aggressive stage.

At that point, it seems surgery is still as good an option as Dattoli’s approach, although he attacks the notion that getting it cut out is an end to the matter. It may not be, even with contained, low-aggression varieties like mine.

The book explores, and partially dismisses, many of the newer approaches, such as cryotherapy (freezing the tumour), hyperthermia (heating it), HIFU (high intensity focused ultrasound), many new drugs (because there is no long-term research done yet) and most versions of surgery.

He strongly advocates the latest approach to radiotherapy – four dimensional (the fourth is motion) intensity modulated (rather than short, high dose) radiation therapy (4D IG IMRT) – which he uses at his clinic, the Dattoli Cancer Center and Brachytherapy Institute of Sarasota, Florida.

With this complex treatment mode, he says the centre can achieve a very precise radiation attack on the tumour(s) with little collateral damage and few long-term after effects (depending, of course, on the patient).

It sounds very expensive. Pictures in the book show space-age technology, which obviously doesn’t come cheaply.

In a couple of discussions in the book, Dattoli borders on the disingenuous when he says centres using other kinds of expensive gear push its efficacy partly because they have big investments to recover.

That said, his record seems impressive, and 14 years of results are highly praised in an “independent” review by Charles E. Myers Jr MD, founder and director of a body called the American Institute of Diseases of the Prostate:

“Many men with intermediate to high-risk cancer treated [by Dattoli] with radiation to the prostate gland and pelvic lymph nodes with external beam radiation and seeds remain free of disease out to 14 years…Radiation therapy is consistently more effective when combined with androgen withdrawal. Faced with these facts, I can only conclude that radiation therapy can kill prostate cancer stem cells or in some way arrest their ability to go on to establish metastatic disease.”

Even ignoring the book’s main thesis (the superiority of 4D IG IMRT), it contains usefully detailed outlines of all aspects of prostate cancer, written in superbly accessible language. Everything is explained and translated for the layperson.

That alone makes it worth the read, although it’s not a quick read, given the fact-heavy nature of the explanations.

It contains other helpful material, including a guide to the foods we should eat (out goes my four-red-meat-meals-a-week diet) and a rundown on the latest drugs being trialled and/or used.

As a footnote, I should add that nothing I read in this up-to-date resource on prostate cancer makes me think I made the wrong decision electing radical prostatectomy. For me, it still feels 100% the right way to go. I believe I was well advised.

Further footnote: I’m interested to know how many of the treatment techniques canvassed by Dattoli are available in NZ. I suspect we trail by a long way, but perhaps there’s some advantage to that: we can observe how various developments pan out in what is undoubtedly the prostate capital (well, country) of the world.

And those 28 questions? I’ve reproduced them here, for those many men in the future who are going to get the bad news:

 Dattoli 1

Dattoli 3Copies of the book can be obtained from:

Dattoli Cancer Foundation, 2803 Fruitville Road, Sarasota, Fl 34237, US.

They cost about $US23 with postage included.

Read a 15-page extract from the book where Dattoli discusses hormone therapy: HERE>

Go to the Dattoli website HERE>

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