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Zytiga (abiraterone acetate) as secondary hormone therapy - Chuck's experience


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Provenge (sipuleucel-T), Zytiga (abiraterone acetate) and Jevtana (Cabazitaxel) are drugs approved for use in the USA, and usually covered by health insurance or USA Medicare.

They are not yet approved or covered in Australia (as of today Friday, 30 September 2011).

Well known prostate cancer supporter and advocate, Chuck Maack (not a doctor), reports of using Zytiga (abiraterone acetate) 'off label' - that is for a non-approved use. He is using it pre-chemotherapy, as a secondary hormone treatment. Its approved use is post-chemotherapy.

ZYTIGA WORKS! Despite the absence of any circulating tumor cells (CTC), and

despite CT imaging with and without contrast unable to identify any sign of

metastasis, it was apparent with rising PSA despite triple hormonal therapy

(Lupron/bicalutamide/Avodart) that my cancer was becoming hormone refractory

(HRPC). Dropped bicalutamide and continued Lupron and Avodart despite PSA

having been rising, but by adding abiraterone/Zytiga, within three weeks PSA

dropped from 2.55ng/ml to 1.61ng/ml.

Side effects experienced with Zytiga: On day three my right kidney felt

uncomfortable, but subsided within another couple days; likely the kidney

was adjusting to the transiting of this new medication. Only other side

effect has been somewhat loss of control of continence. Have had slight

leakage for many years as a consequence of PC treatment, but since beginning

Zytiga that leakage has increased and any liquid intake seems to pass

straight through the system and for the most part, I am unaware the leakage

is occurring. In my pre-cancer days, I always thought "pads" were a women's

necessity. Certainly have come to learn better! But all being said, if

this side effect that can occur with Zytiga intake is topped by a return to

management and control of my cancer, I'll take it. Back to kegel exercises

and now thicker pads!

He comments on the cost:

Zytiga is available to anyone who can pay for it. Certainly important to

check with one's health insurer to see if it will be covered before

ordering. Cost is around $5227.00 for a thirty-day supply, and from the

refills indicated on my initial bottle, there are five more refills - so

apparently the protocol is six months (well, actually 180 days). For those

being prescribed Zytiga upon chemotherapy Taxotere failure, I would expect

all insurers to cover - but again - make sure of written insurer approval

before ordering.

There are trials coming for the administration of Zytiga upon HRPC, so keep

your eyes out and see if a trial available in your area.

That seems to me to work out at around $174 per day, or $31,362 for the full treatment.

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  • 1 month later...

Further information from October 2011.

Zytiga Creeps up on Provenge Prostate-Cancer Drug

By Ransdell Pierson

NEW YORK (Reuters) Oct 11 - Interest in Dendreon Corp's Provenge vaccine (sipuleucel-T) to treat prostate cancer seems to be waning following recent approval of Johnson & Johnson's more-convenient and faster-acting Zytiga (abiraterone acetate), according to some doctors and industry analysts.

"The bloom is off the rose for Provenge because patients are looking for something that can treat them more quickly," and with greater convenience, said Charles Duncan, a biotechnology analyst for JMP Securities.

Although Provenge extended patient lives by an average of about four months in clinical trials, it does not significantly delay progression of symptoms , including the bone pain that's a hallmark of advanced prostate cancer.

Hopes for Provenge were sky high when U.S. regulators approved it in April 2010 for patients with prostate cancer who had failed to benefit from standard medicines. Some analysts had expected the vaccine to capture annual sales of more than $4 billion.

But Duncan, whose company helped sponsor the "Cancer Immunology: A Long-Awaited Reality" conference in New York on October 6th, said Provenge is likely to generate peak annual sales of no more than $500 million because of shortcomings that have become evident to patients and doctors.

They include the time and inconvenience of extracting white blood cells from patients and sending them off to Dendreon plants, where they are combined with vaccine components. Patients then receive the final product through infusions.

Dr. Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center, said many patients and doctors are gravitating instead toward J&J's Zytiga -- a pill approved in recent months for advanced prostate cancer patients who have failed to benefit from chemotherapy.

Zytiga also prolonged life by about four months in clinical trials. But patients experience symptom relief far sooner than with Provenge, said Dr. Slovin, who was interviewed at the conference.

"Abiraterone is taking the market by storm; there is a much faster effect with it" than Provenge, Dr. Slovin said. "Patients feel they're getting something beneficial. Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do."

"The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever. I really don't want to wait. I want to take a pill and go to Florida.' "

Moreover, while Zytiga is expensive -- at about $5,000 a month, usually for eight cycles -- it is far less costly than Provenge.

Dendreon stunned investors in August by withdrawing its own sales forecast for Provenge because it was taking longer than expected for doctors to become comfortable with reimbursement issues for the product, which costs $93,000 for a course of treatment.

"I don't think Provenge will fall out of the arena; I do think it will still be used, but not with the same alacrity as when it first hit our formulary," said Dr. Slovin.

Dr. James Gulley, a director of clinical trials for the National Cancer Institute, said there is a "clear utility" for Provenge.

"Patients love the idea that your immune system is helping you fight cancer," he said. But Dr. Gulley said its manufacturing process poses challenges that have no doubt hampered demand for the product. "The vaccine has to be made for each individual patient."

Dr. Gulley is leading clinical trials of an experimental vaccine to treat prostate cancer that could be taken out of the freezer and injected into patients -- eliminating the hassles seen with Provenge.

The National Cancer Institute developed the vaccine, called ProstVac, and licensed it to Danish biotechnology company Bavarian Nordic. NCI would be entitled to royalties on sales of the vaccine, which is slated to move into late-stage trials in coming weeks.

Dr. Gulley said ProstVac prolonged patient lives by eight months in mid-stage trials -- roughly twice the benefit seen in separate trials of Provenge and Zytiga. But he cautioned that ProstVac's true potential will not be known until its far-larger planned Phase III trials are completed.

He said the vaccine, which coaxes immune system T-cells to attack prostate-specific antigen (PSA) -- could prove to be a bigger drug than Provenge "because it is off the shelf. There are no logistical constraints."

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  • 5 weeks later...

In September 2010, after 14 years on/off/on/off androgen deprivation therapy, I completed my second intermittent androgen deprivation (IAD) that had lasted two months short of 6 years while "maintaining" with dutasteride/Avodart over that entire period.

My PSA had finally reached the 2.0ng/ml plateau I had decided would be the appropriate time to return to adding bicalutamide (generic of Casodex) and Lupron to my continuing Avodart. With this return to ADT3 my PSA fluctuated down to as low as 1.67ng/ml by May 2011.

However, despite this triple hormonal blockade, it then gradually began elevating and with the PSA level reaching 2.55ng/ml.

On September 2, 2011, I began abiraterone acetate/Zytiga 1000mg upon rising each morning (requires empty stomach) accompanied by Prednisone 5mg twice daily along with continuing Lupron and Avodart. In three weeks PSA dropped to 1.61ng/ml. At two months, PSA continued drop to 1.28ng/ml. On December 22nd, at a week short of four months, my PSA continued its drop to 0.74ng/ml. Testosterone has dropped to <3.0ng/dl (as we would expect with Zytiga effectiveness). All other CBC/CMP lab results at this time within normal ranges. CT imaging with and without contrast unable to identify location of any tumor activity though did determine osteopenia. A Circulating Tumor Cell (CTC) test determined zero cancer cells circulating in the blood stream. I am currently scheduled to continue this Zytiga protocol for a total 180 days (six 30-day prescriptions).

Obviously pleased to be among those wherein Zytiga has proven to be effective.

I have been told Abiraterone acetate/Zytiga is not currently (24 December 2011) available in Australia, except on trial. As near as I can figure it, Chuck''s 6 month treatment will cost $30,000.

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