Zytiga Treats Bone Metastases

Evidence Builds for Use of Zytiga in Prostate Cancer

New Agent Treats Bone Metastases and Improves Survival

Chicago—Zytiga (Abiraterone Acetate) not only improves survival in patients with metastatic castration-resistant prostate cancer (mCRPC), but it also doubles the time to skeletal-related events (SREs).

This news comes from analysis of results of the Phase III COU-AA-301 trial. The study revealed that abiraterone (Zytiga) provided a highly statistically significant 3.5-month increase in overall survival (OS) in patients with mCRPC who had progressed after treatment with docetaxel. There were equally significant improvements in all of the secondary end points, such as prostate-specific antigen (PSA) response rate, time to PSA progression and progression-free survival (PFS), but the doubling of the time to SREs and the significant protection from pain progression may be at least as important from the patient’s perspective.

“Clinical benefit of abiraterone acetate in the treatment of bone metastases in patients with mCRPC crosses all dimensions. It improves pain palliation, it delays pain progression, it delays time to SRE, and the effect is sustained over all treatment cycles,”

reported Christopher J. Logothetis, MD, chair, Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston. Presenting the pain control results from COU-AA-301 at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO), Dr. Logothetis said these data confirm “meaningful improvement in symptom-free survival, in addition to the improvement in overall survival.”

In this study (abstract 5420), 1,195 patients with mCRPC who had progressed after previous treatment with docetaxel and had an Eastern Cooperative Oncology Group (ECOG) status score of 2 or lower were randomized in a 2:1 ratio to 1 g of abiraterone acetate or placebo daily. Both groups received 5 mg of prednisone twice daily. Abiraterone acetate, a prodrug of abiraterone, blocks cytochrome P450 c17 (CYP17), an enzyme critical to testosterone synthesis, which, in turn, blocks androgen synthesis by the adrenal glands, testes and within the prostate tumor.

After a median follow-up of 12.8 months, OS, the primary end point, was 14.8 months in the abiraterone group and 10.8 months in the placebo group, generating a 35% relative improvement for the active therapy (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.54-0.77; P<0.001). These results were published in The New England Journal of Medicine just prior to the ASCO meeting (2011;364:1995-2005, PMID: 21612468). The PFS was 5.6 months in the abiraterone group compared with 3.6 months in the placebo group (P<0.001). PSA response rate was 29% in the abiraterone group compared with 6% in the placebo group (P<0.001). Time to PSA progression was 10.2 in the abiraterone group compared with 6.6 months in the placebo group (P<0.001).

The drug was considered even more impressive, however, when investigators dissected abiraterone’s ability to relieve the burden of symptomatic metastases, particularly bone pain. One of the most impressive results was the doubling of time to SRE, defined as pathologic fracture, spinal cord compression or palliative radiation or surgery for bone symptoms, which was a median of 301 days in the abiraterone group compared with 150 days in the placebo group. According to Dr. Logothetis, overall pain, measured in several ways, such as progression of intensity or the interference that pain imposed on daily activities, also was highly significantly less on abiraterone. Moreover, Dr. Logothetis said, actual symptomatic benefit in patients who received a full course of therapy was likely to have been even better than those reflected in this intent-to-treat analysis.

The prostate cancer expert invited to discuss the study at ASCO also emphasized the significance of these pain results, which, although preplanned, were not even formal secondary end points. Although an improvement in survival is generally required in oncology before a new treatment is considered practice-changing, the quality of life in patients with prostate cancer and bone pain deserves attention, he said.

“Not only were they palliated, they were palliated more quickly and they were palliated more fully,” said Michael J. Morris, MD, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York City. “Abiraterone and prednisone do appear to have achieved, or at least preliminarily to have achieved, the hat trick of oncology in prostate cancer. It improved how patients survived, it improved how patients feel, and it improved how patients function.”

Zytiga Approved for use in EU

Johnson & Johnson’s Zytiga has been approved in the EU for late-stage prostate cancer.

Zytiga (abiraterone acetate) is now licenced as a second-line treatment, in combination with steroid prednisone for metastatic castration-resistant prostate cancer (mCRPC), in men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

The drug is an androgen biosynthesis inhibitor, which blocks the production of testosterone, the hormone responsible for fuelling the cancer.

The simplicity of the once-a-day pill, and the absence of chemotherapy side effects means it should have an advantage over Sanofi’s new chemo drug Jevtana (cabazitaxel), which was approved for the same licence earlier this year.

Professor Karim Fizazi, Department of Cancer Medicine, Institut Gustave Roussy, France, an investigator in a pivotal phase III study, said:

“The European Commission’s approval of abiraterone acetate gives new hope to men who are suffering from this late stage of prostate cancer with very few treatment options left.

“The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain.”

The approval was based on trial results which showed Zytiga patients lived an average of 4.6 months longer than placebo patients (15.6 months compared with 11 months).  

NICE has already recommended Zytiga for use on the NHS in England and Wales.

Zytiga for Advanced Breast Cancer

There is a good rationale for using Zytiga against advanced breast cancer since this can be androgen driven as well as estrogen driven and Zytiga cuts off the supplies of both androgens and estrogens reducing their levels to almost zero. Clinical trials are now underway to evaluate the benefits of Zytiga against breast cancer in women who have failed aromatase inhibitor therapy and there are early indications of responses to hormone refractory disease. Here are the details one of the clinical trials.

Randomized phase II open-label study of abiraterone acetate (AA) plus low-dose prednisone (P) with or without exemestane (E) in postmenopausal women with ER+ metastatic breast cancer (MBC) progressing after letrozole or anastrozole therapy.

Abstract:

Background: AA plus P treatment in men with metastatic castration-resistant prostate cancer has demonstrated a survival advantage over P alone. Circulating adrenal steroids including DHEA and DHEA-sulfate can stimulate proliferation of breast cancer cell lines in a low-estrogen environment. Thus, it is hypothesized that depletion of adrenal androgens as well as estrogens by AA, a potent CYP17 inhibitor, inhibits tumor growth by disruption of ER-dependent growth signaling. In a previously reported phase I study of AA in patients (pts) with breast cancer (Basu, ASCO 2011), 2/21 pts who were ER+ were on study for ≥ 11 months; 1 had a confirmed PR and continued on treatment > 14 months. Mechanism-based adverse event of grade 3/4 hypokalemia occurred in 4 pts and was managed with potassium supplementation and low dose corticosteroids. Methods: In the current study, 300 postmenopausal women with ER+ Her2- MBC progressing after letrozole or anastrozole are randomized to either AA 1000 mg + P 5 mg daily or AA + P + E 25 mg daily vs E. Disease must have been sensitive to a non-steroidal aromatase inhibitor (AI) prior to study entry. Subjects are stratified by number of prior therapies and by AI use in adjuvant or metastatic setting. Central review of tissue is required prior to randomization. Gene expression profiling (GEP) (AR, ER, PR, Her2, CYP17, Ki-67, CYP 19, and 3-β-HSD) will be performed on FFPE archival tissue. Pre- and post-treatment circulating tumor cells and fresh tumor biopsies will also be obtained for GEP in a subset of pts. Primary endpoint is PFS. Secondary endpoints are OS, ORR, patient reported outcomes, changes in endocrine markers, and PK characterization of AA and E. Subjects randomized to E may crossover to AA + P at time of disease progression. One interim analysis is scheduled after 50% of PFS events have occurred. After review of interim data, the Data Review Committee will make recommendations regarding study continuation. 23pts from 45 active sites have been randomized as of January 24,2012. (ClinicalTrials.gov Identifier: NCT01381874)

Continued Good Results for Zytiga

Testimonial from a prostate cancer patient:

I have continued good results from Zytiga (Abiraterone). My PSA was 400 and rising rapidly when I started it on March 4th 2012.

March 4th PSA 400.6. Started Zytiga (Abiraterone )
May 26th. PSA. 70.3
June 20th PSA. 57.6

So it dropped another 13 points in a month!! As long as it continues heading "south" I am happy!! Virtually no side effects!

John S. Elliott
Berlin, N.H.

Sent from my iPad

Hot News from ASCO on Zytiga Pre Chemo Results

The news just keeps getting better for Johnson & Johnson's new prostate cancer drug Zytiga (abiraterone). Investigators unblinded a late-stage study of the drug--plus prednisone--for prostate cancer victims who had not been treated with chemotherapy. The blockbuster drug is already approved for treatment-resistant cases and the news heralds a quick-step expansion of the prospective patient population.

Johnson & Johnson ($JNJ) says the independent monitoring committee members for the study were satisfied that they had the results they were looking for on progression-free survival as well as the co-primary endpoint of overall survival along with key secondary endpoints. The move paves the way for J&J to start filing for expanded use later this year.

According to Adam Feuerstein at TheStreet, a J&J spokesperson confirmed that investigators had established a statistically significant response for PFS and a "strong trend" on OS which has been kept top secret until June 2nd, the data in that category was highly statistically significant. The independent data monitors "stopped the trial based on the totality of the data they saw," Kellie McLauglin told TheStreet, they had seen enough to satisfy the FDA approval commitee requirements for registartion of product in chemotherapy naive metastatic prostate cancer. The Phase III clinical trial result for Zytiga pre chemo were astounding comment one inside observer already in Chicago. There was a statistically significant benefit for all secondary endpoints there is no doubt about the data on Zytiga. It makes prostate tumours shrink on a measurable scale and that has been clearly demonstrated in this trial.

Zytiga has a reputation as a faster acting, more convenient therapy for prostate cancer--quick to ease pain and other effects of cancer--has spread among patients and physicians.

"This study has been a key priority for us as we expand our understanding of the utility of Zytiga in metastatic prostate cancer," said William N. Hait, the global chief of Janssen R&D. "We're delighted that these data will soon be added to the growing body of literature about this important medication."

Zytiga Recommended by Oncologists

“I have seen first hand how abiraterone has changed people’s lives; not only the men living with metastatic prostate cancer, but their partners and families as well,” says Dr. Lori Wood, Medical Oncologist, Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia. “This treatment can dramatically improve the quality of life of these men with very little, if any, side effects, and also helps them live longer.”

Dr. Kara Laing, President, Canadian Association of Medical Oncologists and Clinical Chief, Cancer Care Program, feels the same way about Abiraterone (Zytiga).

“So many of our patients have benefited from abiraterone and we have seen significant improvements in their health. As a physician, it’s exciting to now have this option available for our patients in Canada.”

Can Zytiga be used with Salvestrols ?

The combination of Zytiga and Salvestrols make a powerful approach to the treatment of very advanced prostate cancer. This provides two pathways of attack on the cancer cells by two different mechanisms. Firstly the Zytiga blocks all androgen production and the prostate cancer cells are starved of androgens and cannot grow. Those that manage to continue growing are fed salvestrols which react with the CYP1B1 enzyme to destroy any remaining growing tumours. So together they provide a rational approach to the treatment of advanced prostate cancer. This approach has been used safely taking Zytiga at 1000 mg daily and Salvestrols at 6000 points daily. Furthermore it is believed that the salvestrols will prevent resistance to Zytiga which will enable this combination to be used long term.

Zytiga Sales Exceed Provenge

The approval of Johnson & Johnson's (JNJ) drug, Zytiga, earlier in 2011, is a drug which many felt would prove to be a formidable product. Indeed, sales of Zytiga already exceed those of Provenge. Zytiga works by blocking the production of androgens, like testosterone, on which many prostate tumors are dependent.

Zytiga Approved by Health Canada

ZYTIGA™* (abiraterone acetate) receives Health Canada approval for treatment for metastatic prostate cancer

First Oral Treatment for Metastatic Prostate Cancer That Inhibits Androgen Production at All Three Sources

Janssen Inc. announced that after a priority review, Health Canada has approved ZYTIGA™ (abiraterone acetate), an oral medication for the treatment of men with metastatic prostate cancer. ZYTIGA™ is indicated with prednisone for the treatment of men with metastatic prostate cancer (castration-resistant prostate cancer) who have received prior chemotherapy containing docetaxel.

“This approval is an important advancement in the treatment of metastatic prostate cancer,” said Dr. Scott North, Medical Oncologist, Cross Cancer Institute, University of Alberta. “For these patients, the efficacy and safety of ZYTIGA™ will fill an important unmet medical need for additional treatment options. Most importantly, clinical trial results demonstrate extended overall survival and improved pain relief. I believe these benefits provide improved quality of life for many patients.”

ZYTIGA™: Unique Mechanism of Action

Androgens are hormones that promote the development and maintenance of male sex characteristics; however, in prostate cancer, androgens can help fuel tumour growth. Androgen production primarily occurs in the testes and adrenal glands; in men with prostate cancer, the tumour itself is an additional source of androgen. ZYTIGA™ is an androgen biosynthesis inhibitor that inhibits the CYP17 enzyme complex, which is required for the production of androgens. It is the first oral treatment for metastatic prostate cancer that inhibits androgen production at all three sources.

Results of the pivotal Phase 3 study (N=1,195) showed that at the pre-specified interim analysis, treatment with ZYTIGA™ plus prednisone resulted in a 35 per cent reduction in the risk of death (14.8 months vs. 10.9 months) and a 3.9 month difference in median survival compared to placebo plus prednisone. In an updated analysis, results were consistent with those from the interim analysis with a 4.6 month difference between the two arms in median survival (15.8 months vs. 11.2 months). The study was conducted in 147 centres in 13 countries, including 12 centres in Canada; 154 Canadian men participated in the study, which represents approximately 13 per cent of the study population.

“This new treatment is important to me because the oral dosage is very manageable and convenient and I spend less time in treatment,” said Richard Pokorny, who has been living with prostate cancer for 11 years. “I also feel stronger and have more energy, allowing me to do day-to-day tasks and enjoy quality time with my loved ones as we face this disease together.”

About Metastatic Prostate Cancer

Metastatic prostate cancer occurs when cancer has spread beyond the prostate and disease progresses despite serum testosterone below castrate levels.

Prostate cancer is the most common cancer to afflict men in Canada, excluding non-melanoma skin cancer.3 Approximately 25,500 men are expected to be diagnosed with prostate cancer in Canada in 2011, and one in seven Canadian men will develop prostate cancer during his lifetime.3 The incidence rate of prostate cancer has been increasing since 1980, likely due to an increased rate of early detection and the aging population since the chances of developing prostate cancer increases with age.3 However, according to Prostate Cancer Canada, prostate cancer is turning up in men in their 40s.4

Pivotal Study

ZYTIGA™ with prednisone was evaluated in a Phase 3, randomized, placebo-controlled, multi-centre clinical study in patients who had received prior chemotherapy containing docetaxel (N = 1,195). Patients were randomized 2:1 to receive ZYTIGA™ 1 gram daily plus prednisone 10 milligrams (mg) daily or placebo in combination with prednisone 10 mg daily (control arm).

The most common adverse reactions observed with ZYTIGA™ were myopathy, joint pain or discomfort, peripheral edema, hot flush, diarrhea, hypokalemia (low serum potassium), urinary tract infection and cough. Serious adverse reactions with ZYTIGA™ included urinary tract infections, bone fracture and hypokalemia.

Zytiga Approved For Use in Germany

Zytiga has been approved for use in Germany by the drug benefit assessor.

Decisions by Germany’s drug benefit assessor, IQWiG, to recommend novel prostate cancer treatment Zytiga and reject me-too diabetes treatment Trajenta may allay confusion over just how well the country’s new added value assessment process is working.

MDV3100 Versus Provenge

MDV3100 versus Provenge - Which is more Hyped ?

Both the manufacturers of MDV3100 (Medivation) and Provenge (Dendreon Corp) dramatically over hype their products, but which one of them is the most overhyped. Here we look at the evidence for any benefits at all of efficacy of these agents.

Provenge - works as a cancer vaccine to prime the immune cells to attack the cancer. Well thats the theory but what effects does it have in clinical practise against prostate cancer. There is actually little evidence that Provenge offers any life extension or can even reduce PSA levels. Many men are given false hope with Provenge and their PSA levels continue to rise unabated. So where is the evidence that Provege even works at all.

MDV3100 (Enzalutamide) - works as an antiandrogen. This is an analogue of the antiandrogen casodex and could be used for treating casodex relapsed patients. However there is a high relapse rate on MDV3100 so it is unlikely that this drug will provide benefit for longer than a few months. In phase 3 clinical studies MDV3100 did show extension of overall survival of 6 months which is impressive. However there was a 0.6% rate of heart seizures on the MDV3100 treated arm compared to 0% in the placebo arm. This is a highly significant rate of heart failure and amounts to 6 people in a patient population of 1000 which may limit its widespread long term use. Although these cardiotoxicity statistics are being brushed under the carpet by the manufacturers they will surely manifest upon widespread usage as was the case for the antiinflammatory drug VIOXX from Merck which went into widespread usage but had to be withdrawn suddenly from the market due to cardiotoxicity problems.

Zytiga Superior to Provenge

The effects of taking Zytiga are far more pronounced and tangible than with the treatment Provenge. There is little evidence that Provenge even works at all and in many men who have undergone this treatment their PSA continues to rise. Independent testimonials on the benefits of Provenge are hard to find and even the manufacturers promotional video testimonials show no evidence of declining PSA following treatment. Zytiga on the other hand rapidly induces total androgen blockade in all prostate cancer patients. Some respond really well to this blockade and see their PSA rapidly fall from over 1000 to 100 within a month. So Zytiga offers real tangible benefits to prostate cancer patients that result in decreased bone pain from the cancer and a reduction in bone metastases, while all Provenge seems to offer is hype from the stock exchangers with vested interests in the Dendreon Corporation that manufactures Provenge.

Is Lower Back Pain a Side Effect of Zytiga ?

Has anyone experienced severe lower back pain?

Tue Jun 14, 12:02:00 PM PDT

Anonymous said...

Well. I have mild lower back pain and have had since starting ketoconazole + prednisone (over three years).
However, my neurologist insists it's a result of mild arthritis. I experience it only when I exert myself:
standing long periods, raking, bending over, etc.

Thu Jul 28, 09:49:00 AM PDT

Anonymous said...

I have been on Zytiga for a month now. I have severe pain in my lower back sometimes, and also in my upper legs. Has anyone else had this? I'm barely able to function because of the pain medications I have to take and still have breakthrough pain.

Mon Aug 22, 06:15:00 PM PDT

Anonymous said...

My dad had the same symptoms. He did feel very bad and had a lot of back pain. After ca. a week of taking Zytiga, the pain improved. Now he is taking the pills for about a month - he is pain free. But the best news is, his PSA-level lowered from 1230 to 268. Isn't that amazing? His well-being is getting better by the day. Amazing drug. So everybody out there with severe back pain - hang in there. It will get better. We are so grateful for that breakthrough for men with advanced prostate cancer. Thank you, thank you, thank you.
Cornelia (09/13/2011)

Tue Sep 13, 03:23:00 PM PDT

David Rothschild said...

After one month on Zytiga my PSA jumped from 12.8 to 17.1 Has anyone else experienced a rise in PSA upon starting abiraterone? I am going to take it for another month and hope for the best!

Fri Sep 16, 03:16:00 PM PDT

Anonymous said...

I have had a long fight with prostate cancer. It started 2 years ago with a high PSA number. I am on Lupron now and have had radiation along with chemo.
This past June I could hardly do normal functions, in fact I thought I was on my last leg. After getting put on Zytiga I began to recover within a week. After a month I feel as if my biological clock has been turned back 20 years and feel the best I have since this nasty disease started. The first couple months my PSA did rise but then took a steep drop back to 1. I am not experiencing any side effects except the intense hot flashes but then again I think the Lupron is doing that. Thanks to Zytiga I continue to live a very normal active life.

Sun Nov 27, 05:44:00 AM PST

Anonymous said...

I was diagonsed 29 months ago with a psa of 1200 and metatasis to my bones. I was immediately put on Lupron which worked well for 9 months and then psa started rising and turmors grew and spread to more bones. Oncologist took over and went on first chemo Taxotere and then Jevtana. Both failed, psa climbed to 1567. June 2011 went on Zytiga, and psa is now down to 14 and I have been doing well. Had some liver problems, now over, and potasium, getting better. Zytiga has worked for me.

Mon Jan 30, 07:31:00 AM PST

Zytiga Structure

The structure of Abiraterone the key ingredient of Zytiga

Do I Use Abiraterone or Salvestrol ?

I had a RP over 6 yrs. ago and now my urologist wants to start me on a total androgen blockade because of the rate that my PSA is rising { current level of 1.42 }. I am 68.

Do I use Abiraterone or Salvestrol ? I have type 2 diabetes and Atrial Fib if that makes a difference in how you respond.

Also who is available to guide me as to how much to use and when best to take it etc.

I also use 4.5 mg. of low dose naltrexone { LDN }

Answer:

Abiraterone is a very powerful drug used to treat advanced prostate cancer. It is currently licenced for use to treat mCRPC which is metastatic castrate resistant prostate cancer. So unless your disease fits into that category you will not be able to receive Abiraterone.

Salvestrol Platinum can be used to treat prostate cancer even when it becomes hormone independant, and so Salvestrols work beyond Abiraterone. Here is an example of a case where this approach has been used:

Case #3. Prostate Cancer

A 74-year-old gentleman was diagnosed with Prostate Cancer. Subsequently this gentleman spoke with his cousin, a university lecturer, who told him that one of his students was diagnosed with a terminal brain cancer and had recovered after taking Salvestrols. He decided to begin a course of Salvestrol supplementation taking two (350 point) Salvestrol Shield capsules per day. Six months after receiving his diagnosis his PSA level had dropped from 11 to below 1 ng/mL. The patient moved to another country which necessitated a change of doctors. At this point the patient switched Salvestrol products and began taking one (2,000 point) Salvestrol Platinum capsule three times per day after meals, to give a total supplemtation of 6000 points per day. Twelve months after receiving his diagnosis his PSA level had dropped to 0.2 ng/mL. The new doctor continued with the PSA monitoring and upon receiving a subsequent PSA test result the physician said that the PSA level received was as low as it could be and asked if the patient was sure that he had not had surgery. Given the physician’s surprise that such a result could be achieved the patient confessed to taking Salvestrols. The physician then stated that he had other patients he would like to start on Salvestrols. This patient continues to receive PSA test results at the 0.2 ng/ml level and has continues to take one (350 point) Salvestrol Shield capsule per day as a preventative measure, and has now embarked on a fitness program and change in diet.

Fri Feb 10, 2012

First of all thanks for taking the time out of your very busy schedule to educate me. I have decided to begin Salvestrol Therapy ASAP. I will call Acquired Intelligence Inc. today to place my order. Are there enabling supplements that will work synergistically with Salvestrol Platinum ?

My plan is to use the Navvaro Clinic Urine Test to establish a baseline and then to retest after a period of SP use to measure progress. I will also have my PSA tested once in a while. Does this make sense to you. I am fortunate to be able to work closely with an MD who practices complimentary medicine.

Warmest regards,

Don C Waterloo Ontario Canada

Dear Don, here are the responses to your questions.

For maximum effect the salvestrol supplements are taken 3 times a day with meals. It is advised to take the capsules just after a meal for best absorption.

In USA/Canada Salvestrol Platinum contains 1000 points.

In UK/Europe Salvestrol Platinum contains 2000 points

Dosage:

USA/Canada: Take 2 capsules of salvestrol platinum 3 times daily

UK/Europe: Take 1 capsule of salvestrol platinum 3 times daily

It is wise to carry on with PSA monitoring whilst you are on Salvetrol therapy. However do not be surprised if the PSA initally increases in the first month before eventually going down. PSA is an indirect marker of the cancer and often increase initially with any treatment of prostate cancer.

Don asked the question "Are there enabling supplements that will work synergistically with Salvestrol Platinum ?"

The answer is yes, and these are

Biotin

Niacin

Magnesium

Biotin increases the expression levels of the beta salvestrol activase enzyme CYP1B1. Niacin and Magnesium are co-factors needed by the P450 reductase which enables the salvestrol activase to work efficiently.

Biotin is only needed in very small amounts typically 10 ug.

Niacin is available in multivitamin tablets, so a good multivitamin may provide all the co-factors needed.

Having said this I know of people who have recovered from cancer just by taking the salvestrol supplements without needing any other supplements.

I was diagnosed with high-grade (gleason 10) prostate cancer with mets to L5 vertabrae 3-1/2 years ago.  I have been on Lupron and Casodex.  I reached 0.5 nadir and it held steady for about 2-1/2 years.  My PSA has been climbing for the past year...very slowly at about 0.1/month.  Although the PSA value is still low, I understand that high-grade cancers don't produce much PSA. 

I also see a very reputable naturopathic oncologist, Dan Rubin, where I receive I/V vitamin C plus a few other supplements via capsules.

My medical oncologist is recommending abiraterone as the next drug after the Lupron and Casodex stopped working.

I heard about Salvestrol about 6 months ago and took the product for about 4 months.  I started with (5) 1000-point capsules/day, but my PSA continued to climb.  Through emails with Acquired Intelligence, I was instructed to double the dosage to (10) 1000-point capsules/day.  Had a PSA test one month later and the PSA still increased...up 0.1, just like before.  I haven't added Biotin to my protocol, but the other supplements are covered by a multi-vitamin.  I also see a very reputable naturapathic oncologist, Dan Rubin, where I receive I/V vitamin C plus a few other supplements via capsules.

I read recently on this blog that sometimes it could take up to a year for the Salvestrol to work completely...maybe I was over-optimistic about the effect of Salvestrol and probably too impatient after reading the Case Studies using Salvestrol.

Given my high grade of cancer, do you think Salvestrol will work for me and if so, when should I see a response (PSA?)? 

Answer:

There seems to be 2 types of responders to salvestrol therapy, fast responders and slow responders. The fast responders typically see their tumours shrink to half their size within 1 months are are all clear by 3 months. The slow responders may not show signs of response until after several months and may need a year before real signs of improvements are seen.

The PSA levels can be misleading since the PSA is an indirect marker of prostate cancer. Basically it measures the cellular debris from the prostate cancer cells in the bloodstream. However, when undergoing therapy for prostate cancer the PSA will go up before it comes down. This is because the dead tumour cells debris enters the bloodstream as the tumour is dying. So the more prostate tumours dying the more cellular dbris enters the bloodstream so the more the PSA increases. Only after several months will the PSA then start to decline as less tumours are being destroyed.

The salvestrols should be effective at a dose of 2 capsules of Salvestrol Platinum (1000 point) capsules, 3 times daily, taken shortly after meals. For optimum absorption it is best to take these just after youve eaten. The dose can be increased to 4 capsules, 3 times daily, for maximum effect.

I am pleased to hear your medical oncologist is recommending abiraterone. Have a look at my discussions on the new prostate cancer infolink about the optimum dose of abiraterone by searching on "Abiraterone Dose". You could be the first person to be on Abiraterone and Salvestrols. This would be a very interesting approach since you would be attacking the cancer from 2 different angles both of which are synergistic.

Patients Kept Alive For Years on Zytiga

Prof Johann de Bono, who led the trials of Zytiga (Abiraterone) at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, said: "I'm thrilled that this drug will now be routinely available for eligible patients on the NHS.

"Abiraterone acetate is one of only a handful of life-extending drugs for these patients and, importantly, it can also improve the quality of life.

"Some of my patients have been taking abiraterone for several years through clinical trials and are still pain free."

Zytiga Needs Prednisone to Offset Hypokalemia Side Effect

One of the abstracts from this years 2012 ASCO meeting in Chicago investigates the side effect profile for single agent Zytiga and for Zytiga plus prednisone. The key effect of the corticosteroid prednisone is to overcome the side effect of hypokalemia which results from single agent Zytiga use. Hypokalemia is low potassium levels in the plasma and may lead to potentially fatal heart arythmia.

Another abstract at this meeting suggests that a low dose of 5 mg daily of prednisone is able to off set this side effect.


Risk of mineralocorticoid excess syndrome with CYP17 inhibitor abiraterone in prostate cancer patients.

Abstract:

Background: CYP17 inhibitor abiraterone acetate has been used for the treatment of patients with metastatic castration-refractory prostate cancer (CRPC). Hypertension, hypokalemia (low potassium) and edema are the major side effects associated with its use, and may be secondary to the excess of mineralocorticoids due to CYP17 inhibition. We performed a systematic review and meta-analysis of published clinical trials to determine the effect of abiraterone on the development of these side effects.

Methods: Databases including Pubmed (July, 1966 to July, 2011), Web of Science, and abstracts presented at the American Society of Clinical Oncology meetings from 2008 to 2011 were searched to identify relevant studies. Eligible studies were prospective clinical trials of patients with prostate cancer receiving abiraterone acetate at the starting dose of 1,000 mg daily with available data on hypertension, hypokalemia and edema. Incidence and relative risk (RR) were calculated using a random-effects or fixed-effects model.

Results: A total of seven studies including 1,387 patients with CRPC were selected for analysis. The incidences of all-grade hypertension, hypokalemia, and edema were 13.3% (95% CI: 8.3 to 20.5%), 31.4 % (95% CI: 12.5-59.5%), and 23.4 % (95% CI: 15.6-33.5%) respectively. The incidences of high-grade (grade 3 and above) toxicity were low, with a rate of 3.6% (95% CI: 2.6-5.1%), 2.8 % (95% CI: 0.9 to 8.2%), and 2.1% (95%CI: 1.3-3.2%) for hypertension, hypokalemia, and edema respectively. The risk of hypertension and edema did not change with and without the addition of prednisone (p=0.48 and p=0.40, respectively); however, the risk of hypokalemia was significantly reduced with the addition of prednisone (p = 0.003). In comparison with prednisone alone, the addition of abiraterone did not increase the risk of hypertension (RR 1.22, 95% CI: 0.82 – 1.83, p=0.31), but significantly increased the risk of edema (RR 1.36, 95% CI: 1.10-1.69, p=0.004) and hypokalemia (RR 2.04, 95% CI: 1.42–2.92, p<0.001).

Conclusions: There were differential effects of abiraterone on the development of hypertension, hypokalemia, and edema in patients with advanced prostate cancer.

Prostate Cancer Responds to Salvestrols

All stages of prostate cancer from early stage disease to advanced metastatic prostate cancer respond well to salvestrols. This is probably due to the very high expression of the salvestrol activating enzyme CYP1B1 in prostate cancer cells. These cells express high levels of CYP1B1 which activates the salvestrols to their anticancer metabolites and destroy the cancer cells.

Salvestrols work well against Docetaxel and Cabazitaxel resistant prostate cancer.

One of the resistance mechanisms to taxane based drugs such as Jevtana (Cabazitaxel) and Docetaxel is mediated by the enzyme CYP1B1 which has been shown to metabolize these drugs to inactive metabolites. The higher the levels of CYP1B1 then the higher the resistance will be to taxane drugs. However this is the very enzyme that activates the salvestrols so the more resistant cancers will become the most sensitive to salvestrol therapy. In the laboratory salvestrols effectively destroyed chemo resistant prostate cancer cells.

In practise the effects of salvestrols in prostate cancer patients can be amazing. One patient with a PSA of over 5000 saw this drop to less than 100 within a month of taking salvestrols.

Heres some examples of responses to salvestrols in prostate cancer patients:

Case #1.

A 72-year-old male was given a diagnosis of prostate cancer as part of rou­tine monitoring. This gentleman has a long-held belief that phar­maceutical approaches to disease treatment should only be considered as a last resort and preferred to look towards nutrition and nu­tritional supplements to restore his health.

For this approach he took Salvestrol supplementation at a dosage of 1 Salvestrol Platinum (1000 point ) capsule daily combined with a variety of other nutritional supple­ments.

After a period of three months, a PSA test was conducted and the result was within normal limits and he was pro­nounced ‘all clear’. Upon receiving this news he reduced the dose of salvestrols by taking one Salvestrol Shield (350 point) capsule per day as a preventative measure. He continues to be active, physically and mentally. He has had four further PSA tests at three-month intervals and they have all shown results within normal limits.

Case #2.

A 79-year-old male was diagnosed with prostate cancer. A digital rectal examination indicated the presence of a tumour on the left side of the prostate. Prostate cancer was diagnosed and a biopsy scheduled for confirmation. A Gleason Score of 6 (3+3) was assigned to the biopsy results.

Upon receipt of the confirmed diagnosis this gentleman began taking Salvestrols on a daily basis. This comprised three Salvestrol Platinum (2,000 point) capsules per day, taken after meals (6,000 points per day). These were taken in concert with vitamins and minerals that included known salvestrol co-factors such as biotin (625 mcg), niacin (1,000 mg), magne­sium (600 mg), ascorbic acid (3,900 mg), and iron fumerate (20 mg). No dietary changes were made and no change in exercise level was made. In two months of salvestrol supplementation the PSA test result indicated a level lower than that reported prior to his diagnosis.

A period of three months elapsed between receipt of his biopsy results and a consultation with his urologist. The urologist referred the gentleman to the British Columbia Cancer Agency. During the following month the PSA test results indicated levels that led his oncologist to suggest no fur­ther treatment as the cancer was said to be in remission.

Upon receipt of this news the supplementation was reduced to one Salvestrol Platinum (2,000 point) capsule per day for cancer prevention.

Case #3.

A 74-year-old gentleman was diagnosed with Prostate Cancer. Subsequently this man spoke

with his cousin, a university lecturer, who told him that one of his students was diagnosed with a terminal brain cancer and had recovered after taking Salvestrols. He decided to begin a course of salvestrol supplementation taking two (350 point) Salvestrol Shield capsules per day. Six months after receiving his diagnosis his PSA level had dropped from 11 to below 1 ng/mL. At this point the patient switched salvestrol products and began taking one (2,000 point) Salvestrol Platinum capsule three times per day after meals, to give a total supplemtation of 6000 points per day. Twelve months after receiving his diagnosis his PSA level had dropped to 0.2 ng/mL. A new doctor continued with the PSA monitoring and upon receiving a subsequent PSA test result the physician said that the PSA level received was as low as it could be and asked if the patient was sure that he had not had surgery. Given the physician’s surprise that such a result could be achieved the patient confessed to taking salvestrols. The physician then stated that he must be at the cutting edge of research and he had other patients he would like to start on salvestrols. This patient continues to receive PSA test results at the 0.2 ng/ml level and has continues to take one (350 point) Salvestrol Shield capsule per day as a preventative measure, and has now embarked on a fitness program and change in diet.

Zytiga Outperforms MDV3100

This years ASCO abstracts from the meeting in Chicago show a number of new results on the clinical use of Abiraterone (Zytiga).

This abstract shows that Zytiga can work beyond MDV3100 and continues to show activity in MDV3100 relapsed patients.


Abiraterone in patients with metastatic castration-resistant prostate cancer progressing after docetaxel and MDV3100.

Abstract:

Background: Chemotherapy with docetaxel is the standard first-line treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). In patients progressing after docetaxel, both abiraterone and MDV3100 have yielded improved survival for patients with mCRPC. The efficacy of abiraterone in patients pre-treated with MDV 3100 is unknown.

Methods: We investigated abiraterone-prednisone in 24 patients with cancer progression after docetaxel followed by MDV3100. All patients received abiraterone 1000 mg/day plus prednisone 10mg/day. Prostate-specific antigen (PSA) response, symptom response, and time to progression were assessed.

Results: Patient characteristics were as follows: median age: 74 years (53-84), median PSA: 108 ng/mL (2-2541), metastatic sites: bone: all 24 patients, liver/lung: 6 patients (25%), and lymph nodes : 9 patients (38%). Five patients (21%) had a PSA decrease on abiraterone-prednisone. Three patients (13%) achieved a PSA response, defined as a decrease of >50% in PSA, confirmed after≥ 4 weeks. The duration of PSA response was 2, 3 and 4.5 months. Six patients (29%) had a symptomatic response on the pain score and analgesic consumption was decreased. Treatment was well tolerated. Abiraterone-prednisone was discontinued in one patient due to edema and hypokaliemia.

Conclusions: This study shows preliminary evidence that abiraterone-prednisone yields activity in patients with mCRPC pretreated with docetaxel and MDV3100.

Zytiga Cures 10% of Early Stage Prostate Cancers

In results of a clinical trial announced in abstracts of the 2012 ASCO conference show that 6 month neoadjuvant treatment with Zytiga results in complete dissapearance of prostate cancer in 10% of patients with high risk disease. In one third of patients there was significant tumour regression indicating that Zytiga is an exciting agent for neoadjuvant therapy of prostate cancer which may circumvent the need for surgery in some cases.

Could Zytiga Resistance Be Overcome with Salvestrols

Zytiga is a potent CYP17 inhibitor that works by preventing the biosynthesis of all androgens in the body. Resistance to Zytiga is a serious problem in urology leaving few alternative options post Zytiga. Resistance to Zytiga is believed to be mediated by the PI3K and Akt signalling pathway and 2 drugs (GDC0980 and GDC0068 respectively) that are inhibitors of these 2 molecular targets are under clinical investigation in combination with Zytiga.

Salvestrol Q40 has been shown to be a potent inhibitor of the PI3K/Akt signalling pathway, and itself has powerful anticancer effects mediated by the enzyme CYP1B1. Salvestrol Platinum contains a very high concentration of salvestrol Q40 and this supplement would potentiate the activity of Zytiga in metastatic tumour regression activity as well as providing prevention against PI3K/Akt mediated Zytiga resistance. One capsule daily of Salvestrol Platinum is sufficient for prevention of Zytiga resistance but higher doses up to 6 capsules daily can be used for maximum combined therapeutic effect.

Zytiga with Low Dose Prednisone

In a clinical study at the Dana Farber Institute in the USA, researchers used half the dose of prednisone (a steroid) standardly given with abiraterone acetate. This lower dose (5 mg), it is hoped, would reduce the side effects associated with steroids while maintaining its benefits of protecting particular steroid imbalances associated with abiraterone. Since there were no increased side effects from abiraterone, the researchers feel that the lower dose of prednisone (5mg daily) is adequate for most patients.

"Most of the patients in this study had large tumors, high grade prostate cancers and were at high risk for cancer spread," Taplin remarks. "We're very encouraged by the results."

These results show that Zytiga can be safely taken with low dose prednisone (5 mg daily) to good effect, and that the low dose of prednisone is sufficient to prevent the side effects from Zytiga that result from corticosteroid imbalance.

Clinical Study Shows Zytiga Eliminates Prostate Tumours

Abiraterone acetate can help eliminate prostate tumors

The hormone-depleting drug Zytiga (Abiraterone Acetate) approved last year for the treatment of metastatic prostate cancer can help eliminate or nearly eliminate tumors in many patients with aggressive cancers that have yet to spread beyond the prostate, according to a clinical study to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), June 1-5, in Chicago.

The phase II clinical trial, led by investigators at Dana-Farber Cancer Institute and other research centers, examined the use of the drug abiraterone acetate (Zytiga) in combination with prednisone and surgery in 58 men with high-risk prostate cancer isolated to the prostate gland. Participants received either three or six months of the two-drug regimen followed by surgery to remove the prostate. When the treatment was complete, pathology exams showed that one-third of the participants had no or almost no tumor tissue left.

"Very high-risk cancers localized to the prostate are rarely cured by prostatectomy alone," says the study's lead author, Mary-Ellen Taplin, MD, of Dana-Farber. "Therapies that combine surgery with the older androgen-inhibiting drugs have not historically improved outcomes. This unmet need has given rise to efforts to develop new drugs such as Zytiga capable of more completely reducing androgen levels within the prostate tumors."

Taplin will present the data (abstract 4521) on Saturday, June 2, at 8 a.m. CT, Arie Crown Theater,

McCormick Place

.

Androgen, the male hormone, provides the fuel for prostate cancer growth. Conventional therapies target androgen production in the testes and adrenal glands, but not within the tumor itself. Abiraterone acetate is capable of blocking androgen production in all three sites.

In the study, researchers used half the dose of prednisone (a steroid) standardly given with abiraterone acetate. This lower dose, it is hoped, would reduce the side effects associated with steroids while maintaining its benefits of protecting particular steroid imbalances associated with abiraterone. Since there were no increased side effects from abiraterone, the researchers feel that the lower dose of prednisone (5mg daily) is adequate for most patients.

"Most of the patients in this study had large tumors, high grade prostate cancers and were at high risk for cancer spread," Taplin remarks. "We're very encouraged by the results and have begun another phase II study investigating another novel androgen signaling inhibitor, MDV3100, in the neoadjuvant setting for high risk prostate cancer. We are also developing a clinical trial program investigating the addition of the investigational drug ARN509 to abiraterone. To prove the overall benefit of intensive androgen deprivation treatment in conjunction with prostatectomy, a large randomized clinical trial will need to be done."

Zytiga Recommended for use on the NHS

A drug to treat advanced prostate cancer should be given to patients on the NHS, a health watchdog has said.

Abiraterone, marketed as Zytiga, can extend the lives of late-stage cancer sufferers by more than three months.
The National Institute for Health and Clinical Excellence (Nice) revised its recommendations after fresh information from manufacturer Janssen, and the new draft guidance was welcomed by experts.
Professor Alan Ashworth, chief executive of the Institute of Cancer Research, said: "We are delighted by today's decision to allow patients with advanced prostate cancer to receive abiraterone on the NHS.
"This drug was discovered at the Institute of Cancer Research (ICR) and is the result of more than two decades of dedicated work by our scientists and collaborators.
"In clinical trials of men with advanced prostate cancer who have already tried chemotherapy, it has been shown to extend life by an average of four months and improve quality of life."
Cally Palmer, chief executive of The Royal Marsden NHS Foundation Trust, said: "The development of abiraterone by The Royal Marsden and the ICR highlights the national importance of funding pioneering cancer research.
"We are delighted our patients at The Royal Marsden were among the first to benefit from the very latest in drug development and are pleased that patients across the country will now also benefit from our work."
Each year around 37,000 men in the UK are diagnosed with prostate cancer and 10,000 die from the disease. It is the second most common cause of cancer death in men - after lung cancer - accounting for 13%.

This drug was discovered by Professor Gerry Potter at the Institute of Cancer Research and is the result of more than two decades of dedicated work by our scientists and collaborators.

Professor Alan Ashworth

Sir Andrew Dillon, chief executive of Nice, said: "During the consultation on the draft guidance Janssen, the manufacturer of the drug, submitted further information for the committee to consider.
"This included a revised patient access scheme which involves providing the drug to the NHS at a discounted price, further information on which patients would benefit most and clarification on how many patients could receive the drug.
"These factors enabled the committee to revise its preliminary recommendation and now recommend the drug for use on the NHS.
"We are very pleased that Janssen's submission to our consultation means that we are able to produce draft guidance recommending abiraterone - it is an effective treatment, potentially extending life by more than three months, and it also allows patients to be treated at home as it can be taken orally."

NICE Recommend Zytiga

NICE have today issued a final appraisal document recommending Zytiga for use on the NHS which states "Abiraterone in combination with prednisone is recommended as an option for the treatment of castration resistant metastatic prostate cancer".

Prostate cancer wonder drug set for approval in England

• Final approval of abiraterone for England and Wales expected in June
• Prostate cancer charity calls on Scotland to approve drug

Abiraterone is marketed as Zytiga

A drug to treat advanced prostate cancer should be given to patients in England and Wales, according to the NHS rationing body.

Abiraterone, marketed as Zytiga, can extend the lives of late-stage cancer sufferers by more than three months.

The National Institute for Health and Clinical Excellence (Nice) had originally rejected the drug, which costs around £3,000 a month, for not being cost effective.

It provoked an angry response from both patients and cancer charities.

However, today it revised its recommendations after the manufacturer Janssen offered the tablet at a lower undisclosed price.

If Nice gives final approval to the drug it will have to be offered by the NHS in England and Wales from June.

However, in a reverse of the usual trend the drug won't be available in Scotland. In March the Scottish Medicines Consortium turned the drug down saying the cost of abiraterone did not justify the health benefits. This decision could change as it is still in talks with Janssen.

The new draft guidance has been welcomed by experts.

Owen Sharp, Chief Executive of The Prostate Cancer Charity, said: 'This announcement represents a resounding triumph for each of the thousands of men with advanced prostate cancer in England and Wales who know just how much the prospect of precious extra time with their loved ones really means.

'Although today marks a very welcome advancement, it has to be remembered that abiraterone remains out of reach to men in Scotland on the NHS. We need to see every man who needs this drug receive it on the NHS, regardless of where they live in the UK.'

Each year around 37,000 men in the UK are diagnosed with prostate cancer and 10,000 die from the disease. It is the second most common cause of cancer death in men, accounting for 13 per cent.

Sir Andrew Dillon, chief executive of NICE, said: 'During the consultation on the draft guidance Janssen, the manufacturer of the drug, submitted further information for the committee to consider.

'This included a revised patient access scheme which involves providing the drug to the NHS at a discounted price, further information on which patients would benefit most and clarification on how many patients could receive the drug.

'These factors enabled the committee to revise its preliminary recommendation and now recommend the drug for use on the NHS.

'We are very pleased that Janssen's submission to our consultation means that we are able to produce draft guidance recommending abiraterone - it is an effective treatment, potentially extending life by more than three months, and it also allows patients to be treated at home as it can be taken orally.'

Professor Alan Ashworth, chief executive of the Institute of Cancer Research, said: 'We are delighted by today's decision to allow patients with advanced prostate cancer to receive abiraterone on the NHS.

'This drug was discovered by Professor Gerry Potter at the Institute of Cancer Research and is the result of more than two decades of dedicated work by our scientists and collaborators.

'In clinical trials of men with advanced prostate cancer who have already tried chemotherapy, it has been shown to extend life by an average of four months and improve quality of life.'

NICE recommended the use of abiraterone in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed after one docetaxel-containing therapy.

Victory for Zytiga

Approval of Zytiga by NICE for use on the NHS for the treatment of metastatic prostate cancer is a victory for all those who have worked hard to develop this medication.

Chemotherapy and Salvestrols

I am really interested in following this discussion.  My dad is a prostate cancer patient, so I'm interested in your story.  I have been researching a lot of these up-coming drugs, and according to a pharma strategy blog, I have been reading TAK 700 has a similar mechanism of action to Abiraterone, but may allegedly be superior...  although the jury may not be out on that one yet (as far as the trials are concerned).

My dad was on a trial for MDV3100 which didn't work for him but he may have been on the placebo arm, or his PCa is hormone refractory and not receptive to the drug...  It's worth considering whether there is a placebo arm or not when entering a trial as that is the risk that you are taking on.  Also it's worth considering about how your oncologist is and whether they will pull you from the trial if it's not working for you.  They are not supposed to, but you probably have an idea of how much your oncologist has your back...
I have a question.  My dad is on taxotere right now, has just completed 3 cycles.  First diagnosed 1998, RP 1999, remission until late 2008, radiotherapy 2009, androgen blockade 2010, MDV3100 trial 2011, docetaxel 2012.  How much damage does docetaxel/taxotere really do?  I understood it was one of the more "gentle" chemos, and certainly the dosage for mCRPC is 25% lower than for metastatic advanced breast cancer (75mg/m2 vs 100mg/m2).  Is there anything he can do to help deal with the liver damage.  I believe all his tests are coming back ok.  Someone recommended milk thistle.  Any thoughts on this?
 Also, I would like to encourage him to take salvestrols. Could you provide a link & recommendation for purchase? His PSA pre-chemo was 17, post chemo 9 and then 10, so I am not sure how effective it is so I think we need to start looking at alternatives.  I would appreciate any advice really.  He is pretty hard to persuade and usually only responds to things that have demonstrated scientific effectiveness to randomised blinded testing.  He was an engineer/trained as a physicist and is extremely cynical and untrusting, so persuading him is hard.  And he doesn't really subscribe to big-pharma conspiracy theory...
One last question, any thoughts on the issue of refined sugar consumption feeding tumour growth, and fructose (or HFCS) related liver damage, and whether these are significant concerns/factors for a PCa patient?
Any help and advice much appreciated
Best wishes
Hannah

Is it safe to combine salvestrols with chemotherapy

Answer:
Docetaxel is a classic cytotoxic chemotherapy agent that is toxic to normal cells as well as the cancer cellls. It is therefore toxic to other normal cells such as liver cells and consequently is hepatotoxic. Milk thistle can help with the liver and does itself contain salvestrols.

TAK-700 (Orteronel) is similar to Zytiga (Abiraterone) because it works by inhibiting the enzyme CYP17. However it is a weaker inhibitor than Zytiga and there is an important difference between them in that Zytiga is an irreversible inhibitor whilst the inhibition with TAK-700 is reversible. This means that clinically Zytiga is much more efficient at inhibiting the CYP17 enzyme and causes total androgen blockade which TAK-700 is not able to do. So TAK-700 is a weaker partial inhibitor of CYP17 compared to Zytiga which is a potent and irreversible inhibitor.

Salvestrols can safely be taken alongside hormonal therapy agents such as Zytiga and TAK-700. The recomended dose here is 6000 points per day.

Salvestrols can also be safely taken alongside other medications such as chemotherapy. There are clinical results from China which show that Salvestrol Q40 reduces the side effects from taxotere chemotherapy and increases the anticancer effects.

On the days receiving chemotherapy the recommended dose is 2000 points. In the recovery period the dose can be increased to 6000 points daily for maximum effect.