Life Extension Magazine February 2014
Brain Tumor Treatment Breakthrough!
By William Faloon and Lisa Antone
Perhaps the most frightening malignancy one can be diagnosed with is a form of brain cancer called glioblastoma multiforme.
This type of brain cancer has a dismal prognosis, with median overall survival of 12 to 15 months, and a 2-year survival rate of 15% to 26%.1
You may remember that Senator Ted Kennedy was diagnosed with glioblastoma multiforme in May 2008. Despite intervention by brain tumor experts, Sen. Kennedy died in August 2009 — a mere 15 months later.
We at Life Extension® have long-been evaluating new approaches to treat this deadly malignancy. We’ve been frustrated by the paucity of meaningful progress and our inability to make better treatment recommendations.
A study published in the September 5, 2013 edition of the New England Journal of Medicine may represent the most significant advance yet discovered in treating glioblastoma multiforme.
What follows is an overview of this therapy that is available right now to brain tumor patients:
- The cytomegalovirus has been suspected as facilitating the initiation and promotion of brain cancers.2-4 From 50% to as many as 80% of adults in the United States show exposure to cytomegalovirus, but relatively few harbor active viral infection.5
- Doctors followed 75 glioblastoma multiforme patients and found the median overall survival of those withlow-grade cytomegalovirus infection was 33 months. In patients with high-grade cytomegalovirus infection, median overall survival was only 13 months.1
- All but one of the 75 glioblastoma multiforme patients studied had active cytomegalovirus infection, indicating that this virus may be involved in the development of this lethal malignancy. 1
- In glioblastoma multiforme patients with high-grade cytomegalovirus infection, median 2-year survival was 17.2%. Patients with low-grade cytomegalovirus infection had median 2-year survival rates of 63.6%. This suggests that high-grade active cytomegalovirus infection accelerates tumor progression. 1
- Valganciclovir (Valcyte ® ) is an FDA-approved drug used to treat cytomegalovirus infection. 1
- In a double-blind clinical trial of valganciclovir involving 42 patients with glioblastoma, an exploratory analysis of 22 patients receiving at least 6 months of antiviral therapy showed 50% overall survival at two years compared with 20.6% of contemporary controls. This study showed that valganciclovir-treated patients have a median overall survival of 24.1 months compared to 13.7 months in patients not treated with valganciclovir. 1
- Owing to the promising results of this pilot study, glioblastoma multiforme patients at the world famous Karolinska University Hospital received valganciclovir and results were then compared to a control group. Both groups received standard conventional therapy and both groups had a similar disease stage and surgical-resection grade. 1
- The researchers retrospectively analyzed the data on 50 of these brain cancer patients and found the 2-year rate of survival in the valganciclovir group was 62%, whereas 2-year survival was only 18% in the control group. 1
- In 40 glioblastoma multiforme patients who received valganciclovir for at least 6 months, the 2-year survival rate was 70%, with a median overall survival of 30.1 months. 1
- 25 glioblastoma multiforme patients that received continuous valganciclovir treatment after the first 6 months had a 2-year survival rate of 90%, with median overall survival of 56.4 months (4.7 years)! 1
- Recall that current median survival of glioblastoma multiforme patients is only 12–14 months. 1
- Also recall the efforts made to prolong Sen. Kennedy’s life and the best the experts at Duke University Medical Center could do was 15 months.1
The implication from these findings is that treating active cytomegalovirus infections may dramatically reduce progression, and significantly increase survival time, in patients suffering from the deadly brain cancer glioblastoma multiforme. Most exciting is the intriguing data from this retrospective study that valganciclovir treatment in patients with active cytomegalovirus produced an unheard of median survival of 56.4 months (4.7 years) in glioblastoma multiforme patients.1
Not only does this retrospective data involving the continuous use of valganciclovir extend survival in glioblastoma multiforme patients, but it provides an opportunity to add in additional complementary therapies (like metformin) that could improve outcomes even more!
What Brain Tumor Patients Should Do
At the time of surgical resection of the brain tumor, a specimen should be sent for immunohistochemical analysis to evaluate presence and activity of cytomegalovirus.
In glioblastoma multiforme patients with evidence of cytomegalovirus-positive tumor tissue, those who wish to follow the protocol that resulted in unprecedented survival improvements should consult with their oncologist and consider 900 mg of valganciclovir twice a day for three weeks followed by a maintenance dose of 450 mg twice a day indefinitely to be adjusted for side effects such as kidney impairment and bone marrow suppression.1
Valganciclovir should be taken with fatty meals to enhance its absorption/bioavailability.
The price of valganciclovir is beyond outrageous, with the annual cost being around $50,000.
Those who have already had surgery should have their blood tested to help determine cytomegalovirus activity. Patients whose blood test reveals active cytomegalovirus (CMV) infection, which appears to be an important risk factor in some glioblastoma multiforme patients, should have the cost of valganciclovir covered by their medical insurance.
Cancer patients can often have blood tests covered by their medical insurance as long as their oncologist prescribes the tests.
Will Historic Human Carnage Repeat?
Glioblastoma multiforme is a death sentence. Virtually no one survives long-term. It kills 12,000 Americans each year and many more throughout the world.
The findings from this study showing vast survival improvement in brain cancer patients were published in the prestigious New England Journal of Medicine. Previous published studies corroborate the role that cytomegalovirus may have in human cancers and the potential benefit of valganciclovir.
Since 1980, Life Extension has been at the forefront of identifying off-label cancer drugs like cimetidine, aspirin, and metformin, but medical authorities largely ignore us. When properly used, there is intriguing evidence that suggests metformin, aspirin, and cimetidine could spare tens of thousands of Americans from agonizing cancer deaths each year, yet virtually no oncology group routinely prescribes them.
The benefits reported in the New England Journal of Medicine represent the most significant survival advance against this deadly brain malignancy in history, yet these findings were virtually ignored by the mainstream media even though the life-sparing drug (valganciclovir) is available right now.
It is illegal for the maker of valganciclovir to promote it as a treatment for brain cancer. The regulatory system in the United States requires that the maker of a drug conduct extensive clinical trials for each disease a drug is claimed to treat and then submit the trial results to the FDA for approval.
While it is legal for doctors to prescribe valganciclovir off-label—that does not protect a doctor’s medical license if a patient has an adverse reaction. So many oncologists may refuse to prescribe valganciclovir despite findings that it may improve survival of glioblastoma multiforme patients more than three-fold.
So there is the real possibility 12,000 Americans will continue to perish from glioblastoma multiforme each year despite impressive findings showing that valganciclovir could spare many of them from premature death.
Glioblastoma multiforme patients whose tumor specimen reveals immunohistochemical evidence of active CMV infection, or whose blood test is CMV positive for active infection, should ask their oncologist to consider valganciclovir.
My greatest concern is that this valganciclovir study published in the New England Journal of Medicine will be relegated to medical archives and not be utilized to save cancer patients, just as hundreds of published studies on metformin, aspirin, and cimetidine have been ignored by the medical establishment for the past four decades.
The article on the next page provides a more in-depth review of the role that CMV infection plays in the development and progression of brain and other cancers.
For longer life,
Common Virus Linked to Deadly Brain Cancer
By Lisa Antone
Few people would ever suspect that one of the most deadly forms of brain cancer is caused by a common virus carried by the majority of people. Yet that’s exactly the case, according to a number of new studies in prestigious medical journals.
In the same way that cervical cancer and head and neck cancer has been linked to certain strains of the HPV virus, the most common and deadly type of brain cancer, glioblastoma, has been linked to a virus in the herpes family called CMV (short for cytomegalovirus).6,7
A diagnosis of glioblastoma means certain death, with population studies indicating typical overall survival rates of less than a year.8 And unfortunately, this deadly form of brain cancer is the most common malignant brain tumor in the US.8
Establishing a link between this deadly cancer and a common virus is an enormous step in understanding how to treat, and potentially to prevent, early and unnecessary deaths. And more importantly, it led to the discovery of a drug that can quadruple the life span of those who have already been diagnosed with this deadly disease!1
The Dangers Of The CMV Virus
Cytomegalovirus, or CMV, may be the most important virus you’ve never heard of. The prevalence of latent CMV infection is up to100% in most populations of adults worldwide with increasing prevalence in the elderly, and is now considered to play multiple roles in immunosenescence, the gradual fading of immune function with age.9,10
This is a serious problem. Latent CMV infections are strongly associated with frailty in the elderly and dramatically increases mortality risk.11,12 CMV has also been associated with accelerated aging in general, and even with shortening of telomeres (the age-regulating bits of DNA that govern each cell’s lifespan).13 Indeed, a 2013 study found disturbing early signs of immunosenescence in young people who tested positive for CMV, compared with their CMV-negative peers.14
And of course, waning immune function also opens the door for cancers to develop, freed of the ever-present surveillance carried out by a younger, more robust immune system.
And that’s just with the latent form of the virus; the active form is far worse. Active CMV disease in older patients or in those with compromised immune systems is a devastating disease. It can cause hepatitis leading to liver failure, retinitis leading to blindness, severe colitis (large bowel inflammation), pneumonitis (viral pneumonia), esophageal inflammation, and disorders of the central and peripheral nervous systems.15,16
But unlike other herpes viruses, CMV rarely produces detectable symptoms in otherwise healthy people.16 That makes it difficult to diagnose, and dangerously easy to spread. Diagnosing CMV often requires two separate blood tests, several weeks apart, as well as a high index of suspicion by both patient and provider (see sidebar on the next page for an understanding of test results).17 CMV spreads the way other herpes viruses do: by contact with bodily secretions, especially saliva.18
The ease of spread and the absence of symptoms in healthy adults accounts for the very widespread prevalence of CMV.18 Estimates vary, depending on geography, socioeconomic status, and other variables, but at least 35%, and up to 100% of people in some communities, will test positive for CMV.19-21