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Weekly UpdatesA common treatment given to men with early-stage prostate cancer--one that has significant harms--was found to be no more effective in extending life than the "wait-and-see" approach. The study, published last summer in the Journal of the American Medical Association, highlights the fact that doctors have been using this treatment for decades without proof of benefit. Its finding became the centerpiece for an unusual article in a recent issue of the Journal of the National Cancer Institute that candidly discussed the many reasons for overuse, chief among them are the financial incentives that encourage treatment ... but more on that later.
The treatment in question is called androgen deprivation therapy (ADT), aka drugs that shut off the male hormones known to promote tumor growth. It is given to men whose cancer is confined to the prostate and received no other treatment, such as surgical removal of the prostate. The 2008 study that showed ADT does not increase survival was conducted by Grace L. Lu-Yao, MPH, PhD, University of Medicine and Dentistry of New Jersey, and colleagues who drew their information from Medicare claims.
The men in this study were diagnosed with localized prostate cancer in 1992-2002. They were age 66 years and older at the time of diagnosis with a median age of 77 years. Survival results favored the untreated. During the ten year follow-up period, those given ADT had a lower prostate-cancer survival rate (80%) than those not given ADT (82.6%).
Wide variations were seen in the treatment duration--half of the ADT-treated stayed on the drugs more than 30 months. Such long-term use has been associated with 10% to 50% increases in the risks of fracture, diabetes, coronary artery disease, heart attack and sudden cardiac death, according to Dr. Lu-Yao and colleagues. Hot flashes and swollen breasts are some of the common adverse effects.
This is not the first study to show ADT for early-stage disease did not prolong life, though its use steadily increased over the last 20 years. In a telephone interview Peter C. Albertsen, MD, a co-author of the ADT study, acknowledged a trial that randomly assigned men to ADT or no treatment would be ideal. But that type of trial would have taken too long, he continued, "So we did the best we could by going to the Medicare claims data."
Dr. Albertsen, who is a professor and chief of urology at University of Connecticut, Farmington, went on to explain, "It was thought that early use of ADT would offer a longevity benefit, but our analysis is convincing that early use of hormone therapy doesn't make sense. In fact it makes much more sense to wait for the patients to develop symptoms before they are offered this treatment."
That conclusion also calls into question the current practice of giving the PSA (prostate-specific antigen) blood test to symptom-free men, as part of a routine physical exam, though the test has yet to be proven life-saving. And many experts suspect that it causes far more harm than good, particularly in elderly men, because it leads to unnecessary drastic treatments [e.g., prostatectomy] for cancers that would never produce symptoms or become lethal. Furthermore, there is no accurate way to distinguish the cancers that will progress from those that will remain dormant for a lifetime. These concerns led to new recommendations from the U.S. Preventive Services Task Force.
Last summer, the USPSTF announced that men over the age of 75 years should no longer be screened for prostate cancer and men younger than 75 years should know "the benefits of screening for prostate cancer are uncertain and the balance of benefits and harms cannot be determined." With this recommendation, the USPSTF parts company with many other medical organizations like the American Urological Association that recommend PSA testing for all men after the age of 50 years.
With the new USPSTF recommendation in mind, Dr. Albertsen was asked whether it is reasonable to see his study's findings as an example of the harm that results from the aggressive promotion of the PSA test over the last 20 years. "Yes it is," responded Dr. Albertsen, after a moment's hesitation, "because you can only have early, localized cancer [diagnosed] if you are screened--otherwise you'd have a tumor that causes symptoms and that's not what we're talking about here."
There are other forces driving the overuse of ADT, according to James Talcott, MD, director of the Center for Outcomes Research at Massachusetts General Hospital Cancer Center. In a telephone interview, Dr. Talcott, who was not involved in the ADT study, said, "Two drugs [used in ADT]--Lupron and Zoladex--have been aggressively promoted by their makers--Tap Pharmaceuticals and AstraZeneca." Both companies used illegal kickbacks to encourage and reward urologists who were high prescribers of these expensive drugs, although a less expensive drug is widely available.
"Together, these two companies had to pay over a billion dollars to the federal government in fines for kickbacks to urologists [in 2001]," said Dr. Talcott. (The kickbacks included free TVs, VCRs and seminars at resorts.) "Drugs like Lupron and Zoladex--that are given by injection or infusion--are where all the money is made," he continued, doctors can bill for them which is not the case for drugs given orally. "A great majority of men are treated by a urologist and moved on to an oncologist only after they don't respond to Lupron or Zoladex."
Part of the ADT overuse problem is not the physicians' fault, stressed Dr. Talcott. "It's also the payment mechanism. Doctors are paid to do something like give an injection, but talking to patients is a money loser." Dr. Albertsen made a similar point, saying it's easier to give a drug than to explain the counterintuitive option of leaving cancer untreated.
Men are bombarded with the message that early detection is best, observed Dr. Talcott, and yes many cancers are found, but "men are at least tenfold more likely to be harmed than helped by treatment of early-stage symptomless cancer."
Maryann Napoli, Center for Medical Consumers [C] 2009
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