PLCO Data Support Protective Effect of Aspirin in Preventing Deaths

In recent months, the US Preventive Task Force has recommended adults without diabetes or documented coronary artery disease avoid taking baby aspirin to prevent heart attacks and strokes. They believe the risk of bleeding outweighs the benefit derived. They still recommend aspirin prevention in men with known cardiovascular, cerebrovascular disease and diabetes.

The Prostate, Lung, Colorectal and Ovarian Cancer Trial (PLCO) just made the decision-making much more complex. In their study, reported in this month’s JAMA Network Open, they found that taking aspirin as infrequently as 1 to 3 times per month reduced the risk of all-cause and cancer related mortality compared to no aspirin in their study with 146,152 patient participants.

Weekly use of aspirin significantly reduced the risk of mortality from both GI and colorectal cancer and all mortality endpoints irrespective of how heavy you were. When the study looked at 12.5 years of aspirin use 1 to 3 times a month, compared to none, the all-cause mortality was reduced by 16%. The results were even more encouraging when aspirin was taken three or more times per week.

The PLCO Cancer Screening Trial involved participants aged 55-74 who were randomized to a cancer screening group or a control group at 10 United States Medical Centers. This review looked at men and women 65 years or older at baseline. While this study showed a beneficial effect of aspirin in the elderly, other recent studies have been less favorable. The ASPREE study, Aspirin in Reducing Events in the Elderly, found that individuals taking 100 mg of aspirin daily were at increased risk for all-cause mortality compared to those taking a placebo.

The decision to take low dose aspirin, or not, is something you should discuss with your physician so that you can tailor the situation and risks to your personalized needs.

Lung Cancer Screening is Underutilized

Dr. Jinai Huo of the University of Florida (Go Gators!) presented data to Reuters Health that primary care physicians are under-utilizing the technology available to screen for lung cancer. This is a particularly sore topic to me because my associate and I always screened smokers and heavy past smokers for lung cancer with an annual chest x-ray until the United States Preventive Task Force issued guidelines that it didn’t save lives and was not cost effective.  They said, it cost $200,000 in normal x-rays to find one cancer early and it was deemed not worth it.

We actually sold our chest x-ray unit, let go our certified radiology technician and cancelled a contract with radiologists to read our films because insurers stopped paying for chest x-rays after the USPTF ruling.  Twenty years later that same group said “woops” an error was made. The statistical analysis on that study was done incorrectly and actually screening does save lives and is cost effective.

Today we have the fast low dose CT scanner to screen for lung cancer and screening does save lives according to the data.  Who should be screened?

Current smokers or those who have quit smoking within the last 15 years who are 55 to 77 years old and have a smoking history of 30 packs or more per year (one pack per day for 30 years or 2 packs a day for fifteen years).  Screening should be done on individuals in good health so if a lesion is found they are considered well enough to undergo diagnostic tests and treatment.

Screening is also recommended in those individuals over 50 years old with a twenty (20) pack year smoking history and a family history of lung cancer or lung disease or occupational exposure to items associated with causing cancer such as radon.

I inquire about smoking at each visit and have been fortunate in that few of our patients still smoke so we spend less time on counseling for smoking cessation.  If you fall into one of the screening groups mentioned in this article, and have not been screened, please notify us so we can arrange for the testing which will be a low dose chest CT scan.

Prostate Cancer, Digital Rectal Exams, PSA and Screening

The PSA blood test, to detect prostate cancer, clearly has saved lives according to numerous studies. The United States Preventive Task Force (USPTF) recognizes this but has decided that screening for prostate cancer is not a great idea in men aged 55-69. They point out the PSA can be elevated from an enlarged prostate, an inflamed or infected prostate, a recent orgasm while having sex and other causes.

Elevated PSAs led to trans-rectal ultrasound views of the prostate and biopsies of the prostate. These biopsies were uncomfortable, even painful, and often followed by inflammation and infection of the prostate. Many times the prostate biopsy was benign with no cancer detected. The USPTF felt the cost, worry, and potential side effects were a risk far outweighing the benefits of screening. They consequently came out against screening men in this age group.  Naturally this position produced a tidal wave of criticism from urologists and other.

So, the USPTF has produced new recommendations calling for patient education and making a shared decision whether or not to obtain a PSA measurement before you send it out. This is a bit confusing because we always discuss the pros and cons of a PSA before we draw it. Adult men are entitled to hear the pros and cons so they can make their own informed decision.

To complicate matters, a study out of McMaster University in Canada reveals physicians are poorly trained in performing a digital rectal exam. They cite the lack of experience coming out of school and going into training and cite numerous research studies showing a rectal exam is a low yield way to detect prostate cancer. They do not recommend performing digital rectal exams for prostate cancer screening.

This received much media hype and the blur between the efficiency of detecting prostate cancer via a rectal exam and the use of the rectal exam to detect rectal and colon disease has been lost. We perform digital rectal exams to detect prostate cancer and look at the perirectal area for disease. We test the strength and performance of the anal sphincter muscle. We feel for rectal polyps and growths and, in certain situations, test the stool for the presence of blood.

During my internal medicine training my teachers always required a digital rectal exam, stool blood test and slide of the stool as part of the exam. As trainees, we realized the invasiveness of the exam and did our best to be polite, gentle and caring. I always asked for permission first, and still do. How can you tell if something is abnormal if you haven’t performed normal exams?

Last but not least, Finesteride, a medicine used to shrink an enlarged prostate by inhibiting male hormones, has finally been shown to be protective against developing prostate cancer. A study published in the journal of the National Cancer Institute found that men taking it for 16 years had a 21 % lower incidence of prostate cancer.

Does Not Testing the PSA Lead to More Advanced Prostate Cancer?

Mortality from prostate cancer has diminished by almost 40% since the introduction of the PSA test in the late 1980’s. Much of this is due to the use of the PSA blood test for screening purposes. In 2011 The US Preventive Screening Task Force strongly condemned the use of PSA screening. They felt that we were finding too many inconsequential early malignancies that would not lead to death and were being over treated. In their eyes, prostate cancer treatment with surgery and or radiation carried a high price tag with multiple long term complications and the benefit of screening was not worth the risk. Prior to the USPSTF”s 2011 recommendation against screening for prostate cancer with a PSA there were 9000 – 12,000 new cases of prostate cancer diagnosed per month. In the month following the USPSTF recommendation not to screen with PSA the number of new cases dropped by almost 1400 a month or over 12%. Over the next year the decline in prostate cancer diagnosis was 37.9 % for low-risk prostate cancer, 28.1% for intermediate risk, 23.1 5 for high risk and 1.1% for non-localized cancer. Clearly if you do not look for a disease you will not find it.

In the December issue of the Journal of Urology, Daniel Barocas, MD, of Vanderbilt University and colleagues discussed the PSA testing controversy. They too noted that the consequences of not screening for intermediate and high risk prostate cancer by performing the PSA test may lead to individuals presenting with far more advanced disease that is more difficult to treat, has more complications and ultimately leads to disease related deaths. His position was debated by two major urologists in the editorial section of the journal with no firm conclusion being reached.

In an unrelated article, the Center for Medicare Services or CMS announced that it is considering penalizing physicians who test the PSA for screening in Medicare patients beginning in 2018 as part of their paying for value and quality. They said that physicians need to present their patients with an ABN (advanced beneficiary notice) stating that Medicare will not pay for this test, before the blood is drawn or face fines and penalties.

Men in their forties and older have been put in an uncomfortable and inappropriate position by health policy leaders. The truth is we are currently unsure how and when to test for prostate cancer in men with a normal digital rectal exam (DRE). The consequences of not paying for screening will not be known or understood for easily ten to fifteen years. It is clear that early stage disease has the option to be observed for progression with minimal consequences in the short term. Not enough time has elapsed for anyone to know the long term effects of this policy change. Unfortunately, men in this age group are all guinea pigs in the public health policy laboratory while the data to reach a firm scientific conclusion is assembled. The predominant policy today is spending less and doing less. With this in mind, it is best for men to see their doctor, have an annual digital rectal exam, discuss their family history of prostate disease and reach an individual decision on PSA screening appropriate for their unique situation rather than one based on large population policy.

Ambulatory Blood Pressure Monitoring Proposed As Gold Standard

Bllod Pressure - OmronThe US Preventive Services Task Force (USPSTF) recommended that physicians use ambulatory blood pressure monitoring to confirm the existence of hypertension in newly suspected cases before instituting therapy. The USPTF has been making recommendations on appropriate health screening for years now. Their new positions now says that patients 40 years of age or older with an initial BP of 130/85 or higher should be screened for hypertension annually instead of every 3-5 years as previously suggested. The recommendation includes annual blood pressure screening for all adult African Americans. Included in the recommendation is a call for the use of ambulatory blood pressure monitoring. It is felt that blood pressure readings in the doctor’s office may be influenced and higher due to anxiety or “white coat hypertension.” Ambulatory Blood Pressure Monitoring providing multiple readings will give you a true average systolic and diastolic reading which permits you to separate hypertensive patients requiring treatment from anxious individuals.

When evaluating a patient for hypertension we have used the 24 hour ambulatory monitor in my office practice for years. It is a traditional blood pressure cuff designed to inflate six times an hour during daytime hours and four times per hour when you go to bed. Patients are asked to shower or bathe prior to coming to the office and to limit their activities to their normal activities of daily living. The patient drops the device off 24 hours later and we connect it to our computer and print out the readings. The device produces hourly readings plus average readings. The major side effects are the inconvenience of wearing a device which inflates six times per hour. Cost has been a factor since most insurance companies have not seen the wisdom of paying for this. In my experience it allows us to classify someone as normal or normotensive and not institute treatment most of the time. Without this type of device we were dependent on looking for complications of hypertension such as changes in the arteries and veins in the eyes using the ophthalmoscope or changes on your EKG to confirm the diagnosis of hypertension. With the development of vital sign monitoring devices associated with cellphones and computer tablets it will only get easier to accurately monitor ambulatory blood pressures in the future. These devices will additionally allow us to check on whether or not our treatment is actually keeping your BP within the limits it should.

We have one monitor in the office at the current time and ask that you make an appointment to have it placed on you if you wish to be checked.

Low Dose Aspirin Cuts Colon Cancer Risk in Women

AspirinNancy Cook, SCD of Brigham and Women’s Hospital in Boston and colleagues reported in the July 16, 2013 issue of the Annals of Internal Medicine that data from the Women’s Health Initiative including 39,876 women 45 years or older, who were randomly assigned to take 100 mg of aspirin every other day for ten years, experienced a 20% reduction in the risk of colorectal cancer. The study did not show that there was an all-cause reduction in mortality .

The very conservative US Preventive Services Task Force currently recommends aspirin in Women 55 – 79 only if potential benefits are greater than harms. The aspirin group did have more bleeding from peptic ulcers and gastrointestinal bleeding. The article was accompanied by an editorial comment by Peter Rothwell, MD, PhD of the University of Oxford. He felt that the risk of bleeding and the fact that there was no all-cause mortality reduction, or risk in all cause cancer reduction, should result in a tempering of suggestions for widespread use of aspirin in healthy middle-aged women. MedPage Today, the online Journal of the University Of Pennsylvania School Of Medicine, ran a comment from Dr. Randal Burt, MD, a gastroenterologist at the Huntsman Cancer Institute who felt that this was one more piece of evidence that aspirin can reduce colorectal cancer.

It is clear that there are multiple studies showing that aspirin can reduce the risk of colorectal cancer. There are studies showing it reduces the risk of a stroke in women as well.

Like all decisions to take or prescribe a medication, the risks and benefits must be examined first. It is clear to me that in a woman with a strong family history of colorectal cancer, and little or no history of gastrointestinal or systemic bleeding, an aspirin with close monitoring should seriously be considered.

Breast Cancer Screening DOES SAVE LIVES

Eugenio Paci, MD, of the ISPO Cancer Prevention and Research Unit in Florence, Italy working with a European breast cancer screening group, published data in the Journal of Medical Screening that clearly showed that screening mammograms save lives. The study was necessitated because of recent controversial data presented by the US Preventive Services Task Force (“USPSTF”) calling for women to wait until age 50 to begin mammograms and having them every other year rather than annually. The USPSTF recommendations were based on the belief that too many false positive tests led to too many unnecessary and expensive follow-up tests.

The European researchers found that for every 1,000 women screened from age 50 to 51, and followed to age 79, an estimated 7 to 9 lives would be saved and; an additional four cases of cancer would be diagnosed early. The screening resulted in 170 women having to have a repeat non-invasive test to rule out cancer (such as a repeat mammogram and or ultrasound of the breast) and 30 women would have to undergo an invasive test such as a biopsy.

The researchers looked at a 10 year period in Europe and expected 30 deaths per 1,000 women from breast cancer of which 19 could be prevented by screening. Their figures showed that 14 women need to be screened to diagnose one case of breast cancer and 111 to 143 need to be screened to save one life.

I will continue to recommend that patients learn how to perform a breast self exam and perform it regularly. We will begin screening our high risk patients at age 40 and others at age 50.

A thorough annual breast exam by the patient’s doctor is advised. A decision on annual mammograms versus every other year should be decided by the patient’s risk factors, family and personal health history, current examination and past mammogram findings.