Watchful Waiting (Observation) Versus Surgery for Prostate Cancer





 

A new landmark study suggests that some patients with early-stage prostate cancer can be safely observed rather than undergoing radical surgery.


 

 

WATCHFUL WAITING (OBSERVATION) VERSUS SURGERY FOR PROSTATE CANCER

In the United States, prostate cancer is the most common type of non-skin cancer occurring among men, and the second most common cause of cancer death in men.  (Lung cancer, an almost completely preventable form of cancer, sadly, remains the most common cause of cancer death for both men and women.)  The American Cancer Society estimates that, in 2012, more than 240,000 new cases of prostate cancer will be diagnosed, and more than 28,000 men will die from this form of cancer.

The debate surrounding the ideal management of early-stage prostate cancer has revolved around “watchful waiting” (observation) versus aggressive treatment with surgery or radiation therapy.  In many cases, prostate cancer is a slow-growing cancer, and when it arises in older men in particular, it seldom leads to death.  On the other hand, there are more aggressive variants of prostate cancer that spread rapidly, and these forms of prostate cancer can indeed lead to death.  The dilemma regarding which patients can be safely observed and which should be subjected to aggressive treatment has been difficult to resolve, however, because it can be difficult to determine, up front, which patients will benefit from treatment and which will not.

Last year, I reviewed a prospective randomized clinical research study from Sweden which revealed a significant improvement in survival among patients with prostate cancer who underwent prostate cancer surgery, when compared to patients who were managed with “watchful waiting”  (Prostate Cancer: Watchful Waiting Versus Surgery (Prostatectomy).)  Now, a similar new prospective randomized clinical research study provides additional important clinical information that may help doctors to identify selected prostate cancer patients who can be safely observed, thus avoiding radical cancer treatments that are associated with a high incidence of incontinence and impotence, as well as other potentially serious complications.  This new study appears in the current issue of the New England Journal of Medicine, the same journal that published last year’s Swedish prostate cancer clinical research study.

In this prospective randomized study, 731 men with newly diagnosed prostate cancer were randomly assigned to undergo radical prostate cancer surgery (prostatectomy) versus observation only.  This group of research volunteers, with an average age of 67 years, was then followed for approximately 10 years, and their outcomes were carefully monitored.  It is important to note that all of these men had early-stage prostate cancer, which appeared not to have spread outside of the prostate gland.

Following 10 years of monitoring, on average, 47 percent of the men who underwent prostatectomy died, while 50 percent of the men in the observation group died (this small difference in overall survival was not statistically significant.)  When the researchers looked at the risk of death caused specifically by prostate cancer, or due to complications associated with prostatectomy, 5.8 percent of the men in the prostatectomy group died directly as a result of either their prostate cancer or due to complications of surgery, while 8.4 percent of the men in the observation group died due to their prostate cancer, for a relative cancer-specific survival difference of 37 percent and an absolute difference of 2.6 percent in favor of the men who underwent surgery instead of observation.  Importantly, however, this observed difference in cancer-specific survival did not quite achieve statistical significance, suggesting that the cancer-specific survival benefit of radical prostatectomy in men with early-stage prostate cancer is, in general, either nonexistent or very small, at least over a 10-year period of time.

Importantly, when the authors of this study assessed prostate-specific antigen (PSA) levels, specifically, as a predictor of survival among the two groups of men who participated in this study, they found that prostatectomy did, in fact, significantly improve survival among men with a PSA level greater than 10 nanograms per milliliter (ng/ml), compared to observation alone.

As is often the case, pundits on either side of the prostate cancer treatment debate will find some ammunition in this study’s findings to support their respective positions.  Those experts who espouse aggressive treatment for most or all early-stage prostate cancers will note the nearly 3 percent improvement in absolute survival associated with radical prostatectomy, although, in this study, this difference in absolute survival was not considered to be statistically significant.  (However, it should be noted that the observed survival advantage associated with surgery in this study would have actually been higher, and perhaps statistically significant as well, had there not been a postsurgical death of one of the patients in the prostatectomy group.)  On the other hand, proponents of “watchful waiting” will point to the very small difference in observed death rates between these two groups of patients, and the relatively large number of adverse events associated with radical prostatectomy (21 percent).  However, in my view, this study’s findings offer a reasonable, evidence-based, “middle ground” strategy, based upon patients’ PSA levels.  Specifically, for older patients who have a PSA level below 10 ng/ml and no worrisome microscopic features that suggest an aggressive variant of prostate cancer, observation may indeed be a reasonable alternative to prostatectomy, based upon the findings of this landmark study.  (Unfortunately, this study did not assess radiation therapy, which is the other common form of treatment for early-stage prostate cancer.)

In completing my review of this important clinical study, I should also note that 1 out of 5 patients who enrolled in this prospective study did not remain within their assigned groups and, therefore, crossed over into the opposite group after they entered into this study.  However, while this factor does somewhat complicate the analysis of the data collected in this study, it probably does not affect the overall accuracy of the study’s conclusions.

I do not believe that this important but admittedly imperfect study will, by itself, completely resolve the ongoing debate regarding the optimal management of early-stage prostate cancer.  However, as one of only a very few well-performed randomized prospective clinical studies that have directly compared radical surgery with observation alone, and with reasonable long-term follow-up of patients, this is a very important clinical research study for both patients and their prostate cancer physicians alike.  Because of this study, both patients and their doctors will now be better able to make individualized, evidence-based decisions regarding the likely risks and benefits of surgery versus careful observation as an initial approach to prostate cancer management.


At this time, more than 8 percent of Americans are unemployed.  According to the Bureau of Labor Statistics, however, the unemployment rate for veterans who served on active duty between September 2001 and December 2011 is now more than 12 percent.  A new website, Veterans in Healthcare, seeks to connect veterans with potential employers.  If you are a veteran who works in the healthcare field, or if you are an employer who is looking for physicians, advanced practice professionals, nurses, corpsmen/medics, or other healthcare professionals, then please take a look at Veterans in Healthcare. As a retired veteran of the U.S. Army, I urge you to hire a veteran whenever possible.


For a groundbreaking overview of cancer risks, and evidence-based strategies to reduce your risk of developing cancer, order your copy of my bestselling book, “A Cancer Prevention Guide for the Human Race,” from AmazonBarnes & NobleBooks-A-MillionVroman’s Bookstore, and other fine bookstores!

Within one week of publication, A Cancer Prevention Guide for the Human Race was ranked #6 among all cancer-related books on the Amazon.com “Top 100 Bestseller’s List” for Kindle e-books. Within three months of publication, A Cancer Prevention Guide for the Human Race was the #1 book on the Amazon.comTop 100 New Book Releases in Cancer” list.




Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


 

Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author


 

I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people from around the world who visit this premier global health information website every month.  (More than 1.3 million pages of high-quality medical research findings were served to the worldwide audience of health-conscious people who visited Weekly Health Update in 2011!)  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.


 






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Surgeon Performance Impaired After Drinking Alcohol the Day Before Surgery

Welcome to Weekly Health Update


“A critical weekly review of important new research findings for health-conscious readers”



 

SURGEON PERFORMANCE IMPAIRED AFTER DRINKING ALCOHOL THE DAY BEFORE SURGERY

Surgeons, like pilots, are held to a very high standard of conduct when it comes to alcohol and drug use. Unlike pilots, however, there are no rules barring surgeons from having a few beers, or other alcoholic drinks, on the day or evening before they enter the operating room to perform surgery.

While most surgeons drink alcohol responsibly, some surgeons (like people in any other profession) may occasionally have a few more drinks the day or evening before they report for duty than might be considered prudent. When a surgeon has a few more alcoholic drinks than they might have planned on the day before they are scheduled to perform surgery, most will undoubtedly assume that “sleeping it off” overnight will leave them fresh and in tip-top shape to wield the scalpel in the operating room on the next morning. However, a newly published clinical research study suggests otherwise….

A newly published prospective, randomized clinical study, which appears in the latest issue of the Archives of Surgery, included two groups of study volunteers. A total of 8 expert laparoscopic surgeons were included in one group, while the other group consisted of 16 university science students. All 24 participants were trained to use a computer-based laparoscopic surgery training device that is routinely utilized to train new surgeons in laparoscopic surgery skills. The science students were then divided into two groups. The “control” group abstained from alcohol for the 24-hour period prior to being tested on their laparoscopic skills, while the other half of the students (the “experimental group”) were allowed to drink alcohol freely until they felt themselves to be “intoxicated.” The 8 expert laparoscopic surgeons were all permitted to drink alcoholic beverages “until intoxicated.” The following day, all 24 study volunteers were tested on the laparoscopic training device at 9:00 AM, 1:00 PM, and 4:00 PM. All study participants also underwent breathalyzer testing to measure their blood alcohol level, and only one of the volunteers had a blood alcohol level above the legal limit (for driving) of 0.1 percent at 9:00 on the morning after their drinking binge.

Among the science students, performance deteriorated in all of the tested laparoscopic surgery skills among those who had consumed alcohol on the day prior to testing (when compared to the “control group” of students). The outcome was not any better for the expert laparoscopic surgeons, either. These experienced surgeons, all of whom consumed multiple alcoholic drinks on the day before testing, showed significant deterioration in the time that it took them to perform specific laparoscopic surgery skills, as well as a significant deterioration in their coordination and in the number of technical errors that they made. Moreover, this significant deterioration in surgical performance was still detectable at 4:00 PM on the day after these study volunteers had consumed multiple alcoholic beverages, and despite blood alcohol levels well below the legal limit for driving.

As previous research with airline pilots has shown, alcohol consumption within 24 hours of performing critical tasks can cause significant cognitive and physical impairment, even when blood alcohol levels are zero, or near zero. The findings of this clinical study of surgeons came to similar conclusions, and these findings suggest that surgeons should avoid the consumption of multiple alcoholic drinks within 24 hours of entering the operating room.

For a complete evidence-based discussion about how to live an evidence-based cancer prevention lifestyle, order your copy of my new book, A Cancer Prevention Guide for the Human Race For the price of a cheeseburger, fries, and a shake, you can purchase this landmark new book, in both paperback and e-book formats, and begin living an evidence-based cancer prevention lifestyle today!

For a groundbreaking overview of cancer risks, and evidence-based strategies to reduce your risk of developing cancer, order your copy of my new book, A Cancer Prevention Guide for the Human Race,” from Amazon, Barnes & Noble, Books-A-Million, Vroman’s Bookstore, and other fine bookstores!

On Thanksgiving Day, 2010, A Cancer Prevention Guide for the Human Race was ranked #6 among all cancer-related books on the Amazon.com “Top 100 Bestseller’s List” for Kindle e-books! On Christmas Day, 2010, A Cancer Prevention Guide for the Human Race was the #1 book on the Amazon.comTop 100 New Book Releases in Cancer” list!


Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity



Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link:

Texas Blues Jam



I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people, from around the world, who visit this premier global health information website every month. (More than 1.2 million health-conscious people visited Weekly Health Update in 2010!) As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.





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Physician Error

 

Welcome to Weekly Health Update


“A critical weekly review of important new research findings for health-conscious readers”


PHYSICIAN ERROR

Ah ne’er so dire a Thirst of Glory boast,
Nor in the Critick let the Man be lost!
Good-Nature and Good-Sense must ever join;
To err is human, to forgive divine.

Alexander Pope (1688-1744)

 

According to the prestigious Institute of Medicine, between 50,000 and 100,000 patient deaths are caused each year in the United States by negligence on the part of doctors, nurses, and other health care providers.  Nearly 1,000,000 patient injuries per year are also attributed to human error in the delivery of health care.

The presumptive causes underlying negligence in patient care are multiple and varied, and continue to be the subject of much debate among patient safety experts.  However, virtually all such experts agree that largely preventable human errors account for the vast majority of patient injuries and deaths associated with negligent patient care.

In the operating room, where I spend much of my time, as a cancer surgeon, we have adopted patient safety “check lists” inspired by the airline industry, and which are designed to reduce the possibility of errors during surgery.  At our institution, the patient’s identity (and the surgical procedure to be performed) is confirmed, twice, by everyone in the operating room before an incision is made.  Towards the end of the surgical procedure, an additional “debriefing” is performed, and the surgeon reviews the procedures that he or she has just performed.  The operating room nurse also confirms that all sponges, needles, and instruments have been accounted for, in an effort to reduce the possibility that any of these foreign bodies will be left within the patient.

 

One important aspect of physician error is that of errors in diagnosis.  In a newly published clinical study, which appears in the current issue of the journal Pediatrics, 1,362 pediatricians at three major academic medical centers, and 109 affiliated clinics, were invited to anonymously complete an Internet-based survey regarding their self-perceived frequency of diagnostic errors.  These doctors included experienced academic pediatricians, experienced community-based pediatricians, and resident doctors who were training to become pediatricians.  Altogether, 53 percent of the queried pediatricians agreed to complete the anonymous survey. 

More than half (54 percent) of these responding doctors indicated that they made significant diagnostic errors at least one or two times per month.  Not surprisingly, the resident doctors in training acknowledged the highest number of diagnostic errors, with 77 percent of these trainees admitting to at least one or two significant diagnostic errors per month.

Based upon their anonymous responses, nearly half (45 percent) of these 726 pediatricians believed that one or more of their diagnostic errors had harmed patients at least once or twice per year. 

When asked to analyze the underlying causes for their errors, these doctors cited the following explanations:  failure to gather adequate patient history information, inadequate physical examination, inadequate review of the patient’s chart, and inadequate coordination of care and communication among the providers involved (“inadequate teamwork”). 

Specific examples of diagnostic errors cited by these pediatricians included viral illnesses being misdiagnosed as bacterial infections, misdiagnosis of medication side effects, misdiagnosis of psychiatric disorders, and misdiagnosis of appendicitis. 

When asked to offer solutions to common diagnostic errors, these pediatricians most commonly recommended the implementation of electronic health records, as well as closer patient follow-up.

(It is important to note that, in view of the human tendency to “under-report” personal failures, it is very likely that the true incidence of significant diagnostic errors is actually considerably higher than what these pediatricians have self-reported in this study.)

 

In a perfect world, we physicians would never make the wrong diagnosis, or miss a diagnosis altogether, or miss an adverse reaction to medications or other treatments.  We would never prescribe the wrong medication or perform the wrong operation; and we would never, through acts of either commission or omission, perform anything less than a perfect surgical operation.  Unfortunately, the practice of Medicine, as with all human endeavors, will never become a “zero error” profession.  However, all of us, both patients and physicians (and physicians are patients, as well), certainly would agree that every effort must be made to drive preventable patient care errors down as close to “zero” as is humanly possible. 

While it is unlikely that human error can ever be completely eliminated, in Medicine or in any other profession, the findings of this important study are significant, and point to areas where substantial improvements in the delivery of health care can be achieved by physicians and other health care providers (and, I might add, by patients as well). 

 

Look for the imminent publication of my new landmark evidence-based book, “A Cancer Prevention Guide for the Human Race,” in August of this year. 



Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author


For a different perspective on Dr. Wascher, please click on the following YouTube link: 

http://www.youtube.com/watch?v=7-Tdv7XW0qg



I and the staff of Weekly Health Update would like to take this opportunity to thank the more than 100,000 new and returning readers who visit our premier global health information website every month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.



 

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