By Sharon Reynolds
NCI Cancer Bulletin Staff Writer 

Prostate Cancer

New data from the Prostate, Lung, Colorectal and Ovarian (PLCO) randomized screening trial show that, after 13 years of follow up, men who underwent annual prostate cancer screening with prostate-specific antigen (PSA) testing and digital rectal examination (DRE) had a 12 percent higher incidence of prostate cancer than men in the control group but the same rate of death from the disease.

No evidence of a mortality benefit was seen in subgroups defined by age, the presence of other illnesses, or pre-trial PSA testing. The results were published January 6 in the Journal of the National Cancer Institute.

When the PLCO researchers published their initial prostate screening results in 2009, which also revealed no prostate cancer mortality or overall mortality benefit from annual screening, critics countered that participants had not been followed long enough to detect a difference in prostate cancer mortality, if one existed.

“The natural history of prostate cancer is so long that 10 to 15 years of follow up is usually the window we look for” when determining the effectiveness of a screening intervention, explained first author Dr. Gerald Andriole, who is chief urologic surgeon at the Siteman Cancer Center at Barnes-Jewish Hospital in St. Louis and the Washington University School of Medicine.

Overdiagnosis?

The persistent increase in incidence of prostate cancer in the screening arm of the study may indicate that regular screening can lead to overdiagnosis—finding tumors that never would have caused symptoms or death.

“Even if there was just a tiny mortality benefit [from prostate cancer screening], overdiagnosis wouldn’t be so bad if we didn’t hurt people. But we do hurt people by finding a lot of trivial cancers that are most often overtreated,” explained Dr. Andriole.

The PLCO began in 1993 and enrolled men through mid-2001. More than 38,000 men were randomly assigned to annual screening for 6 years (including DRE for the first 4 years and PSA testing for all 6), and the same number of men were assigned to usual care.

Because prostate cancer screening is so common, more than half of the participants in the control arm underwent at least one prostate cancer screening test outside the trial.

This contamination made it more difficult to determine whether annual testing affected mortality. However, “the level of screening in the intervention arm was substantially greater than that in the control arm throughout the trial screening period,” wrote the authors.

“Every time we screened [in the intervention arm] we got a bump of excess cases,” said Dr. Philip Prorok, a lead NCI investigator on the study. “What we can’t say for sure is whether we would have seen more of an effect on mortality had there been absolutely no screening in the control arm.”

Studies differ

Another recent large trial, called the European Randomized Study of Screening for Prostate Cancer, did report a mortality benefit for prostate cancer screening.

Although that trial had less contamination in the control arm, it had other limitations that could bias the results, such as differences in the treatments given to men in the screening and control arms.

To help reconcile the differing results from these two trials—the largest trials to date of organized prostate cancer screening—an effort is under way by the NCI-funded Cancer Intervention and Surveillance Modeling Network (CISNET) to use mathematical modeling to tease out how differences in the trial designs and populations may have contributed to the disparate trial results, explained Dr. Paul Pinsky, an NCI investigator on the PLCO trial and consultant to the CISNET project.

“Even though the results seem to be disparate, because one [trial] found a [statistically] significant protective effect [on prostate cancer mortality] and one didn’t, it could be because of the ways the trials were designed and carried out,” he said. The CISNET study began last year and is examining data from the two trials.

Men and their health providers agree that a more definitive answer is needed as doctors and policy makers seek to understand which, if any, men may benefit from routine prostate cancer screening.

In October 2011, the United States Preventive Services Task Force released new draft guidelines for prostate cancer screening for public comment.

The new draft guidelines, which are based in part on PLCO findings, recommend against routine PSA testing in men who do not have prostate cancer symptoms.

Some doctors think the new recommendations go too far in not accounting for the informed decisions of individual men.

“If prostate cancer constitutes a continuum of disease and its overdiagnosis and overtreatment are mainly limited to low-grade disease, then instead of completely eliminating the potential benefits of screening along with the risks, why not consider managing low-risk patients differently?” asked Drs. Robert Volk from the University of Texas M. D. Anderson Cancer Center and Andrew Wolf from the University of Virginia School of Medicine in a commentary published last month in JAMA.

Practice appears to be moving in this direction, with a greater emphasis on active surveillance instead of immediate treatment for some men who have prostate cancer that is thought to be at low risk of progressing.

A big advance, explained Dr. Andriole, would be the ability to predict, even before a biopsy, whether a man with an elevated PSA level is likely to have an aggressive versus a nonaggressive cancer.

“There’s a lot of effort now being put into this, and not just for prostate cancer, but for a lot of other cancer types as well,” added Dr. Prorok. “If we diagnose someone with symptoms, or you find something on a screening test, can we eventually find a way to determine for which individuals the cancers are in fact aggressive and need more aggressive treatment, versus some that need less aggressive treatment or don’t need any treatment at all?”

Researchers are looking for biomarkers, including genes and proteins, that may give clues to a cancer’s aggressiveness. “If we could selectively change our criteria for biopsy such that only men who are at high risk for aggressive cancer get biopsied, we might be able to substantially shift the overall risk/benefit [ratio] of screening,” said Dr. Andriole.

To learn more:

• Read the National Cancer Institute’s booklet: What You Need to Know About Prostate Cancer.

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.

This story comes from KHN partner ‘s Shots blog.

Prostate Cancer

The same group that caused a ruckus by recommending against mammograms for women in their 40s is about to tell men that a routine blood test for prostate cancer does most of them more harm than good.

The problem is that the test doesn’t do enough to save lives and subjects many men to additional tests and surgery. The side effects, including impotence and incontinence, outweigh the benefits for men in good heath, according to reports about the findings of the U.S. Preventive Services Task Force.

An independent group of medical experts, the USPSTF is in the business of grading the evidence for common tests and procedures. Under the auspices of the Agency for Healthcare Research and Quality, the group’s decisions increasingly serve as guidelines for what doctors do and what insurers and the government will pay for.

The USPSTF has been working on the PSA test for a while. In fact, the group had pretty much reached a decision in 2009 that the evidence for routine PSA testing should be graded “D” (which constitutes a recommendation against the service), according to an article coming inThe New York Times Magazine this Sunday and already posted online.

But the controversy such a recommendation is sure to cause led to a postponement of votes on it, Shannon Brownlee and Jeanne Lenzer report in the story.

Now it’s finally coming out, perhaps as early as today. “The harms studies showed that significant numbers of men — on the order of 20 to 30 percent — have very significant harms,” pediatrician Virginia Moyer, chairwoman of the task force, told the Washington Post.

This year, about 241,000 cases of prostate cancer are expected to be diagnosed, according to estimates from the American Cancer Society. About 34,000 men will die from it. More than 20 million U.S. men have their PSA’s tested each year.

A federally funded study presented at a meeting of urologists this spring found that, overall, early surgical removal of the prostate was no better than waiting to see how the cancer would progress. And there were more side effects among men who had surgery.

In a Times editorial published in March, Dr. Richard Ablin, who discovered prostate specific antigen, lamented the overuse of the test. Yes, the test has its place, he wrote, to monitor men after treatment for prostate cancer and in screening men whose family histories put them at high risk.

“But these uses are limited,” Ablin concluded. “Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit.”

While the USPSTF’s decisions carry a lot of weight, a separate report out today shows the limits of its ability to change medical practice.

The Center for Public Integrity finds that 40 percent of Medicare spending on cancer screenings, or about $1.9 billion over five years, is wasted on tests, including PSA, for people older than the cutoff recommended by the USPSTF.

Opposition to a change in PSA recommendations is certain. Dr. Benjamin Davies, a urologist and cancer specialist at the University of Pittsburgh Medical Center, tweeted this morning:

the data for screening healthy patients <65 is strong, not debatable, and level 1. Hard to tweet all of the evidence

He called the USPSTF’s determination “soulless” and faulted some of the evidence the group, including this Swedish study, used to make its decision.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

By Sandra G. Boodman
This story was produced in collaboration with 

Every year like clockwork, Anna Peterson has a mammogram. Peterson, who will turn 80 next year, undergoes screening colonoscopies at three- or five-year intervals as recommended by her doctor, although she has never had cancerous polyps that would warrant such frequent testing. Her 83-year-old husband faithfully gets regular PSA tests to check for prostate cancer.

Doctor inspects mammogram. Photo by Bill Branson/NCI

“I just think it’s a good idea,” says Peterson, who considers the frequent tests essential to maintaining the couple’s mostly good health. The Fairfax County resident brushes aside concerns about the downside of their screenings, which exceed what many experts recommend. “Most older people do what their doctors tell them. People our age tend to be fairly unquestioning.”

But increasingly, questions are being raised about the overtesting of older patients, part of a growing skepticism about the widespread practice of routine screening for cancer and other ailments of people in their 70s, 80s and even 90s.

Critics say there is little evidence of benefit — and considerable risk — from common tests for colon, breast and prostate cancer, particularly for those with serious problems such as heart disease or dementia that are more likely to kill them.

Too often these tests, some doctors and researchers say, trigger a cascade of expensive, anxiety-producing diagnostic procedures and invasive treatments for slow-growing diseases that may never cause problems, leaving patients worse off than if they had never been tested. In other cases, they say, treatment, rather than extending or improving life, actually reduces its quality in the final months.

“An ounce of prevention can be a ton of trouble,” observed geriatrician Robert Jayes, an associate professor of medicine at George Washington University School of Medicine. “Screening can label someone with a disease they were blissfully unaware of.”

Dartmouth physician Lisa M. Schwartz cites one such case: a healthy 78-year-old man who was left incontinent and impotent by radiation treatments for prostate cancer, a disease that typically grows so slowly that many men die with — but not of — it.

The U.S. Preventive Services Task Force, an independent panel of experts that evaluates the risks and benefits of screening tests, does not endorse PSA testing or routine colon screening after age 75.

The panel, whose recommendations will guidesome coverage decisions under the 2010 federal health law that expands access to screening, says there is no evidence for or against mammography after age 74 and recommends that most women stop getting Pap smears to detect cervical cancer after 65.

So far the task force’s guidelines appear to have had limited impact. Researchers in June reported in the journal Cancer that nearly half of primary-care doctors would advise a woman with terminal lung cancer to get a routine mammogram — even if she was 80 years old.

Last May, Texas researchers reported in the Archives of Internal Medicine that 46 percent of 24,000 Medicare recipients with a previous normal test underwent a repeat colonoscopy in less than seven years and sometimes as few as three — compared with the 10 years recommended by the task force.

In nearly a quarter of cases, the repeat test was performed for no discernible reason. (Medicare is supposed to cover the screening test, which can cost about $2,000, only once a decade if no cancer or polyps have been found, but the program paid for all but 2 percent of the procedures reviewed by the Texas researchers.)

“More is not always better, and that becomes particularly true in older Americans where the dangers of medical care grow,”said Michael LeFevre, a professor of family medicine at the University of Missouri School of Medicine who is co-vice chair of the task force. “The older you get, the more likely it is that something else is going to make you sick or die.”

Colon polyps take 10 to 20 years to become cancerous, while the risks from colonoscopy, including intestinal perforation and heart attack, substantially increase after age 80.

Experts point to several reasons for the persistence of overscreening: habit; incentives that pay doctors and hospitals for individual procedures; quality assessments that rely on how many patients receive such tests; physicians’ fears of missing something important or of upsetting elderly patients — or their children — by suggesting that screening is unnecessary because a patient is too old or too sick to benefit.

In an era where discussions about end-of-life care are branded as “death panels” and curtailing unnecessary and expensive testing is regarded by some as rationing, experts say it is not surprising that overtesting endures. Many doctors say it’s easier to simply order a test than to discuss its risks and benefits with patients.

But some doctors believe it’s time to resist. “I think we need to say we can’t do everything for everybody, and it doesn’t make sense,” said Washington radiologist Mark Klein, who recently performed a virtual colonoscopy on a 99-year-old woman. Klein said he considered not doing the procedure but decided to go ahead because he didn’t learn how old the patient was until she was lying on the table, having undergone the prep.

“The most important thing on any referral is the date of birth,” said Klein, who said he tries to talk some older patients and their doctors out of pursuing tests and treatments he considers overly aggressive. “The game is not finding things, it’s can you improve mortality? And if you do find something, it’s very hard for a doctor to say, ‘Don’t do anything.’ ”

While cancer screenings are most common, other tests are overused among the elderly, Klein and others say. They include cholesterol testing, which can lead to the prescription of statin drugs that require regular blood tests to check liver function; typically, cholesterol plaque takes years to accumulate, and statins confer only a modest benefit in the elderly.

Likewise, CT scans of the heart or whole body can unearth suspicious findings, such as lung nodules, which trigger a painful and risky lung biopsy, but often turn out to be benign.

First Mammogram — At 100

Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice and an author of the 2011 book “Overdiagnosed,” said that overtesting may reflect in part the use of screening tests as a barometer of quality. “Unfortunately that’s how we’ve measured quality: Did they get tests? And doctors are being judged and paid accordingly. So all these crazy things get done that don’t help people.”

The American Cancer Society doesn’t support an upper age limit for colonoscopy or mammography, although the group does not endorse PSA testing.

The society’s director of cancer screening, Robert C. Smith, said he thinks underscreening is a bigger problem than overtesting. “As long as a patient is in good health and a candidate for treatment, they are a candidate for screening indefinitely,” he said.

But Smith says there are limits. He recalls the loud cheer at a medical meeting after it was announced that a 100-year-old woman had just undergone her first mammogram.

“Several of us were just shaking our heads in disbelief because it makes absolutely no sense whatsoever to put a 100-year-old woman through a mammogram,” he said.

Telling someone that screening is no longer necessary can be dicey, as California family physician Pamela Davis discovered when she advised her robust 86-year-old mother to stop getting mammograms and routine colon tests.

“I have many, many patients who are like my mother,” said Davis, who directs the family medicine residency program at Northridge Hospital Medical Center. “It’s not about shortchanging them” but about putting screening in context. “Part of keeping people healthy and elderly is keeping them away from the hospital. Sometimes I’ll say, ‘Well, if we do this heart test and then find something then you’ll need a procedure.’ And they’ll say, ‘Oh, I don’t want heart surgery.’ And I’ll say, ‘Why do the test?’”

Baltimore internist Mary Newman said she largely hews to the task force recommendations, and she jokes to patients that “after 85, everything’s optional.” She considers Medicare’s new annual wellness exam, part of the health law, a good time to raise the subject of screening. Newman said she focuses on concerns that geriatrics specialists say matter most in old age: maintaining hearing and vision, stabilizing blood pressure and addressing problems related to dementia and mobility.

In some cases doctors counsel against testing — but patients demand it. Alan Pocinki, an internist who practices in the District, said he tried to persuade an 80-year-old patient, a survivor of several heart attacks, to stop PSA testing. The man’s son, a Boston oncologist, agreed with Pocinki, but the patient insisted.

The elevated reading led to a biopsy, which found cancer. Pocinki said the patient contracted a serious infection from the biopsy, his cancer is being monitored through “watchful waiting,” and he has repeatedly said he wishes he’d never had the test. “He always tells me, ‘I know you told me not to do it.’ ”

Screening The Dying

Why do doctors continue to screen terminally ill patients? Smith, of the American Cancer Society, thinks a primary reason is that they avoid difficult conversations that would involve telling patients they won’t live long enough to benefit.

“Just because it’s hard for doctors doesn’t mean it’s not a conversation worth having,” said Camelia Sima, a biostatistician at Memorial Sloan-Kettering Cancer Center in New York and lead author of the 2010 JAMA study. Doctors may regard additional tests as relatively inconsequential, but Sima notes that they can cause additional pain and suffering in the form of biopsies, surgery and chemotherapy.

To Dartmouth’s Schwartz, the message for older patients, regardless of the state of their health, is essentially the same: “It’s not always in your best interest to do more or to keep looking. But we never seem to talk about the downside of testing.”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

In the 11 years since the Food and Drug Administration (FDA) approved the first robotic surgical system for conducting abdominal and pelvic surgeries, its use has skyrocketed.

The da Vinci Surgical System is now used to perform as many as 4 out of 5 radical prostatectomies in the United States. The robotic system is also increasingly being used to treat other cancers, including gynecologic and head and neck cancers.

According to da Vinci’s manufacturer, Intuitive Surgical, Inc., more than 1,000 of the robotic systems are in hospitals across the country.

Dr. Peter Pinto sits at the da Vinci robot console to perform minimally invasive prostate surgery. (Photo by Bill Branson, NIH)

Several recent studies suggest that the ascendance of robotic prostatectomy has had numerous consequences, including a mass migration of prostate cancer patients to hospitals with robotic systems and an overall increase in the number of prostatectomies performed each year.

The latter trend has raised some concern because it coincides with a period during which prostate cancer incidence has declined slightly.

How robotic prostatectomy proliferated so quickly, and what it means for patients and the health care system, is still a matter of study and debate. But the shift appears to have altered the surgical treatment of prostate cancer permanently, observed urologic surgeon Dr. Hugh Lavery of the Mount Sinai Medical Center in New York.

“I think that traditional open and laparoscopic prostatectomies have faded,” Dr. Lavery said. The available data indicate that patients and surgeons “are pushing for the robots,” he added, “and they’re getting them.”

A Compelling Technology, an Intrigued Audience

Type “robotic surgery prostate cancer” into an Internet search engine, and the results will typically include glowing testimonials from patients who were treated with robotic surgery and videos of da Vinci’s surgical instruments roaming about the peritoneal cavity suturing, cutting through tissue, removing fat. In these videos, the surgeon is on the other side of the room, head buried in a console, and hands at the robot’s controls, maneuvering the instruments with the aid of a camera that offers a crisp, 3-dimensional image of the surgical field. (Read more about how the robotic system works.)

Da Vini Surgical System. (Photo: Intuitive Surgical, Inc.)

Dr. Peter Pinto sits at the da Vinci robot console to perform minimally invasive prostate surgery. (Photo by Bill Branson, NIH) [Enlarge]

The Internet videos are just one component of the extensive marketing campaign behind da Vinci by individual hospitals and the system’s manufacturer.

A study of 400 hospital websites, published online in May, found that 37 percent of the sites featured robotic surgery on the homepage, 61 percent used stock text provided by the robot’s manufacturer, and nearly one in three sites had claims that robotic procedures led to improved cancer control.

“The tendency is to associate better technology with better care,” explained the study’s lead investigator, Dr. Marty Makary of the Johns Hopkins University School of Medicine.

Dr. Makary said he performs most operations, including complex pancreas surgery, laparoscopically because he believes the robot does not offer sufficient tactile feedback and takes more operative time. Traditional laparoscopy, however, is now rarely used for prostatectomies because the procedure is considered technically demanding, according to several researchers.

Patients often arrive for an office visit knowing that they want a prostatectomy performed with the robot, said Dr. William Lowrance, a urologic oncologist at the Huntsman Cancer Institute at the University of Utah. “It may be based on something they saw on the Internet or because of a friend or relative who had a good experience” with robotic surgery, he explained. Approximately 70 percent of the prostatectomies he performs are done with da Vinci.

Patient-to-patient referrals and the fact that the robotic procedure is minimally invasive have been two key drivers of the robot’s popularity, said Dr. Ash Tewari, director of the Prostate Cancer Institute at New York-Presbyterian Hospital/Weill Cornell Medical Center, who performs nearly 600 robotic prostatectomies a year.

Several studies have documented that there can be a fairly steep learning curve before surgeons achieve proficiency with the robot. But according to Dr. Warner K. Huh, a gynecologic oncologist and surgeon at the University of Alabama Birmingham Comprehensive Cancer Center, the robot makes it easier to perform many minimally invasive procedures.

“For many surgeons, they feel they can do a minimally invasive procedure more effectively and safely robotically, and I think that’s a big reason that it’s taken off,” Dr. Huh said.

The growth of robotic surgery is more than just a marketing phenomenon, agreed Dr. Tewari. “It has been supported with a lot of good science,” he continued. “We want to make this field better and beyond the hype of robotics.”

What the Science Says So Far

Based on studies to date, there seems to be agreement that robotic surgery is comparable to traditional laparoscopic surgery in terms of blood loss and is superior to open surgery in terms of blood loss and length of hospital stay. Recovery time may also be shorter following robotic surgery than open surgery.

Photo: Intuitive Surgical, Inc.

But for the big three outcomes—cancer control, urinary control, and sexual function—there is still no clear answer as to whether one approach is superior to another, Dr. Lowrance noted.

A large, randomized clinical trial comparing any of the approaches seems out of the realm of possibility at this point. At Weill Cornell, Dr. Tewari has approval to conduct a trial comparing robotic prostatectomy with open surgery. But the trial never got off the ground because there are not enough patients willing to be randomly assigned to surgery without the robot, he said.

A randomized trial may not even be that informative. “Many open surgeons have excellent outcomes, which may be hard to improve upon,” said Dr. Lavery. “I think that if you have an expert surgeon doing either procedure, you’re likely to have an excellent outcome.”

The Peak of the “Robotic Era”?

The remarkably swift proliferation of the da Vinci system in surgery suites across the United States appears to have had population-wide effects. In a study Dr. Lavery presented at the American Urological Association annual meeting in March, he showed that, from 1997 to 2004, the number of prostatectomies performed in the United States was fairly stable, around 60,000 per year.

From 2005 to 2008, however—what Dr. Lavery and his colleagues called the first true years of the “robotic era”—the number of prostatectomies and robotic procedures spiked. The number of prostatectomies rose to roughly 88,000 in 2008, and the number of robotic procedures jumped from approximately 9,000 in 2004 to 58,000 in 2008.

The number of prostatectomies rose to roughly 88,000 in 2008, and the number of robotic procedures jumped from approximately 9,000 in 2004 to 58,000 in 2008.

Two other recent analyses that looked at smaller geographic regions—New York, New Jersey, and Pennsylvania in one study and Wisconsin in the other—yielded similar results. But they also showed something else: Hospitals that acquired robots saw a significant increase in the number of radical prostatectomies they performed. At the same time, the number of procedures at hospitals that did not acquire a robot fell.

“The overall result has been a sudden, population-wide, technology-driven centralization of procedures that is without precedent,” wrote Dr. Karyn Stitzenberg of the University of North Carolina Division of Surgical Oncology and her colleagues, who conducted the study in New York, New Jersey, and Pennsylvania.

Whether the rise in the number of procedures has meant that patients who might have been strong candidates for a different treatment, including active surveillance, instead opted for surgery is “speculative,” Dr. Lowrance said.

“My own feeling is that radical prostatectomy rates in general have probably peaked and are on their way down,” he said, in part because of the increased emphasis on active surveillance in men with localized, low-risk prostate cancer.

Cost Implications Unclear

Another uncertain aspect centers on whether there has been any economic fallout from the increased use of this fairly expensive technology. Hospitals are not paid more for procedures using the robot, despite the fact that its use carries significant extra costs.

The robot itself runs anywhere from $1.2 million to $1.7 million (and many hospitals have several), a required annual maintenance contract is approximately $150,000, and about $2,000 in disposable equipment is required each time the robot is used. Studies have suggested that using the robot may add as much as $4,800 to the cost of each surgery.

Not Just for the Prostate: Robotic Surgery Makes Inroads in Gynecologic Cancers 

The meteoric growth of robotic surgery to treat prostate cancer over the past decade has been mirrored by a similar growth in the treatment of gynecologic cancers, such as cervical and endometrial cancer. (Robotic surgery for gynecologic cancers typically involve a hysterectomy, which may be accompanied by lymph node dissection.)

Minimally invasive surgery with traditional laparoscopy has been a common treatment for gynecologic cancers for two decades, said Dr. Warner Huh of the University of Alabama Birmingham Comprehensive Cancer Center. But many surgeons have switched to the robotic procedure.

In particular, the robotic procedure has given surgeons an important new option for treating obese women, Dr. Huh said. Traditional laparoscopy often cannot be performed on obese women, so before robotic surgery these patients typically had to have open surgery.

“An open surgery in these patients is extremely difficult to do,” he said. “Some of these women had horrific complications related to their incision.”

Obesity rates in Alabama are among the highest in the nation, so robotic surgery has provided an important new clinical option for many women in the state.

The average hospital stay following open surgery in obese patients was 4 to 5 days, he said. Now, with the robotic procedure, the average stay is often 24 hours or less. Complication rates have dropped from anywhere between 5 to 10 percent with open surgery to 1 to 2 percent with robotic surgery.

“It’s completely changed how we manage these diseases in morbidly obese women,” Dr. Huh said.

Shorter hospital stays and less need for blood transfusions may offset some of these costs, however. In fact, data from a study that Dr. Lowrance and his colleagues have in press indicate that, after adjusting for various factors and excluding the fixed cost of the robot, the cost of robotic prostatectomy and the medical care needed for the ensuing year is comparable to the cost of open surgery and the ensuing year of care in a group of Medicare patients.

Although no other surgical robots have been approved by the FDA, at least two companies are developing similar robotic systems that could, eventually, compete with da Vinci, Dr. Lavery noted, which could reduce costs further.

The dramatic centralization of robotic prostatectomy procedures could be a double-edged sword, Dr. Stitzenberg and her colleagues concluded. A multitude of studies have demonstrated that higher volume is linked to better outcomes, suggesting that having fewer centers performing prostatectomies could improve the overall quality of care. But centralization also raises the specter that access to care could be impaired, particularly in rural areas where market forces could limit the availability of surgeons who can perform the procedure.

The rapid growth of robotic prostatectomy is a proxy for the larger debate about the role of technology in medicine, Dr. Lowrance believes. For example, intensity-modulated radiation therapy and proton-beam therapy—which cost tens of thousands of dollars more than robotic surgery—are also gaining popularity as treatments for localized prostate cancer, even though neither has been shown to produce better outcomes than standard radiation therapy.

“The big question is: How do we balance the uptake of new technology and its cost with the additional [clinical] value it may provide?” he continued. “It’s hard to do those types of studies, but we have to continue to ask whether [a new technology] is always worthwhile.”

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.

In today’s fast-paced world, waiting — whether it’s at the doctor’s office, in line at the grocery store or for an Internet connection — is rarely considered a good thing.

But when it comes to certain medical conditions, delaying treatment while regularly monitoring the progress of disease — a strategy doctors refer to as “watchful waiting,” active surveillance or expectant management — may benefit some patients more than a rush to pharmaceutical or surgical options.

Patients want to know what they’re waiting for, says urologic oncologist E. David Crawford, MD, chairman of the Prostate Conditions Education Council and associate director of the University of Colorado Comprehensive Cancer Center.

The purpose is to watch in order to see whether a condition progresses. That way, patients and physicians know what kind of threat a disorder poses and they can make a better decision about how urgently treatment is needed. Some people might never need treatment, for instance with a slow-growing cancer. Other people can delay treatment for months or years.

Precancerous conditions may also be monitored with active surveillance. One example is ductal carcinoma in situ (DCIS), or abnormal changes in the ducts of the breast. DCIS may eventually progress into an invasive form of cancer, but most cases do not, so some physicians promote regular monitoring to avoid or delay the side effects of breast surgery, chemotherapy or radiation.

Syd Ball

Often, active surveillance is associated with cancer treatment, particularly cancers that may progress slowly. There’s evidence that active surveillance offers particular benefit for prostate cancer, follicular lymphoma, myeloma and chronic lymphocytic leukemia. Ovarian, endometrial and uterine cancer might also warrant active surveillance at some point during treatment.

When Syd Ball, a nuclear engineer from Tennessee, was diagnosed with prostate cancer, he chose active surveillance over immediate surgery or radiation therapy.

“When I was diagnosed, it did shake me up,” Ball said. “Once I talked to the doctor, and got the statistics about my chances, then I felt there was no question about what to do. Being an engineer, if you give me the risk statistics on it, I’ll tend to believe that the best course of action is based on what my chances are.”

Watchful waiting allowed Ball and his physician to get a better idea of his risk — whether his cancer was growing and how quickly. If the cancer grew quickly, then he knew he should start treatment. If not, he could wait. Ball was not looking forward to possible treatment side effects that could interfere with his quality of life and wanted to delay or avoid them if possible.

The concept of active surveillance isn’t limited to cancer treatment. It occurs across a variety of medical conditions. Pediatricians or family doctors may recommend watchful waiting for children with ear infections, since many resolve without treatment from antibiotics.

Physicians who treat chronic lower back pain might employ watchful waiting, monitoring patients regularly instead of immediately performing surgery to see if symptoms resolve on their own or whether stress management, strengthening exercises and other strategies effectively manage pain.

The physicians of couples trying to conceive a child sometimes suggest watchful waiting for a period of time before starting infertility tests and treatments, because most healthy partners conceive within a year without added intervention.

Women with endometriosis whose pain isn’t severe, who do not want to have children or who are approaching menopause may choose active surveillance, rather than deal with the side effects of surgery or hormonal treatments. And women with ovarian cysts who have mild or no symptoms might be advised to delay active treatments until symptoms become severe, because surgery carries the risk of infection and bowel and bladder damage.

What Happens While You Wait?

Though it’s a common misconception among patients, watchful waiting isn’t just ignoring the disease or disorder, hoping it will go away. “Active surveillance is a term that defines the fact that it’s not just wishful waiting or delayed treatment,” Crawford says. Physicians actively monitor the situation, and if needed, will jump in and begin active treatment, he says.

If you and your physician agree that active surveillance is a good idea, you’ll need regular checkups, and, depending on your condition, medical testing, such as blood tests, biopsies or imaging scans like MRIs or CAT scans, will be part of your regular monitoring. For conditions like chronic back pain, your doctor may recommend you make changes to your dietary habits, exercise regimen or lifestyle.

“We don’t want to let things fall through the cracks. With active surveillance, frequently we would be following patients as often as you would when they are on treatment, checking tumor markers and monitoring for new problems or symptoms they might have,” says Deborah Armstrong, MD, an associate professor of both oncology and of gynecology and obstetrics at the Johns Hopkins University School of Medicine. “It is different from someone who is at the end of their treatment options. It’s not ‘Should I try this?’ That’s a different concept. The concept of watchful waiting is that you do plan that you will be starting treatment but you’re going to delay it.”

The length of time active surveillance is recommended varies from person to person and is based on a variety of factors, including your age and general health, how severe your symptoms are, how quickly the disease progresses and the risks of delay. Physicians may monitor some patients, such as Syd Ball, for more than a decade without changing course. In other cases, active surveillance may take place for only for a few months ─ or in the case of ear infections, a few days ─ before having to move on to active treatment.

Nikkie Hartmann

Nikkie Hartmann, a public relations professional from Chicago, came to the process of active surveillance after more than a decade of battling papillary thyroid cancer. Hartmann, given a cancer diagnosis during her freshman year of college, underwent total thyroid removal surgery, as well as radioactive iodine treatments.

Though her blood tests still show elevated levels of cancer markers, the side effects of the radioactive iodine treatments and lymph node biopsies have proved uncomfortable and time consuming ─ and the active surveillance offers a break from the treatments while keeping an eye on her disease.

“The doctor didn’t use the phrase watchful waiting or active surveillance, but he said ‘watch and wait,’” Hartmann said. Though she’s still monitored with blood tests and will require additional diagnostic testing and possible treatments if she chooses to have children, within the last year Hartmann and her doctors have adopted an active surveillance stance that delays radioactive iodine treatments and lymph node biopsies for now.

Knowing the side effects that biopsies and radioactive iodine treatments can cause, Hartmann says that she’s at peace with the decision. “I was relieved when they told me that they recommended watching and waiting,” Hartmann said.

Asking About Watchful Waiting

Has your doctor recommended active surveillance? Here are some questions to ask as you consider your options:

• What is the expected course of the disease?

• If I wait, will the disease be harder to treat later?

• What types of monitoring will I receive while under active surveillance? How often?

• At what point would you recommend I move from active surveillance to treatment?=

• Are there therapies or activities I can do to slow or halt the course of the disease?

Waiting Isn’t for Everyone

Active surveillance is not without risks, however. For some types of cancer, for example, there’s a risk that the cancer may be harder to control if treatment is delayed. Doctors do not recommend active surveillance for fast-growing, aggressive or late-stage treatable cancers.

For other conditions, such as chronic back pain or endometriosis, there’s the risk that painful symptoms may worsen during active surveillance, eroding quality of life and making it difficult to work.

Though active surveillance offers a delay in the physical symptoms caused by treatment, the emotional issues associated with this choice prove difficult for some patients to handle.

“A lot of difficulty comes from the historical context of how we’ve treated cancer,” said Jamie Studts, Ph.D., a psychologist who treats oncology patients and an associate professor at the University of Kentucky College of Medicine. “The idea is very foreign to people that you have cancer in your body and you’re not doing anything to get it out.”

It takes a significant discussion and a decision-making process shared between doctor and patient to understand the pros and cons and how that can be the best way to manage their care at a particular time, Studts says.

“The other problem is the perception of potential rationing of care,” Studts adds. Particularly if people don’t have resources, they could feel like they’re being mistreated or undertreated or not treated fairly if active surveillance is suggested.

But Dr. Armstrong offers reassurance that active surveillance doesn’t mean less face time with your physician: “I spend as much time with these patients as with patients I’m treating. At every point we say, ‘If we see this, we are going to do this. Let’s see what the disease looks like, then we’ll decide if we need to do treatment.’”

For some people, the anxiety of watchful waiting cannot be overcome, Armstrong said. Regardless of the statistics and the doctor’s recommendation, patients who could benefit from active surveillance sometimes insist on and receive treatment instead.

In addition, the influence of a family member or partner who doesn’t fully support active surveillance may erode a person’s initial decision to use it, Dr. Studts says.

Making the Decision

“Watchful waiting may allow people to have a good quality of life and have the tumor completely arrested. Take diabetes. You don’t cure diabetes, you manage it. With cancer, maybe we don’t have to get it all, maybe we can arrest it or stop it so it doesn’t spread or doesn’t affect major organ systems,” Studts said.

So how do you decide whether active surveillance is for you?

The starting point for making the decision is a trusting relationship with your physician, Armstrong says. “This is a situation where patients have to have trust in the physician, trust that the physician is doing the right thing. It’s easier to treat someone than it is to do watchful waiting. The main issue is that people need to be comfortable with the concept and their doctor is doing the right thing,” Armstrong says.

“Trust your gut if it doesn’t feel right and get a second opinion. You have to be your own advocate, and if you don’t feel comfortable, get more information,” Hartmann says.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.