Articles Posted in Radiation Therapy

A preliminary report shows that surgery that spares the breast in patients with a certain kind of early-stage breast cancer has better survival rates than mastectomy.

The study findings, reported Consumer Affairs, “defy the conventional belief that the two treatment interventions offer equal survival, and show the need to revisit some standards of breast cancer practice in the modern era, …”

Breast-conserving therapy (BCT), according to a paper presented at the Breast Cancer Symposium earlier this month, involved lumpectomy plus radiation for patients with early-stage, hormone receptor-positive breast cancer. Lumpectomy is the removal of only the mass with the tumor, not the whole breast (mastectomy). Hormone receptor-positive breast cancer (HR+) is when the cells have receptors for either estrogen or progesterone, which invites growth. Hormone receptor status is a primary factor in how a patient’s breast cancer is treated.

In the 1980s, according to Consumer Affairs, studies concluded that (BCT) and mastectomy were equal in terms of survival among women with early-stage breast cancer. But because those studies were conducted when not much was understood about breast cancer biology – for example, subtypes, how and where it recurs and its potential to metastasize, or spread beyond the original site – they don’t have much relevance in today’s more advanced cancer analysis.

As reported by, the study’s data and conclusions haven’t been published in a peer-reviewed journal, so they must be considered preliminary. And the five-year survival rate was significantly different between patients who had only a mastectomy or lumpectomy, regardless of their hormone receptor status.

Patients treated with BCT (lumpectomy plus radiation) showed an unadjusted five-year overall survival of 96 in 100. The rate for the mastectomy patients was 90 in 100. Among women who had no radiation, only breast-conserving surgery (BCS) the rate was 87 in 100.

Dr. Catherine Parker and her colleagues at the MD Anderson Cancer Center in Houston analyzed how the choice of treatment affects survival according to each tumor’s biology. The analysis involved 16,646 patients newly diagnosed with stage I breast cancer who were treated in 2004 and 2005.

More than 11,200 were treated by BCT, 3,587 by mastectomy and 1,845 by BCS. The mean age was 59 in the BCT subgroup, 62 in the mastectomy group and 66 in the BCS group. The follow-up period was nearly seven years.

Tumors were classified by hormone receptor status – HR+ was positive for receptors for estrogen, progesterone or both, and HR- was negative for both types of hormone receptors. The primary outcome was overall survival.

The study made two key points, according to Dr. Harold Burstein of the Dana-Farber Cancer Institute in Boston. One confirms many previous studies showing that in terms of survival, BCS is at least as effective as mastectomy. Two is that the combination of radiation and lumpectomy is very important for overall survival.

Burstein told MedPage Today that the second take-away “has been a controversial point. The benefits in some of the studies have been rather small.

“What’s clear in this population-based study of thousands of women is that adding radiation therapy – even for the favorable-prognosis stage I breast cancers – helps women do better in terms of survival down the road.”

We would add that any time you can avoid a more invasive procedure in favor of a less traumatic surgery, such as lumpectomy over mastectomy, you reduce your risk of complications, such as infection, and also the psychological fallout from losing part of your anatomy.

To learn more about breast cancer, see our backgrounder.

A couple of weeks ago, we wrote about urologists who, according to clinical guidelines, use too much radiation to treat prostate cancer pain. Here’s some related have-you-no-shame prostate cancer news brought to you by your local urologist.

According to a study in the New England Journal of Medicine, (NEJM) an awful lot of urologists are making decisions about treatment for their prostate cancer patients based on whether or not they own intensity-modulated radiation therapy (IMRT) facilities. One-third of men whose doctors own such equipment get that therapy for about $35,000 per treatment course. But before they were financially invested in radiation equipment, the same doctors prescribed that therapy for only 13 of 100 of their patients.

As discussed in Bloomberg, prostate cancer is the most common tumor diagnosed in the U.S.; nearly 240,000 men will get a diagnosis of prostate cancer this year. As we’ve blogged often (here and here), a diagnosis of prostate cancer presents a complicated scenario; the range of appropriate treatment moves from watchful waiting (no intervention unless and until the pathology changes in certain ways) to hormone therapy to surgery, chemotherapy and radiation. As Businessweek summarizes, “While only about 12%, or 29,270 men, will die from it this year, all will have to decide how, and whether, they want to treat the cancer.”

They shouldn’t have to do so through the filter of a physician who can line his or her pockets if one therapy is chosen over another.

The men treated with radiation in the NEJM study were newly diagnosed. They were at low risk of dire consequences because their cancer hadn’t spread. The 10-year survival rate for all prostate cancer is 98%, and for many people with the study subjects’ diagnosis, watchful waiting is appropriate-not radiation.

Jean Mitchell, the author of the report and a professor of public policy at Georgetown University in Washington, D.C., compared the use of the radiation therapy among urologists before and after they acquired the $2 million machines for their practices. She studied use of the technology among doctors who didn’t own it, and urologists at 11 National Comprehensive Cancer Network centers, the country’s gold standard of care.

Analyzing claims data from Medicare, Mitchell found that urologists who didn’t own the equipment prescribed use of it for more than 15 in 100 of their patients in 2010, compared with about 14 in 100 five years earlier. Among the NCCN, the ratio was the same for both years-about 8 in 100. But among docs who began to refer patients to treatment facilities in which they had a new ownership interest, it was 44 in 100.

In an interview with Businessweek, Mitchell said, “The patients are going to do what their physician tells them to do. The patient becomes almost like an ATM machine, with the doctor extracting as much revenue as they can.”

A urologists’ association spokesman said the doctors who own radiation oncology equipment use the technology appropriately. Would you expect anything different?

As Businessweek notes, physicians aren’t allowed to refer their patients for treatment in facilities they own because of the financial conflict of interest. But for patients’ convenience, radiation, as well as some other in-office “ancillary” services such as blood work and X-rays, are exempted from that law. Why radiation, which is a treatment and not an ancillary service, was exempted is not clear, Mitchell told the news outfit.

We’ve outlined the harms of overtreatment and those of radiation. The practitioner/owner scenario has great potential to harm patients from both.

Mitchell’s study found that doctors who owned the IMRT were treating men 80 and older just as aggressively as younger men with early stage prostate cancer. While prostate cancer usually grows slowly, the side effects of radiation (erection and urinary problems, for example) can be immediate. So using this treatment on older patients opens the door for them to experience harm and no benefit.

Medicine is not immune to greed: Mitchell’s study, Businessweek notes, supports similar findings with other forms of self-referral. Some urologists have pathology labs within their practices, giving themselves more business by biopsy. We’ve noted other medical specialties with physician-owners who line their pockets primarily because they can.

If you or a loved one is diagnosed with early-stage prostate cancer, and the urologist advises radiation treatment, ask why it is appropriate; what results are expected, and how soon; what the risks are; and … who owns the facility where the treatment is recommended to occur.

Although radiation can be a vital diagnostic tool and a life-saving cancer treatment, its dangers are well-documented (see our backgrounder on radiation overdose injuries).

A recent study published in the Journal of the American Medical Association (JAMA) suggests that doctors might be using radiation therapy too often for patients with advanced-stage prostate cancer. That puts them at risk of normal cell damage, skin irritation, diarrhea, bleeding and other problems. It also adds to the cost of their treatment.

Radiation therapy is prescribed to treat pain in patients whose prostate cancer has spread to their bones. This intervention is not for improving chances of survival in these advanced-stage cases, only to address severe pain. Radiation treatment of 10 sessions or more is recommended only in fewer than 10% of cases, and only if the patient’s cancer also might have spread to nearby soft tissue.

As discussed on, the researchers found that very few prostate cancer patients receive only one radiation treatment to reduce pain; more than half of the patients they studied got more than 10 treatments.

Radiation also is prescribed to treat pain caused by other kinds of cancer that have spread to the bones in advanced stages. But researchers aren’t certain if a single session is used appropriately in those situations.

The study analyzed Medicare claims from more than 3,000 males who underwent radiation therapy from 2006 to 2009. Only 3 in 100 of the prostate cancer patients got a single session of palliative radiotherapy. (“Palliative” means easing the effects of a condition, not treating or resolving it.) But more than half of the study’s prostate cancer patients got more than 10 radiation treatments.

The cost for a single treatment averaged $1,900; it was $5,000 for 10 or more treatments.

According to AboutLawsuits, previous studies found that the benefits of radiotherapy for pain relief were no greater for multiple sessions than they were for only one if the patient’s bone metastasis was uncomplicated. Those studies concluded that one treatment typically is sufficient to provide the maximum pain relief possible.

So why aren’t those results reflected in common practice?

In some cases, the researchers speculate, doctors might be worried about pain recurring after only a single treatment. Some doctors might not be aware of the previous research on radiotherapy. Some might be financially motivated, because they’re paid per treatment.

Researchers say that single treatments often are better for the patient’s quality of life, and should be standard care. If your doctor recommends radiation therapy for prostate cancer pain, discuss the benefits and risks of single versus multiple treatments. Get a second opinion if you’re not convinced that the best practice for your situation is more than one treatment.

Learn more about radiation therapy from the National Cancer Institute’s fact sheet.

Old habits die hard, and in this regard the medical profession is no different from any other. Researchers at the Yale School of Medicine were surprised, though, at the results of their study showing that despite the fact that radiation has limited benefit for some older women with breast cancer, the treatment is still being prescribed.

A large clinical trial conducted by the National Cancer Institute (NCI) concluded that radiation for some women older than 70 with early stage, low-risk breast cancer offered limited benefit. So significant was the 2004 NCI trial that breast cancer treatment guidelines were changed to place radiation therapy in the “optional” category for these patients.

But the Yale researchers found that in the years following implementation of the new guidelines, there has been minimal change in the clinical care of older women with breast cancer. Their report was published in the March Journal of Clinical Oncology along with an editorial echoing our feeling that the perpetual motion treatment machine needs to be overhauled.

“[T]he medical community may react differently to withholding a treatment than to adding a new treatment,” it read. “Adding a new treatment with the possibility of improving patient outcomes is likely more motivating than the ability to omit a treatment without harm.”

“… Some older women with breast cancer are clearly being overtreated. Offering radiation therapy to a woman with a good-prognosis tumor and a life expectancy of less than five years does not seem indicated, yet more than 40 percent of such women were treated with radiation. These women were at risk for unnecessary adverse effects, inconvenience of treatment and possibly increased personal costs for a treatment that was unlikely to offer them any benefit.”

The complication, as the editorial points out, is that identifying patients unlikely to survive five years is tricky. Still, there must be a greater acceptance that “The cost of whole-breast irradiation is more than $7,000 per patient, and the benefit in this group of patients is small. In our current health-care system, physicians are incentivized to favor treatment over no treatment, particularly when either option is considered appropriate.”

Medicare beneficiaries diagnosed with early stage breast cancer were studied before and after the large NCI clinical trial was published. Nearly 8 in 10 patients received radiation before the study, and 3 in 4 received it after.

Even among the oldest women (85-94 years), the use of radiation decreased only four percentage points, from 37 percent before the study to 33 percent after.

Typically, older women with early stage breast cancer receive breast-conserving surgery followed by radiation therapy. The latter is designed to reduce recurrence of the disease. But many older women have less aggressive tumors; they are at lower risk for tumor recurrence.

“Clinical trials are considered the gold standard of medical research and in this case the trial was influential enough to lead to a change in treatment guidelines,” said Yale’s lead author. “We expected it to have more of an impact on clinical care at the bedside.”

It’s time to for this proven theory to be put into practice. As the researchers noted, the U.S. government invested more than $1 billion in comparative effectiveness research as part of the American Recovery and Reinvestment Act of 2009. The point of such efforts, which we’ve discussed before, is to choose the most effective, cost-efficient treatments for a given disorder; they’re meant to overrule the default of “just in case” treatments.

“Our societal interest in funding this type of research is appropriate,” Yale’s researchers concluded, “and the need is great, but we must ensure that the results of such research extend beyond the journal page and are actually incorporated into clinical decision-making.”

To learn more about breast cancer treatment, see our guide.

A new study might add to the perception that U.S. medical care is uncontrollably expensive thanks in part to unnecessary tests. “Screening by Chest Radiograph and Lung Cancer Mortality” concludes that people who have an annual chest X-ray do not have a significantly lower mortality rate than people who don’t.

The study, whose lung data are part of a larger investigation into cancers of the prostate, colon/rectum and ovaries, examined people who were given either annual chest X-rays (chest radiography) or standard medical care without screening. In the 13 years’ of the study, 1,696 lung cancers were detected in chest radiograph group and 1,620 lung cancers in the control group. The radiograph group reported 1,213 lung cancer deaths, and 1,230 in the control group.

The results weren’t really a surprise; researchers said the study confirmed expectations rather than setting new ones.

Some healthy patients believe that safeguarding their good fortune means having any screening that can yield information. Often their physicians accommodate them out of an abundance of caution, a desire to please the customer or a fear (usually irrational) of being sued if they are perceived to have practiced poor medicine.

But as with recent guidelines announced by the U.S. Preventive Services Task Force (USPSTF) about Pap tests, mammograms and prostate-specific antigen tests, sometimes a test, especially for generally healthy people, serves little purpose other than addressing professional insecurity and reducing one’s bank account. And in the task force cases, it can cause harmful side effects.

A smoker or someone with a family history of lung cancer might not qualify as someone who can ignore advice to get screened. But now, the best practice for people at risk for lung disorders might not be a chest X-ray. The recent National Lung Screening Trial concluded that early detection of lung cancer from a spiral CT scan reduced the risk of mortality.

A spiral CT uses X-rays to generate multiple images of the entire chest; a standard chest X-ray generates a single image of the entire chest in which parts of the anatomy overlie one another.

The National Cancer Institute study involved current and former smokers, and compared a CT scan group with a chest X-ray group, not people with no known lung problems or those who hadn’t been screened at all. Still, the best way to diagnose lung cancer doesn’t seem to be with a chest X-ray, and unless you’re having a respiratory issue, you don’t need one as part of your annual physical exam.

The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans – used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer.

Even a “routine” CT scan of the abdomen, ordered thousands of times every day in the United States for patients with belly pain, carries a large risk of downstream cancer, just from that single scan.

Dr. Rebecca Smith-Bindman, MD, of the University of California San Francisco, estimates a 20-year-old woman who undergoes a CT scan of the abdomen and pelvis has a one in 250 chance over her lifetime of getting cancer just from that single dose of radiation. This number was in a talk she gave recently at UCSF, as reported by her colleague Bob Wachter, MD, a patient safety expert at UCSF.

More scary statistics are in two articles Dr. Smith-Bindman and her colleagues published in Archives of Internal Medicine in 2009. There, they estimated that a single CT scan of the heart’s arteries (called a CT coronary angiogram, and promoted as being safer than the usual test called a cardiac catheterization) would cause cancer in one in 270 women and one in 600 men who underwent the test at age 40.

One problem is a huge range in the amount of radiation used at different facilities. Dr. Smith-Bindman’s group found a 13-fold variation from the lowest to the highest radiation exposure between scanners running the exact same imaging study.

She blames lax regulation by the Food and Drug Administration and lack of aggressive self-regulation by the medical physicists, working in hospitals, who are supposed to protect patients.

Most patients have no idea of the amount of radiation in one CT scan. It’s estimated to be about 200,000 times more than the radiation you get from going through an airport whole-body scanner, or about 450 times more than a simple chest X-ray.

Once people start to appreciate the risk, they realize that the pretty pictures produces by CT scans can have a very expensive cost down the road. It’s something to remember the next time you see a billboard advertising “whole body scans” for healthy checkups, or “virtual colonoscopies” (to pick two examples of the heavily hyped types of CT scans now available).

Article first published as The Coming Cancer Epidemic from Overuse of CT Scans on Technorati.

A physician who gave nearly 100 veterans with prostate cancer incorrect doses of radiation has been sanctioned by the Nuclear Regulatory Commission (NRC). The errors involved the incorrect placement of iodine-125 seeds in patients to treat prostate cancer.

Out of 116 such brachytherapy procedures performed at the facility between 2002 and 2008, the VA reported that 97 were carried out incorrectly. The NRC investigation found that Dr. Gary Kao, a radiation oncologist at the VA Medical Center in Philadelphia, took part in 91 of the 97 incorrect procedures. In several cases, the incorrect doses were caused by Kao having implanted the seeds in nearby organs or surrounding tissue.

As a result, the NRC ruled that Kao cannot take part in agency-related activities without undergoing more training. The NRC also issued a separate order requiring Gregory Desobry, a medical physicist who worked at the same facility, to notify the agency if he accepts employment in that capacity involving NRC-regulated activities within 20 days of beginning such work. Last year, the NRC fined the Philadelphia VA hospital $227,500 over the incidents.

Source: Philadelphia Inquirer

To view a copy of the NRC decision, click here.

Many women with early breast cancer do not need to have their armpit lymph nodes removed, according to a new study. Currently, this painful procedure has long been routine, as physicians believed it would prolong women’s lives by keeping the cancer from spreading or coming back. However, the study shows that removing the cancerous lymph nodes is unnecessary when women receive chemotherapy and radiation, which wipes out most of the disease in the nodes.

The study indicates that for about 20% of women (40,000 women a year in the U.S.), the removal of the cancerous lymph nodes doesn’t (a) alter the treatment plan for the patient; (b) improve survival rates; or (c) make the cancer less likely to recur. And it has a downside, since it can cause complications like infection and lymphedema, a chronic swelling in the arm.

Experts say that the new findings, combined with similar ones from earlier studies, should change medical practice for many patients. However, they warn that change may come slowly because the notion that the nodes must be removed is very deeply ingrained.

The current approach to surgical treatment of breast cancer is to cut out obvious tumors – because lumps big enough to detect may be too dense for drugs and radiation to destroy – and to use radiation and chemotherapy to wipe out microscopic disease in other places. Until now, physicians believed that even microscopic disease in the lymph nodes should be cut out to improve the odds of survival.

The new results do not apply to all patients, only to women whose disease and treatment meet the criteria in the study, which were:

Early tumors at clinical stage T1 or T2 (i.e. less than two inches across).

Biopsies of one or two armpit nodes found cancer, but the nodes were not enlarged enough to be felt during an exam, and the cancer had not spread anywhere else.

The women had lumpectomies, and most also had radiation to the entire breast, and chemotherapy or hormone-blocking drugs, or both.

The study included 891 patients with their median age in the mid-50s. After an initial “sentinel” node biopsy, the women were assigned at random to have 10 or more additional nodes removed, or to leave the nodes alone. In 27 percent of the women who had additional nodes removed, those nodes were cancerous. But over time, the two groups had no difference in survival: more than 90 percent survived at least five years. Recurrence rates in the armpit were also similar, less than 1 percent.

Dr. Grant W. Carlson, a professor of surgery at the Winship Cancer Institute at Emory University, who authored an editorial that accompanied the study, said that by routinely taking out many nodes, “I have a feeling we’ve been doing a lot of harm.”

Source: The New York Times

You can read an abstract of the study here.

Why do patients who need focused, precise doses of radiation get walloped with huge overdoses that cause serious and even fatal injuries? A deadly combination of non-user-friendly radiation equipment, incompatible software when machines from different manufacturers are cobbled together, user error by the technicians administering the radiation, and lax regulation by federal authorities: All these are major issues in the ongoing expose by the New York Times of malpractice issues in radiation therapy.

In the latest installment, the team led by reporter Walt Bogdanich focuses on linear accelerators, machines that originally were intended to give broad-beam radiation doses to large swaths of the body, but now are increasingly modified to deliver what are supposed to be precise, focused radiation beams. The therapy is called stereotactic radiosurgery, and it allows hospitals who lack the more expensive competitor device, gamma knife surgery, to compete for radiation therapy business when the patient needs a very focused, intense dose to sensitive tissue — such as a nerve deep in the brain.

But without proper setup, and without an easy way to see when the machine’s beam has not been focused properly, tragedies can happen, as the reporters document.

One issue that this blog has focused on in other contexts with medical devices: The lack of a mandatory public registry to gather prompt reports of injuries and errors so that problems can be nipped in the bud rather than injuring patient after patient. The society of radiation oncologists is now asking for the creation of such a registry by the Food and Drug Administration. But the FDA lacks legal authority to force anyone other than a manufacturer to make a report.

How can patients protect themselves? Make sure the radiation unit you go to is well established, not brand new, and that the technicians are certified in the field of medical physics. More tips can be found in our previous article on the subject here.

The Food and Drug Administration has canceled its policy of giving rubber-stamp approval to marketing of powerful new radiation therapy equipment like linear accelerators. From now on, the manufacturer of the machine is going to have to prove the equipment has proper safety checks to prevent dangerous overdoses of radiation to patients.

The New York Times ran a series in January 2010 that exposed some horrific tragedies that occurred, particularly when hospitals rushed into operation new and complicated equipment without thorough safety checks and training of technicians. The series also showed that the equipment often lacked simple fail-safe devices such as a way of preventing the machine from delivering a walloping overdose of radiation even if one had been inadvertently programmed by a technician.

But since the FDA only has power over manufacturers and not over hospitals themselves, it still will be possible for poorly trained technicians to cause errors that hurt patients by either delivering overdoses or underdoses of radiation.

In a follow-up article, the New York Times’ Walt Bogdanich quotes Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, as saying the more serious problems stem from shortcomings in staffing, personnel competency and hospital quality assurance programs:

“I’d also caution that however commendable tougher standards for premarket approval of software may be, its not clear that F.D.A. has the expertise to police this,” Dr. Amols said. “In fact, I’m not sure anybody does. That’s one of the big problems with software. It comes down to a qualified user recognizing that something is amiss.”

While the government regulators are getting their act together, my advice for patients is to always make sure you get radiation therapy at only a leading center that has been doing it for a long time. Make sure the center employs licensed, certified technicians to operate the therapy machines. Don’t be dazzled by the new smell and clean look of a spanking-new therapy center. That could be a sign that people aren’t well trained yet to keep you safe.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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