Breast Cancer Stats: Notes from the 2012 ACS Report, and a Key Question

Earlier this month, the ACS released its annual report on Cancer Facts and Figures. The document, based largely on analyses of SEER data from the NCI, supports that approximately 229,000 adults in the U.S. will receive a diagnosis of invasive breast cancer (BC) this year. The disease affects just over 2,000 men annually; 99% of cases arise in women. Non-invasive, aka in situ or Stage 0 BC, including DCIS, will be found in approximately 63,000 individuals.

The slightly encouraging news is that BC mortality continues to decline. This year, the number of expected deaths from BC is just under 40,000. From the ACS document: “Steady declines in breast cancer mortality among women since 1990 have been attributed to a combination of early detection and improvements in treatment.”

Survival data, from the report:

For all women diagnosed with BC, the 5-year relative survival rate has risen from 63% in the 1960s to 90% today. At 10 years, for women of all stages combined, the relative survival is 82% and at 15 years, 77%. Traditional staging still matters: For women with localized BC (that has not spread to glands or elsewhere outside of the breast), the 5-year relative survival at 5 years is 99%. For women with lymph node involvement, 5-year relative survival is 84%.

For those with metastatic disease, 5-year relative survival is 23%. The report cautions: these “stats don’t reflect recent advances in detection and treatment. For example, 15-year relative survival is based on patients diagnosed as early as 1990.”

Since 1990, we’ve seen testing and widespread use of (no longer) new drugs like Herceptin, taxane-type chemotherapies, aromatase inhibitors and other meds in women with MBC. In addition, it’s possible that better palliative care and supportive strategies, along with more effective treatments for infectious and other complications, may have extended survival.

What we’ve got to ask, and about which data are remarkably elusive, is this: What is the median survival for women with metastatic BC (MBC) in 2012?

Your author has spoken with several leading, national authorities on the subject, and no one has provided a clear answer. The reason for this informational hole is that SEER data includes the incidence of new cases at each stage, and mortality from the disease, but does not include numbers on stage conversion – when a woman who had early-stage disease relapses with Stage IV (MBC). There’s astonishingly little current data about on how long women live, on average, after relapsing.

20 years ago, oncology fellows learned that the median survival of women with MBC was around 3 years. Now, that is pretty much still what doctors tell patients, but there’s a sense that the picture is no longer so bleak. Much of what we know about survival of women with MBC comes from clinical trials of patients with particular subtypes (e.g. Her2+ or negative disease). That information, on subtypes and responsiveness to particular drugs, is crucial. But we also need to know the big picture, i.e. exactly – give or take a few thousand women – how many are alive now with MBC?

This information might inform research funding, planning of medical and social services, besides understanding the course of the illness and extensiveness of this problem. And if survival has indeed improved, that measurement, straightforward as it should be, might offer hope to those living with the disease, today.

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What Causes Breast Cancer? Reviewing the IOM Report on BC and the Environment

Earlier this month the IOM issued a big report on breast cancer and the environment. The thick analysis, commissioned and sponsored by the Susan G. Komen for the Cure®, was authored by an expert panel. Their task – to assess all available information on what causes BC, and make recommendations accordingly – was essentially impossible. Some immediately critiqued the work and, perhaps implicitly, the funding – for its failure to yield sharp or clearly-actionable insights into BC causes.

The document starts, blandly, with some straightforward stuff. The recommendations for lifestyle changes seem paternalistic when not obvious. Where the report gets interesting, and offers value, is in considering a few specific environmental toxins that might be causative in the current breast cancer epidemic. While proving that any one (or several) of the chemicals listed below causes  BC will be difficult, developing a clear, working list of likely compounds that merit research attention is an important step.

Some background:

Each year, over 230,000 women in the U.S. develop a breast tumor. The problem, in terms of preventing breast cancer, is that most established risk factors – like being older, later age at menopause, being young at the time of first menstruation and some genetic traits – aren’t amenable to intervention.

For this project, the IOM committee interpreted the term “environment” broadly – it considered all possible causes of BC that aren’t directly inherited through DNA, including factors that might influence a genetic disposition. They looked at a wide range of exposures: “how a woman grows and develops during her lifetime; what she eats and drinks; the physical, chemical, and microbial agents she encounters; how much physical activity she engages in; medical treatments and interventions she undergoes; and social and cultural practices…”

What they found, with my comments interspersed and conclusions:

The most convincing evidence linked BC to hormone therapy with estrogen and progesterins, ionizing radiation (as might occur in medical procedures like CT scans; the amount of radiation in mammography is too low for concern, the committee emphasizes), excess weight (i.e. being fat, or more-than-fat) in postmenopausal women, and alcohol (addressed here, previously).

Where they found no clear link: smoking (surprise! the evidence is limited, they say), personal use of hair dyes, non-ionizing radiation (like that emitted by microwaves and other electrical devices).

On the up side: Physical activity appears to lessen a woman’s breast cancer risk.

Quite a few factors fell into a gray zone, for which “the evidence is less persuasive but suggests a possible association with increased risk.” These are: exposure to secondhand smoke (this might be a cause, but smoking isn’t? seems unlikely, ES), nighttime shift work (steroids/stress effect? Or just too much junk food).

Finally, they name some chemicals: benzene, ethylene oxide, or 1,3-butadiene (these may be present in some workplaces; one might be exposed from breathing auto exhaust, pumping gas, or inhaling tobacco smoke, they indicate) and bipsphenol A (BPA) – one of the “biologically plausible hazards in the environment.” As they indicate, animal data provide clear evidence for a mechanism by which BPA, which is widely-used in plastic containers and food packaging, might cause breast cancer. “But studies to assess the risk in humans are lacking or inadequate.”

The IOM committee study authors consider the difficulties in testing environmental hazards. Of course, as they point out, it wouldn’t be ethical to deliberately expose women to potentially harmful substances in a clinical trial. For this reason, they advocate more research in animals and in vitro systems. But those kinds of experiments are limited, in their words: “they can provide indications that a chemical or other agent may cause harm, but these models are approximations of human experience.”

So we’re stuck with a lot of inconclusive data, and an obvious moral imperative not to systematically test the effects of possible environmental toxins on women who might develop BC. There’s a table posted, with strategies to reduce risk, but it recommends for the most part obvious things, and an annoyingly-toned paragraph:

These actions include avoiding unnecessary medical radiation throughout life, avoiding use of postmenopausal hormone therapy that combines estrogen and progestin, avoiding smoking, limiting alcohol consumption, increasing physical activity, and, particularly for postmenopausal breast cancer, minimizing weight gain. Some of these actions may have additional health benefits beyond their potential contribution to reducing breast cancer risk. In many cases, women can be aided by the actions of others, including their families and health care providers.

(Why don’t they just say: “be a good girl, get rest, and stay slim?”)

The segment on the future and needed research emphasizes the need for research on early-life exposure to chemicals, pre-menopausal obesity, and other factors that may influence development of BC later on in a woman’s life. This makes sense to me.

The most troubling findings have to do with the chemicals. Carcinogens like benzene are hard to put a finger on, when it comes to causing cancer in a population where cars are abundant and oil leaks often, and occasionally abundantly, into large gulfs of water. The BPA issue is a genuine concern, with little clear data in humans. Until those data are evident (which, if it takes decades to show the effects on youngsters exposed who develop BC in, say, their 40s), will not be for a while – you have to wonder if doctors should recommend more drastic steps to avoid routine exposure to and ingestion of potentially toxic chemicals.

If you’d like to read about this report and some of the concerns about chemicals that might cause BC, I recommend this post by Julia Brody, of the Silent Spring Institute.

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Learning From the San Antonio Breast Cancer Symposium, At a Distance

There’s a ton of BC and women’s health news this week. But yours truly is, among other things, not in San Antonio where is the 34th annual San Antonio Breast Cancer Symposium.

NTW, quite a few major news outlets are covering this business closely and carefully, as are some bloggers I know. Upon reading the news, I was simultaneously impressed by the number of new drugs for metastatic breast cancer that are being tried, and daunted upon realizing how difficult (read: IMPOSSIBLE) besides costly it’ll be to sort out these drugs used in so many combinations. Rather than recapitulating the data, some of which was published on-line this week in the NEJM, and most of which are still preliminary, I thought I’d just list some of the drugs being tested, and add a bit about how they’re administered and might work:

Entinostat is an oral histone deacetyalase (HDAC) inhibitor that’s not yet available in the US by any prescription off protocol.

Everolimus is a tablet (i.e. a pill) designed to inhibit an enzyme called mTOR. It’s sold for use in some cancers under the brand name Afinitor.

Exemestane is a tablet that reduces estrogen production. It’s an aromatase inhibitor sold as Aromasin. (This drug was approved by the FDA in 2005; it’s not quite so new, but is being tested in distinct settings, mainly in women with early-stage BC.)

Pertuzumab is a monoclonal antibody that binds Her2, in a distinct way from Herceptin.

Obviously this is but a partial list of drugs discussed at the meeting. Still, it’s heartening to this one oncologist to review even a short list of diverse new agents that might arrest the disease.

The history of the SABCS is interesting.  From the organization’s website:  the first meeting was held in November 11, 1978 during what’s said to have been “Breast Cancer Awareness Week.” The original conference’s sponsors included the Cancer Therapy and Research Center (CTRC, at UT San Antonio), the Texas Division of the ACS, the University of Texas Health Science Center at San Antonio (UTHSCSA) and the Bexar County Medical Society. Some 141 physicians and surgeons attended what’s described as one-day course.

It grew…

Now, the SABCS hosts a 5-day program with physicians, scientists, patients, advocates, reporters…from around the world. It’s jointly-sponsored by the CTRC and American Association for Cancer Research (AACR) and the Baylor College of Medicine.

The Alamo (WC image)

Next year, maybe I’ll go to the 35th annual event, and see what’s really happening in San Antonio.

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The BC Sisterhood Takes on Sex After Cancer and What Oncologists Don’t Say

A hit in the women’s breast cancer Twitter league came my way from the Breast Cancer Sisterhood®. Brenda Coffee, a survivor and founder of the Survivorship Media Network, offers a serious post on What Your Oncologist Doesn’t Tell You About Sex.

There’s a music video, Don’t Touch Me that’s annoying but depressingly right on how some women feel in menopause –  a frequent and under-discussed aspect of chemo or hormonal therapy for BC, followed by a grounded and unusually frank discussion about what happens to women after cancer treatment, menopause and sex.

Brenda’s right; none of this was included in my med school curriculum or oncology fellowship. Although, in fairness and quite seriously, this was a subject on mine and some other oncologists’ radar long ago. Cancer treatments can have lasting effects on sexuality in men and women.

Worth checking out Brenda’s network and her candid post. You can follow her @BCSisterhood on Twitter.

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Thinking of Someone with MBC in the Hospital Now

My fingers stopped this morning for a while when I came upon a reference to @whymommy. Last thing I read about her condition, she was at home having a tough but cozy Thanksgiving at home. Now she’s in the hospital and in her words, OK.

Susan is a woman in her 30s with metastatic breast cancer. People, including me, have described Susan as an astrophysicist, mom, wife… But the main thing is she’s a person.

Each counts.

Hope she gets to go home soon and feels better –

#EndBC

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Final Word on Avastin, and Why We Need Better Physicians

Today’s breaking breast cancer news is on Avastin. The FDA has just announced, formally, that it will rescind approval for the drug’s use in people with metastatic breast cancer. Commissioner Dr. Margaret Hamburg writes this her statement:

I know I speak on behalf of the many physicians that have been involved with this issue here at the Food and Drug Administration and elsewhere in saying that we encourage patients, and those who support them, to ask hard questions and demand explanations concerning the drugs that are recommended to treat serious illnesses.

On this much I agree with Dr. Hamburg – that patients and others, including doctors who prescribe treatments to patients with likely incurable illnesses, and all medical conditions, for that matter, should ask hard questions.

Others have already, immediately expressed that the FDA did the right thing. Because they think the FDA’s decision was rational, and it was. Likely there’ll be an editorial in the paper I usually read, celebrating the victory of reason over anecdote. The WSJ, whose words tend to align more with business interests, will likely be critical. Opponents of health care reform will, inappropriately and mistakenly, use this as an example of rationing, which it isn’t.

The fact is that many, and possibly most, medical treatments are given in the absence of studies to justify their use. So you might ask, instead, why give chemotherapy to most stage IV cancer patients. Or why give it in the adjuvant setting? Apart from some tumors, like some kinds of lymphoma and leukemia, and common breast and testicular cancers, and a few others, when carefully measured the benefit is often slim.

What I think is that Avastin is a scapegoat of sorts, a costly drug not particularly worse than many others, nor better, and that helps a small minority of women with a lethal disease for reasons their doctors can’t predict or explain.

We experiment, on insurance and Medicare dollars, with so many costly treatments. Bone marrow transplants, at a cost of hundreds of thousands of dollars per patient, for example, are given to some with little formal proof of benefit for the approved indications. But there’s a lobby for these treatments. Support comes from hospitals profiting from transplant procedures and, more subtly, from academic physicians who’ve built careers in that field and write papers about their benefits, complications and management. I might cite other complex, costly and unproved examples in oncology, surgery and other fields of medicine, but that’s not the real point for today.

What I wonder is, ironically, because the data on Avastin were collected so carefully, that its lack of effectiveness over a population of women was better-documented than has been the lack of evidence for other drugs and regimens. Besides, there’s no group of hospitals and doctors whose profit and livelihood, respectively, depends on giving Avastin to just a few people with metastatic breast cancer. There was just Genentech, an easy big-Pharma target, and a few women, pleading for continued access to a drug that’s helped to keep them alive.

(I wonder, also, had those patients who testified been men, would their words have been taken more seriously?)

Meanwhile, doctors can keep giving Avastin to patients with other forms of cancer, for which its efficacy is not so different as you might think. Like any drug, this drug’s response varies from patient to patient for every tumor type that it might be given. And the physicians can still give Avastin, as the commissioner points out in her decision, to women who can pay for it, by circumstances of their particular insurance, or good fortune of wealth. But some of these women’s families will be hurt hard by this FDA decision. Most are in the 99%.

And so maybe what we really need are better doctors, not only in oncology, who would carefully monitor patients when they give any and every medical treatment and stop it if it’s not working, and continue only if it helps, and would communicate and obtain informed consent through meaningful discourse.

If we had that, we’d save a lot of money, and get better care.

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Visiting the Scar Project Exhibit

On Friday I visited the Scar Project exhibit at Openhouse, on Mulberry Street just south of Spring. Photographer David Jay offers penetrating, large, wall-mounted images of young people with breast cancer.

The photos reveal women who’ve have had surgery, radiation, reconstruction or partial reconstruction of the breasts. Some are strikingly beautiful. Some appear confused, others confident. Some look right at you, defiant or maybe proud. Some, post-mastectomy, adopt frankly or strangely sexual postures. Others hide a breast, or turn away from the lens.

This collection is not for everyone. The photos of ravaged bodies of women with cancer might be upsetting, if not frankly disturbing, to some who look at them. Not everyone chooses to do so.

The women’s scars and expressions are telling. Though not representative, these images reflect wounds not often-shown in medical journals, or elsewhere.

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On Alcohol and Breast Cancer, Guilt, Correlations, Fun, Moderation, Doctors’ Habits, Advice and Herbal Tea

Few BC news items irk some women I know more than those linking alcohol consumption to the Disease. Joy-draining results like those reported this week serve up a double-whammy of guilt: first – that you might have developed cancer because you drank a bit, or a lot, or however much defines more than you should have imbibed; and second – now that you’ve had BC, the results dictate, or suggest at least, it’s best not to drink alcohol.

The problem is this: If you’ve had BC and might enjoy a glass of wine, or a margarita or two at a party, or a glass of whiskey, straight, at a bar, or after work with colleagues, or when you’re alone with your cat, for example, you might end up feeling really bad about it – worse than if you had only to worry about the usual stuff like liver disease and brain damage, or if you could simply experience pleasure like others, as they choose.

The newly-published correlative data, in the Nov 2 issue of JAMA, are clear. The findings, an offshoot of the Nurses’ Health Study, involve over 105,000 women monitored from 1980 until 2008. The bottom line is that even low levels of alcohol consumption, the equivalent to 3-6 drinks per week, are associated with a statistically significant but slight increase in breast cancer incidence. And the more a woman drinks, the more likely she is to develop breast cancer.

All things considered, it might be true that alcohol is a breast carcinogen, as Dr. Steven Narod calls it in the editorial accompanying the research study. Still, there’s no proof of cause and effect: Other factors, like consuming lots of food or perhaps some yet-unidentified particularity about living in communities with abundant food and alcohol, are potential co-variables in this story. But what if it is true?

From the editorial:

These findings raise an important clinical question: should postmenopausal women stop drinking to reduce their risk of breast cancer? For some women the increase in risk of breast cancer may be considered substantial enough that cessation would seem prudent. However, there are no data to provide assurance that giving up alcohol will reduce breast cancer risk.

How I see it is this: Everything’s best in moderation, including enjoyment of one’s life. You work, you rest, you have some fun.

This evidence is not like the strong data linking cigarettes to smoking that officials sat on for a few decades under the influence of the tobacco industry. This is a plausible, mild, and at this point well-documented correlation.

I don’t deny the sometimes harmful effects of alcohol; no sane physician or educated person could. But if you have a glass of wine, or even a second, so long as you don’t drive a car or work while affected, I don’t see it as anyone’s business but your own. More generally, I worry about how much judging there is by people who behave imperfectly, and how that can make individuals who are good people in most ways feel like they don’t deserve to be happy or enjoy their lives.

Women, in my experience, are generally more vulnerable to the put-downs of others. And so my concern about the BC-alcohol link is that this will, somehow, be used, or have the effect of, making survivors or thrivers or women who haven’t even had breast cancer feel like they’re doing the wrong thing if they go to a party and have a drink. And then they’ll feel badly about themselves.

Really I’m not sure what more to say on this loaded topic, except that it points to the deeper and broader ethical dilemma of doctors who are not all perfect examples of moderation, expecting and asking other people to change their personal habits when they themselves like to go out and have fun, and drink, at parties, or have wine in the evenings over dinner in the privacy of their homes.

How shall I resolve this post?

Last night I sipped Sleepytime tea, manufactured by Celestial Seasonings, before reading a book. The stuff is said to be 100% natural, with “a soothing blend of chamomile, spearmint and lemongrass.” I tried it first a few weeks ago and, by a placebo effect or through real chemistry, it helps me sleep more soundly.

I’ve absolutely no idea what are the effects of “Sleepytime tea” on breast cancer. It might help, it might hurt, or it might do nothing at all.

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Brief Report: Annual Meeting of the Metastatic Breast Cancer Network

The Metastatic Breast Cancer Network held its fifth annual meeting in Baltimore over this past weekend. Most of the nearly 300 registrants were women living with MBC.

The lively group of women coalesced in the face of unexpected, pre-seasonal wintry weather. At an evening reception they stood, sat, waited for drinks and lined up for buffet food. Some lingered, chatting at round tables for well over an hour beyond the party’s official end-time. Over breakfast and lunch breaks the next day, there was plenty of reconnecting, hugs and catching up.

Like other medical conferences, there were plenary and breakout sessions on the educational program. You could choose, for example, between panels on “Treatment of Bone Metastases,” “Role of Surgery in Soft Tissue Mets” and “Managing Side Effects.”  Later, fuzzier and perhaps more intense sessions covered “Role of the Caregiver,” “Nutrition and Wellness” and a “Living with MBC.” Plenary talks ranged from introductory, light remarks to hour-long lectures on breast cancer immunotherapy, clinical trials and epigenetics. I took extensive notes.

Two highlights from this noteworthy gathering:

In introductory remarks shortly after 9AM, MBCN Board member Shirley Mertz recalled attending her first conference of this group, and the feelings she experienced upon meeting other women in similar straits. Her message was this: “Take a look around, you are not alone.”

Late in the day Dr. Stephen Baylin, a professor of oncology and medicine, prefaced his talk as follows: “It’s a privilege – talking with you, hearing what the disease is like, hearing your questions.” He was standing at the podium of Turner Auditorium at Johns Hopkins. “Please teach me,” he said – rare words emanating from the front of a prestigious medical school lecture hall.

Indeed, there’s a lot a doctor might learn at a conference like this. I did, for sure.

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Arizona Cheerleaders Cause Community Stir With Breast Cancer Awareness Shirts

This story, shared today by Debbie Woodbury, warrants ML Annals of Pink inclusion:

The Arizona Republic reports on a divided community in Gilbert, AZ. At issue is the high school cheerleading team’s plan to wear pink tee shirts with the slogan: “Feel for lumps – save your bumps” on the back. The group’s intention was to raise awareness and funds for the Susan G. Komen Foundation. 

The school’s principal said no to the controversial outfits due to their “unacceptably suggestive” content.

What strikes me, among other interesting aspects of this story and what it reflects about BC awareness in 2011, is how the arguments (so needless!) about fundraising play out so differently, depending where you live and the newspapers you might read.

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Mammograms Could Save More Lives Than You Might Think

I’m wondering is how to bring mainstream health journalists and women who are, lately, choosing not to have mammograms, to their senses about a persuasive but flawed argument put forth by a Dartmouth epidemiologist and others in a crew of seemingly like-minded, hopefully well-intentioned, some perhaps tenure-seeking and others grant-needing, circulatory bias-confirming academics who meet and discuss and write about the so-called dangers of mammography.

Maybe some doctors and journalists think they’re doing the right thing by informing a naïve body of women who, in the words of an LA Times writer today, think only correlative and simple thoughts.

From Screening mammograms save fewer lives than you think:

If you or someone you know discovered she had breast cancer thanks to routine mammography screening, and if you or that friend with breast cancer got treatment and today is cancer-free, it’s natural to assume that the mammogram was a life-saver.

But odds are, it wasn’t….

First things first: the title makes an assumption about what I, or you, or any reader, thinks.

Second, the story offers two factoids: first – that over 75% of women diagnosed with BC by screening mammography wouldn’t have died from the cancer if they hadn’t had mammography; and second – that no more than 25% of those same women can rightly credit a mammogram for saving their lives. But this is just one stat, or falsehood, based on the true, assumption-free relationship between 75% and 25%.

Dr. H. Gilbert Welch, who recently likened mammography-taking to gambling, plays freely with impressive-sounding information sources. He and his coauthor used data from the NCI. Seemingly hard to argue with those kinds of numbers. But they used old data, again, and employ numerous assumptions (what the authors call generous, but I wouldn’t) to render calculations and “prove” their point published in the Archives of Internal Medicine.

The manipulative tone is set in the paper’s abstract:

“…We created a simple method to estimate the probability that a woman with screen-detected breast cancer has had her life saved…

Simple? Don’t you believe it.

There’s a Well post in the New York Times today covering the same Archives of Internal Medicine article. Not surprisingly, this draws positive feedback in the comments and Twitter-chatter. Some of the more understandable discussion comes from women with metastatic disease whose tumors were missed by screening mammography. Notably, neither paper quotes an oncologist.

Here in the U.S. where we do spend too much on health care, we all know women whose breast tumors were missed by screening mammograms. This happens, and it’s awful, but it doesn’t and certainly shouldn’t happen so often as some doctors seem to think. Extrapolating from personal observations to draw conclusions about a procedure’s value is flawed reasoning, either way.

I agree with many of Dr. Susan Love’s school, and most of the NBCC agenda, and others that say breast cancer prevention would be better than treatment. How could I not?

But until there’s a prevention for BC, which I’m sorry to report is unlikely to happen before 2020, especially because it’s really 15 or 20 or maybe even more diseases that would, presumably, need distinct methods of prevention, and until there are better, less damaging and less costly remedies, mammography may be the best way for middle-aged women to avoid the debilitating and lethal effects of late-stage disease. And for society to avoid the costs of that condition and its treatments, which are huge.

—-

post shortened 12/18/12

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3 Differences between Prostate and Breast Cancer Screening

Days ago, the USPSTF issued a new draft for its recommendations on routine PSA measurements in asymptomatic men. The panel’s report is published in the Annals of Internal Medicine. The main findings are two: first, the absence of evidence that routine PSA testing prolongs men’s lives, and second, that PSA evaluation may, on balance, cause more harm than good.

Not surprisingly, there’s been considerable coverage of this by the media, and some controversy. For decades, many men have had their PSA checked, knowingly or not, by their physicians. The PSA test  measures the level of Prostate Specific Antigen, a protein produced and sometimes secreted by prostate cells, normal, inflamed or malignant, into the bloodstream.

As an oncologist, I don’t find the panel’s recommendations surprising. There’s never been strong data to support the hypothesis that routine PSA testing reduces mortality for men in any age group. Prostate cancer is often indolent, a slow-growing kind of tumor for which a “watch and wait” approach may be best, especially when it occurs in elderly men who are most likely, even in the absence of treatment, to die of another cause. The complication rate of prostate surgery is fairly high, although this “cost” of screening likely varies, depending on the skill of the surgeon. Still, and understandably, there are men who swear by this measurement, whose lives have been, in some cases, saved by early detection of a high-grade tumor upon screening.

For today, I’d like to consider some key differences between breast and prostate cancers, and the potential value of screening:

1. Breast cancer tends to affect younger patients than prostate cancer.

Based on SEER data, the median age of a breast cancer diagnosis in the U.S. is 61 years. The median age of death from breast cancer is 68 years. For prostate cancer, the SEER data show a median age of 67 years at diagnosis, and for death from prostate cancer, 80 years.

So the potential number of life-years saved by early detection and intervention is, on average, greater for breast cancer than for prostate cancer.

2. Screening for breast cancer has improved over the past 25 years.

Because the blood test for PSA hasn’t changed much in decades, it’s reasonable to consider studies and long-term survival curves based on data going back to the 1980s.

Mammography, by contrast, is much safer and better than it was 25 years ago, for various reasons: increased regulation of mammography facilities (more care with the procedure, better training and credentialing of technicians) according to the FDA’s Mammography Quality Standard Acts Program ; development of ultrasound methods to supplement mammograms in case of suspicious lesions (lessens the false positive rate overall); the advent of digital technology (lessens the false positive rate in younger women and others with dense breasts); more breast radiology specialists (expertise).

The data reviewed by the USPSTF in issuing their 2009 recommendations for BC screening were decades old, and, as I’ve considered previously, irrelevant to modern medical practices. A recent article in the NEJM points to the problem of the panel’s reliance on the Age trial for women in their 40s. That trial involved the obsolete method of single-view mammography.

3. Mammography involves a woman’s consent (in the absence of dementia – a separate ethical issue).

A woman knows if she’s getting a mammogram. She may not ask sufficient questions of her doctor, or her doctor may not answer them well, but in the end she does or doesn’t enter into a radiology room, volitionally. She decides to get screened, or not. She can choose to have a mammogram every year, or every other year, or not at all.

There’s no ethical problem, as reported for some men, of patients learning they have an abnormal PSA, after blood was drawn indiscriminately, without their knowing the test was being performed.

This perspective might, and should, later extend to consider additional differences between these two kinds of malignancies (each of which is really a group of cancer subtypes), a fuller discussion of the impact of treatment on survival for each type, and the relative risks of screening due to differential complication rates of biopsies and other procedures.

To be clear, there’s no perfect screening test for either cancer type. Far from it. But the merits and risks of each procedure should be weighed separately, and with care.

All for today.

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More on DCIS

More, a magazine “for women of style & substance,” has an unusually thorough, now-available article by Nancy F. Smith in its September issue on A Breast Cancer You May Not Need to Treat.

Ductal Carcinoma in Situ (DCIS) in the breast, histopathology w/ hematoxylin & eosin stain, Wiki-Commons image

The article’s subject is DCIS (Ductal Carcinoma in Situ). This non-invasive, “Stage O” malignancy of the breast has shot up in reported incidence over the past two decades. It’s one of the so-called slow-growing tumors detected by mammography; a woman can have DCIS without a mass or invasive breast cancer.

While some people with this diagnosis choose to have surgery, radiation or hormonal treatments, others opt for a watchful waiting strategy. The article quotes several physicians, including oncologists, who consider the surveillance approach favorably and otherwise.

In 2009 the NCI sponsored a conference on diagnosis and management of DCIS. The participants issued a helpful, albeit technical, consensus statement.

The bottom line is that optimal treatment for DCIS remains uncertain because doctors don’t yet know the natural course of this early-stage breast malignancy. The ClinicalTrials.gov website lists active and ongoing studies.

 

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A Life-Changing Day

Today marks 9 years, exactly, since Dr. L. gave me the Call.

It was a Wednesday afternoon. I was in clinic, caring for patients with blood diseases. In between seeing my patients and supervising the residents and fellows, I checked my voice mail. The message from Dr. L. said I should please contact her. Already, by the tone of her voice, I knew the results of the needle biopsy I’d had the morning before. It was positive. I had an infiltrating ductal carcinoma in the left breast.

I stayed to finish seeing the patients. Around 6PM, I went back to my office to complete notes and return calls. Only after all that was done, my desk set with a decipherable stack of tasks and charts – just in case someone else should need to complete my work, I went home.

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Glad to Spot a Pink Ribbon

This morning I walked into a Starbucks and noted a woman wearing a little pink ribbon on the lapel of her suit. She appeared to be in a meeting, speaking seriously with a small group of people dressed for business.

How great is that, I thought, that she wears the pink ribbon unabashedly, in this October of 2011. She sees nothing wrong with raising awareness about breast cancer, or expressing her concern about this killer of women. Kudos!

In some circles now it’s fashionable to bash pink symbols, to say how breast cancer shouldn’t be prettified, or commercialized, or overblown. What I’d say is, of course, the disease isn’t beautiful, or good, or inherently profitable, or to be perceived as a gift. It’s none of those things.

But we take for granted, lately, how open people are about breast cancer and its complications. Twenty years ago, and even ten, many women I knew took their treatments silently. Few disclosed their illness to others in the community. Many lacked open sources of information or support. For some, breast cancer was a source of shame.

Times have changed, indeed.

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NEJM Publishes New Review on Breast Cancer Screening

With little fanfare, the NEJM published a feature on breast cancer screening in its Sept 15 issue. The article, like other “vignettes” in the Journal, opens with a clinical scenario. This time, it’s a 42 year old woman who is considering first-time mammography.

The author, Dr. Ellen Warner, an oncologist at the University of Toronto, takes opportunity to review updated evidence and recommendations for screening women at average risk for the disease. She outlines the problem:

Worldwide, breast cancer is now the most common cancer diagnosed in women and is the leading cause of deaths from cancer among women, with approximately 1.3 million new cases and an estimated 458,000 deaths reported in 2008.(1)

On screening:

The decision to screen either a particular population or a specific patient for a disease involves weighing benefits against costs. In the case of breast-cancer screening, the most important benefits are a reduction in the risk of death and the number of life-years gained….

She breaks down the data for mammography by age groups:

For women between the ages of 50 to 69 the evidence is clear, she says. For those over 70, there are little data to support breast cancer screening. There’s a consensus that screening isn’t appropriate for women with serious coexisting illnesses and a life expectancy of less than 5-10 years.

For those between the ages of 40-49, Warner challenges the revised 2009 USPSTF recommendations on several counts. She critiques those authors’ weighting of data from the Age trial of 161,000 women, emphasizing the use of an antiquated (single view) mammography technique and flawed statistics. She considers:

…However, this change in remains highly controversial,22, 23 especially because of the greater number of years of life expectancy gained from preventing death from breast cancer in younger women. According to statistical modeling,19 screening initiated at the age of 40 years rather than 50 years would avert one additional death from breast cancer per 1000 women screened, resulting in 33 life-years gained.”

What I like about Warner’s analysis, besides its extreme attention to details in the data, is that she’s not afraid to, at least implicitly, assign value to a procedure that impacts a young person’s life expectancy relative to that of an older person.

She goes on to consider digital mammography and the Digital Imaging Screening Trial (DMIST [NCT00008346]) results. For women under 50 years, digital mammography was significantly more sensitive than film (78% vs. 51%).

The article is long and detailed; I recommend the full read including some helpful tables, with references to the major studies, and charts.

In concluding, the author, who admits receiving grant support from Amersham Health (a GE subsidiary), consulting fees from Bayer and lecture fees from AstraZeneca, returns to the hypothetical patient, and what might be said to a woman in her 40s who lacks an outstanding risk (such as a genetic disposition or strong family history):

…Mammography screening every 2 years will find two out of every three cancers in women her age, reduce her risk of death from breast cancer by 15%. There’s about a 40% chance that further imaging (such as a sonogram) will be recommended, and a 3% chance for biopsy with a benign finding….

In my opinion (ES) this is key – that the chances of a false positive leading to biopsy are only 3% for a woman in her 40s. If those biopsies are done in the radiology suite with a core needle, every 2 years for women of average risk, the costs of false positives can be minimized.

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1 in 70 Women Develops Breast Cancer Before Reaching 50 Years

A post in yesterday’s Well column, about coverage of breast cancer by the media, focused on the first-person narrative of NBC’s Andrea Mitchell. Journalist Tara Parker-Pope writes:

Her announcement has generated much discussion in the blogosphere, including an analysis by Gary Schwitzer, publisher of HealthNewsReview.org, who writes that Ms. Mitchell made some missteps in discussing her cancer.

The Times column goes on to consider what was said, and how it might have been said better, and I agree with much of it. But mainly it’s a meta discussion, journalists talking about how other journalists consider breast cancer facts, figures and narratives.

Buried deep is this number, that according to the NCI, one in 69, or for the sake of simplicity – approximately 1 in 70 – women in the U.S. will receive a diagnosis of BC in her forties. That is an astonishingly enormous proportion of women under 50 years affected by a devastating disease.

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Breast Cancer Avastin Update

This afternoon Ed Silverman of Pharmalot reports that Roche has proposed a compromise to the FDA over Avastin’s use in women with metastatic breast cancer. The drug would be approved for use only in combination with paclitaxel (Taxol), for which the data are strongest, and with special warnings.

He writes:

The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide.

This sounds like a reasonable solution. As I have considered elsewhere, the FDA commissioner’s decision is pending.

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Mammography Update!

This week I’ve come across a few articles and varied blog posts on screening mammography. The impetus for rehashing the topic is a new set of guidelines issued by the American College of Obstetricians and Gynecologists. That group of women’s health providers now advises that most women get annual mammograms starting at age 40.

Why every year? I have no idea. To the best of my knowledge, there are no data to support that annual mammograms are cost-effective or life-saving for women in any age bracket at normal risk for BC.

Pertinent also, is a recent paper* in the Annals of Internal Medicine supporting a personalized approach to BC screening and mammography for women over the age of 40, and an editorial* to go with it.

“Talk to your doctor,” is the point for patients. (Women’s breasts are not all the same.)

“Talk with your patient,” is the point for doctors: Consider your patient’s breast density, family health history and personal preferences. Great idea!

We need an Annals paper to tell us this?

My personal view, synthesizing all the medical literature of which I’m aware, and taking account all of my prior experiences as a practicing oncologist, and not forgetting I’m a woman, now 50, who had an early-stage breast cancer discovered by a radiologist – and this is not medical advice – is as follows:

For women of normal risk, such as without a strong family history or a prior cancer:

1. Start with a baseline, digital mammogram at age 40. The image should be digital first, because this kind of technology is better for visualizing dense breast tissue which is more common in pre-menopausal, younger women and second, because digital images can more easily be shared with another doctor, for a second or more expert opinion if necessary.

2. Get mammograms every other year, unless there’s a significant abnormality that requires follow-up sooner. Until what age? Hard to say. (A complex topic… hold that thought for another post.)

3. Supplement mammography every other year with monthly self-examination of the breast. This inexpensive method of feeling one’s own breasts, regularly and methodically, has not been shown to save lives in randomized clinical trials. But I am convinced that if it’s done right – when a gynecologist, PCP, internist or other caregiver takes the time to teach her patients how to do the breast self-exam properly  – as I used to instruct my patients in the clinic, women can help themselves to catch breast tumors early.

4. Mammograms should be done, exclusively, by appropriately-trained radiologists who spend the bulk of their time reading mammograms, performing sonograms of the breast and taking occasional biopsies, as appropriate. (Sorry, general radiologists, but that’s how it is. Would you want your mother’s breast image examined by a radiologist who also reads hip films and MRIs of the brain?) The rate of false positives is lower when mammograms are performed by specialized “breast” radiologists.

5. Take advantage of the fact that mammography centers have been regulated for nearly two decades by the FDA. Be sure that the place where you get your mammogram is MQSA-accredited.

All for now –

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*subscription required for full text

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Patients’ Words, Unfiltered, Medical Journalism and Evidence

Yesterday’s post was not really about Avastin, but about medical journalism and how patients’ voices are handled by the media.

L. Husten, writing on a Forbes blog, cried that the press fawned, inappropriately, over patients’ words at the FDA hearing last week, and that led him to wonder why and if journalists should pay attention to what people with illness have to say, even if their words go against the prevailing medical wisdom.

There’s a fair amount of controversy on this. For sake of better discussion in the future, I think it best to break it up into 3 distinct but inter-related issues:

1. About health care journalism and patients’ voices:

A general problem I perceive (and part of why I started blogging) is how traditional medical journalists use patients’ stories to make a point. What some of my journalism professors tried to teach  me, and most editors I’ve dealt with clearly want, is for the reporter to find a person with an illness, as a lead,  and then tell about the relevant news, and provide some expert commentary – with at least one person speaking on each “side” of the issue, of course – and then end the story with some bit about the patient and the future.

I argue that this form of medical journalism reduces the patient to an object, used by the story-teller in order to capture the reader’s attention. So, with exceptions and always with the person’s consent, I prefer to offer my own story, from my perspective, so as not to use the patient as a vehicle or literary device.

So it appears that Husten is OK with using patients’ voices to tell a story (and sell papers/clicks?), but not with presenting their views unfiltered if they don’t mesh with the party line or a particular point an editor wants to make. This lies at the center of the journalism issue.

(As an aside, a few recent published studies have found value in analyses of patient-reported symptoms, unfiltered even by their doctors.)

2.  About Avastin:

My impression is that some beast cancer advocates, including a National Breast Cancer Coalition representative who spoke at the FDA hearing, have chosen to “take the hit” on this particular issue because they need and want to appear rational. The straightforward-seeming argument is that the data show Avastin doesn’t work and is often harmful, so it shouldn’t be FDA-approved for women with metastatic BC. From the perspective of a BC advocacy group, it may not be worth pushing for a drug that helps only around 5% of patients.

The problem is there’s no biomarker for Avastin responsiveness, because this drug doesn’t target a particular genetic marker. Rather it works by cutting the blood supply, which could vary even within a particular patient’s mets in different organs. The only way to test if Avastin works in a patient is to give the drug, with informed consent, and see how it goes. Unlike, say, a bone marrow transplant, which runs in the range of hundreds of thousands of dollars and, once done, is irreversible, you can give one dose of Avastin and stop it, or two and stop it, if it doesn’t work or it is not well-tolerated.

Based on my experience as an oncologist and patient who’s received some risky interventions, I don’t think Avastin is more toxic than many or even most cancer drugs. Rather, its side effects have been heavily pushed by the media and public health/epidemiology academics in the past two years, who perhaps wish to make a larger point about this costly drug and evidence based medicine (EBM).

3. About evidence-based medicine: I’m in favor of EBM, especially in principle. The problem is that published medical data is too-often flawed and also, that some patients are, really, outliers.

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