After Breast Cancer, Get a Gym Membership!

Earlier this month the Journal of the American Medical Association (JAMA) published a myth-busting paper on weight lifting for women at risk for lymphedema after breast cancer treatment.  The study was neither large (154 patients at max, whittled down to 134 at analysis) nor high-tech (interventions involved gym memberships, weight training and lifting in neighborhood facilities like YMCAs).

The results were clear: working out with hand-held weights, carefully, is good for most women who’ve had surgery for breast cancer (BC).

Lymphedema, or swelling due to a damaged gland, can develop in a patient’s arm after removal of lymph nodes in the armpit. The uncomfortable condition can be disabling by impairing arm or hand movements. It affects a significant number of BC patients: among women who’ve had have just a sentinel lymph node removed, lymphedema affects roughly 6%; for those who’ve had complete axillary (armpit) lymph node dissection, the incidence is around 30%. There are roughly 2.5 million women living in the U.S. after a breast cancer diagnosis; most are at elevated risk for lymphedema.

Years ago, doctors commonly advised patients not to lift weights or perform strenuous exercises with their arms after a mastectomy or lumpectomy with lymph node dissection. To a lesser extent, this happens still today. As reported in the JAMA article:

Breast cancer survivors at risk for lymphedema alter activity, limit activity, or both from fear and uncertainty about their personal risk level, and upon guidance advising them to avoid lifting children, heavy bags, or other objects with the at-risk arm.9,10 Such guidance that deconditions the arm, increasing the potential for injury, overuse, and, ironically, lymphedema onset.11 Adherence to these precautions may limit physical recovery after breast cancer and, for some women, result in lost employment. Furthermore, activity avoidance may deter survivors from performing regular exercise…

The researchers recruited women in the Philadelphia area who’d undergone surgery for localized, unilateral breast cancer sometime between 1 and 5 years before the study. Each had at least 2 lymph nodes removed in surgery. The median age was around 55 years. The women were divided into two balanced groups before randomization – they received a year’s membership at a gym and a trainer for the first 13 weeks, or not.

So it’s good news that the women in “weight lifting intervention” group developed less lymphedema. What’s more, those women became stronger and sported a lower percentage of body fat. All of these differences were statistically meaningful and, for the most part, quite strong. Perhaps more remarkably, in a pre-planned subset analysis of women who’d had 5 or more lymph nodes removed, the proportion who experienced lymphedema in the weight-lifting group was only 7%, compared with 22% in the controls. That difference was highly significant, with a p-value of 0.003. The findings, in sum, show that it’s safe for women who’ve had breast cancer surgery to work out in a way that includes a careful, progressive upper body strengthening.

About a week ago, I was alerted to this article by Dr. Ramona Bates, a plastic surgeon who authors Suture for a Living. She’s had several recent, excellent pieces on this subject including a post on lymphedema and the JAMA report. I chose to write on this, in part, because it meshes with my professional and medical history.

In my case, I got conflicting advice on the matter. I wanted to continue swimming because it helps my scoliotic back. But some colleagues suggested that arm-intense strokes might be best avoided after mastectomies. A cosmetic surgeon rightly told me that some strokes might have untoward effects on implants. So I relied on my judgment: I chose to swim because it made me feel better and stronger. In the past year, I’ve started lifting a few small weights, carefully and slowly.

In the end, this is a story of a small clinical trial and the value of common sense in medicine. Weight lifting is not only safe; it can reduce the incidence of lymphedema in women at risk. But “old wives’ tales” still persist in some doctors’ minds; these need be dispelled. Finally, I can’t help but wonder what would happen if every woman could have a year’s membership at a local gym –

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The Loss of Elizabeth Edwards

Dear Readers,

I am sad to learn of the death of Elizabeth Edwards, who died earlier today of metastatic breast cancer at the age of 61. She has taught countless people about what it’s like to live with cancer.

My thoughts are with her family now.

-ES

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End of October, Breast Cancer Fatigue

Today the author fears she is suffering from breast cancer fatigue syndrome, an unofficial and possibly infectious condition that she named this morning, that comes from too much thinking about breast cancer and the incidence of which peaks in October, and/or that she may be suffering from writing-about-breast-cancer fatigue syndrome, an affliction of some bloggers.

So she will take the rest of the afternoon and evening off, and do some reading and enjoy the weekend with her family.

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Annals of Pink: Chilean Miners Don Ribbons

The Santiago Times reports that the rescued Chilean miners donned suits and pink ribbons, the latter in honor of breast cancer awareness month, at a ceremony at the the presidential palace, la Moneda.

Sure, the pink scene’s getting to be a bit much around here. But I don’t belittle this gesture; the miners’ intentions are surely well-meaning, and in places like northern Chile where they lived and worked, BC doesn’t get the overblown attention it does here, at least not yet. Not even close.

So kudos to the miners, from this one blogger in NYC.

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Stem Cells, Breast Reconstruction and a Magazine Cover

The cover of the November print edition of Wired features large, unnatural-appearing cleavage. Inside and toward the back of the issue, a curious article ties together stem cells and the future of breast reconstruction. It got my attention.

Wired, November 2010 issue

The detailed and admittedly interesting piece, by Sharon Begley, describes what’s science or science fiction: first humans, such as some plastic surgeons, remove adipose tissue, a.k.a. fat, by a well-established cosmetic surgery procedure called liposuction, from a body part where there’s a fat surplus – such as the belly or backside; next, laboratory workers purify and grow what are said to be stem cells from that that fat; finally, they use a nifty, calibrated and expensive device to inject those fatty stem cells where women want, such as in a hole or dimpled breast where a tumor’s been removed.

The story starts, unfortunately and distractingly, with a portrait of a male, enterprising and PowerPoint presentation-giving CEO of a biotech company, Cytori Therapeutics. Toward the end of the article, the author provides stats to support the potential business. Ultimately, improved breast cancer survival means that greater numbers of women will live more years after a lumpectomy or mastectomy, she explains. The reconstruction market may expand further, still, because some women opt for prophylactic mastectomies upon positive genetic testing for a BRCA mutation. Others, without cancer or high risk, might simply want to use these adipose-derived stem cells for cosmetic breast augmentation. What’s clear, if nothing else, is that women’s breasts are perceived as a commodity.

In between the money elements of the discussion, there’s some cool science about adipose-derived stem cells, which according to the cited scientists are quite prevalent in fatty tissue and relatively easy to grow if you give them some blood to feed on in the lab. A putative advantage of the cells is that they draw blood vessels to the area of engraftment, which is a concern to this oncologist (me) and, evidently, to an FDA panel that has not yet approved of this innovative method of breast reconstruction in women who’ve had breast tumors.

I’m not convinced, at least from what’s reported in this Wired article, that the cells used in this process are true stem cells, based on the high numbers the scientists describe finding so readily, and in rich proportions, in human fat tissues. It could be, for example, that what they’re isolating are really primitive adipose cells that can, indeed blend into the breast tissue and even recruit blood vessels as described, but aren’t true, pluripotent stem cells – the kind that can form any kind of blood cell or heart cell or neuron. Perhaps stem cells just sound sexy, at least to investors.

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New Findings on Postmenopausal Hormone Replacement Therapy and Breast Cancer

This week the Journal of the American Medical Association (JAMA) published results of a large study with significant implications for women who consider taking hormone replacement therapy (HRT). The new findings are based on careful examination over 16,000 individuals, part of the larger Women’s Health Initiative, who were randomly assigned to take either a placebo, or Prempro – a combination pill that includes estrogen, extracted from equine (horse) urine, and medroxyprogesterone acetate, a synthetic progesterone compound.

The extended data confirm that women who take hormone replacement therapy are more likely to develop breast cancer than those who don’t take it. But this finding has been seen previously, and was one of the reasons why the randomization was halted earlier on –

What’s new is that the breast cancers in women who took hormone replacement therapy are more invasive, with greater extension to the lymph nodes, and more deadly. Women ages of 50 to 79 years who take hormones are roughly twice as likely to die from breast cancer as those who don’t take hormones, and are more likely to die earlier, of any cause.*

In 2002, JAMA published a landmark report on an earlier analysis of the same trial, which was halted because of the evident toxicity, then, of hormone replacement therapy. Before that time, the treatment was thought – on theoretical grounds – to reduce the risk of heart disease.

The drugs were marketed heavily throughout the 1990s, particularly through gynecologists and primary care physicians, and later to women directly – an “ask your doctor” kind of thing. In tangible ways, these drugs tend to make women feel younger and suppler, with fewer hot flashes. Many women I knew were eager to try these hormone supplements.

My perspective is that of an oncologist. Knowing that most breast cancer cells have receptors on their surfaces for estrogen and progesterone – steroid hormones that stimulate growth of normal mammary (breast) tissue cells in healthy women – the findings seem entirely plausible. . Besides that the hormones can bind receptors on cancer cells’ surfaces and trigger growth pathways, there may be other effects. The authors of the new JAMA article suggest, for example, that the hormones can enhance the blood vessels that “feed” breast tumors, and so might make them worse.

Denise Grady provides a thorough report in the Times on this topic. As she points out, approximately 3 million women in the U.S. still take hormone replacement therapy. Before the 2002 report, as many as 6 million postmenopausal American women were prescribed this kind of medication. The incidence of breast cancer in North America has declined since 2002, and most oncologists and epidemiologists ascribe much of that improvement to reduced use hormone replacement therapy.

Still, many doctors still prescribe hormone replacement therapy. There’s a huge potential market for these drugs, and so a lot of money’s at stake, besides women’s health. Based on U.S. census data from 2000, the number of women between the ages of 50 and 79 approached 40 million and, today, is likely larger still.

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*The absolute numbers run like this:

Among the 8506 women randomized to take hormone replacement therapy (HRT), there were 385 BC cases detected; among the 8102 assigned to placebo, there were 293 cases identified. (This was a statistically significant difference.) These numbers can be whittled down, then, to a total of 678 BC cases – out of 16,000 women on the trial – who developed BC. The pathology was similar between the two groups, in terms of molecular subtypes. But the invasiveness – in terms of lymph node involvement – was higher in the HRT group, as was the mortality: 25 women died from BC in the HRT group; 12 women died from BC in the placebo group. (This was also significant, but with a p value of just 0.049).

One caveat, or limitation, to the study is that the authors didn’t have access to detailed information on the women’s treatments, which may or may not have differed between the groups. A strength of the study is the relatively long follow-up, of 11 years on average.

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October 13 Would Be National Metastatic Breast Cancer Awareness Day

According to the most recent figures available, roughly 160,000 people are living with metastatic breast cancer in the U.S. The number may be higher now, based on progressive availability of new drugs – especially in the past decade – that are slowly extending the average life-expectancy of women with Stage IV disease.

Last October, the U.S. Senate (on 10/13/09) and House (retroactively, on 10/28/09) voted to support the designation of October 13, 2009, as a National Metastatic Breast Cancer Awareness Day. The point was to draw public attention to the distinct needs of metastatic BC patients: women who live every day with this condition but, for the most part, are not heralded in pink.

My hope is that before October 2011, President Obama will make this day official: October 13 should be National Metastatic BC Awareness Day – so that women with advanced disease will know they’re not forgotten and, rather, will catch the public’s eye.

My pick for NMBCA Day’s official color: gray, to signify seriousness and uncertainty; but of course every woman should choose her own style!

Please see a related HuffPo piece; that includes patients’ and others’ viewpoints on this topic.

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Five Ways to Improve the Quality and Success of Breast Cancer Screening by Mammography

Here are some ideas on how we might reduce the incidence of metastatic breast cancer, by making high-quality mammography available to all women:

1. Modernize all breast imaging facilities. All should comply with the Mammography Quality Standards Act and Program (MQSAP) of 1992.

2. Ensure that radiologists, technicians and other BC screening workers are up to date: requirements for continuing medical education in an academic, unbiased (non-pharma or biotech setting), should be strict. We depend on practitioners’ current knowledge of breast imaging methods, breast biopsy techniques, hygiene, information technology (IT) and patient privacy laws.

3. Implement digital mammography in all screening facilities; Digital images allow radiologists to adjust the contrast, magnify or otherwise highlight areas of concern, to better analyze potential lesions without subjecting patients to extra x-rays.

4. Supplement mammograms with sonograms of the breasts. These inexpensive tests can help radiologists discern cysts and other benign lesions from malignant tumors. In some situations, a radiologist inspecting a sonogram can spot a small solid abnormality that’s missed in a mammogram. In principle, this low-rad combo – of digital mammography and breast sonography – would increase sensitivity and specificity of breast cancer screening.

(5.) Consider transmitting digital images to breast screening centers, so that expert radiologists can review every woman’s films.

As Sue, a woman who’s had breast cancer told me last month: “You don’t want a radiologist who’s just looked at someone’s broken foot examining your mammogram.” She’s right: Expertise can make a huge difference in clinical outcomes.

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Eight Years

Today marks exactly eight years since Dr. L., the fine radiologist who may have saved my life, called to let me know about my breast cancer diagnosis.

With deep-felt thanks to my doctors, my friends, my family,

ES

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By |October 9th, 2010|Breast Cancer, from the author, Life, Life as a Patient|Comments Off on Eight Years|

Why I Went for My Screening Mammogram

Dear Readers,

This week marks eight years, exactly, since I had an abnormal mammogram that led to my breast cancer diagnosis. I was 42 years old, and lucky because the excellent radiologist who discovered my tumor was a super-specialist in breast imaging, the kind of radiologist who spends her work-time analyzing mammograms, performing breast sonograms and taking biopsies of suspicious lesions. She doesn’t often look at hip films or ordinary x-rays. She just does mammograms, mammograms and mammograms, and sometimes additional tests to evaluate abnormalities she detects in those. She knew her stuff.

I was afraid to get a mammogram because I didn’t want to learn I had cancer. Back then, my breasts were so glandular it was hard for me, an oncologist, to discern what might be a pathological lump, or not. I feared having a “false positive,” and undergoing multiple tests to evaluate abnormal images that would turn out to be nothing but big-bill inducing benign lesions.

Really I was hesitant in visiting her office. I didn’t have time for cancer, because I was in pain from a crumbling spine and needed to get my back fixed before even opening up the possibility of additional medical problems. I wanted to work as much as I could then, before and after that big reconstructive spinal surgery, so that I might continue research and publish more papers. Besides, my sons were young then – ages 8 and 10 – and I didn’t want to not be able to make dinner because I was throwing up, or die.

Not getting a mammogram was a way of not finding out. The shoemaker’s kids don’t get shoes. An oncologist doesn’t get a mammogram…

My general internist, whom I trusted, insisted that I go for screening. “You’re over forty, you know,” she said. But I had no family history of the disease, then – this has since changed, and I didn’t consider myself at increased risk. Ultimately I went for the mammogram because I knew it was the responsible thing to do, to take care of myself.

When I had the mammogram, and the sono to evaluate an abnormality, and the core needle biopsies in the next week, I wasn’t afraid so much as I was annoyed by all the inconvenience. “Who has time to be a patient?” was my attitude. I came to each doctor’s appointment armed with research articles and colleagues’ manuscripts to review. I had meetings to attend, and responsibilities, and participated actively in a typical two-career family kind of up-and-out-early way of raising our sons.

All of that is behind me now, as is the chemo,  hair loss, some incidental fractures, surgeries, generalized fatigue and sad times that followed. How lucky I am that I went that day. There is no doubt in my mind.

Next year, approximately 45,000 women in the U.S. will die of metastatic breast cancer. Why I advocate for screening mammograms is because I know that a significant fraction of those advanced cases, perhaps half or more, could be prevented by early detection. That benefit would be a boon to the public health: perhaps as many as 20,000 – 30,000 women spared per year from morbidity, suffering and mortality of metastatic breast cancer, which is currently an incurable, costly disease.

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Notes on the 2010 Swedish Mammography Report, and the Press

I’m not sure why editors buried last week’s report on the new Swedish mammography study. The positive findings appeared only on page 24 of Thursday’s (Sept. 30) print edition of the New York Times. My husband didn’t hear about it on NPR on his way home from work. The moms in my community didn’t see Dr. Gupta talking about this on TV.

The new findings – linking mammograms for women aged 40 to 49 to a big drop in BC death rates years later – seem to confound journalists’ notions on screening’s lack of effectiveness in this disease. But they’re no surprise to doctors like oncologists who have experience caring for breast cancer patients.

The Swedish study, with lead and senior authors in the Department of Radiation Sciences at an oncology center at Umeå University in Sweden, was presented at an annual ASCO* breast cancer symposium and published on-line** last week in the ACS journal Cancer. The data reveal that for women living in Sweden where mammography was offered every 18 or 24 months to women ages 40 to 49, breast cancer-related deaths fell by approximately 26 percent.

In some ways, the new report is similar to a highly-publicized paper published a week earlier in the NEJM: both are based on historical data, between 1986 until 2005, extracted from comprehensive, public databases in a Scandinavian nation. What’s different here, besides the positive results and younger age group focus, is that follow-up was much longer in this Swedish study: 16 years after a BC diagnosis; it was a measly 2.2 years in the Norway study.

Adapted from Fig 2 in Swedish study; the blue arrow points to ~2.2 yrs, the average follow-up in the Norwegian data

This graph to the right, adapted from Figure 2 in the original Swedish report, shows the crude cumulative breast cancer mortality per 100,000 person-years. The solid line shows survival for women found to have BC in the study group – those women living in areas where mammography was provided between ages 40 and 49; the dashed line shows the same for the controls – those living in areas where women between 40 and 49 years “were not invited to attend” service (i.e. government-financed) screening.

The light blue arrow, which I’ve added, points toward the 2.2 year mark, the average follow-up for patients in the recent Norway study. What’s evident is that such a short interval is not nearly sufficient – it’s far too early – to assess the effects of mammography on mortality in women with BC; over years, the divergent curves show a marked benefit of screening.

As an oncologist, I know this finding meshes with reality; breast cancer tends to kill women years, rather than months, after the time of initial diagnosis; you wouldn’t expect mammography to make a dent in a mortality curve until after 4-5 years or so, especially if you factor in possible lead-time bias, as the Swedish study authors did.

Some legitimate concerns about the Swedish study include that it comes from a radiology group with an “interest” in having mammography be effective. Let’s say that’s true, but it also may be that those physicians become breast cancer researchers with good intentions, and that mammography does save lives by catching early-stage BC. It would be foolish to deny that radiologists, oncologists and others in the field have the most experience with breast cancer imaging, diagnosis and treatment.

This positive report should be scrutinized, yes, but no more or less than the other papers on the same subject that have been highlighted, selectively, in the media. How journalists cover mammography studies, and that they do so with an open mind, matters a lot.

*disclosure: I am an ASCO member.

**full-text by subscription

***Hellquist, B. N., Duffy, S. W., Abdsaleh, S., Björneld, L., Bordás, P., Tabár, L., Viták, B., Zackrisson, S., Nyström, L. and Jonsson, H., “Effectiveness of population-based service screening with mammography for women ages 40 to 49 years,” Cancer, 2010, Volume and pages pending (on-line only, citation in progress)

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Why It’s So Hard to Assess False Positives, and How We Might Reduce Them

It’s been nearly a year since we “learned” about the false positives issue, and still there’s hardly any data published on this much-maligned cost of breast cancer screening by mammography.

From the U.S. Preventive Services Task Force November 2009 paper in the Annals, on the lack of information on the incidence of  FP’s:

“Published data on false-positive and false-negative mammography results, additional imaging, and biopsies that reflect current practices in the United States are limited. The probability of a false-positive screening mammography result was estimated at 0.9% to 6.5% in a meta-analysis of studies of sensitivity and specificity of mammography published 10 years ago <ref. 38>. The cumulative risk for false-positive mammography results has been reported as 21% to 49% after 10 mammography examinations for women in general <39–41>, and up to 56% for women aged 40 to 49 years (41)

False positives happen in mammography when a woman has an abnormal result that looks like it might be breast cancer, but upon a further workup – which might involve another, more expert radiologist taking a look, or a sonogram, or an MRI, or even a breast biopsy, but in the end the problem turns out not to be breast cancer.

Why is it so hard to ascertain how often false positives occur?

1. The rate of false positive mammograms is, most likely, declining (i.e. the number is in flux).

Reduced errors would result from two factors: improved methods, such as by adaptation of digital mammography, and by more careful application of extant technology due to progressive compliance with the FDA’s Mammography Quality Standards Act and Program.

2. There’s no precise definition of what constitutes a false positive in mammography, and what isn’t. As I’ve suggested previously, finding a pre-malignant condition like LCIS or an early-stage malignancy like DCIS should not be “counted” as a false positive. If over-treatment occurs, that reflects an error in clinical decision-making rather than in mammography, per se.

3. The false positive rate varies among radiologists and medical centers. That’s because a radiologist who spends her days doing nothing but reading mammograms and breast sonograms will, overall, have a lower FP rate than a general radiologist who also handles hip fracture films and MRIs of the brain.

What are financial costs of false positives? I’m not aware of any new data on this.

How can we reduce the costs of false positives in mammography? My suggestions:

1. Radiologists should be well-trained and carefully-credentialed. As in surgery and other fields in medicine, the physician’s skills and experience affects the probable outcome.

2. Avoid doing breast biopsies in an operating room whenever possible. A fine needle aspirate or core needle biopsy, performed under local anesthesia, is almost always sufficient for diagnosis and less costly.

3. Thinking for the future: Maybe, one good application of Telemedicine would be in sharing digital mammography images, so that no matter where a woman lives, her test could be checked by a radiologist working in a central cancer center and who specializes in breast imaging.

4. Do the procedure every other year for women of average risk for breast cancer (rather than annually). Quite a few theoretical calculations of mammography costs “stack” the purported costs by assuming the procedure is done every year, but there’s no data to support such frequency.

In sum, there’s every reason to think the rate of false positives in screening mammography is falling and that costs from errors will diminish in the future.

Many, if not all, of the costs attributed to false positives will be reduced by advances in technology, better training of radiologists, and education of physicians (oncologists, surgeons, primary care physicians) who recommend the procedure and make decisions based on the results.

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It’s Not About the Money

A recent NEJM article, Lessons from the Mammography Wars, opens with a quote from the 18th Century philosopher-economist Adam Smith:

People of the same trade seldom meet together . . . [without] the conversation end[ing] in a conspiracy against the public.

The Wealth of Nations (1776)

The opinion piece, published on Sept. 8, considers the controversy that surrounded last year’s U.S. Preventive Service Task Force recommendations for screening mammography in the context of broader issues. It contains some serious accusations:

“Advocates of breast-cancer screening, particularly breast radiologists, immediately took action, denouncing the panel’s statements as government rationing, suggesting that the panel members had ignored the medical evidence…

Ultimately, what’s incriminated is the self-interest of doctors:

“…Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members’ interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool’s dream to expect the guild…to compete on true value when the opportunity to inflate perceived value is readily available.

OK, readers, so how do I recommend we resolve this thorny issue?

Physicians should be on salaries, set in such a way that their earnings aren’t based on the procedures they order or perform. For example, I don’t think a surgeon should earn more money if he or she performs a greater number of biopsies or mastectomies, as opposed to spending time examining and speaking with patients who are contemplating those procedures. I don’t think an oncologist should earn more money by ordering or administering more infusions of chemotherapy, as opposed to recommending a “wait and watch” type approach, palliative care, or giving pills that are effective in some malignancies.

If physicians’ potential profit motive clouds the mammography debate, as the authors contend, that doesn’t mean that mammography is ineffective. Rather it signifies that doctors and scientists should analyze data and make clinical decisions in the absence of financial or other conflicts of interest.

If patients could know that their doctors don’t have a vested interest in mammograms, or any other test or procedure they might prescribe, they’d trust them more. It’s for this reason, above all, that we should disconnect doctors’ decisions from economic gain.

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What’s Missing in the Recent Mammography Value Study

This week’s New England Journal of Medicine includes an article*on the potential benefit of breast cancer (BC) screening by mammography. The paper, authored by a group of epidemiologists and biostatisticians from the Cancer Registry of Norway, Harvard University, the Dana Farber Cancer Institute and Stockholm’s Karolinska Institutet, suggests that mammography has a relatively small influence on survival.

The work, along with an accompanying editorial* by H. Gilbert Welch, M.D., M.P.H., got front-page attention in the Times and elsewhere. My friends want to know why this particular research study was featured and, really, what it showed.

So here’s my take –

The analysis:

The researchers studied chronological trends in BC diagnosis and mortality in Norway. To see if mammography had an effect, they divided the country into two groups, “screening” and “non-screening,” based on when a state-sponsored mammography screening program was implemented in each of 19 counties there. The national plan, which required that each region establish a centralized, multidisciplinary BC care team before participation, began in 4 counties in 1996 and gradually expanded to include all of Norway by 2005. According to the authors, all Norwegian women between the ages of 50 and 69 years have been asked to participate in screening mammography since 2005; 77% have done so; Norway’s nationwide cancer registry is nearly 100% complete.

They evaluated a total of 40,075 women (“subjects”) who received a diagnosis of BC between 1986 and 2005.

Major findings:

For women between the ages of 50 and 69, BC-associated mortality** fell from 25.3 to 18.1 in counties where a government-sponsored mammography program was implemented early on, and from 26.0 to 21.2 in counties where mammography was not covered, over a similar time frame. Because BC-associated mortality declined in all regions of Norway, regardless of whether mammography was offered, the authors conclude that screening can’t account for all the reduction in mortality.

By their calculations, mammography accounts for roughly 10 percent of the enhanced survival. (This finding was not statistically significant.)

The authors suggest that recent progress in BC survival – which in their study improved significantly in all regions of Norway – comes, for the most part, from better care and treatments.

What’s wrong with the paper? I see several key flaws:

1.  The average follow-up is only 2.2 years after diagnosis, with a maximum follow-up of 8.9 years (“Results,” p. 1206). This is far too short a follow-up interval to measure the benefit of mammography or any sort of intervention in women with breast cancer. When BC recurs it’s often after several years and, occasionally, decades later.

2. Among women under the age of 50 there was a slight increase in BC-mortality noted: A non-significant relative increase in mortality, of 4%, after the introduction of the screening program for older women (p. 1207, Table 1). This worrisome finding is not adequately addressed by the authors; one might wonder – did fewer women in their forties go for mammograms after 1996, since they were only recommended and covered for older women? (My concern is that reduced screening, now, in younger women might lead to an increase in BC mortality.)

3. Digital mammography was not evaluated in this study.

4. The authors detected the greatest benefit of screening among women with Stage II BC; there was a “marked” 29% reduction in mortality relative to the historical counterparts for that group who were screened, as compared to only a 7% reduction in mortality for women with Stage II tumors in counties where screening was not available over the same historical interval (p. 1207). This observation suggests that mammography screening is most life-saving for women with Stage II tumors. As an oncologist, I find this highly-plausible; the purpose of mammography is to identify tumors in early stage and spare women morbidity and mortality associated from advanced disease.

5. There’s no mention of the absolute number of lives saved by the procedure according to the authors’ calculations, but I think this is an important number to keep in mind when we assess the procedure’s value. If the paper’s conclusion is true – that mammography reduces BC-associated deaths by just 10 percent – then in Norway, with a total population of 4.8 million and where some 4,791 women in the study died (p. 1206), these results support that mammography spared approximately 480 lives in those 20 years.

My spin:

Mortality in the U.S. from breast cancer has declined by roughly a third since the implementation of wide-spread mammography screening. Here, where some 45,000 women die each year of BC, we’d save 4500 lives per year if the added value of mammography is just 10 percent, as suggested by the new study. If the benefit of screening mammography is higher – in the range of 45 percent, as was supported by a 2007 paper, also published in the NEJM – then the value would exceed 20,000 women’s lives per year. If the benefit is only 25 percent in terms of reduced mortality, that would result in over 11,000 lives saved, per year in the U.S.

As for the editorial, first I’ll say that the opening statement – that “no screening test has ever been more carefully studied than screening mammography,” is misleading. While this was, indeed a well-organized and careful study, among other issues it was far too short in patients’ follow-up to measure the impact of mammography on BC survival. The Annals papers, which caused so much controversy last year, relied heavily on old data and did not at attempt to examine the efficacy of digital mammograms.

What’s needed, still, for public health policy in the U.S. is evidence regarding the long-term outcomes after digital mammography performed in FDA-regulated, modern facilities by skilled, board-certified radiologists applied every other year in women who are over the age of 40 in the context of modern, adjuvant treatments and current pathology methods.

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As for the analysis by G. Kolata in the Times, where she wrote:

“…it indicates that improved treatments with hormonal therapy and other targeted drugs may have, in a way, washed out most of mammography’s benefits by making it less important to find cancers when they are too small to feel.”

I’d say the opposite is true:

It’s precisely because there are effective treatments for early-stage disease that it’s worth finding breast cancer by mammography. Otherwise, what would be the point?

Metastatic breast cancer is quite costly to treat and, even with some available targeted therapies, remains incurable.  Despite so many advances in treating early-stage BC, the survival rate at 5 years is under 25 percent for women with Stage IV disease.

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*abstract available, otherwise by subscription

**mortality rates: per 100,000 person-years

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Stepping Back, and Thinking Forward to October

Before jumping into the raring-to-go, already re-sparked debate on the value of breast cancer screening, or not, I thought I’d step back today and consider the background of what I won’t call the “mammography wars.”

So here’s the first point on this subject: happily, it’s not a war. This is about medical progress, or lack of progress, and what may or may not spare women morbidity (what doctors and stats types call illness) and mortality (death). This is not a battle by any sane measure.

The discussion should be civil and fair, ideally without assumptions and bias. (Of course it’s impossible for me to be unbiased on this subject – I am a trained oncologist, I’ve treated women with breast cancer who responded to chemotherapy drugs and witnessed their subsequent well-being, and I’ve seen women with metastatic breast cancer who died with disease eating through their bones and brains. And I had breast cancer, and was lucky that mine was found in an early stage. So far am well in that respect, eight years ago next month and counting -)

So I have bias, yes, but my second point is that we all do. Every journalist does, whether or not they’re up front about their life-experiences and community background, and so does every medical researcher and public health official who authors a paper and is not a robot. We delineate stories, analyze and represent data based on points we want to make and, in some medical journals – even for some trials that aren’t funded by drug companies – publish to serve academic, career or even what we think are idealistic, cost-saving, pain or procedure-sparing often high-minded goals.

Data can be very tricky to sort out and among.

The problems with mammography studies, as partly-detailed in the current NEJM paper, is that it’s considered impossible to do a controlled, randomized trial in which half of the women undergo screening and half don’t. (I might argue this assumption; now, that so many women and doctors are questioning the merit of mammography, maybe we could do a truly randomized trial involving a few thousand women in the U.S.) This issue relates to the important topic of ethics and real-life dilemmas oncologists face when they set up studies for evaluation or treatment of humans some of whom are likely to die.

But before we delve into the details of this study, and next month (October), what I hope is that we’ll keep some facts in mind:

The National Cancer Institute estimates that 40,000 women will die of breast cancer this year in the U.S. There’s been dramatic progress in how we manage this once-dreaded condition: prior to 1926, fewer than 20 percent of women survived for 5 years after diagnosis. By 1950, the overall 5-year survival rate among Caucasian women with breast cancer was 60 percent. Now, the overall 5-year survival rate is around 91 percent.

A question central to today’s discussion – which does at least acknowledge the decline in breast cancer mortality – is the extent to which mammography is responsible for this trend, as opposed to other factors such as increased awareness about cancer, better cancer treatments and other variables.

What concerns me is the tone of the debate on mammography, that it shouldn’t subtly or not-so-subtly, denigrate women’s valid concerns about their health. The quote with which today’s front-page story ends is this: “I think we have to respect what women want to do.” The way the story is framed insinuates that a decision to undergo mammography is based on something other than reason.

To be clear: this is not about what women want. It’s not about emotional turmoil, comfort, stress or people’s feelings. It’s about the efficacy of state-of-the art mammograms and whether or not those, when taken by skilled, well-trained radiologists in carefully-regulated modern facilities save women’s lives, at a reasonable cost (however we might calculate that) and reduce illness by detecting breast cancer in its early stages.

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A Walk, or Race, for the Cure

“You can get discomboobulated in this place,” a NYC police officer told me today when I asked him the way.

This morning, some 25,000 or so men, women and children converged on Central Park for the Susan G. Komen Foundation‘s 20th annual Race for the Cure. It was my first time witnessing the event:

pink shirts, umbrella and rainbow, waiting for the start

I AM THE CURE

woman in black, pushing stroller

woman with Victoria's Secret umbrella

men, walking together

WTFC poster, held high

walkers in blue, near the Sheep Meadow

finish line with red light

Scan Van in the Park

ML is learning to use her camera.

School tomorrow!

p.s. 9/13: discomboobulated is not a typo!

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New NY State Law on Information for Women Undergoing Mastectomy

A few days ago, NY State Governor Paterson quietly signed a new public health law* on information and access to breast reconstructive surgery. From the details provided on my state’s Open Legislation website, it seems this took place on August 13.

The purpose of the new law is to assure that all women undergoing mastectomy in NY are told about reconstructive surgery options and that insurance will cover those additional procedures.

What’s curious are two things – first, why so little coverage of this event? It is end-of-summer, I suppose.

But maybe editors and people like me who are educated in medicine and read newspapers are out-of-touch with the fact that many women who have breast cancer – over 200,000 each year in the U.S. – still don’t really know about breast reconstruction during or after cancer treatment. In my community, people read books and ask multiple doctors in second and third opinion before deciding whether to undergo a trans-flap or have implants inserted and then, once electing for implants, attempt a careful review the not-so-current literature on silicone vs. saline…

The reality is that many women, particularly poor women without newspapers or internet access in their homes, don’t know about any of this. They don’t know their insurance covers pretty much all of these options, by law. Now they will, or should as of Jan 1, 2011. Good.

The other curiosity is that a Montefiore Medical Center-affiliated plastic and reconstructive surgeon is said to have authored this bill, which was sponsored by State Senator Ruth Hassell-Thompson. The doctor’s intentions were surely good; he advocated its passage based on the sad case of a single mom who, after undergoing mastectomy and seeing several physicians, still wasn’t aware that she might undergo breast reconstruction. Nonetheless, it’s not surprising that a plastic surgeon in the Bronx cares about this legislation.

There is a dark side to this, unfortunately. Even among the women with good insurance and purportedly top docs, the results of reconstructive breast surgery are sometimes devastating to the women who undergo these procedures. These are no boob-jobs, and there’s widespread misconception about that. So I hope the law, also, might eventually protect women from botched attempts at reconstruction, an under-reported problem that might also be newsworthy.

*addendum – first link above adjusted because the previous url, http://www.cnbc.com/id/38743477 is no longer available, ES 2/14/11

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The “Survivor” Term After Breast Cancer: Is There a Better Expression?

I hope this post will be the start of a long conversation on breast cancer survivorship. The question is, what’s the right, PC and emotionally-sound, sensitive but not sappy term to describe the situation of a person who’s living after breast cancer?

Some might say, who cares if you’ve had it?

Once, about six years ago, a colleague – an oncologist in my community – I met on the street stopped and asked me how I’d been. I said, well, I’d been out for a while because of some health problems. I mentioned that I had breast cancer among other things. “Who doesn’t have breast cancer?” she quipped, and then we talked about medical offices.

So what? was her point.

Sure, everyone’s got stuff by the time they approach their 50th birthday. Life would be pretty boring if we didn’t. And my personal history happens to include BC.

OK, NBD.

Why it matters, at least in my situation, is that I’m writing about health issues including breast cancer. So I think it would be deceptive to not mention this loaded “credential.” In a few weeks I’ll be teaching med students again, and although I don’t think that episode of my life is central to my capability as a teaching physician, I do think (and hope) it makes a difference.

Thinking more generally:

A lot of women, me included, have major physical changes upon undergoing treatment for BC. My hair was curly for most of a year. My breasts are gone. My bones are thinner and I’m estrogen-deprived. Sound depressing? It is, for as many as 30 to 40 percent of women at some point after their diagnosis. It’s not a minor experience in the physical, emotional or life-changing sense.

TV aside, the problem with the “survivor” term is that, maybe, it implies some sort of heroism or strength. But as an oncologist who happens to have had good insurance, knowledge and friends in the field, I just see it as, largely, the luck of the draw: there’s no reason for me to survive while another woman struggles and succumbs to metastatic disease.

I can’t deny to my readers, family, friends and others that I’ve had breast cancer, because it does affect my writing, feelings, capabilities and outlook. But I wish there were a better term for my status.

Any ideas?

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Suggestions to Reduce Errors in Breast Cancer Pathology

A prominent article in yesterday’s New York Times considers some troubling problems regarding inaccuracy in breast cancer diagnosis and pathology. The main point is that some women get needless, disfiguring and toxic treatments after being told they have breast cancer when, it turns out, their condition was benign.

My main take on this situation – which doesn’t just apply to breast cancer – is that, whenever possible, patients should get a second opinion on biopsy results before undergoing major treatment. The costs of a second pathology review is sometimes covered by insurance, but sometimes it’s not; either way, that’s money well-spent, especially if the opinion is rendered by an appropriately-credentialed, expert pathologist who works in a state-of-the-art facility.

From the doctor’s perspective there’s responsibility, too. Surgeons shouldn’t lop off a woman’s breast without knowing that the pathology is real. Well-trained oncologists know they’re supposed to review the pathology, to make sure the diagnosis is true, before giving chemo. The Times story indicates that the Cancer Treatment Centers of America has a specific policy in this regard, that doctors there must review the pathology for patients who are new to their system. This wise policy, common in some hospitals and tumor boards such as where I practiced, makes it less likely that oncologists or other doctors will give inappropriate treatment.

From an administrative standpoint, there could be better regulation to assure quality. Pathologists who are employed, busy evaluating tumor specimens without supervision, should be board-certified and required to be up-to-date in the specialized fields of their practice. And laboratories (as opposed to pathologists who work there) should be closely monitored because pathology errors can arise from faulty stains, use of poor-quality or old reagents, incorrect calibration of a machine, lack of appropriate “controls” for each batch of cases evaluated, etc.

A related story appeared earlier this year, also in the Times, on the variability of pathology reports. That article reported on how different pathology labs provide disparate results on whether a breast tumor has estrogen and progesterone receptors in the malignant cells, and whether the malignant cells express Her2 – the target of Herceptin – or not. The lack of agreement among pathologists renders treatment decisions difficult. The piece focused on a physician who couldn’t decide if she should take Herceptin or not, because she received conflicting reports about her tumor.

Getting the diagnosis right underlies many cancer care problems and undue costs. If I were an insurance company executive, I’d recommend that my firm cover the costs of a second pathology opinion in all cases. It’s far less costly to find out that a “tumor” is not really malignant than to pay for surgery, chemotherapy and radiation that’s not needed.

Better still, I’d insist that biopsy specimens be evaluated by pathologists who are trained in current methods and who work in trust-worthy laboratories.

Such a policy would reduce false positives in cancer diagnosis, and would thereby reduce the toxicity and costs of unwarranted cancer treatments. With better diagnostic facilities, those patients who do have cancer would not be so afraid to undergo the treatments they really need, because they’d be confident that they and their doctors were making decisions based on reliable information.

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Mind over Matter? Don’t Kid Yourself (on Stress and BC)

I learned of a new study implicating stress in reduced breast cancer survival by Twitter. Three days ago, a line in my feed alerted me that CNN’s health blog, “Paging Dr. Gupta,” broke embargo on the soon-to-be-published paper in the journal Clinical Cancer Research. It seems the story – that women who undergo a stress relief program live longer after breast cancer recurrence – couldn’t wait.

“Less stress helps breast cancer patients” is the title of the rushed post. What the researchers, based at Ohio State’s Comprehensive Cancer Center, report is that psychological intervention helps to increase the quality of life and survival among women with recurrent breast cancer.

The intervention at issue is this: weekly, small-group meetings of BC patients for 4 months after their initial surgery and diagnosis. Led by clinical psychologists, the women met 18 times and discussed strategies to reduce stress, improve mood, strengthen social networks, eat better, exercise and adhere to medical treatments.

The current report is an extension of previous findings among an initially larger group of women at the time of BC diagnosis. Then, the researchers randomized 227 patients after surgery, all with stage II or III disease, either to receive the intervention, or not, after an initial psychological assessment and blood tests to check their immune function. The women were overwhelmingly Caucasian, mostly with stage II tumors, well-educated and, for the most part, had ER/PR+ tumors. What the researchers noted was that:

…As predicted, patients receiving the intervention showed significantlowering of anxiety, improvements in perceived social support,improved dietary habits, and reduction in smoking…

In 2008, the same Stress and Immunity Cancer Project investigators reported in the journal Cancer that the psychological intervention reduces BC recurrence and prolongs survival. Here’s where the results become both exciting and suspicious. In 2007, with a median follow-up of 11 years, 62 women (29%) in the initial study had recurrent disease. The proportion among those who’d received the intervention was indeed lower, confirming the authors’ hypothesis that the intervention would help prevent BC from coming back. But the p-value for this difference was 0.034, barely meeting the threshold for statistical significance. Similar results were observed for overall survival among the women who’d attended the group sessions: they had a reduced risk from death with a minimally-significant p-value (0.028) for the difference.

Now, the Ohio group reports on the 62 patients who relapsed. Before going further, I should say that it’s a bummer of a result from a medical perspective and from mine as a BC survivor out at seven years. Group support aside, 44 (71%, yikes!) of the patients with recurrent disease have died with a median time until death (after recurrence) of 2.8 years (range: 0.9 – 11.8 years).

What the authors conclude is that the psychological intervention improved survival after BC recurrence. How the data flowed is this: among the recurrences, there were 33 women who’d been randomized to the assessment only, “A” arm of the original trial and 29 who’d been randomized to the intervention, “I” arm. These numbers were whittled down to 18 patients who could be followed for continued study on the “A” arm and 23 women on the “I” arm. So the total number of women evaluated in this new report is small: just 41 women.

Among those, the women who received the psychological intervention were more likely to survive, with what’s called a hazards ratio of 0.41. Here again the p-value is valid but marginal (p= 0.014). The authors show a very limited amount of data regarding test-tube based studies of natural killer (NK) and T lymphocytes in the different patient groups, and suggest in the paper’s abstract that “immune indices were significantly higher for the intervention arm.”

What would have killed this paper (pardon the verb) had I been a reviewer is this: among the 41 women with recurrent disease, there was a major difference in the treatments they received. According to the “Patients and Methods” section of the paper, in the section on “adherence, chemotherapy dose intensity,” the authors indicate that just 6 of the “A” patients received chemo in the 12 months following the recurrence, while 13 of the “I” patients got chemo in the same period.

My math: only 6 of the 18, or 33 percent of the “A” group (assessment-only) patients received chemo, while 13 of the 23 (56 percent) of the “I” (intervention) patients got chemo in the year after recurrence. That’s a huge difference in medical treatment among a very small number of patients.

My point: the small difference in survival after recurrence among those women who received structured psychological support, years earlier, may be attributable to the prompt chemotherapy they received upon relapse of the cancer. This seems a more plausible explanation than that group therapy-type sessions make a difference in tumor biology or treatment resistance. (Neither outcome is proved by this study.) The difference may also derive from better overall health in the women who initially received the intervention that included advice and support regarding diet, exercise, smoking cessation and medication compliance.

My opinion:

I think there can be tremendous value in psychological support for people with illness of any kind, whether that’s provided casually by supportive families and friends, one-on-one psychotherapy, medication and/or group meetings. And it’s easy to envision that meetings in which women with similar disease situations and concerns get together and discuss coping mechanisms, how to stay healthy, eat better and exercise could have positive effects on overall survival.

But the immune benefits of stress relief, like those presented in David Servan-Schreiber’s like-minded Anti-Cancer, are bogus. There’s no scientific evidence that the sort of NK or T cell changes tested in this study help or hurt breast cancer growth. It’s possible that a revved-up, stress and steroid-driven immune system might help kill cancer cells, or might favor their expansion. It could go either way. The effects of stress steroids on tumors vary and are complex. Prednisone and similar steroids, for example, which resemble the body’s natural stress steroid cortisol, are well-established and effective components of most lymphoma treatment regimens and once were a mainstay of breast cancer treatment. My point is not that the immune system doesn’t affect tumor growth. (I think it can and does.) But the effects are complicated and differ among individuals and according to the specific tumor type.

On linking stress and breast cancer: this argument, which is all that it is in the absence of better data, is patronizing and demeaning to women. It’s the kind of advice we offer children, that if they think and do the right things the outcome will be favorable. Oncology doesn’t work that way. If a woman’s breast cancer comes back, it’s not because she didn’t go to support groups or relax sufficiently. Tumors grow due to inherent, malignant properties of the cancerous cells and other biological factors in the body, such as other illnesses that may, indeed, weaken the immune system or limit a person’s capacity to receive effective treatment.

I’m all for stress reduction, as an aim in itself. But it’s not a cure for cancer.

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