Breast Cancer

Veronica had a mammogram on the advice of her GP; she had been unwell for months and had pain in one breast. She had to wait three months for an appointment - she was 45, too young to have been invited for routine breast screening. After the mammogram, she was recalled for a scan and a biopsy. Then she was told she had "ductal carcinoma in situ" (DCIS).

"You're completely freaked out to hear the word 'carcinoma'," she says. "The consultant said initially he'd take out a 'small area' the size of a golf ball. But another mammogram showed more areas of DCIS and they said they were looking at breast removal. I was stunned. They didn't offer me any options: just that the whole breast should come off. Somewhere in there, they said that not all DCIS becomes full-blown cancer but that they treat it as if it would." An oncologist she saw, for a second opinion told her: "I don't know why you've come to see me we can't tell you what you've got until it's off and in the pot." She was appalled.

Just 10 years ago, Veronica might never have known she had breast cancer and it might never have become fatal anyway. Today, the detection of DCIS, abnormalities often no bigger than a pencil point, represents nearly 20% of breast cancer diagnoses and doctors have no idea what to do about it. They disagree over whether DCIS, which involves the calcification of the milk ducts, is a precancerous condition that should be monitored but requires no treatment, or a tumour that is not yet invasive and needs to come out.

Arguments over DCIS highlight the larger controversy surrounding mammography. Mammograms are picking up smaller and smaller tumours, but it is not clear that they are saving lives. One in nine women in England and Wales will develop breast cancer. It killed 11,363 of us in the year 2000. Set up in 1988, the NHS breast cancer screening programme claims to save at least 300 lives per year, and predicts that this will rise to 1,250 per year by 2010. Only women aged 50-64 are invited to be screened the changes in breast tissue density that mammography detects are easier to spot in the breasts of older women, and the risk of developing breast cancer increases with age. For a woman of 25, the estimated risk is 1 in 15,000; for a woman of 40, it's 1 in 200.

For a 50 year-old, the risk is 1 in 50; by 70, it's 1 in 15. In 2000-01, of the 1.3m women screened in England, 8,345 were diagnosed with cancer. Moves are afoot to extend the programme to screen women up to the age of 70 by 2004, and an NHS trial is in progress to examine the benefits of screening women in their forties, as is already routine: in the US. Yet an increasing number of healthcare professionals are speaking out against what may be a misguided use of limited resources.

"Screening is the worst idea medicine ever had;" says Dr Keith Hopcroft, an Essex GP and vociferous dissenter. "It's one of those concepts that sound so intuitively attractive catching [the illness] at an early stage. But the reality can be very different. Healthy patients are often left with the perception that there is something wrong... We underestimate the anxiety we're creating. Apart from that, we're pouring an enormous amount of time and money into this for an arguable benefit. The assumption is that picking cancer up early is a good thing, but in many cases it would have shown itself anyway all screening does is let a woman know she has cancer for longer:'

Last November, the NHS breast-screening programme produced a leaflet that was supposed to reflect what Julietta Patnick, the programme's national coordinator, called "the beginning of a more open and adult relationship with women".

"Mammography is the most reliable way of detecting breast cancer early but, like other screening tests, it is not perfect," the leaflet states. "Some cancers are difficult to see on the x-ray: some cannot be seen on the x-ray at all; and the person reading thc x-ray may miss the cancer." it doesn't say that the cancer the screening detects might not have needed treatment in the first place.

While mammography detects some potentially deadly cancers, it also picks up many times more cancers that might never become symptomatic during the patient's lifetime, or that could be treated just as easily if detection were left until the woman could feel the lump herself Thus for every woman saved by early diagnosis, many others receive painful, and potentially dangerous, treatment to destroy turnouts that pose little or no threat- tuntours that they might die with, not of. That notion flies in the face of what most of us have come to believe about breast cancer that all tumours will kill us if untreated and that catching them early is our only hope, a belief reinforced by doctors who feel compelled to treat the vast majority of turnouts as if they were deadly because they lack the tools to determine which really arc. So healthy women risk the side effects of anti-cancer 'treatments because doctors must err on the side of caution. The side effects include organ and nerve damage, pain, infertility (more of an issue in the US, as women arc screened from the age of 40), depressed immunity, cognitive impairment, decreased bone density, and the risk of leukaemia- to say nothing of the psychological toll of a woman being left to worry about a recurrence of breast cancer for the rest of her life.

The early-diagnosis approach to breast cancer emerged in the first part of the 20th century, when women often didn't visit their doctor until their tumours were the size of oranges. It was firmly entrenched by the 1960s,whcn soft-tissue x-rays, or mammograms, were put to use. The American Cancer Society was encouraging regular self-examination; the purpose of mammograms was to detect tumours still earlier. The UK's screening programme, which prides itself on having been one of the first of its kind, had achieved national coverage by the tnid-1990s. Last year, it detected more cancers than ever before, including an increase in the number of small cancers detected. Of those, 4,041 were invasive cancers smaller than 15 millimetres that would be highly unlikely to be found with the human hand.

But for almost as long as mammography has been in widespread use, it has had its critics. The current round of debate began last autumn with the publication of a Danish study, the Cochrane review on screening with mammography, in the medical journal The Lancet. The article argued that the early studies that led to the establishment of national screening programmes by supposedly showing the benefits of mammography were so flawed that their results were meaningless. It concluded: "The currently available reliable evidence does not show a survival benefit of mass screening for breast cancer." An independent panel of scientific advisers to the US National Cancer Institute, the Physician Data Query, announced that it agreed with these findings. It concluded that the evidence that mammography saves lives was insufficient to say if women of any age should get a yearly mammogram. The counterattack began immediately. Ten American medical groups took out full-page newspaper adverts stating that lives would be lost if women were discouraged from getting mammograms.

At issue is the meaning of seven clinical breast-cancer trials conducted in North America and Europe since the early 1960s,whiclx tracked the survival rates of women who received regular mammograms and compared them with those of women who had regular clinical breast exams but very few, if any, marninograms. Five of the trials appeared to show an improvement in survival among those receiving regular mammograms. The improvement was as much as 30% for women aged 50 and older. The Lancet article re-analysed the data, concluding that the five that showed a benefit suffered from methodological errors that invalidated the conclusions. In one that began in the 1960s, 153 out of 30,131 women who received mammograms died of breast cancer after 18 years of study, compared with 196 out of 30,131 women who did not receive screening. So while that is a 30% difference, it's based on a difference of 43 women out of more than 60,000.

Mammography supporters counter that the Lancet article inflated the importance of tiny errors in the clinical trials and ignored statistical adjustments intended to correct methodological flaws. A Swedish study published in March said the article was "misleading and scientifically uninformed"; it reviewed the trials and stated that population screening of women aged 40-69 led to a 21% reduction in breast-cancer mortality. This would mean chat of 2,000 women aged 60-69 screened for 15 years, five lives will be saved.

The World Health Organization (WHO) has placed its weight behind breast-cancer screening; its International Agency for Research on Cancer re-evaluated the evidence and concluded that there is a 35% reduction in mortality from breast cancer among screened women aged 50-69. According to Patnick," This means that out of every 500 women screened, one life will be saved. We know breast screening works." Cancer Research UK also maintains this view, claiming that women who attend regular screenings may reduce their risk of dying from breast cancer by more than 60%.

But the debate over routine mammography goes further than the debate about the various clinical trials. Regardless of any benefit that these clinical trials might (or might not) suggest, there is one important fact that they overlook: the overall death rate from breast cancer has scarcely budged over the past three decades.

The latest statistics show that 70.2% of British women aged 50-64 were screened at least once between 1999 and 2001.The mortality rate has dropped from 37.9 per 100,000 in 1971 to 31 per 100,000 in 2000- a modest reduction when one considers the vast increase in the number of screenings. Some experts, moreover, argue that the drop is mostly the result of improved treatments - especially the hormone blocker tamoxifen, which can cut a woman's risk of breast-cancer recurrence by 25% (although its possible side effects include uterine cancer). Even those in favour of screening estimate that only a third of the drop in mortality is directly due to the screening programme.

The average size of tumours picked up by mammography has steadily decreased during the past 20 years; about 60% of breast cancers are now "localised" (less than 2 centimetres long and not yet spread to the lymph nodes). Some of these would never have become symptomatic, or may have disappeared. But as mammography picks up ever tinier lumps, doctors have little choice but to treat them as if they were deadly, though most turn out not to be. "If you take 10 women with [early] turnouts and treat them with surgery, radiation and chemo, one will die anyway," says Susan Love, a prominent American breast-cancer surgeon and frequent critic of mammography. "Two will be cured, and seven would have got better with local treatment. Out of the seven who would have survived without radiation or chemo, an unknown number will suffer significant, permanent side effects from the treatment."

To a woman facing the possibility that she is among the unlucky percentage with an aggressive tumour, unnecessary chemotherapy and radiotherapy may seem a small price to pay for peace of mind. But as a matter of public-health policy, over-treatment caused by mammography is a real problem. False positive results are common, not because of medical negligence but because screening is an imperfect tool. According to a recent article in the British Medical journal, a 60-year-old woman screened annually for 10 years has a 50% chance of having at least one false positive leading to follow-up testing, and a 20% chance of a false positive leading to biopsy. But the same article found that most women did not view this as an important harm of screening. Only 6% of respondents were aware of the possibility of a non-progressive cancer being detected.

The most troublesome area of over-treatment is DCIS. As few as one in four women with DCIS may go on to develop an invasive turnout, yet a DCIS diagnosis is now one of the most common reasons a woman undergoes a mastectomy, as the tiny lesions are often scattered throughout the breast and cannot be removed individually.

Mastectomies for DCIS fell from 71% in 1983 to 43.8% in 1992,but the paradox remains: which women with an invasive cancer are usually offered removal of the lump and radiotherapy or chemotherapy, women diagnosed with the less threatening condition, DCIS, often receive the most aggressive treatment.

Hazel Thornton, an independent advocate for quality in research and health care, was diagnosed with DCIS after a routine mammogram 10 years ago. After a biopsy, she was invited to take part in a clinical trial into the treatment of DCIS that would have involved her having a course of radiotherapy. She refused, and instead took tamoxifen for 17 months, before stopping because of its unpleasant side effects. Ten years on, she is alive and well, with no invasive breast cancer. In a letter to the British Medical journal published in March, she pointed out that the aim of the NHS screening programme on its establishment in 1988 was to reduce mortality from breast cancer by 25% by the year 2000. In fact, it had reduced it by, at most, 6.4%, as a government health official admitted at the time.

Thornton criticised the programme for failing to give full information about screening: "The leaflet does not provide even the most basic details about the benefits, risks, limitations, and consequences, or alternatives, of mammographic screening. The social and financial, as well as the physical, consequences can be considerable and should be described, as the General Medical Council [in a 1998 publication] recommends. Healthy women should be provided with this information so that they can make their own personal trade-offs according to their individual circumstances, health profile and preferences, not fobbed off with the benefits of 'catching it early."

Professor Michael Baum, a London breast-cancer surgeon, has also questioned the merits of screening. Baum set up the NHS screening programme in the southeast of England in 1987, but resigned in disgust as he felt women weren't being told the full story. "The best estimate is that you need to screen 1,000 women over 50 for 10 years to save one life.The value of one life saved is infinite; you can't put a price on it. But hundreds of women will suffer false alarms, unnecessary surgery and over-treatment as a result of screening. Women should be treated as intelligent human beings, not coerced into screening."

In its most recent report, the UK National Screening Conunittee (NSC), the policy-making body for all types of health screening, states: "Screening developed as a public health service designed to improve the health of populations. Many individuals benefited while some suffered adverse effects, but in population terms there was a net health gain... As more is known about the psychological consequences resulting from both false positive and false negative tests, and as social attitudes change, this approach is no longer acceptable... and each individual should appreciate the risks and benefits for them as an individual:"

Medical research focuses on finding smaller tumours. Scientists at Guy's hospital in London are developing a technique that uses a minute fibre-optic tube, which can pass through the nipple, to look for precancerous abnormalities in cells; they predict that the device could identify "warning signs" up to 10 years before the appearance of an invasive tumour. At Oxford university, researchers are working on a new computer technology to improve the accuracy of screening and enable detection of cancers of lung.

"We've gone from seeing women come in with fruit-sized tumours to detecting tumours that are no bigger than a needle," says Dr Barron Lerner, author of The Breast Cancer Wars. "There's this persistent sense that if you just make the mammograms better, this wonderful, life-saving bounty will occur. We have reached the limits of early detection."

Dr Angcla Raflle, a consultant in public health medicine, oversees the breast screening programme in the Bristol area. She is keen to stress that the staff do a wonderful job-anybody who queries the wisdom of screening lays themselves open to harsh criticism.

"The introduction of breast screening in this country has made breast cancer care and treatment far better organised," she says. "But we have to distinguish that argument from how many people are helped as a direct result of mammography."

She gives as an example the figures for the Bristol area. Out of a health population of lm, the screening programme invites 30,000 women a year for breast screening. Of those, 23,500 are screened. About 1,200 are told something is wrong, and to come back for further investigation; between 130 and 150 each year are told that they have screening-detected breast cancer." How many lives we have saved is something that people will argue about till the end of time," says Raffle.

"The best optimistic estimates are from the Office for National Statistics, who say it's 7% of the 21% mortality drop. Translate that into simple numbers and it equates to, at best, 200 lives saved per year nationwide. Scale that down to our Bristol population and that works out at six lives saved per year, of those 130 screen-detected cancers. Every one of those 130 women thinks, 'Thank God for screening, or I wouldn't be here today' But most of them would have done well anyway, some are going to do badly, and in those cases screening made no difference, and it's only six who've had that real benefit- or none if Cochrane is right"

The issue polarises medical professionals, continues Raffle. "One camp of people say that if you're plain about those facts, it will undermine the screening programme. Should you give people information about screening before they accept their first invite, if that may deter them from coming? The implication of the NSC report is that we should be honest about how labour-intensive screening is, how few people it helps, how many it puts through the mi1l. And if the consequence is that fewer people come, it's a free country. But people who don't understand screening-because they've been fed this propaganda for 30 years that the best way to tackle cancer is early detection, and it saves countless lives - are asking whether we should screen for everything, when we've actually got queues of patients who are not getting the care they need because we can't fund it:'

The UK breast-screening prograuune cost 52m in 1999-2000, an average of 40 per woman screened.Those same resources, Raffle believes, would be better spent on making sure that every aspect of breast-cancer treatment meets the standards we would want for a friend or relative: making sure there is ready access for any woman to self-refer if she has anything she's worried about, the prompt assessment of anybody with symptoms or family-history worries, proper support from breast-care nurses, better resourced chemotherapy units (which are overcrowded and understaffed), reduced waiting times, symptom control, bereavement support for families, and more research into better treatments. "More and more research into refining the ways of doing screening is throwing good money after bad."

One simple way in which resources could be better spent is in the adequate provision of radiotherapy. Britain has about half the number of radiotherapy machines per million people as France or Germany, and a third the number of the US - and many hospitals have to switch their machines off because of understaffing.

A third of people who train as radiographers never even enter the profession, put off by its low status and poor pay. And queues for treatment on the NHS are increasing.

A recent, leaked Royal College of Radiologists study shows that, contrary to government targets, the average waiting time for radiotherapy has risen, from 5.1 weeks in 1999 to six weeks in 2000.

At hospitals in Brighton and Hanunersnuth, for example, patients can wait up to three months for treatment. According to a WHO study,British women with breast cancer have a 67% chance of living for five years, compared with a more than 804% chance in France and Sweden.

Lack of facilities means that, in some parts of the country, women are given unnecessary mastectomies because local NHS trusts don't have the facilities to offer radiotherapy. The most recent national survey of facilities for which tables are available (2001) shows wide discrepancies between still underfunded health trusts.

Barring a breakthrough cure for breast cancer-unlikely in the near future - there are two ways that the public-health community can respond to the over-testing dilemma. One is to continue pushing women to get mammogram, while conducting studies costing millions to prove, hopefully, that the benefits outweigh the costs.

The alternative is for doctors and politicians to turn their focus - and money- to better patient care and new technologies to help doctors predict more accurately which tumours need aggressive treatment and which can safely be left alone.

For nearly a century now, doctors have used the size of a tumour, whether it has begun to invade surrounding tissue, and the presence of cancer cells in the lymph nodes, to diagnose breast cancer.

But these crude surgeons' measures do not take into account our emerging understanding of cancer genetics. Over the past two decaees, basic research has shown that every tumour contains a unique set of genetic mutations. Some mutations allow cells simply to reproduce but not invade surrounding tissue.

Others give cancer cells the power to break free from the primary turnout and travel through the bloodstream to distant locations in the body. Researchers can now identity thousands of the mangled bits of DNA that drive cancer cells. And in the past two years they have begun to figure out which mutations can serve as accurate markers for a patient's prognosis.

These efforts have been made possible by a new tool: microarrays, or gene chips, tiny silicon wafers that detect genetic mutations and deliver that information to a computer. Trials are underway to sort out which of several thousand mutations are most likely to indicate how aggressive or indolent a nunour is and whether or not it has already nutastasised.

Using a breast tumour's genetic fingerprint would represent a paradigm shift in how doctors think about breast cancer - and transform the way they treat it. A new technology called ductal lavage is enabling researchers to flush cells from the lining of the milk ducts, where all breast cancers begin, in order to look for the earliest stages of cancer and to monitor DCIS.

In as little as five years' time, microarrays could allow doctors to determine which cancers require aggressive treatment -and which don't. "History tells us to be cautious.

It will be two or three years before we have confidence that microarrays are really as powerful a tool as early studies suggest," says Carlos Caldas, a practising oncologist and a researcher in the cancer genomics programme at Cambridge university.

But the effect of using them to help doctors stop over-treating breast cancer-and perhaps even leave sonic breast cancers alone - is, he says, "potentially staggering':

In the meantime, he says: "We are doing the best we can with the tools we have, which have not changed significantly for the last 25 years. If you have 200 women with tumours that look exactly alike, and you treat 100, there will be more alive in 10 years in the group you treated, but the crystal ball we are using now is very cloudy."

Until we have a better predictive tool, he wrote recently, "To save a sizable but small percentage of lives, many, patients who would have been cured by surgery and radiotherapy alone go on to receive unnecessary and frequently toxic treatment."

Better yet would be new treatments that can keep even advanced breast cancer at bay. One Israeli medical technology company is developing a new technique for treating cancer that uses a focused ultrasound beam to burn away the tumour inside the breast, obviating the need for surgery.

Dr Dov Maor, chief scientist for the manufacturer In Sightec, claims that the patient will feel no pain as her tumour is destroyed, and that the breast will be left looking normal because the dead tumour is absorbed by the body.

A sinular technique is already being used at St Mary's hospital in London to remove non-cancerous womb fibroids. Elsewhere, researchers at Manchester's Christie hospital are looking into a drug derived from the yew tree as an alternative to chemotherapy, while a team at University College London has just published results from a trial of a new drug, Arimidex, which may soon replace tamoxifen, since it does not appear to have the potentially harmful side effects.

But medical research is slow, and currently as much money is being spent on funding further trials into screening as into all the other aspects of cancer research combined. The attitude of most of the medical and public health establislanient is to leap to the defence of breast screening.

"We desperately need a proper debate;' pleads Hazel Thornton." We shouldn't just be looking at the woman whose life is saved. We are inflicting this NHS breast-screening programme on a whole population-more than lm women every year.

"It seems odd that we go trawling our healthy population. Why go looking for the disease? Why not use the money and expertise that we have to deal with women who have symptoms?"

Submitted By:
SHANNON BROWNLEC
The author is a markle senior fellow at the New America Foundation.

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Comments

Bravo for printing this article about the overtreatment of DCIS and the downsides of mammograms I'm in the US and currently going thru a similar situation. I refused a biopsy in favor of monitoring a very small 9mm group of microcalcifications. I am not going to have my breast subjected to unnecessary invasive procedures. We need women to stand up, educate themselves and fullly understand what they are getting themselves into when they walk into a clinic for a screening without symptoms. thank you for bringing these issues to the forefront.

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