New Studies on Colon Cancer Screening by Colonoscopy and Fecal Blood Testing

Last week the NEJM published two major papers on screening for colon and rectal cancer. The most notable finding supports that colonoscopy – when done properly and not necessarily often – saves lives.

The NCI estimates that doctors will find over 103,000 colon and 40,000 rectal cancers, and the number of deaths will exceed 51,000 this year in the U.S. According to the ACS, colorectal cancer ranks third as a cause of cancer mortality in men and in women. In light of these numbers, the potential for screening to reduce deaths and costs of treating people with advanced disease is great.

Both analyses are unfortunately – almost dauntingly – complicated. An accompanying editorial, by Drs. M. Bretthauer and M. Kalager lends some perspective.

colon adenoma pathology, H&E stain, (Wiki Commons: "Nephron")

The first report comes from a group of researchers led by Ann Zauber, PhD, a biostatistician at MSKCC. This team examined long-term outcomes among 2602 adults who had adenomatous polyps removed between 1980 and 1990, followed by colonoscopy recommended at varying intervals in a trial. With a median follow-up of 15.8 years, there were only 12 deaths from colon cancer in the study population – essentially half the number expected by comparison with SEER data.

The main limitations I see in this report are two. First, what might be considered a good thing – the high compliance rate: 81% of those with adenomas underwent some follow-up colonoscopy. And second – along a similar vein – that the colonoscopies were performed by highly-trained physicians at academic centers in a trial that mandated a certain degree of thoroughness and quality. Some criticism of the work is that the findings won’t translate to the community at large, as mentioned in the editorial and in the paper itself. That’s because some “real world” gastroenterologists don’t perform the procedure so carefully. Apart from the trial, many people are genuinely hesitant about having colonoscopy out of concern about its unpleasantness and also costs. Compliance with colonoscopy recommendations runs low.

These are valid concerns. But they don’t abrogate the value of the procedure. Rather, they point to the need for rigorous training of doctors who do colonoscopy, for close monitoring of facilities where it’s done (and in path labs, where the specimens are evaluated), and for insurance or a national health plan to enable patients, if they choose, to have this potentially life-saving screening test covered.

The second study, from a group in Spain, examined the relative merits of checking stool samples for blood every two years vs. colonoscopy every ten years in over 50,000 people. The preliminary finding – after just one “round” of colonoscopy in those assigned to that trial arm, is that a higher proportion complied with fecal blood testing than with colonoscopy. Among those who underwent colonoscopy, cancers and adenomas were found in a greater fraction. But the absolute number of cancers detected was essentially the same in each group, because more people assigned to fecal screening completed the task.

My take from these reports, combined, is that periodic colonoscopy has the potential to halve the number of deaths from colon cancer in the general population. But it’s an unpleasant, invasive and expensive test that does carry some risks. The quality of the test – both in terms of its thoroughness and risk of complication – would depend, in part, on the training and experience of the doctor who performs the test. So, as with mammography, I favor heavy regulation and careful certification of physicians who perform these procedures.

As to how colonoscopy relates to fecal blood testing as a screening method at the population level, and the optimal start and frequency of either test, those remain uncertain. Dr. Zauber, it turns out, heads the NCI-funded National Colonoscopy Study. This ongoing work will, hopefully, shed light on how testing for blood in stool samples compares with colonoscopy in colon cancer screening and, ultimately, costs and mortality from late-stage disease.

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50-50, A Serious Film About a Young Man With a Rare Cancer

scene from "50/50"

The other evening I watched 50/50, a film about a 27 year old man with a rare kind of cancer, a malignant schwannoma. The tumor is growing and pushing into the protagonist’s lower spine. The movie, based in part on the true story of scriptwriter Will Reiser, surprised me by its candor.

Actor Joseph Gordon-Levitt smoothly portrays Adam Lerner, who soon finds out he has cancer. The opening scene captures him jogging in an early morning. He seems a nice, cautious and perceptive young man in a relationship. His rowdier buddy, played hardily by Reiser’s real-life friend Seth Rogan, proves loyal during Adam’s chemotherapy and, later, big spine surgery.

By its cast, I expected this might be a guys’ flick. Yes, there are jokes about sex and cancer. But the film reveals the young man wincing during sex because he’s in pain and can’t hide it. The young women are pretty much all attractive, but they’re not interchangeable props; the relationships are complicated and plausible.

An unexpected perk in the movie is the realistic family dynamic. Lerner’s mother, a worrying sort, wants to be there for her son and doesn’t trust that his girlfriend will sufficiently help him. Anjelica Huston effectively fills the mother’s role. Lerner rarely answers her calls, while she’s biding her time with a husband who, due to Alzheimer’s, doesn’t comprehend what’s going on. She respects her son’s privacy, but feels, understandably, isolated and scared.

The doctors are flawed, of course. The oncologist at the start doesn’t directly tell Lerner of his diagnosis but, instead, speaks into a dictaphone about the malignancy. He refers Lerner to an analyst of some sort, a young woman with little experience, for talk therapy.

When Lerner goes for surgery, the pre-op scene is frighteningly realistic to anyone who’s ever had a young family member go through this kind of surgery. The family and friends are worried. The patient, calmest of all among the group, can’t determine what will be his fate.

The term schwannoma derives from Schwann cells. These elongate cells normally envelop long nerves and rarely become malignant. Most schwannomas, or neurofibromas, are benign; these can cause pain and other symptoms by pressing on nerves, but don’t usually don’t spread or grow quickly. The names can be confusing, as there are several similar-sounding terms for these growths. Some people inherit a disposition to these non-malignant tumors. Rarely, as seems to have been the case in this story, a schwannoma takes an aggressive, invasive and sometimes lethal course. Another name for the cancerous form is malignant peripheral neural sheath tumor, or MPNST.

50/50 refers to the odds of Lerner’s survival, about which he read somewhere on the Internet shortly after his diagnosis. I’d give the movie a high score, 90+, mainly for its lucid, accessible approach to a cancer patient’s experience and concerns.

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Counterfeit Drugs, A New Concern for Patients

This week the FDA issued an alert about fake Avastin. The real drug is a Genentech-manufactured monoclonal antibody prescribed to some cancer patients. Counterfeit vials were sold and distributed to more than a dozen offices and medical treatment facilities in the U.S. This event, which seems to have affected a small number of patients and practices, should sound a big alarm.

Even the most empowered patient – one who’s read up on his drug regimen, and engaged with his physician about what and how much he wants to receive, and visited several doctors for second opinions and went on-line to discuss treatment options with other patients and possibly some experts – can’t know, for sure, exactly what’s in the bag attached to his IV pole.

Counterfeit Avastin (images from FDA)

Scary because patients are so vulnerable –

The problem is this. If you’re sick and really need care, at some point you have to trust that what you’re getting, whether it’s a dose of an antibiotic, or a hit of radiation to a bone met, or a drug thinner, is what it’s supposed to be. If vials are mislabeled, or machines wrongly calibrated, the error might be impossible to detect until side effects appear. If you’re getting a hoax of a cancer drug in combination with other chemo, and it might or might not work in your case, and its side effects – typically affecting just a small percent of recipients – are in a black box, it could be really hard to know you’re not getting the right stuff.

What this means for providers is that your patients are counting on you to dot the i’s. Be careful. Know your sources. Triple-check everything.

The bigger picture – and this falls into a pattern of a profit motive interfering with good care – is that pharmacists and doctors and nurses need time to do their work carefully. They need to get rest, so that they’re not working robotically, and so that they don’t assume that someone else has already checked what they haven’t. And whoever is buying medications or supplies for a medical center, let’s hope they’re not cutting shady deals.

This issue may be broader than is known, now. The ongoing chemo shortage might make a practice “hungry” for drugs. And with so many uninsured, some patients may seek treatments from less-than-reputable infusion givers. The black market, presumably, includes drugs besides Avastin.

If I were receiving an infusion today, like chemo or anesthesia or an infusion of an antibody for Crohn’s disease, I’d worry a little bit extra. I mean, who will check every single vial and label and box? Think of the average hospital patient, and how much stuff they receive in an ordinary day – including IV fluids that might be contaminated with bacteria.

It’s scary because of the loss of control. This circumstance might be inherent to being a patient – in being a true patient and not a “consumer.”

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73 Cents: A Film on Regina Holliday’s Work, and Patient Advocacy Through Art

Yesterday I took a field trip to meet Regina Holliday, an artist and patient advocate. She fielded questions after a screening of 73 Cents, a short film about why she painted a mural by that name in the days after her husband died with metastatic kidney cancer. He was 39 years old.

At the time of her husband Fred’s diagnosis, both she and her husband held several jobs but he lacked health insurance. In a video, Holliday describes how his diagnosis and care were delayed.

“73 Cents” refers to the price, per page, Holliday needed to pay to get a copy of her husband’s chart when he entered a new medical facility. According to the film, she was told she’d have to wait 21 days to get his records, even though he was acutely ill and dying. Now a widow with two young sons, she pushes for patients’ rights to access to their health  records and, more generally, for a patient-centered approach to medical care.

The film-makers’ point: The unreasonable price of the medical records, combined with the delay in receiving them, exemplifies unnecessary harms patients encounter in an outdated, disjointed health care system.

Holliday has several ongoing projects, including the Walking Gallery. In that, she represents health care stories on the backs of people’s jackets. The idea is to take the message of the mural – which is one patient’s story, and necessarily static – and take it further.

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Oh, No Methotrexate!

structure of MTX (PubChem; NCBI)

I was astonished to learn that methotrexate supplies are running short. This chemotherapy may soon be unavailable to patients who need it. And it’s not just kids with leukemia, as the Times story highlights effectively.

Methotrexate is an old, bread-and-butter cancer kind of drug, a basic ingredient in standard regimens for many tumor types. I’ve personally administered this medication to patients with breast cancer, lymphoma, leukemia, head and neck tumors, ovarian cancer, colon cancer and people whose tumor cells spread to the brain. Doctors prescribe this drug, also, in a few non-malignant conditions, like rheumatoid arthritis.

Methotrexate has been used in cancer wards for over 50 years. And like other beyond-patent meds, it’s become less profitable to manufacture MTX compared to much costlier new agents. Hard to perceive this shortage as anything but a tragedy – that the business of health care renders valuable, inexpensive drugs out of reach.

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Do Adults Need Physicians to Tell Them to Exercise?

According to a new CDC report, only 1 in 3 doctors advise their adult patients to exercise. The survey-based findings are limited, in part, because they rely on people’s recollection of whether they’d visited a physician in the previous year and what they were told. Nonetheless, the study revealed some clear trends:

1. In 2010, 32.4% of adults who’d seen a health care professional were advised to begin or continue with exercise or other physical activity. That fraction’s up significantly from 2000, when a slim 22.6% of patients recalled their doctors telling them to get a move on.

2. Among folks over 85 years, nearly 29% say they were told to exercise. That number’s nearly doubled since 2000, when only 15.3% of elderly patients reportedly received this kind of advice.

3. Adults with diabetes were told to increase their activity more often than those with high blood pressure, cardiovascular disease and cancer. Compared with healthy weight adults, obese people were twice as likely to have been told to exercise by a physician or other health professional.

An underlying message is that doctors should be prodding their patients to exercise. From the report:

Research points to the benefits of physical activity for reducing the risk of chronic health conditions (1–4). Engaging in regular physical activity can reduce medication dependence, help maintain functional independence, and improve the quality of life for older adults (5,6). Physicians and other health professionals can be influential sources of health information, and exercise counseling by primary care physicians has been shown to increase patients’ participation in physical activity (6–9).

There was discussion about this yesterday on Twitter, stemming in part from a USA Today article on the report. And here’s the essence of the short-form debate:

Some suggested that doctors don’t tell patients to exercise because they, themselves, are overweight. Or it’s because they don’t feel comfortable recommending for others what they don’t do themselves. While this might explain some physicians’ behavior or discomfort with the topic, it can’t explain that of the majority.

So why don’t more doctors prescribe exercise for their patients?

Reasons I wonder about include a lack of time for “non-essential” communication, especially in clinics. In specialists’ offices, the omission of exercise could have to do with the visit’s purpose. A gastroenterologist or internist who evaluates a patient for a problem like diarrhea, say, might not think to ask about exercise. For some doctors it might be, problematically, an attitude issue – that they just don’t care that much, or think it would be a waste of time to discuss the matter of exercise.

Whatever the reasons are that most doctors don’t bring up the issue, one might ask this: Why do adults need doctors to tell them about the health benefits of regular exercise? After all, it’s common knowledge – the kind of thing taught in elementary school, like nutrition should be – that regular exercise is good for most people. As we age, being out of condition makes every task in life, like walking a few blocks, harder.

In an ideal world, we’d have most adults exercising regularly, and doctors who’d occasionally intervene and counsel patients about what they shouldn’t do because of a particular medical condition, like arthritis or heart limitation. I guess we’re not there yet –

All for this week,

ES

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NIH Sponsors New Website to Help Patients Understand Clinical Trials

This week the NIH launched a new website, NIH Clinical Research Trials and You. In a Feb 6 press release, NIH Director Dr. Francis S. Collins said “The ability to recruit the necessary number of volunteers is vital to carrying out clinical research.” The idea behind the website is to help patients understand how clinical research works, and what it’s like to participate.

The site offers a menu of “basics” about clinical trials, addressing topics like:

  1. What are clinical trials and why do people participate?
  2. What is clinical research?
  3. Who participates in clinical trials?
  4. What do I need to know if I am thinking about participating?
  5. What questions should I ask if offered a clinical trial?
  6. How am I protected?
  7. What happens after a clinical trial is completed?
  8. How does the outcome of clinical research make a difference?

There’s an imperfect glossary of terms, a selection of patients’ and investigators’ stories, information for kids in research, and other resources including a link to the clinical trials database:  ClinicalTrials.gov.

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Thank You, Rachel and Susan

Yesterday morning, two women who were active in the on-line breast cancer community died.

Rachel Cheetham Moro (1970 – 2012) was a critical thinker who vigorously supported BCAction and the NBCC’s 2020 deadline. She was a generous and thoughtful on-line friend to many women in the metastatic and more general BC community, where she used the handle @ccchronicles. Her blog provided a running, witty commentary on breast cancer news and trends. Interspersed, she detailed occasional and lately, more frequent visits to the hospital, a Florida vacation, and reflections on her earlier years. In a recent post, she included this wonderful high school photo.

high school photo, from the Cancer Culture Chronicles

Dr. Susan Niebur was a mother in her late 30s, an astrophysicist and blogger who generously shared her experiences at her Toddler Planet blog and elsewhere, including on Twitter as @whymommy. She dealt with inflammatory breast cancer starting in April, 2007. In recent months she wrote less frequently, but  positively somehow, while taking radiation treatments for painful bone mets, going in and out of the hospital and, most recently, receiving hospice care at home.

Susan Niebur in 2011, Toddler Planet

Each of these women inspired many people I know. They were brave and open, and helped others to understand what it’s like to face progressive, metastatic disease. Their words didn’t only affect people with breast cancer, but influenced also their loved ones, and individuals who face all sorts of limiting illness.

Thank you, both, for what you’ve taught me about life.

ES

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Study Finds Wide Variation in Reoperation Rates after Lumpectomy for Breast Cancer

The Feb 1 issue of JAMA includes a major report on the practice of lumpectomy in the U.S. The study examined what happened to 2,206 women at four medical centers who opted for breast-conserving surgery at the time of breast cancer diagnosis. The main finding was that after lumpectomy, nearly one in four women had another operation to remove cancerous cells in the breast. Among all the breast cancer patients who began with a lumpectomy, 8.5% wound up with a mastectomy.

These are staggeringly high rates of re-operation in women who opted for small procedures to begin with. Many of the women who had additional procedures did so for concern over having “clean margins” – that upon removal of a tumor, the edges of the specimen don’t reveal malignant cells. Re-excision for patients with negative margins varied by hospital; at one medical center the re-excision rate was 1.7%, at another it was 20.9%. Analysis by surgeon revealed huge variation, with re-excision rates ranging between 0 and 70%. The incidence of positive margins was 14%.

What further clouds the story is that among women who did have positive margins, meaning that cancerous cells were evident along the edge of the lump removed, nearly 15% didn’t have a second procedure. The big picture is that there was little pattern – or reason evident, at least at the collective level – for the surgeries and decisions to re-operate after lumpectomy for breast cancer.

The study, funded by the NIH, was sufficiently large to merit concern. It involved careful chart and pathology review of the specimens through a consortium of four medical centers around the country: the University of Vermont, Kaiser Permanente Colorado, Group Health in Washington State and the Marshfield Clinic in Wisconsin. And it reflects current practice; the surgeries took place between 2003 and 2008.

Lumpectomy is a very common procedure – and a significant issue, in terms of costs, and risks, and decisions women make every day upon receiving a new BC diagnosis. An estimated 60-70% of newly-diagnosed breast cancer patients choose breast-conserving surgery. So we’re talking about 160,000 or so lumpectomies per year in the U.S. (very approximate, ES: 2/3 of 240,000 new BC cases).  The variable results affect cosmetic outcome – the very reason many women choose lumpectomy to begin with and, potentially, the rate of BC recurrence.

The authors discuss: “Our finding…suggests that patients under similar clinical conditions are likely to undergo reexcision based on the treating surgeon and not just the clinical characteristics.” They offer possible explanations, including differences in surgical training, surgeons’ confidence in their operative techniques, how tumors are assessed in the operating room, and variation in how pathologists review specimens and “call” the margins positive or negative.

All of this meshes with my experience – knowing women who’ve had breast-conserving surgery and then got mixed information about the results and what to do next. You’d think lumpectomy would be a standard procedure by now, and that decisions about what to do after the procedure, surgically speaking (let alone decisions about chemo, hormonal treatments and radiation) would be straightforward in most cases.

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Komen Update – Future Plans?

As many ML readers are aware, late this morning, the Susan G. Komen Foundation announced it will not cut current grants or funding to Planned Parenthood. This reversal comes as welcome news to those who support the agency and its work. The New York City branch issued this statement.

Still, many breast cancer advocates, activists and others question Komen’s priorities. This episode draws attention to debate within the BC community about the relative merits of spending charity dollars on screening, education, awareness, research and other concerns.

The long-term fallout from this week’s news and the agency’s reversal aren’t known. As I suggested earlier, Komen’s leadership might take this opportunity to reassess its mission and goals.

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