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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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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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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A Note on the Komen Fiasco

When I first heard the Susan G. Komen Foundation is nixing its financial support of Planned Parenthood, I thought it might be a mistake. Maybe a rogue affiliate or anti-choice officer had acted independently of the group’s core and mission, and the press got the early story wrong. I waited for Nancy G. Brinker, Komen’s surviving sister, to step in and deny the BC agency’s change of plans. That didn’t happen.

Rather, in a stilted video released yesterday, Brinker defends her agency’s decision as part of a “strategic shift” having to do with funding for any organization under investigation. That’s a bogus excuse, as others have detailed.

Komen, the world’s largest BC agency, has been under scrutiny for some time. Through its early fundraising campaigns and walks, the group raised public awareness – and discussion – of the disease. Since its inception in 1982, the agency has invested over $1.9 billion in education, breast-cancer screening, research and other grants. The discourse has changed, though. Now, many are critical of Komen’s historic focus on BC education and screening, including mammography, and tire of seeing so much pink.

This week’s outcry over the agency’s political turn has been fierce. It’s not too late for Komen’s leadership to take note, change course and revise its agenda.

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What is the Disease Control Rate in Oncology?

Last week I came upon a new term in the cancer literature: the Disease Control Rate. The DCR refers to the total proportion of patients who demonstrate a response to treatment.

In oncology terms: The DCR is the sum of complete responses (CR) + partial responses (PR) + stable disease (SD).

Another way of explaining it: Some people with cancer have measurable, growing tumors. For example, a man might have a sarcoma with multiple metastases in the lung that are evidently progressing. If the patient starts a new treatment and the lung mets don’t shrink but stop getting bigger, that might be considered a stabilizing effect from the therapy, and his response would be included in the DCR.

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Regorafenib, an Experimental Pill Tested in Colon and Rectal Cancer Patients, on Conference Agenda

Tomorrow the American Society of Clinical Oncology* will host its 9th annual GI Cancers Symposium. Bloomberg and the LA Times have already reported findings of a paper, still in abstract form, to be presented on Saturday.

The drug of interest is regorafenib, a pill that loosely inhibits quite a few kinases – enzymes critical in cell signals that control growth of normal cells, tumors and blood vessels. The experimental med, manufactured by Bayer, is also known as BAY 73-4506. The new data emerge from an international, randomized Phase III trial that goes by a loaded acronym: CORRECT.

The study included 760 patients with advanced colon or rectal cancer whose tumor progressed after receiving standard treatments. Participants received either the study drug or BSC (best supportive care) and a placebo. According to the paper, BSC includes antibiotics, pain meds, radiation for bone mets, steroids and some other treatments. The median survival in patients who received the Regorafenib was 6.4 months, compared with 5.0 months in patients who got the placebo. This difference, of 1.4 months in the median, was statistically significant. The “disease control rate” – a term that warrants separate explanation – was 44% in the regorafenib group c/w 15% in the placebo group.

The most frequent high-grade toxicities reported so far include a skin reaction affecting patients’ hands and feet, fatigue, diarrhea, elevated bilirubin in the blood, and high blood pressure. (Question to ask the oncologist who’s presenting these data at the meeting – was the elevated bilirubin from liver damage or hemolysis? With all the $millions spent on this trial, surely someone’s followed up on that detail.)

The language of the report and investigators’ comments are reminiscent of some regarding Avastin for advanced breast cancer. According to a media release: “…a subset of patients in the trial have responded particularly well to regorafenib, continuing to have stable disease for a relatively long time; research is ongoing to find ways to identify these individuals.” There are no biomarkers known to check for Regorafenib responsiveness.

What’s odd is that, according to the abstract, # LBA385, all patients entered the study between May, 2010 and March, 2011. This means some subjects were evaluated for less than a year, and the longest observation period for any patient on the trial is 20 months. Seems early to draw meaningful conclusions about the long-term toxicity and possible benefits of a cancer drug, especially for tumor types, like colorectal cancer, that don’t generally grow fast (c/w a condition like acute leukemia).

The list of investigators’ disclosures regarding ties to industry is too long to post here. You can find them at the tail end of the release. The FDA has assigned Fast Track status to this drug, according to Bayer.

*I am an ASCO member.

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The Emperor of All Maladies: A Narrative of Cancer History and Ideas

This week I finished reading the Emperor of All Maladies, the 2010 “biography” of cancer by Dr. Siddhartha Mukherjee. The author, a medical oncologist and researcher now at Columbia University, provides a detailed account of malignancies – and how physicians and scientists have understood and approached a myriad of tumors – through history.

The encyclopedic, Pulitzer Prize-winning book is rich with details. In the first half, Mukherjee focuses on clinical aspects of malignancy. He works both ancient and modern stories into the narrative; the reader learns of Atossa, the Persian queen of the 6th Century BCE who covered her breast disease, and Thomas Hodgkin, who in the 19th Century dissected cadavers and noted a “peculiar” pattern of glandular swelling in some young men, and Einar Gustafson, aka Jimmy, who was among the first children cured of leukemia in the 1950s.

The second half is a tour-de force on cancer biology; the author winds distinct threads of cancer science. He moves from century-old observations of cells with abnormal chromatin, through viral theories and hard-to-prove carcinogens, to the brave new world of oncogenes, targeted therapies, and current cancer genomics. He narrates the rift between clinical oncologists who, primarily, treat patients empirically and think less about science, and cancer researchers, who generally attend separate conferences and concern themselves with mechanisms of tumor growth and theoretical ways of blocking them. He relates a gradual, albeit slow, coming together of those two fields – of clinical and molecular oncology.

Mukherjee leaves the reader with a sense of cancer as a vast, infinitely diverse group of diseases that can mutate and adapt while a person receives treatment. The oncologist’s new goal, he suggests, is not so much to eradicate the disease as to learn more about its nature and course, to monitor each patient’s tumor and adjust medications as the cancer – or burden, as the term implies – shifts and mutates within the person who carries it along, within, for years and even decades.

It takes a long time to understand the workings of cancer cells; this book offers insights for oncologists and patients alike.


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

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

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

Survival data, from the report:

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

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

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

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

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

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

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

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ACS Issues Annual Report on Cancer Stats: Some Key Findings, and Notes on Survivorship

ACS (annual report header)

This week the ACS released its annual report on Cancer Facts and Figures in the U.S. The journal Cancer analyzes and considers the data in a helpful articleSome of the key and mainly positive findings have been covered elsewhere:

Between 1990 and 2008, death rates from cancer in the U.S. declined rather steadily, overall, by 22.9% in men and 15.3% in women. More recently, between 2004 and 2008, the incidence of cancer has declined slightly in men (0.6% per year) but it’s been stable in women. During this most recent period for which complete data are available, the overall death rates continued to drop – by 1.8% in men and by 1.6% per year in women.

This is generally good news. Still, the total number of people in the U.S. who will receive a new cancer diagnosis in 2012 is estimated at 1,638,910. Some 577,190 people will die of a malignancy, which approximates to 1,500 cancer deaths per day in the U.S. Cancer is second only to heart disease as the cause of death in North America. Most cancers, some 77%, arise in people aged 55 or older; conversely, approximately 23% arise in people under 55 years of age. The NIH estimates that in 2007, direct health expenditures for cancer in the U.S. totaled $103.8 billion.

Some notes on survivorship:

The latest estimate is that 12 million people are alive in the U.S. after a cancer diagnosis. This number includes people who are undergoing treatment and many who are in remission. Another encouraging detail: from 1975-77, the overall 5-year survival was just 49%. Now, between 2001 and 2007, overall 5-year survival stands at 67%. In other words, in 1975, just over half of cancer patients died within 5 years of their diagnosis; by 2007, two thirds of cancer patients were alive at 5 years.

The report includes a critical section on a few kinds of cancers for which the rates are increasing. These include cancer in the oropharynx (mouth and throat) associated with human papillomavirus (HPV); esophageal cancer (adenocarcinoma type), melanoma and tumors of the pancreas, liver, bile duct, thyroid, and some kinds of kidney cancer. The Cancer journal has a separate article on these.

The full and detailed document, at 68 printed pages, deserves close review in many particulars. Next week I’ll go over the new data for breast cancer.

All for now,

ES

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

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

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

Some background:

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

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

What they found, with my comments interspersed and conclusions:

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

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

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

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

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

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

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

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

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

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

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

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

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Noting the Death of Christopher Hitchens from Esophageal Cancer

The author is saddened to learn that Christopher Hitchens died late yesterday evening at the age of 62, roughly a year and a half after receiving a diagnosis of esophageal cancer. He was a prolific and articulate man; I respected him for his words.

His essays on the language and cancer might be of particular interest to some readers of this blog.

The NCI reports there are some 17,000 new cases of esophageal cancer in North American each year; it’s not a common tumor, and most cases arise in men. The annual number of deaths from esophageal cancer approaches 15,000 in the U.S. These numbers are telling: it’s not an easy disease to have, or to treat.

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

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

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

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

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

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

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

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

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

It grew…

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

The Alamo (WC image)

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

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

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

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

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

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

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Thinking of Someone with MBC in the Hospital Now

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

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

Each counts.

Hope she gets to go home soon and feels better –

#EndBC

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Cervical Cancer Screening Update: on Pap Smears, Liquid-based Cytology and HPV

The latest issue of the Annals of Internal Medicine contains 2 noteworthy papers on cervical cancer screening. The first, a systematic review of studies commissioned by the USPSTF, looked at 3 methods for evaluating abnormalities in women over 30 years:

high-grade cervical cell dysplasia (Dr. E. Uthman, Wikimedia Commons)

1. Conventional cytology (as in a Pap smear; the cervix is scraped and cells splayed onto a microscope slide for examination);

2. Liquid-based cytology (for LBC, the NHS explains: the sample is taken as for a Pap test, but the tip of the collection spatula is inserted into fluid rather than applied to slides. The fluid is sent to the path lab for analysis);

3. Testing for high-risk HPV (human papillomavirus). Currently 3 tests have been approved by the FDA in women with atypical cervical cells or for cervical cancer risk assessment in women over the age of 30: Digene Hybrid Capture 2 (manufactured by Quiagen), Cobas 4800 HPV (Roche) and Cervista HR HPV (Hologic); another Roche Diagnostics assay, Amplicor HPV, awaits approval.

These HPV assays use distinct methods to assess DNA of various HPV strains.

There’s a lot of jargon here, and I have to admit some of this was new to me despite my nearly-due diligence as a patient at the gynecologist’s office and my familiarity as an oncologist with the staging, clinical manifestations and treatment of cervical cancer. Who knew so many decisions were made during a routine pelvic exam about which manner of screening?

The main points I took away from this paper:

1. Liquid-based cytology is similar to conventional Pap smear cytology for detecting high-grade dysplasia (abnormal cells) and cervical cancer.

2. It seems that at some medical centers, and possibly overall, there’s a lower proportion of inadequate cell specimens when practitioners skip the slides and use the liquid method. This means that fewer women need be called back for another procedure.

3. Finding HPV sequences in the cervix yields many false positives, in terms of malignancy.

The researchers conclude that further studies are needed to sort out how HPV testing can improve or supplement cervical cancer screening. The main limitation is that many young women are infected with potentially cancer-causing strains of HPV, but most don’t get cervical cancer. When cervical cancer does develop that’s usually later on, a decade or longer after the relevant viral infection.

The second Annals article, a helpful narrative review, considers the practical implications of the above findings. The authors state that over 40 types of HPV can infect the cervix. They review that progression to cancer occurs along these 4 steps: HPV transmission, acute infection, persistent infection causing precancerous changes and eventually, in a subset of those infected, invasive cervical cancer.

Figure 1 is remarkably clear:

Prevalence of high-risk HPV and incident cases of cervical cancer in the U.S., 2003–2005. Surveillance Epidemiology and End Results (SEER) data for incident cases among females aged 15 to 19 years and 50 to 64 years.

The graph shows that the prevalence of HPV infection is highest among teens and women in their early 20s, and decreases in older women. By contrast, the incidence of cervical cancer rises steadily in women over 30 years and remains elevated among women in their 40s. The authors show, separately, that the rate of cervical cancer in older women is low.

The central point is that high-risk HPV infection and associated inflammation of the cervix are common in young women, but cervical cancer is rare among those under 30 years. The investigators conclude that cervical cancer screening in women younger than 20 years may be harmful. They also state that evidence supports discontinuation of cervical cancer screening in most women who are over 65 years old.

Two asides on this otherwise non-bloggy topic –

It’s great that the Annals provides the full text of these papers open-access, free of charge to the public.

Amazing how well-accepted is the concept of some viruses causing cancer, today. This was a heretical idea 25 years ago in academic medicine; now it’s dogma.

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Final Word on Avastin, and Why We Need Better Physicians

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

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

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

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

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

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

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

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

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

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

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

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

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President Obama Talks About Smoking and Tobacco

Today’s ML comes straight from the Oval Office. President Obama talks about smoking, and how hard it is to stop, and what can be done to reduce the use and long-term health consequences of tobacco.

What I like about this Presidential health advisory:

He credits the ACS, which is sponsoring a smokeout today.

He’s clear about the problem’s scope: “Today 46 million Americans are still hooked, and tobacco remains the leading cause of preventable, early deaths in this country.”

He doesn’t deny his own history. His experience lends credibility to his words; he understands how hard it is to stop smoking once you’ve begun.

He considers a solution: “We also know that the best way to prevent the health problems that come from smoking is to keep young people from starting in the first place.”

He reflects on the power of tobacco companies, which are fighting requirements for candid warning labels on their products.

All in 1 minute and 34 seconds!

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Visiting the Scar Project Exhibit

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

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

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

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

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