, ,

Male Breast Cancer: Facts and a Personal Perspective

23 November 2014

Guest Post by Dr. Oliver Bogler

When thinking about a post on male breast cancer, one person came to mind –  Dr. Oliver Bogler. As a cancer researcher, Dr. Bogler has a very unique perspective on his diagnosis, treatment, and the larger problem of research disparities when it comes to male breast cancer. Here is his guest post: 

My personal encounter with breast cancer started with my diagnosis in September of 2012. My story is very typical. As I have written more extensively about it elsewhere let me be brief: I felt a lump, and after a few months of denial I had it checked out, and then very quickly was diagnosed and treated at MD Anderson Cancer Center in Houston, where I also work. More on that below, but let’s first look at some facts about the male disease.

About Male Breast Cancer
Approximately one in every hundred people diagnosed with breast cancer is a man. That’s about 2,200 new cases a year in the USA. Men have breasts, meaning that they have the same lobular glands and ducts that women have, though they have less tissue and it does not produce milk. Accordingly, male breast cancer is typically ductal carcinoma and hormone receptor positive and Her2 negative, which is also the most common type of breast cancer in women. Men are diagnosed later in life, typically, with a median age at diagnosis of 68, or about 7years older than women. For that reason men also present more often with more advanced forms of breast cancer – stages III and IV are more common, and stage I very rare. One possible explanation is that a lack of awareness results in delayed diagnosis, and so more advanced presentation at a later age.

Treatment regimens for men are essentially identical to those used for women, and outcomes are very similar, as far as we know. Because male breast cancers are typically hormone receptor positive, hormone therapy with the anti-estrogen tamoxifen is commonly an important part of the therapy. It suppresses male estrogen, and thereby other hormones also, which are co-regulated, including testosterone.

Many websites, including those of the American Cancer Society and the National Cancer Institute provide fundamental information about male breast cancer. Interventional clinical trials on breast cancer that men are eligible for can be found here (ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world).

My advice: if you feel a lump, any lump, go see a doctor right away.

My Journey – Our Journey
One of the reasons I hesitated to get my lump checked out was that my wife had been diagnosed and treated for breast cancer about 5 years before me. I couldn’t really grasp the improbability of it hitting our nuclear family twice. Being Irene’s care taker and then a patient allows me to say with confidence that the treatments for men and women are identical: we both had up-front chemotherapy in a two step regimen: 12 rounds of weekly Taxol and then 4 rounds of the combination FAC at three week intervals. MD Anderson physicians prefer to give the chemo first as it provides an opportunity to see how the tumor responds. Then we both had surgery – modified radical mastectomy with axillary lymph node dissection – followed by 6 weeks of radiation to the chest wall. Now we both take hormone therapy – aromatase inhibitors for Irene, good old tamoxifen for me. Evidently we feel that marriage is all about sharing experiences 🙂

What we know about male breast cancer and opportunities to learn more
What do we know? Probably not enough. I do accept that the treatment men receive is effective – there are some relatively small-scale, hospital registry based studies showing this. When adjusted for age and stage at diagnosis, it looks like men do as well as women with today’s approaches. On the other hand, the possibility that a sex-hormone driven cancer may have important differences between men and women cannot be excluded. Very encouraging is a current, larger registry trial in a network of European and US cancer centers with about 1,200 men that will provide a robust baseline outcomes data set and afford the opportunity to collect tissue and study the disease. It is the kind of research that was being done 20+ years ago in women.

An analysis I wrote about on my blog and in Breast Diseases Quarterly [Bogler, O. (2013) Male Breast Cancer: Opportunities for Research and Clinical Trials. Breast Diseases: A Year Book Quarterly 24(3), 216-218] suggests that there is very little primary research on the male disease. There are no laboratory models, cell lines or other tools. Few if any grants supporting this kind of fundamental biology are in evidence, and aside from the inclusion of male breast cancer in the epidemiology of rare cancers it is hard to find any support for research from the National Cancer Institute or foundations. Given that the NCI alone spends $600M on breast cancer research, there is in my mind ample opportunity to dedicate some to this question. Perhaps 1% would be a good start?

On a similar note, men are only eligible for about 30% of breast cancer clinical trials found on clinicaltrials.gov, suggesting that access is a real issue. Of course in some instances our inclusion may not make sense, but I believe that in many instances inertia rather than a biological rationale underlies the exclusion of men. Both of these areas provide significant opportunities to learn more about the male disease and how best to deal with it clinically.

The Awareness Gap
Being a man with what is widely understood to be a women’s cancer leads to some dissonant experiences. To me these are mostly mildly funny, and not an issue – being asked how I get a mammogram for instance (the same way you do…), or filling out a form that asks me whether I am pregnant or when my last period was. Its fine – I get it. Mostly women here, and mostly the men in the waiting room aren’t wearing the medical arm band. But having breast cancer as a man is still (local) news worthy, and has modest shock value – that is surprising. The issue here is that a lack of awareness is probably a contributing factor to the delayed diagnosis in men and that means in some cases in their earlier death. It is certainly contributing to the underfunding of research and exclusion of men from trials. We need to change that.

A key challenge for men with breast cancer is the phenomenal success of the breast cancer awareness community. While the excesses of “pink” are unfortunately common these days, I do acknowledge the amazing work the community has done, and am deeply grateful for it. Alone the fact that we can have frank, open discourse about breast cancer, any cancer, is a tribute to the brave women who came out with their disease in the past 50 years. Then, the mobilization of public and private resources for awareness, screening and research is a tremendous accomplishment. And the US is a clear leader in this – a significant cultural accomplishment. But if this huge silver lining has a tiny, tiny black cloud it is that pink leaves almost no room for awareness about men. Breast cancer actually is not a sex-specific cancer like ovarian, uterine, testicular or prostate – it just appears to be. A great illustration of this phenomenon for me is the NFL players who in October don pink in support of women with breast cancer (hurray!) and completely fail to take the opportunity to also mention that they themselves could be diagnosed with this disease one day (booo!).

I want to close by being clear: I am not advocating for male breast cancer at the expense of other forms of breast cancer. Not at all. I want it to have its place with, and alongside. And in proportion – 1% would be a good start. Perhaps my concerns are not dissimilar from those of the inflammatory, triple negative or metastatic breast cancer communities: being outside the pink mainstream presents awareness challenges, which in turn make it harder to gain the resources needed to change the fate of many women and men with breast cancer.

 Dr. Oliver Bogler is a cancer researcher, male breast cancer patient, and male breast cancer advocate. His blog can be found at Entering a World of Pink.

/by
,

Tamoxifen Gel Shows Promise

15 July 2014

A study published today in Clinical Cancer Research demonstrates that tamoxifen applied to the skin in a gel form was as effective as oral tamoxifen in decreasing breast cancer cell growth and was associated with fewer side effects in patients with ductal carcinoma in-situ (DCIS).

Dr. Seema Kahn and colleagues randomized 27 women diagnosed with DCIS to receive either tamoxifen gel or oral tamoxifen for 6-10 weeks prior to surgery. They measured blood and breast tissue concentration of tamoxifen as well as the proliferative activity (growth rate – also known as Ki67) of breast cancer cells before and after treatment. They found that both forms of tamoxifen resulted in a decrease in the growth rate of cancer cells. Both groups showed similar concentrations of tamoxifen in the breast tissue, but the women who used the gel had lower tamoxifen concentrations in the blood.

Tamoxifen is used to treat breast cancer and is also used to reduce the risk of developing breast cancer in those at high risk. In women who have been diagnosed with breast cancer, tamoxifen can reduce the risk of cancer returning and can improve overall survival rates. However, many studies have shown that women often stop tamoxifen due to side effects. Those side effects can include vaginal discharge and exacerbation of menopausal symptoms such as hot flashes, sleep and mood disturbance, depression, and weight gain. The two most significant potential complications related to tamoxifen use are uterine cancer and blood clots. The study was too small to note any difference in side effects, but as the concentrations of tamoxifen in the blood are lower in patients using the gel, it is thought that this might result in fewer side effects.

This was a small study and many questions remain, but it is promising that an effective form of tamoxifen associated with fewer side effects may be eventually be available for widespread use.

/by
,

(Reasonable) Fear Prompts “Extra” Mastectomy Decision

** 6 December 2018 – Editor’s Note:
The NSABP B-39 clinical trial results were recently presented at the San Antonio Breast Cancer Symposium. This study compared 3 forms of radiation therapy. After 10 year followup, approximately 4% of patients who underwent whole-breast irradiation after lumpectomy developed cancer recurrence in the same breast. This is lower than what was quoted below (10-15%, point #3) which was based on older data. This new study demonstrates that the recurrence rate after lumpectomy and radiation (4%) is nearly equivalent to that of mastectomy (1-3%).

3 June 2014

A study was recently published evaluating the reasons why women diagnosed with breast cancer might undergo a contralateral prophylactic mastectomy. First, some definitions:
–       Mastectomy – removal of the entire breast
–       Prophylactic mastectomy – removal of a breast that does not have cancer
–       Contralateral prophylactic mastectomy (CPM) – removal of the breast that does NOT have cancer, in a patient undergoing mastectomy for cancer on the other side

The study, which was published in JAMA Surgery, concluded that “Many women considered CPM and a substantial number received it, although few had a clinically significant risk of contralateral breast cancer. Receipt of magnetic resonance imaging at diagnosis contributed to receipt of CPM. Worry about recurrence appeared to drive decisions for CPM although the procedure has not been shown to reduce recurrence risk. More research is needed about the underlying factors driving the use of CPM.”

Some background information:
1.  Over 25 years’ worth of data exists showing that long-term survival is equivalent whether a woman undergoes a lumpectomy or a mastectomy:  In other words, you will not live any longer if your breast is removed.

2.  There is no difference in the likelihood of metastatic disease (spread outside the breast – most commonly bones, liver, lung and brain) whether you have a lumpectomy or mastectomy.

**see editor’s note, above. 
3.  Lumpectomy followed by radiation therapy (this is also called breast conservation therapy, or BCT) generally has low rates of “in breast recurrence” or “in breast new primary” – low rates of the original cancer coming back in the same breast, or a new cancer developing in the same breast.  These rates are historically about 10-15%, although these rates are likely reduced with modern adjuvant antihormonal, radiation, and chemo- therapies.

4.  Even though much more breast tissue is removed (~99% of breast tissue cells) mastectomy is still associated with a 1-3% risk of cancer recurrence at the site of breast removal.  This is usually in the skin or muscle.

5.  CPM is associated with a 20-40% complication rate, especially unplanned additional surgery

6.  The average woman’s risk of developing a new cancer in the opposite breast is approximately 0.5-1% per year. If a cancer develops in the contralateral (other) breast, it is considered a “new primary” – a whole new breast cancer. Even though it might be the same type as the original cancer, it is generally not considered a recurrence. If the original cancer is estrogen / progesterone receptor positive, taking tamoxifen or aromatase inhibitors can reduce the risk of cancer returning after a lumpectomy, and can reduce the risk of a new cancer developing in the other breast. However, lumpectomy or mastectomy for the original cancer does not alter the rate of new breast cancer development.

7.  Women who carry a BRCA gene mutation have a 60-80+% lifetime risk of developing breast cancer in either breast, and a high risk of developing a new breast cancer, so bilateral mastectomy is often recommended. These patients are generally excluded from the discussions regarding whether or not CPM is a reasonable option due to their extremely high risk.

Over the past 20 years, research studies have supported a “less is more” approach to breast cancer surgery such as: BCT,  narrower margins of normal tissue removed around cancer, and less extensive lymph node removal. Before instituting these changes, studies were done to ensure that less aggressive surgery does not impact long-term survival rates. Despite these advances, there has recently been a steady increase in the rate of mastectomy, as well as CPM.  In article after article, physicians are scratching their heads.  The use of MRI, inadequate education, unrealistic expectations from reconstructive surgery, the “celebrity effect”, as well as fear and anxiety have been blamed.

The “new” study and our thoughts:
The recent study in JAMA Surgery focused on a small subset of women (8%) from a national database that elected CPM as part of treatment for unilateral breast cancer.  The authors reported that of 106 patients who received CPM, “80% indicated it was done to prevent breast cancer from developing in the other breast,” leaving only 21 patients (1.5%) from their sample of 1447 surveyed women that elect CPM for reasons other than the prevention of the development of a new contralateral breast cancer.  However, the author’s conclusions ignore this and direct the reader’s attention instead to patients’ concern for recurrence, stating, again, that “worry about recurrence appeared to drive decisions for CPM.”

The problem with this type of analysis is this:  when ‘patient fear’ is discussed, it frequently is implied by the reporting media that hysterical women are running to the operating room to be unnecessarily operated on by uneducated surgeons.

Judging the merits of a surgical procedure or treatment on the fact that few women “are likely to experience a survival benefit,” is not reflective of the complexity of the treatment decision-making process for women with a new diagnosis of breast cancer.  Faced with a multitude of decisions to make in a short time frame, it is not surprising that many such patients will report anxiety concerning recurrence.

The truth is simple:  surgical choice is a combination of factors. There is little doubt that some physicians do not spend the time needed to hear the concerns of their patients and respond to them appropriately. Conversely, some patients do not want to hear all of the facts, preferring simply to opt for what seems the “safest” approach, even though the science says otherwise.

What we see in our offices is a rational fear: Many women understand that the type of surgery does not determine their survival.  While of utmost importance, survival is not the only thing that is important to women being treated for breast cancer. Women worry about having to repeat the whole process in another year or so if something new shows up on a mammogram or if a lump is felt. Women question the value of annual mammography for surveillance when their initial tumor was not picked up by a mammogram. Women have seen their family members and friends develop complications from radiation therapy and from attempts to perform additional surgery after radiation therapy. While women understand that a mastectomy is no guarantee that they will remain cancer-free, to many it is such a significant decrease in the rate of recurrence or new primary cancer that they feel it is an acceptable trade off for the complication rates that have been reported in patients who undergo a CPM with reconstruction.  Physicians also agonize over the decision.  Properly educated patients are in the best position to make decisions regarding their own breast health care, but even the best education does not alleviate all anxieties, nor can it eliminate all risk.

Physicians and researchers talk about the increasing rate of CPM as a crisis. But the real crisis is that at this point, we simply do not have options for women that they are comfortable with. Unnecessary surgery is a concern for patients and physicians. However, until we can look a woman in the eye and give her more accurate information about her individual risk of recurrence or new primary disease, it is our opinion that the decision for CPM should be between a woman, her family, and her physicians.

Additional Reading:
JAMA Editorial: Contralateral Prophylactic Mastectomy – An Opportunity for Shared Decision Making
Medscape Article – Misconceptions and Fear Prompt Contralateral Mastectomy
The Patient Perspective: Blog Post by Catherine Guthrie

Deanna J. Attai, MD
Michael S. Cowher, MD

/1 Comment/by
,

Breast Cancer – The Celebrity Effect

12 November 2013

Over the past year, breast cancer and mastectomy has been in the spotlight due to attention from celebrities such as Angelina Jolie and Amy Robach.

There is no question that when public figures share their stories, awareness is raised. The unfortunate part is that important facts are usually omitted from the conversation, and misinformation is spread. While anyone has the right to discuss their disease, public figures should be held to a different standard. Their information reaches millions, and their words are held as truth. Unfortunately, we rarely if ever have the complete story. Most often, an announcement is made about upcoming or recent surgery, and statements are made about “beating cancer” or “being cured”. In the absence of information about the pathology report, stage of disease and other factors, these statements do nothing to educate or inform. I would not expect anyone, including someone in the public eye, to disclose their medical records. However a simple statement such as “I am choosing this treatment with the advice of my physicians” can go a long way towards acknowledging that the treatment decisions are complex and unique to the individual.

Some important points:
– Early detection does not equal cure. Some breast cancers are so aggressive that they will go on to metastasize regardless of how early they were found. Some breast cancers will never metastasize, even if they become quite large. Tumor biology – the behavior of the individual cells – is more important than the size of the tumor at diagnosis. Statements such as “a mammogram saved my life” do not apply to every breast cancer case.

– You will not live any longer if you have your breast removed. The survival rates from breast cancer are the same whether you undergo a lumpectomy with radiation or a mastectomy. Statements such as “I had a mastectomy because I’m young and wanted to be aggressive” have no basis in reality. You can be appropriately aggressive by having a lumpectomy followed by radiation, depending on the extent of your tumor. More surgery is not better.

– Breast cancer can come back even after the breast has been removed – the risk is approximately 1-5%. After lumpectomy and radiation, the risk of cancer retuning in the breast is approximately 5-10% with modern techniques. Statements such as “I had a mastectomy so I don’t have to worry about cancer anymore” also has no basis in reality. With either surgery (lumpectomy or mastectomy), there is a risk of cancer metastasizing, or showing up somewhere else in the body. Any invasive breast cancer has the potential to shed cells from the main tumor into the bloodstream. Those malignant cells may then form tumors in other areas of the body, such as the bones, lungs, liver, and brain. The type of surgery (lumpectomy versus mastectomy) does nothing to reduce the risk of metastatic disease, and the survival rates are equal regardless of the surgery performed.

– In patients who undergo removal of the ovaries (due to the increased risk of ovarian cancer), there still is a slight risk of developing ovarian or primary peritoneal cancer, which mimics ovarian cancer in it’s growth and aggressiveness. Patients who have had breast cancer or are BRCA mutation carriers are also at increased risk for the development of cancers in addition to breast and ovarian, so lifelong surveillance is important.

– Many have the misconception that if they undergo a mastectomy, they will not require chemotherapy. Chemotherapy is given based on the tumor stage as well as tumor biology – the decision is made on the aggressiveness of the cancer. As mentioned above, a mastectomy does not prevent the cancer from spreading, so chemotherapy may still be required after mastectomy.

– Radiation therapy is utilized after lumpectomy to reduce the risk of cancer returning in the breast. While radiation is generally not needed after mastectomy, there are some cases where it is required. Similar to the decision for chemotherapy, the decision for post-mastectomy radiation depends on the stage of disease and tumor biology.

– The recovery from surgery is not always straightforward and most patients are not “back to a normal life” a few days after surgery. As with any surgery, there can be unexpected complications and additional procedures may be needed.

– Reconstructive techniques, while much improved, can never guarantee a perfectly natural or symmetric result. Reconstruction after mastectomy is a much different operation than undergoing implants for cosmetic purposes. Once the breast has been removed, it can never be replaced. The skin (and nipple if preserved) are numb, and the feel and appearance are different. Many patients are very happy with the cosmetic results of their reconstruction, but realistic expectations are needed.

– In regards to BRCA genetic testing, some women struggle tremendously with the decision even to be tested. There are implications not only for the patient but also for her relatives. In patients who test positive for a mutation, there are also difficult decisions to be made regarding surveillance versus prophylactic surgery.

There’s Another Side to the Amy Robach Breast Cancer Story is an excellent post by Gary Schwitzer of the HealthNewsReview on the subject.

 

/3 Comments/by
,

Clinical Trials

11 November 2013

One of the first things that might be discussed when you are looking at your cancer treatment options is whether or not there are clinical trials that you might qualify for. While many still view clinical trial participation as being a “guinea pig” in an experiment, it is important to understand that the clinical trial process is designed to protect patients. Any clinical trial needs to be overseen by an Institutional Review Board (IRB), an independent ethics and monitoring body dedicated to protecting human subjects from physical or psychological harm.

If it were not for clinical trials, we would still be performing radical mastectomies on all women with breast cancer – randomized studies have shown us that more aggressive surgery does not lead to improved outcomes. We are able to offer shorter courses of radiation therapy thanks to the data generated from large studies, and medications such as trastuzamab, previously used only in patients with advanced metastatic disease, are now considered first-line therapy in selected patients with early-stage cancer.

The post discussing clinical trials was written by Carmen Gonzalez, Communications Project Manager at Heath Services Advisory Group of California, Inc., and originally appeared on the #BCSM Community Website.

Clinical Trials 101 – Guest Post by Carmen Gonzalez
The world of clinical research can present a hornet’s nest of almost incomprehensible clinical jargon to the average Jane or Joe. Added to that reading burden is finding what study is right for you.  Assuming you have waded through all the public information, there remains the task of asking the right questions so that your experience is productive, worthwhile, and fits your life. In this blog, I will cover “just the basics,” arming you with the essentials to find what you need.

How to Find Them
If you are starting at square one, you probably don’t know how to find clinical studies. First, start by inquiring from trusted sources, including your doctor and other medical professionals with whom you’ve established trust.  If searching for breast cancer-related studies, visit disease-specific sites where patient-centered resources are available which feature clinical studies, e.g. The Susan Love Research Foundation’s Army of Women. Being the empowered patient that you are, expand your knowledge of available studies further by seeking out online clearinghouses, such as BreastCancerTrials.org, a non-profit dedicated to helping breast cancer patients connect with researchers. BreastCancerTrials.org compiles the trials from ClinicalTrials.gov. and Cancer.gov—comprehensive libraries of ongoing studies— into one hub, so it saves you two less searching chores. There’s an added benefit with BreastCancerTrials.org: they use your health history to guide you to the right trial, and they eliminate a lot of clinical jargon that can trip up novices to clinical research. While you can choose to see all the trials available, their screening tools make it easier to find what you need.

If you do decide to explore ClinicalTrials.gov directly to explore clinical studies, be forewarned: technical clinical language lies ahead. Search  trials by inserting general terms, such as “breast cancer,” “stage 2,” and “HER-positive.” To tame what could be a fire hose of responses, insert search terms that narrow your focus, such as the disease topic with your location and other distinctive traits, e.g. “Chicago” AND “breast cancer” AND “metastatic cancer.”

Here are a few rules of the road when considering different categories of studies.  Research trials are either observational or investigational, meaning only as to the latter are patients given a treatment. There are four basic types of investigational studies : Phase I, II, III, and IV studies.

—Phase I refers to studies which are being conducted for the first time in humans, having been successfully tested in animal models. Phase I studies are exploring the safety of the drug or device, and are typically involved with  small number of participants.
—Phase II studies involve a larger group of study volunteers to test if the drug or device is effective, commonly against a placebo. If a drug or device is successful in its phase I and II stages, then a significantly larger study group is involved in a Phase III study.
—Phase III studies help to determine if the drug or device is as good or better than the standard of care. During this phase, issues of safety are also closely watched. While success at the phase III stage poises the drug or device for likely market approval by the FDA, another phase is needed.
—Phase IV is imposed to see if late-breaking safety issues arise in the wider marketplace. What does this boil down to for you? The more phases the drug or device has passed successfully, the safer it  has proven to be. Foolproof? No. Remember Vioxx? That’s why Phase IV is so important.

What to Ask About
Whether you are healthy or sick, an appropriate clinical study has to fit into your life for it to be meaningful and worthwhile. That means that you need to have a full understanding of the study’s implications to your health and full knowledge of the obligations before you. Let’s consider these topics separately. First, dig into whether this study offers you significant personal benefit, and if it advances the science in the field. Start by asking how this study advances scientific knowledge and how it improves your prospects of recovering, improving, living longer, or in better managing your disease.
Ask the study team if the research offers a novel treatment, device, or delivery method.  Once you get answers to these questions, mull them over with your doctor if you’re unsure of its potential benefit to you.

Once the overarching considerations meet with your satisfaction, use the following checklist when asking the clinical study team about the study’s logistics:

  • Are there any anticipated side effects? What are they and their severity?
  • How long is my study obligation? (e.g. number of days, weeks, months, years)
  • How many visits in total will require my in-person presence at research clinic?
    • How many visits per week or month does this mean for me?
  • Are there additional visits to other specialists beside the research clinic? (e.g. imaging tests at a radiology lab)
    • How far away are these office from the research clinic?
  • What other study duties are required of me?
    • Is there a diary I have to keep?
    • Am I required to take study medications at home?
    • Is there a medical device I have to use?
    • Are there dietary or activity restrictions?
  • Are there any post-study activities required of me? (e.g. phone check-ins)
  • What is the stipend offered for my participation? Is my travel compensated?
  • When will the study officially end? When and where can I obtain the study’s results?

Once you inquire about what is involved, now ask about the likely impacts on your family. This is often overlooked and leads to unanticipated conflicts, so tackle them beforehand. While you can walk away from any study at any time, it will save you considerable time and frustration to find the right fit upfront. Consider asking the following:

  • Does the schedule conflict with family vacations or other commitments? Is there a way to accommodate these priorities? For example, if study visits are required at a time of day that is inconvenient, will the team consider other time slots or weekends?
  • Does the study impose obligations that conflict with your religion? Take the fasting periods of Ramadan for example, and some studies conducted during the summer might not work with your requirements.

Be realistic about where you are in your emotional life as well. If you are undergoing grieving for a marriage or loss of a loved one, you might not be ready to be a study volunteer. Acknowledge your own expectations and biases regarding the study and discuss those reservations and hopes with the study team. They can provide able counsel to help you determine if participation makes sense at this moment.

What To Expect
If you are placed in a control group—study volunteers who are not receiving the active study medication or device—then any positive response you experience will be attributed to what is called the “placebo effect.” You won’t know whether you were assigned to a placebo or “active” group, as that would defeat the scientific process. However, sustained dramatic improvement tends to suggest that patients were in the “active” group. For patients to gain answers to which groups they were in and the overall impact of the study, they must wait for the trial’s conclusion. In the U.S., study teams are required to post their results on ClinicalTrials.gov upon completion, but faithful adherence is spotty at best. To ensure you get the answers you need, aside from your personal outcome, request the results from the study team and create a tickler on your calendar to remind those in charge to keep you posted.

If during the course of the study, you experience unwanted side effects, immediately report your symptoms to the study team right away for intervention. Depending on the study, there are some minor  side effects that are anticipated, but in all cases, report your experience no matter what. For patients with multiple pre-existing medical conditions, there may be fewer studies for which they are eligible, but that rarely rules out everything.

In studies that span several months or years, the mere slogging pace of the study can impose a weariness commonly called “study fatigue”—not an ailment, but an acknowledgement of growing impatience. Be honest with yourself if you can endure a long-term study and the duties that come with it. While you can’t predict all the events that might upset your study schedule commitments, understanding and knowing how you manage everyday routines will give you a candid idea of your likely study visit consistency. Armed with these tips, you can make better decisions concerning study involvement.

PBS Need to Know: Dispelling the Myths Surrounding Cancer Trials

/by
, , , , , ,

Breast Cancer Diagnosis and Treatment, BRCA Testing, PinkWashing, and More!

16 October 2013

This is one of my most comprehensive interviews to date. It aired on Santa Clarita Valley TV and I had the opportunity to discuss a wide range of topics, including breast self-exams, male breast cancer, genetic testing for breast cancer, “pink washing” and more! Many thanks to SCVTV as well as Tami Edwards and Dave Caldwell, for spending so much time on such important topics.

/0 Comments/by

Misconceptions and Fears Prompt Contralateral Mastectomies

16 September 2013

The following article appeared in Medscape and covered a recent study suggesting that many women base their decision to undergo a mastectomy on fear. I was happy to contribute my thoughts to what is a very complex issue and a very difficult decision for so many women. ~DJA

Fran Lowry

Sep 16, 2013

Women with breast cancer, especially younger women, are choosing to have their healthy breast removed because of mistaken beliefs about the effectiveness of mastectomy and unfounded fears about the risks for contralateral disease.

In a cross-sectional survey of 123 women with early bilateral breast cancer who chose to undergo contralateral prophylactic mastectomy (CPM), the overwhelming majority cited improving their chances of survival (94%) and reducing the risk that cancer will develop in the other breast (98%) as their primary reasons for deciding to have the additional surgery.

The results appear in the September 17 issue of the Annals of Internal Medicine (Ann Intern Med. 2013;159:428-429).

Read more

/1 Comment/by
, ,

Breast Cancer Overdiagnosis and Overtreatment

3 August 2013

What’s in a name? In the case of cancer, there are myths, fears, and misinformation – more than perhaps any other illness.

Cancer encompasses hundreds of different diseases and each one is complex. Even women diagnosed with exactly the same “type” of breast cancer and who undergo the same treatment can have very different outcomes. Not all cancers are equal and not all cancers are lethal.

While early detection and treatment were once equated with improved survival, we now know that tumor biology (characteristics governing the behavior of spread and response to treatment) plays an extremely important role in the prognosis of an individual cancer. There is an increasing recognition that current screening tests, meant to diagnose cancer in the earliest stages, will often diagnose lesions that have minimal potential to become aggressive or lethal. As our screening technology improves, we are detecting more patients in early stages or with pre-cancerous conditions and we are treating those patients with surgery and other potentially toxic therapies.

In 2012, the National Cancer Institute convened a working group to “evaluate the problem of ‘overdiagnosis’ which occurs when tumors are detected that, if left unattended, would not become clinically apparent or cause death.” Unrecognized overdiagnosis, they stated, “generally leads to overtreatment”1.

The recommendations of this panel were recently published in the Journal of the American Medical Association: Overdiagnosis and Overtreatment in Cancer, An Opportunity for Improvement.  The authors provide five recommendations:
1. Physicians and patients alike need to acknowledge that screening results in overdiagnosis – especially in breast, lung, prostate and thyroid tumors.
2.  The term ‘cancer’ should be reserved for describing lesions with a reasonable likelihood of lethal progression if left untreated.
3.  Create observational registries for low malignant potential lesions in order to better understand prognosis and best treatment options.
4. Mitigate overdiagnosis with an ultimate goal of preferential detection of consequential cancer while avoiding detection of inconsequential disease.
5. Expand the concept of how to approach cancer progression by controlling the environment in which cancerous conditions arise.

While these are certainly laudable goals, some important points should be made, especially in regards to breast cancer and ductal carcinoma in-situ – the most important being that we do not currently have biomarkers or other indicators that can clearly distinguish a potentially lethal cancer from a more indolent one. The field of cancer genomics is rapidly changing, and today more than ever, we can obtain very sophisticated prognostic information regarding an individual’s tumor. Despite that, Dr. Larry Norton, medical director of the Evelyn H. Lauder Breast Center at Memorial Sloan Kettering Cancer Center, stated “Which cases of DCIS will turn into an aggressive cancer and which one’s won’t? I wish I knew that. We don’t have very accurate ways of looking at tissue and looking at tumors under the microscope and knowing with great certainty that it is a slow-growing cancer”2.

Regarding the modern management of DCIS, there are three points to remember:
1. When DCIS lesions diagnosed by needle core biopsy are surgically removed (which involves removal of substantially more tissue from the abnormal area), there is an approximately 15% rate of ‘upstaging’ to invasive ductal cancer 3. Put another way, one cannot always reliably predict the behavior of an entire lesion based on a core biopsy specimen.
2. During surgery for DCIS, axillary lymph node metastases have been demonstrated up to 20% of the time, usually indicating missed microinvasion or invasion 4.
3. Finally, if DCIS recurs, 50% of the time it is invasive 5.

What is important to be aware of is that any woman with breast disease, including DCIS, should be presented with the information necessary so that she may gain an understanding of where her diagnosis stands in the biological spectrum and the wide array of choices she has for treatment. DCIS is far from simple, and it is not to be taken lightly. Clearly there are cases where ‘watchful waiting’ is safe – but we cannot always reliably predict who will truly benefit from treatment. Moving forward, we need to be aware of the facts – what medical technology can provide the patient and the physician now, and we need to ask how we can drive this conversation in the future.

Deanna J. Attai, MD, FACS
Michael S. Cowher, MD

/1 Comment/by
, ,

BRCA Gene Testing and Prophylactic Mastectomy

14 May 2013
BRCA gene testing and prophylactic mastectomy were thrust into the spotlight when Angelina Jolie announced in May 2013 that she tested positive for a BRCA mutation and underwent preventative surgery. The interview below discusses who should be tested, and some of the issues to consider regarding prophylactic surgery.

Read more

/1 Comment/by
, ,

Endocrine Therapy For Breast Cancer

11 May 2013

In May 2013, I was invited to give a talk with my colleague Dr. Carol Connor at the annual meeting of the American Society of Breast Surgeons.  Our topic was “Endocrine Therapy for Breast Cancer”, and we discussed the literature supporting the use of tamoxifen and aromatase inhibitors for breast cancer, as well as adverse effects and treatment of adverse effects. We were then invited to submit a manuscript which was published in the Annals of Surgical Oncology. The following is a summary of our talk and manuscript. I would like to express my appreciation to the #BCSM Community, who responded to my request for information about adverse effects  – it allowed me to discuss not only the literature, but also real patient experiences.

Read more

/2 Comments/by