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.

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 MD Anderson Cancer Center, 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.

- 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.

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.

References:

1. Hawley ST, Jagsi R, Morrow M, et al. “Social and Clinical Determinants of Contralateral Prophylactic Mastectomy” JAMA Surg. 2014; Online ahead of print.

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

Last week, the British Medical Journal published a Canadian Study which concluded that mammograms are not effective in reducing breast cancer deaths. The study involved 90,000 women. However, there are some major flaws in the study, and “rapid response” letters to the editor were published within hours of the study release. So while the headlines scream “mammograms are not helpful”, the study is in question and it may not be possible to draw this conclusion.

While previous randomized trials have shown a reduction in breast cancer mortality due to screening mammography, there is no doubt that mammography is far from perfect. We have to screen a large number of women to diagnose one with breast cancer. In doing so, a percentage of women will require additional imaging and/or will undergo a needle biopsy for a benign finding. Mammography is not as helpful in younger women and in those with dense breast tissue. In addition, as technology has improved to allow us to see through the breast with more detail, we are diagnosing cancer (and precancerous conditions) that may never become a threat to a woman’s life. We are trying to find the balance between early detection which often (but not always) leads to improved survival, versus over diagnosis and over treatment.

Part of the problem is our technology. The results of screening mammography are highly variable depending on the patient’s age, breast density, weight, use of hormone therapy, and other factors. We have a one-size-fits-all test, which as every one knows, is really one-size-fits-none. We are also limited in who we screen. Women younger than 40 without a family history of breast cancer have no routine screening recommendations, and mammography is not very helpful in this age group. Many will use this as an argument for the use of ultrasound or MRI examinations. While these modalities may be extremely helpful in a given patient, they have not been proven to be effective in reducing mortality from breast cancer when applied to a general screening population.

It is important to realize that we have an imperfect technology, and our application of that technology to the individual is also imperfect. More research is needed to determine who is actually at risk, and who will truly benefit from screening. In addition, screening needs to be more individualized - a mammogram is not the right screening tool for all. Dr. Peter Beitsch, Past-President of the American Society of Breast Surgeons, has said on many occasions that “female and 40 is no longer acceptable for screening mammography - we need to risk assess each woman individually and use appropriate breast imaging tailored to them.”

In addition to more individualized screening, research is needed into which cancers even need to be treated. Many breast cancers found on mammography may never become a threat to a woman’s life. However, a hallmark of cancer is cell mutation - the slow-growing cancer today may not behave that way in the future, so at this point we err on the side of over treatment, as we cannot reliably predict future biologic behavior. Dr. Robert Miller, a medical oncologist who the Senior Director, Quality and Guidelines and Medical Director, CancerLinQ, at the American Society of Clinical Oncology, stated that “we simply can’t tell if early breast cancer diagnosed by mammogram will be indolent or not. For the individual patient we can’t say it’s ‘over diagnosis’. ”

And that’s really the bottom line. For an individual patient, we do not always have the right answer - our science and technology are just not there yet. While this is frustrating for many patients as well as for physicians, it is exciting to be practicing in a time when we are making progress (albeit slow) towards more individualized screening and treatment recommendations.

American Society of Breast Surgeons Statement

Lola Butcher

Twitter Bio: Breast Surgeon, #BCSM Co-Moderator, Teacher, Advocate, Author, Organic Vegetable Gardener, and Gluten-Free

Facebook Bio: Dr. Deanna J. Attai is a breast surgeon dedicated to state-of-the-art minimally invasive care for women with benign and malignant breast disease. Areas of expertise include ultrasound, minimally invasive breast biopsy, cryoablation for benign and malignant tumors, and accelerated partial breast irradiation. Dr. Attai is actively involved in research and patient and physician education in addition to her busy clinical practice.

Deanna Attai, MD, a private-practice surgeon in Burbank, Calif., is best known in the social media world for her leadership in the Breast Cancer Social Media community, including her role as co-moderator of the BCSM TweetChat every Monday evening. She is featured in 25-and-counting videos on her YouTube channel. She blogs regularly about breast cancer topics on her website; shares personal reflections on her wellness blog; and promotes breast cancer awareness and knowledge on her Facebook page.

Like many physicians, she initially was dubious about the benefits of social media and waded in only to support a professional organization. A lot has changed since then.

“If you had told me a few years ago that not only would I be on Twitter, but I would be driving an hour and a half to the funeral of a woman I got to know through Twitter and that I would have this huge following on social media, I would have never believed it because this is so far removed from anything I have done previously,” she said.

“But this has changed me personally, it has definitely changed me professionally, and all for the better. And I can’t imagine practicing without it at this point.”

How did you get involved in social media?

“It’s all the fault of the American Society of Breast Surgeons [ASBS]. I am chair of the communications committee, and in 2011, the staff person I work with and I thought that we might be able to use social media to increase the visibility of our organization and also offer patient education.

“I had to go before the board of directors and explain why, as an organization, we need to be involved in social media. And I can tell you, I got a lot of blank stares at that meeting.

“Before I went to the board meeting, I set up a Facebook page for my practice. And then I opened a Twitter account, and I just started following and listening. I followed a lot of cancer organizations, I followed a lot of news media organizations. I started following some professional organizations. And then, I started noticing the conversations that were going on specifically related to breast cancer among patients and advocates.

“The first time I realized that I really have a role on Twitter was one night when two women on Twitter were discussing one of their friends who had just been diagnosed with Paget’s disease. One said, ‘Her doctor told her she needs a mastectomy, but I also read that maybe she could get an MRI.’ And I just sort of watched these women with a little bit of horror, thinking, why are doctors not answering these questions? So I kind of butted in and said, ‘I’m a breast surgeon, can I give you any guidance?’

“And I ended up doing the same thing that I do day in and day out if a colleague or friend calls me and says, ‘My mother was just diagnosed—what do I need to do?’ I explained the usual workup for Paget’s disease and the surgical options, depending on what the MRI showed. I found out where in the country she was located, and I got on the American Society of Breast Surgeons website to find a couple of ASBrS members in the area in case she wanted a second opinion.

“I got an email from that woman about a month later, saying the patient had the MRI, the cancer was localized, she had a lumpectomy—and thanking me for my help. That was when I realized there are so many patients who are just not getting the information they need from their physician, and they are going online to look for information whether we are there or not.

“So I think it’s part of our responsibility as physicians to make sure that the information is accurate, and that people are getting the answers they need. And even if we just raise a couple of questions that they can take back to their own physicians, then we’ve done our job.”

The #bcsmchat on Twitter is the envy of every medical community that is interested in social media. What makes it so successful?

“Two breast cancer survivors who are very active on Twitter—Jody Schoger [@jodyms] and Alicia Staley [@stales]—started the breast cancer social media weekly chat in July 2011. I missed the first one, but I joined the second, and basically have participated ever since. I came on as an official co-moderator in October 2011.

“The success is due to the integrity and the vision of Jody and Alicia. When they first found each other on Twitter, they realized that no one was really talking about breast cancer in a constructive way. A lot of times the people who are online looking for information about cancer have not had a pleasant experience with their diagnosis and treatment and they need to discuss issues or problems. So Jody and Alicia sought to provide a supportive environment and evidence-based information and avoid perpetuating media hysteria and misinformation.

“The community essentially polices itself. Some people come on to the chat trying to promote their specific agenda and companies come on to promote their products, and that gets shut down very quickly.

“We are having docs join in left and right, and it’s fantastic. The patients absolutely love it because they have this whole network of specialists that are available to them, even outside of chat hours. Patients sometimes send out a tweet asking a question about a study or something they have read, and they will tag a couple of us and we all respond. It provides us a good opportunity to help empower and educate patients.

“Jody, Alicia, and I come up with weekly topics. I tend to take the lead when we are talking about medical things. For example, when we did a chat based on the American Society of Breast Surgeons’ meeting in May and the American Society of Clinical Oncology Breast Cancer Symposium in September, I basically rounded up the docs who were going to be involved, came up with the topics, and I moderated.

“If Jody is leading the discussion on a certain topic, I’ll be the one in the background, fielding the side questions or the things that may not be exactly pertinent. So we often have multiple conversations going on at once. It often takes the three of us to keep it under control.

“One week we had a topic scheduled, and two of the group members, both with end-stage metastatic disease, died that morning, within hours of each other. So, that night we spent most of the chat talking about them—the issues of death and dying, but also honoring our members.

“Jody and Alicia and I all kind of patrol the hashtag (#bcsm) during the week. People will send out tweets using the hashtag—maybe it’s someone who has written a blog post, maybe it’s somebody posting an article, sometimes it’s someone saying, ‘First day of chemo today; I’m scared.’ We call it our ‘bat signal,’ and we tell people if they have any questions or issues during the week, just send out a tweet with #BCSM and we’ll all come running.”

How has social media affected your practice?

“You don’t use social media to get patients. I don’t think anyone will come to me just because I have a good Facebook page or because I’m on Twitter. But Twitter gives me a huge network—just like it does for the patients—of specialists all across the country that I draw from, personally and professionally, for my own education and for what I can provide to my patients. And these are some of the leaders in their field. So I have access to the best and the brightest in medical oncology and surgery and other specialties.

“Also, the interactions I have with patients on Twitter have made me realize just how difficult our treatments really are for them. Of course, we see the patients who come to our offices and we ask them questions, but when we hear these women talking online, it lets us see what happens behind closed doors. It gives us a window into what really is going on with our patients and how our treatments and our words really affect them.

“This has changed the way I interact with my patients. I am much more aware that they are putting on their happy face when they come into the office. The reality is I just have to dig a little deeper to get to the issues that are concerning them.”

What is the #bcsm-LATweetup?

“There are several of us who are in southern California, and one of the #bcsm members came up with the idea that we should all get together. So maybe five or six of us met—that’s a Tweetup—and it was like we were all long-lost high school friends.

“When we scheduled the next one, another member, Donna Peach (@danceswithpens), said she wanted to come. She was a writer by trade and a dancer and such an incredibly warm and loving person that we all really gravitated towards her.

“By the time our TweetUp was scheduled, it was clear from Donna’s blog and her tweets that she was not well and probably towards the end stage. While we were sitting at the restaurant waiting for her, one of our group, Lori Marx-Rubiner (@regrounding) got a text saying Donna’s husband couldn’t find a handicap ramp—Donna was in a wheelchair by now—and they were going to turn around and go home. And Lori got up from the table, ran out, and basically stopped traffic to help get Donna out of the vehicle and wheel her up to the table. And we were all together for about an hour.

“Donna made such an impression on us that when she passed, it was like we had known her all our lives. Three of us drove down to the funeral. We had known her for only a little while, but she was a family member.”

What advice do you have for physicians who have not yet tried social media?

“When I started using Twitter, one of the first things I did was look at organizations like the American Cancer Society and check who is following them and I would start following some of those people. That led me to a few patients and advocates who seemed to have a prominent voice, and I looked to see who was following them and who they were following. And that is how I started figuring how who I need to listen to. There were many I started following initially whom I later un-followed because their voice wasn’t anything I wanted to hear.

“The best way to start is just to go in and look and listen. And you will figure out where your community or where your niche is. Or you may never say a word. You may just use it to soak in the information, and that’s perfectly fine. The whole world is open to anyone, which is incredible.

“Also, don’t be afraid as a physician in social media to humanize yourself. I put a lot of my garden stuff on my blog and on my Facebook page. I’ll get more ‘likes’ when I post vegetables from my garden than any breast cancer story that I post. And the feedback that I get, both from my patients and from the people that I haven’t met but who follow me online, is ‘Oh, my gosh, the doctor is a real person.’”

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.

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 Phase III 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, 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

Surgical techniques have also improved, so that in women undergoing a lumpectomy, oncoplastic techniques can be utilized, which combine removal of the tumor with plastic surgery techniques to improve the cosmetic results. In patients that require or opt for mastectomy, a skin-sparing and nipple-sparing approach may be utilized in selected patients. This surgery, combined with immediate reconstruction, results in a more natural appearance after mastectomy.

Cryoablation is an non-surgical technique that has been evaluated in clinical trials, and has been shown to be effective for certain small breast cancers. Additional studies are underway, and this procedure may in fact replace surgery in certain patients.

Women Have New Options for Breast Cancer Surgery

One problem with traditional breast surgery is the inability to fully assess whether or not all cancer has been removed at the time of lumpectomy. It is important that a clear margin, or rim of tissue around the tumor, is obtained. This information cannot always be obtained in the operating room. The MarginProbe device is used in the operating room, and can detect cancer cells within 1 millimeter of the surgical margin. If a positive reading is detected, additional tissue can be removed at that time, decreasing the possibility that the patient will need another operation. The device is accurate in approximately 70% of cases, and has been shown to significantly reduce the rate of re-operation after lumpectomy.

The panel was moderated by Liza Bernstein and I was joined by Dr. Ann Becker-Schutte. We discussed how as clinicians our practice and interaction with both our patients and patient communities has been impacted by our involvement in social media, specifically the Breast Cancer / Social Media (#BCSM) tweet chats. Ann and I are both very involved in the Breast Cancer Social Media Community, which was started in 2011 by Jody Schoger and Alicia Staley. The #BCSM community has served as a model for other on-line health communities, and a key feature which sets it apart is that it is more than a “support group.” The #BCSM tweetchat has always included key stakeholders in anyone’s breast cancer journey, including medical and radiation oncologists, nurses, surgeons, mental health professionals, as well as patients, advocates, caregivers, researchers, and more. Always at the forefront is the goal of providing education and support in a welcoming and non-threatening environment.

While more and more physicians are interacting with their patients on Twitter and in other forums, this is not routinely integrated into psychology or surgery practices. Ann and I had the opportunity to discuss why we initially opened Twitter accounts, how we got involved in a growing patient community, and how our on-line presence and interactions have impacted our clinical practices.

Many thanks to Dr. Chu and the planning committee of MedicineX for asking us to participate in this discussion, and to Liza for serving as an excellent moderator.

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.

The findings highlight the need for doctors to take the time to explain the true risks and benefits of CPM, Pamela R. Portschy, MD, and Todd M. Tuttle, MD, from the University of Minnesota in Minneapolis, Minnesota, write in an accompanying editorial.

The 10-year cumulative risk for contralateral breast cancer is only 4% to 5%, the editorialists note, citing other research. In addition, “CPM is not likely to improve breast cancer survival rates.”

“The apparent discordance between patient perceptions and realistic expectations provides a teachable opportunity for physicians treating newly diagnosed patients with breast cancer,” the editorialists write, adding that the women in the study identified physicians as the most important source of information about CPM.

The study authors do not want their participants to be judged for their beliefs. “The purpose of our study was not to pass judgment on these women, because for some, for example those with BRCA mutations, it may be the right decision,” lead author Shoshana M. Rosenberg, ScD, MPH, from the Susan F. Smith Center for Women’s Cancers at the Dana-Farber Cancer Institute in Boston, told Medscape Medical News.

“Our aim was to really understand why women are deciding, in greater and greater numbers, to have this surgery,” she explained.

Nonetheless, there is more at stake for these women than just undergoing an extra surgery.

A recent study of 4200 breast cancer patients, presented at the annual meeting of the American Society of Breast Surgeons in May, found that women opting for CPM had twice as many postoperative complications as those opting for a single mastectomy.

Doctors Are Most Important Sources of Information

In their study, Dr. Rosenberg and her team surveyed 123 women from 8 academic and community hospitals in eastern Massachusetts who had early-stage cancer in 1 breast but who elected to have both of their breasts removed.

The women were part of a larger cohort study of 550 women diagnosed with early-stage breast cancer in 1 breast only from November 2006 to November 2010.

All the women were 40 years of age or younger at the time they were diagnosed; 26% had a first-degree relative and 62% had a second- or third-degree relative who had been diagnosed with breast or ovarian cancer. About one quarter of the women had a BRCA1 or BRCA2 gene mutation.

A 23-item questionnaire was administered to the women who reported having a bilateral mastectomy. They were asked how they made their decision to have bilateral mastectomy and about their knowledge, perception of risk, and breast cancer worry.

The vast majority (95%) said that the decision to remove the healthy breast gave them peace of mind.

The women also reported that doctors were their most important source of information when they were making their decision. More than half of the respondents (68 women) indicated that they were the first to bring up the issue of CPM. Half of the women reported that their physicians discussed reasons not to have the surgery.

A third of women reported that the number of surgeries or procedures needed was higher than they expected, and 42% reported that their sense of sexuality was worse than they expected after surgery. A similar percentage of women reported that they felt self-conscious about their appearance.

Removing the healthy breast might be the right decision for some women, Dr. Rosenberg emphasized. “But,” she said, “we want to make sure they are making this decision in a setting where it’s informed, and also where they are supported. Obviously, when you get a breast cancer diagnosis, it’s a very anxious time; there are a lot of worries, fears, and concerns. We think these issues should be addressed. The decision-making process needs to be supported.”

Women Not Making Well-Informed Decisions

In an interview with Medscape Medical News, Dr. Tuttle, one of the editorialists, said he is very concerned that women do not appear to be making well-informed decisions about their care.

“Many women have unrealistic expectations of what having their opposite breast removed will do,” he said.

“We did a study that was published last year in which the women we interviewed thought their average risk of getting cancer in the opposite breast over 10 years was more than 30%, when the actual risk is about 4% to 5%. The take-home message from this study, which is a great study, is that physicians need to take time and explain the facts to their patients.”

Dense Breasts a Factor?

The decision-making process for women newly diagnosed with breast cancer is extremely complex, according to Deanna J. Attai, MD, a surgeon and director of the Center for Breast Care in Burbank, California.

Physicians might wonder why so many women are choosing CPM or even mastectomy for early-stage cancer, but their patients do provide some answers, Dr. Attai told Medscape Medical News.

“There is no question that many women make their decision based on fear and an inflated sense of risk,” she said.

Dr. Attai pointed out that most of the women felt that the worry that subsequent screenings would fail to detect a contralateral breast cancer was a very important factor in making their decision, but she noted that this was not stressed by the study authors.

“Personally, I think this is a big factor. This study evaluated women under 40. There is no question that most women under 40 have relatively dense breast tissue, and there is no question that mammography is less sensitive in these women. Many younger women detect their breast cancer when it is palpable,” she said. “If your cancer was not picked up on a mammogram, you have very little faith that future mammograms would be helpful in detecting a contralateral cancer.”

Dr. Attai also said that a 40-year-old woman’s risk of developing a contralateral breast cancer could be more than 20%, assuming that she lives to age 80. But, “with chemotherapy and endocrine therapy, that risk can be less than 10%,” she added.

Dr. Attai said that breast cancer surgeons attempt to present all of the facts about surgery to their patients. “We tell them that the potential complication rate of the surgery can be as high as 50%, including the issues of unplanned operations, less than ideal cosmetic results, sexual side effects, and self-image issues,” she explained. “I also tell my patients that a 10% to 20% risk of developing a contralateral breast cancer also is an 80% to 90% chance of not developing a contralateral breast cancer.”

Dr. Attai said she is very direct with patients who come into her office initially saying they want a CPM.

“I tell them they need to hear me out while we discuss the realities of no increased survival, overestimation of risk, and so on,” she said.

One Real-World Example

Dr. Attai offered the following recent example from her practice.

“The patient is in her early 40s and her stage I breast cancer was detected on a screening mammogram. She came to me wanting bilateral mastectomy. She had seen 2 other breast surgeons and had opinions from 3 plastic surgeons,” Dr. Attai recounted. The patient was “well-informed” about the lack of survival benefit, the low risk of developing a contralateral breast cancer, and the potential complications (including self-image, sexual) of this surgery.

However, 2 of the patient’s friends had been treated for breast cancer with lumpectomy and radiation, and their experiences colored the patient’s outlook. “One was diagnosed with a contralateral breast cancer 18 months later, and then opted for bilateral mastectomy. She had horrible problems with healing on the radiated side and underwent 2 or 3 other procedures,” Dr. Attai explained. “The other friend had a lumpectomy and radiation and has a severely contracted treated breast, which is very hard and fibrotic. She has seen multiple reconstructive surgeons who have informed her of the complexity of her case and that any attempt at reconstruction is likely to result in several procedures.”

“None of these women have a family history of breast cancer or are BRCA positive. My patient told me today that she knew she made the right decision for herself, and the experience of her friends reinforced that,” Dr. Attai said.

“No matter how much we educate patients, we cannot take away their personal experiences. Because breast cancer is so common, everyone knows someone who has been treated, and there are always horror stories. I think acknowledging and discussing a patient’s personal experiences and biases is extremely important. Some of that can be overcome by education, but not all,” she added.

Dr. Rosenberg, Dr. Tuttle, and Dr. Attai have disclosed no relevant financial relationships.

Ann Intern Med. 2013;159:428-429. Abstract, Editorial