Caution When Using Robotically-Assisted Surgical Devices in Women’s Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication


Audience

  • People with breast cancer or those at high risk for breast cancer who are considering the surgical removal of one or both breasts (mastectomy) using robotically-assisted surgery
  • People considering robotically-assisted surgery for the prevention or treatment of other cancers
  • Health care providers who perform robotically-assisted procedures as part of cancer prevention or treatment
  • Health care providers who advise patients on the need for mastectomy

Medical Specialties

Breast Surgery, Obstetrics and Gynecology, Gynecological Oncology, General Surgery, Surgical Oncology, Endocrine Surgery, Hepatobiliary Surgery, Thoracic Surgery, Urology, Colorectal Surgery, Medical Oncology, Radiation Oncology, Oncology Nurses, Primary Care.

Device

Robotically-assisted surgical devices enable surgeons to perform a variety of surgical procedures through small cuts (incisions) in a patient’s body. This type of surgery may help reduce pain, blood loss, scarring, infection, and recovery time after surgery in comparison to traditional surgical procedures.

Computer and software technology allow a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in three-dimensional high definition.

Purpose

The FDA takes women’s health issues very seriously. The FDA is issuing this safety communication because it is important for health care providers and patients to understand that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. There is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival. Health care providers and patients should consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider this information to make informed treatment decisions.

Summary of Problem and Scope

Since robotically-assisted surgical devices became available in the US, robotically-assisted surgical procedures were widely adopted because they may allow for quicker recovery and could improve surgical precision. However, the FDA is concerned that health care providers and patients may not be aware that the safety and effectiveness of these devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer. Patients and health care providers should also be aware that the FDA encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.

Current evidence on use of robotically-assisted surgical devices

The safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established. However, the FDA is aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.

To date, the FDA’s evaluation of robotically-assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques. To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.

The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established. The FDA is aware of peer-reviewed literature reporting clinical outcomes for the use of robotically-assisted surgical devices in cancer treatment including one limited report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery). In this report minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared (New England Journal of Medicine, November 2018).

To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer. The labeling for robotically-assisted surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by the FDA.

Recommendations for Patients

Before you have robotically assisted surgery to prevent or treat cancer:

  • Be aware that that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your health care provider to make the most informed treatment decisions.
  • Before choosing your surgeon, we recommend asking the following questions:
    • Ask your surgeon about his or her training, experience, and patient outcomes with robotically-assisted surgical device procedures.
    • Ask how many robotically-assisted surgical procedures like yours he or she has performed.
    • Ask your surgeon about possible complications and how often they happen.

If you had treatment with a robotically-assisted surgical device for any cancerous condition and experienced a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Recommendations for Health Care Providers

  • Understand that the FDA has not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
  • Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.
  • The FDA recommends that you take training for the specific robotically-assisted surgical device procedures you perform.
  • Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically-assisted surgical devices.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
  • Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight. For further information, please refer to the FDA’s Investigational Device Exemption website.
  • If any of your patients experience adverse effects or complications with a robotically-assisted surgical device, we encouraged you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

FDA Actions

  • Robotically-assisted surgical devices are novel and complex systems and the FDA reviews each robotically-assisted surgical device system individually, based on the complexity of the technology and its intended use.
  • The FDA is monitoring adverse events in the literature and reported to the FDA to inform our understanding of the benefits and risks of robotically-assisted surgical devices when used for specific indications.
  • The FDA encourages academic and research institutions, professional societies, robotically-assisted surgical device experts, and manufacturers to establish patient registries to gather data on the use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeon’s learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.
  • The FDA will update this communication if significant new information becomes available.

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with robotically-assisted surgical devices. If you experience adverse events associated with the use of these devices for treatment of cancerous conditions, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

98% Of Mastectomy Patients Would Have Reconstruction Again, Study Says


Women who have breast reconstruction after an mastectomy are satisfied with their decision, have low complication rates and 98% would do it again, reports a study in Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

In addition, breast reconstruction after preventive mastectomy was as safe as, or safer than, reconstruction in women with breast cancer and had excellent cosmetic results.

“Breast cancer is a terrible diagnosis and decisions regarding treatment are never easy. This study shows that women with cancer in one breast who choose to have their other breast removed as a preventive measure are happy with their decision and a high percentage would do it again,” said Scott Spear, MD, study co-author and past ASPS president.

The study examined 74 women who had preventive mastectomies and subsequent breast reconstruction between 2000 and 2005. Forty-seven patients had breast cancer in one breast and elected to surgically remove their other breast (unilateral prophylactic mastectomy). Twenty-seven patients did not have breast cancer, but chose to surgically remove both breasts due to a high-risk of developing breast cancer (bilateral prophylactic mastectomy). The cosmetic outcome was scored by 14 surgeons who looked at post-reconstruction photos and evaluated the result on a 1 to 4 scale (4 being an “excellent” result).

The study found that women who had a bilateral prophylactic mastectomy were 100% satisfied with their breast reconstruction and 100% of them would have the surgery again. 94% of women who had unilateral prophylactic mastectomy were satisfied with their reconstruction and 96% of them would have reconstruction again.

The complication rate for reconstruction in women who had bilateral prophylactic mastectomy was 3% and 10% for those who had unilateral prophylactic mastectomy. Additionally, the study noted the cosmetic assessment for all patients was a score of 3 out of 4.

“These women look and feel the same or better and their risk of cancer has been taken off the table,” said Dr. Spear. “For women who know they are at risk, this option [bilateral prophylactic mastectomy] gives them the opportunity to be active about their health and appearance rather than reactive. They can have excellent cosmetic results, low surgical risk and a high level of satisfaction with their breast reconstruction. This is empowering for women.”

Breast-Conservation or Mastectomy: Should Patients Retain Choice?


Patients with small operable breast cancers are typically given a choice between breast-conservation surgery and mastectomy. The rationale for providing women with the option is that overall survival is thought to be similar between the two strategies. Recent outcomes data, however, seem to tip the scales in favor of breast conservation. Yet other factors, such as a lifetime of surveillance and anxiety associated with testing, lead some women to insist on mastectomy.

In light of the evidence that seems to support better outcomes after breast-conservation surgery, is it still appropriate to give women a choice? This question was tackled in a debate at the 33rd Annual Miami Breast Cancer Conference.

Choice implies that the two options are equal, said one of the speakers, J. Michael Dixon, MD, of the Edinburgh Breast Unit of Western General Hospital of the University of Edinburgh in Scotland, but the evidence is clear that breast conservation is a better therapy than mastectomy, with less morbidity and fewer complications, and long-term outcomes that are at least as good and possibly superior. Dixon reviewed some of that evidence for attendees.

A study by Hwang et al found better overall survival with breast-conservation surgery compared with mastectomy in women with stages I or II breast cancer over 19 years of follow-up (HR 0.81, P<0.0001). Breast conservation plus radiation was equivalent or superior in all age groups in hormone receptor (HR)-negative or -positive disease. Recent evidence from Norway in women with early breast cancer shows worse adjusted breast cancer-specific mortality with mastectomy versus breast-conservation surgery (HR 1.64, 95% CI 1.43-1.88).

In women with invasive breast cancer, overall survival was superior for breast-conservation surgery (HR 0.87, P<0.001) after correcting for disease stage, age, and adjuvant therapies. In a separate analysis of women with invasive breast cancer, mastectomy was associated with an excess adjusted risk of breast cancer-specific mortality (HR 1.7, 95% CI 1.3-2.4) compared with breast conservation regardless of the mode of detection of the cancer.

In an examination of the Dutch Cancer Registry Study, presented at the 2015 San Antonio Breast Cancer Symposium, overall survival was significantly better with breast-conservation surgery compared with mastectomy for any stage of disease.

The perception persists, though, Dixon continued, that mastectomy is associated with a lower rate of recurrence. This perception is contradicted by newer evidence showing that the rate of locoregional recurrence may actually be higher with mastectomy alone, even in patients with a more aggressive disease such as triple-negative breast cancer (TNBC), and that overall survival is perhaps superior to breast conservation in some TNBC patients.

Complications and costs are higher after mastectomy, he noted, particularly when breast reconstruction is performed: “Mastectomy is a poor operation … and should no longer be offered as a choice,” he said.

On the other hand, Patrick Borgen, MD, of Maimonides Medical Center in Brooklyn, N.Y., and the meeting’s program chair, countered in his presentation that although assessment of the Surveillance, Epidemiology, and End Results (SEER) database demonstrated a superior overall survival rate with breast conservation versus mastectomy alone or mastectomy with radiation, the difference was marginal in favor of the former after controlling for tumor size and lymph node status. The slight advantage to breast conservation found in SEER is consistent with the work cited by Dixon, but does not come close to warranting the elimination of mastectomy in the conversation, Borgen said.

Further, the picture is more complex than the small but real improvement in outcomes observed with lumpectomy plus radiation. The complexity of the decision is illustrated by the increase in the rate of mastectomy as a percentage of breast cancer surgeries since 2005, with the greatest growth in the rate of mastectomy occurring in younger women (age 20 to 39) at diagnosis. Women with high levels of anxiety, for instance, have worse mean quality-of-life scores after breast-conservation surgery compared with patients post-mastectomy.

Other data suggest that regret rates after mastectomy are low, said Borgen — “thus demonstrating in the main that women have made a good choice for themselves.”

Accessibility to a radiation oncologist is also an important factor in the choice and receipt of breast-conservation surgery in early-stage breast cancer: Another SEER database analysis found that the odds of having breast-conservation surgery compared with mastectomy were positively correlated with radiation-oncologist density.

Borgen noted that the aesthetic results after breast-conservation surgery affect patients’ satisfaction with the procedure and act to confirm or cast doubt on a woman’s decision to have the procedure. Breast asymmetry was found to be a determinant of patient satisfaction, with women with more pronounced asymmetry less likely to be satisfied with their decision and less likely to be certain about their decision.

Borgen concluded that surgical oncologists should not remove options from their armamentarium based on perceived desirability, but rather, must “strive to openly and completely share the real risks, benefits, and alternatives … in an effort to reconcile a reasonable means to an end for each patient.

Why are more women having mastectomies?


 

In May, Angelina Jolie announced that she was having a double mastectomy even though she was healthy. Since then, according to one British clinic, the number of women requesting a similar operation has risen fourfold. Are women too readily taking on the risk of breast removal?

When Angelina Jolie announced earlier this year that she had undergone a double mastectomy to avoid the risk of breast cancer, she was not alone. The pop singer Michelle Heaton had a similar operation last year – the details of which she shared with viewers of the Lorraine show. And Sharon Osbourne has done it recently, too. When she found out she had a genetic mutation which increased her risk of cancer, she said: “I decided to just take everything off. I didn’t want to live under that cloud.”

It’s a trend, if that’s the right word, that has been rumbling for a while, but it was Jolie’s disclosure which sent shockwaves through the world of cancer care. After her announcement in May, doctors reported that the number of women requesting mastectomies rose steeply.

“The number of women requesting breast-removal surgery rose fourfold [after Jolie’s statement] and the number requesting genetic tests to detect susceptibility was up 67 per cent,” says Professor Kefah Mokbel, of the London Breast Institute at Princess Grace Hospital. “It concerns me that some women will be over-treated.”

Currently about 18,000 mastectomies are performed on the NHS each year in England. That figure has risen by more than 50 percent in the past 10 years. While there is no official figure to show how many of these are preventative operations given to women without cancer, as was the case with Jolie, it is also thought to show a marked increase. Mokbel believes there are two reasons for this: “Fear and desperation.”

“The word cancer strikes such a level of fear that people want to do everything possible to stop it recurring – even if that means more invasive, unnecessary surgery,” he says. “And people such as Angelina Jolie have made it more acceptable. There used to be a stigma associated with the word mastectomy, but not any more.”

In some ways it’s astonishing that this is where we are with cancer treatment in the 21st century. How has something as crude as chopping off body parts become relatively normalised? Just because the medical profession can now carry out good breast implants, is this what we should be offering in terms of “treatment” – bearing in mind that a reconstructed breast has no sensation and is often without nipples? And have we become so risk-averse that removing our breasts is preferable to living with the possibility that one day we might develop cancer?

Mokbel is right about the fear factor. The majority of women interviewed for this piece speak of nothing but the enormous relief the moment they came round from the anaesthetic. “The fear lifted instantly,” says Helen Brown, who had a double mastectomy last year. “Just knowing I didn’t have to face the dread of annual check-ups was hugely liberating.”

Brown, who has breast cancer running in her family, remembers how mastectomies were done in the past. Her aunt, whose five older sisters all contracted breast cancer, had one 30 years ago. “In those days, it was all hushed tones, the big c-word, no one ever even mentioning your breasts,” she says. “There was no reconstruction. Women were savaged by surgeons who didn’t give a monkeys about their long-term care or looks. Stick a couple of pairs of socks in your bra and you’ll be fine, they said. My aunt went from being quite a big lady to having literally no boobs at all. It was quite mutilating.”

Nurse Helen Brown, 40,found a lump when I was 37: 'It was very weird; I had a dream that I'd found one and woke up and checked myself and there it was' (Anna Huix)

Nurse Helen Brown, 40,found a lump when I was 37: ‘It was very weird; I had a dream that I’d found one and woke up and checked myself and there it was’ (Anna Huix)
Dr Andrew Baildam, professor of breast surgery at Barts in London, was one of the first to carry out preventative mastectomies and reconstructions in the UK. “[Ten years ago] it was almost regarded as unethical,” he says. “These are women who don’t even have cancer. A lot of surgeons wouldn’t do it. But as techniques have become more refined, it has become much more routine.”

Baildam estimates that he carries out about 10 operations a year on women without cancer. The most frequent method is the one Jolie opted for, in which the breast tissue is removed and expanders are placed under the pectoral muscles. These little pockets are gradually filled with saline over a few weeks and once enough space is created, the liquid is drained off and implants are inserted. The other method is to take tissue from the stomach or back and use it in a reconstruction. The advantage of this is that, unlike implants, they don’t have to be replaced every 10 to 15 years – but it does leave nasty scars.

“There are technical challenges associated with the surgery,” says Dr Baildam. “These are women who haven’t had cancer and want to look as close as they can to how they did before.”

Which is why the increasing numbers of celebrities apparently cruising so easily through is problematic. Actress Kathy Bates took to Twitter to announce news of her double mastectomy. “I don’t miss my breasts as much as I miss Harry’s Law,” she tweeted cheerfully of the TV series she’d been starring in. The singer Beverley Craven, meanwhile, breezily told the Evening Standard of her three daughters, who have a 50 per cent risk, that, “Once they’ve had babies and breastfed them, they will undergo double mastectomies” – as if their boobs are disposable parts designed to be shed once used.

“We need to be vigilant,” says Mokbel. “We want to be sure women avoid over-estimating the benefits of having this procedure. Sometimes women develop nasty infections or have problems with the implants and end up with disfigurement of the breast. Also, because a reconstructed breast usually has no sensation, it can seriously affect psychosexual function.”

A new study published in the American medical journal Annals of Internal Medicine in September confirms Mokbel’s concerns. The research, carried out by Shoshana Rosenberg at the Dana-Farber Cancer Institute in Boston, discovered that increasing numbers of women with early-stage breast cancer are opting to remove not just the affected breast but the healthy one too. “It’s particularly concerning in young women. They have the highest rates and we are trying to work out why,” says Rosenberg. “Our study suggests the peace-of-mind factor is huge. Even though maybe they have only a very small chance of developing breast cancer in the healthy breast, for some women, any risk is too much.”

Bridgid Nzekwu opted for a double mastectomy after she was diagnosed with breast cancer at the age of 42 and told she had a 25 per cent chance of developing cancer in the other breast. She insisted on having both breasts removed and went through a nine-hour operation in which excess fat was taken from her abdomen to build new ones. It took two weeks before she could stand up because of the tummy tuck, she now needs a further operation to repair some bulgy scar tissue, and currently she has no nipples – yet still, she says, she would tell any woman to do the same.

“I didn’t feel comfortable living with unnecessary risk, and to me 25 per cent was unacceptable,” she says. “Why would you hang around and wait for the cancer to come when you can just get rid of it? Once it was done I felt exhilarated. Now my risk is around 2 per cent.”

While Nzekwu is very happy with her reconstruction, some of the women in Rosenberg’s study were less so. Asking them how they felt after surgery, nearly a third said their confidence about their appearance was worse than they thought it would be, while 42 per cent said their sense of sexuality was worse than expected.

Broadcaster Bridgid Nzekwu, 43, says: 'One of the advantages of having a double mastectomy is that you get a much better result cosmetically' (Anna Huix)

Broadcaster Bridgid Nzekwu, 43, says: ‘One of the advantages of having a double mastectomy is that you get a much better result cosmetically’ (Anna Huix)
“My fear after the Angelina Jolie experience is that a lot of women will step forward and say me too,” says Dr Baildam. “For women of high risk, it is highly effective; we just need to be sure surgery is offered only in the right context.”

Rosenberg agrees. “We are concerned about women who are not high risk who are deciding to do this,” she says. “We need to address the underlying anxiety so these women don’t do anything they regret.”

Plus, concludes Mokbel, there is a lot that can be done to reduce risk before turning to the knife. Exercise routines and changes to diet can reduce the risk from 25 per cent to below 10 per cent. “I don’t think we as doctors can refuse to do it; we just need to ensure women know it’s a massive decision and don’t take it lightly.”

Helen Brown

40, nurse

“I found a lump when I was 37. It was very weird; I had a dream that I’d found one and woke up and checked myself and there it was, exactly where it was in the dream.

“I’ve got a family history of breast cancer, but even so, I still thought they would tell me it was a cyst or an old milk duct. But they said, ‘It’s come to you. You’re going to need a mastectomy next week.’ It was so fast. I felt like I’d jumped on a conveyor belt that I couldn’t get off.

“My brain shut down. I totally lost control. A lot of cancer patients will say this – that the first day of diagnosis is the worst, the moment you hear your death knell. But then four days later the doctor came back and said it was benign. I couldn’t believe it. I had told everyone I knew; I’d called my sister in Australia and made plans for my three children during the treatment.

“That was a turning point for me. I thought, ‘There is no way I’m going to go back to check-ups to go through that again.’ So I booked myself in for a double mastectomy and reconstruction.

“The fear lifted instantly. I remember waking up from the anaesthetic and thinking all that dread, it’s all gone. I went from 85 per cent risk to 5 per cent. It was liberating. And as it turns out, there were some pre-cancerous cells there, so I feel completely justified. Now I have enviable boobs and I kept my nipples.”

Heather Johnson

44, Pilates instructor

“My aunt was diagnosed with breast cancer at 38 and was dead by 43. It hit me hard. My mum was 58 when she was diagnosed. It came back twice; eventually she had a double mastectomy and we thought that was it. Seven years later they found a lump on her reconstructed breast, which is incredibly rare. The breast was removed but when she went for her six-month check they found it had spread to her liver and bones. She died two years ago.

“It was due to my mum’s encouragement that I got a double mastectomy. As soon as I stopped breastfeeding my last child at the age of 32 I went and had a mammogram. I had some benign cysts but the doctor said to me, ‘It’s a matter of when, not if, these lumps become cancerous.’

” I sat down with my husband and said, ‘I don’t want to live with this fear.’ Deciding on a double mastectomy wasn’t difficult after what I’d witnessed with my mum and aunt.

“After the surgery I found it hard to breathe for a while and I certainly found it difficult to look at myself. I was without nipples for two years. You lose something so feminine about yourself.

“I hate it when people tell me how brave I’ve been. I took the easy way out. The women who fight cancer are the brave ones. I’m still amazed that women are so afraid to give up their breasts if cancer is the sure-fire alternative. I would do it again in a heartbeat.”

Bridgid Nzekwu

43, broadcaster

“As a teenager I had Hodgkin’s lymphoma; the treatment was two lots of chemotherapy and a month of daily radiotherapy. In 2007, it was discovered that people who had been through this treatment have a higher-than-normal risk of developing breast cancer. They called me in for annual breast screenings.

“In 2012, they realised a lump I had in my breast had become cancerous. Because I’d had such massive doses of radiotherapy in my teens, the hospital couldn’t give me any more. The only option was to remove my breast.

“I said I wanted both breasts off now. I was 42 at the time and had a three-year-old; I wanted to eliminate my risk. They said it was completely healthy and there was no reason to remove it. So I transferred to another hospital and had both breasts removed and immediate reconstruction.

“One of the advantages of having a double mastectomy is that you get a much better result cosmetically. They look better if they are done at the same time and they are more likely to match. Also, because I’d been through cancer in my teens, I knew I just couldn’t go through it again.

“Now, although I’m taking Tamoxifen [a hormonal therapy used to treat breast cancer], I’m in early-stage menopause; I’m having hot flushes and I’m trying to stave off the weight gain that goes with it. All of that is preferable to not being alive.”

Breast cancer in numbers

1 in 8 women will be diagnosed with breast cancer in their lifetime

136 women a day were diagnosed with breast cancer in 2010

80% of women live for at least five years with breast cancer (it was 50 per cent in the 1970s)

18,000 mastectomies are performed by the NHS each year (up 50 per cent over the past decade)

‘My diagnosis hit me in the face’: readers on living with breast cancer.


The rosy glow of ‘Pinktober‘ is everywhere this month, so we asked Guardian readers how cancer has changed their lives

‘I had chemotherapy during my last two trimesters of pregnancy’

Heidi, breast cancer patientHeidi, 44, Indiana

I was pregnant when diagnosed with breast cancer, and had chemotherapy during my last two trimesters of pregnancy. I’ve had lumpectomies, a mastectomy, reconstruction, oophorectomy, chemotherapy, radiation, and have taken more medicine than I can remember. My son was born healthy, strong and very handsome, in spite of his dangerous start. He is wonderful. Chronic pain and fatigue are constant reminders of my cancer, but knowing I persevered for someone other than myself is the greatest reward.

On ‘Pinktober’: To me, the positive comes from helping other people going through this journey – women, men, children. When one person in a family is diagnosed, they all play a part in what happens after diagnosis. Friends, colleagues or church members all want to help, but are sometimes unsure what to do. I’ve found great comfort in helping people identify those needs.

Also, not all charities actually care about breast cancer patients. Some, horribly, only see cancer as a business model or a strategic plan to help boost product sales or worse, careers. People need to diligently research where their money is going, and if it actually helps patients.

‘Two experiences with breast cancer: my wife’s and my own’

Oliver, breast cancer patientOliver, 47, Houston, Texas

I have two experiences with breast cancer: as caregiver for my wife as she went through treatment six years ago, and my own diagnosis and treatment starting in September 2012. We had near-identical treatments: six months of chemo, mastectomy and then radiation, followed by years of Tamoxifen. Of course the odds of this are small. Sharing this experience has brought us closer in an unexpected way, and we understand each other’s fear of recurrence completely.

On ‘Pinktober’: The stark reality of what breast cancer means to many people gets lost [in awareness campaigns.] The focus is on early stage disease in women, with relatively easy treatment and good outcomes. People are invited to celebrate cancer. For many it is a threat to their well being, even their life. Male breast cancer, metastatic breast cancer, triple negative breast cancer, inflammatory breast cancer and breast cancer in young women all get lost.

‘I tested positive for the BRCA gene mutation’

Lori, breast cancer patientLori, 46, New York, New York

I was diagnosed with breast cancer on 28 March 2011. The tumor was in my left breast and was an invasive ductal carcinoma that was 3.5cm long, Estrogen, Progesterone and HER positive, stage IIB. The only reason I even knew something was wrong was that I had pain in my left breast. I went to the doctor who referred me to a radiologist. I was given a mammogram, an ultrasound and a very, very painful biopsy. After a very long weekend, I was told by phone that I had cancer.

I was presented with three options: a lumpectomy, a single mastectomy, or double mastectomy. The deciding factor would be a test for the BRCA gene mutation, but this would delay any action by at least two weeks. After careful consideration that day, I opted for a double mastectomy. I joked that I had wanted a breast reduction anyway and that it should be a matching pair, but honestly, I had a strong suspicion about how the test would turn out since Ashkenazi (eastern European) Jews, of which I am one, have the highest risk of being a carrier. As it turned out, I was right.

A few nights before the double mastectomy, I decided that the only way to decimate a bully (cancer) is to laugh at it. So I invited my friends to my “Bye Bye Boobies” Party. We spared no insult to the boobies that were making my life hell. A Triple-D red velvet cake, lots of dairy products and a song, set to “Bye Bye Baby” to wish them boobies a long goodbye.

On ‘Pinktober’: It misses the actuality of what breast cancer really is. Pink ribbons infantilize the disease and make it appear to be cute – “Pretty in Pink“. There is nothing about breast cancer that is pretty or pink. More information needs to get out to the public about the genetic factors and environmental factors that cause breast cancer and how we need to address these in a way to put people out of harm’s way.

‘I began to think about this as a journey of silver linings’

Ljuba, breast cancer patientLjuba, 31, Cupertino, California

My breast cancer diagnosis hit me straight in my face. I had given birth to beautiful twin girls nine months prior. Saying that my husband and I had our hands full would be putting it mildly. I got “the call” while being told about a potentially necessary skull surgery for one of my twin daughters. “Do you have some time to talk?” my doctor asked. I knew it before she talked me through the rest. My husband knew just by looking at my face. Talk about curveballs.

Me? Now? I was 31, too young for any routine screening. With two babies and a very aggressively growing tumor. One week it measured at 1cm, three weeks later it was estimated at 4cm. The next couple of weeks revolved around waiting for more tests and appointments, while feeling and seeing the mass in my breast grow. This was my rock bottom. It could only get better from there.

But this is where the unexpected part came in.

My daughter didn’t need the surgery after all and I was referred to one of the best cancer centers in the US. The first word that I heard from my oncologist was “curable”. I was surrounded with a team of doctors, surgeons, nurses, dieticians and genetics specialists. I received my first chemotherapy and suddenly began to think about this as a journey of silver linings. An aggressively growing tumor also meant in my case that it was “hungry” and thus eagerly absorbing the chemo. It was half its size after two treatments. The fast metabolism of a young and otherwise healthy body initially caused the cancer to grow quickly, but on the flip side mastered the task of coping with the side effects of the nuclear cocktails injected into my veins.

I lost my hair and started wearing a wig. Getting ready in the morning became a piece of cake. No endless manoeuvring of styling tools and products – perfect salon hair in seconds. My nails stopped growing and manicures would last for weeks. I had a double mastectomy a month ago and am in the process of plastic reconstruction. I can choose my bra cup size and these babies will never sag – what’s not to like? Sure, there were plenty of “one step forward, two steps back” moments in my journey and I am not at the finish line quite yet, but focusing on maintaining a sense of normalcy in my life (I worked part-time, taking days off for treatment, and most of my colleagues still don’t know of my diagnosis) helped me to get through this. But at the core of everything were the silver linings. They will continue to carry me to the last page of this chapter of my life.

On ‘Pinktober’: While I support awareness initiatives, especially for serious illnesses, breast cancer awareness month here in the US has a slightly foul aftertaste of what we call a Hallmark holiday. Pink ribbons on everything from yogurt to toilet paper. A potentially lethal and devastating disease reduced to a sparkly bumper sticker. And while I am thrilled that a percentage of these funds goes towards research, I can’t get rid of this foul aftertaste.

‘I never had a breakdown cry or questioned why’

Amy, breast cancer patientAmy, 39, Huntsville, Alabama

I found out in April, at age 38, that I had breast cancer. I never had a breakdown cry or questioned why. Surprise! Not even once! It’s not because I’m unaware of how serious cancer is, nor is it because I’m in some denial of what I have or what I could lose. It’s not because I’m especially strong or fearless.

I believe it helps that I look at the entire process through the eyes of acceptance and think about what I’m gaining. I accept that I have cancer and the possible outcomes. I accept that it does not define me. I will gain knowledge and experience from having cancer, as well as gain the ability to display my beliefs and principles, and set a good example for my children and family. I believe the most important life lessons don’t come from easy paths; it’s the struggles that show us what we’re made of.

Cancer throws you into a new world, one that can be consumed by your own existence, pain, and treatment. Finding a way to step outside of yourself and look beyond your own cancer is beneficial. There is good in making time and focusing on others, because someone else always has it worse.

When I look around during any chemotherapy treatment, I see that it could be worse: someone younger, someone older, someone suffering more, someone suffering alone … the list goes on. I have spent every one of my chemo sessions talking to the nurses, doctors and volunteers that come my way. I try to remember something personal about them for when I see them again. I have joked and teased with my chemo buddies and tried to make them laugh and feel better, because often I see how lucky I am when I’m there. I see people of all ages afraid, unsure and worried. I feel fortunate by getting to know someone and find a way to get a smile or laugh out of them, and most of the time I do. That is a gift for me!

Cancer does not define me, how I handle cancer defines me. I am going to keep my crazy positive outlook and feel fortunate that I have the ability to fight cancer.

‘I had to learn to shut out the opinions of other people’

Lana, 52, Denver, Colorado

I had stage two triple negative breast cancer, no metastases. Several friends and family members were mortified that I was going to have chemotherapy. They insisted I should try alternative therapies or homeopathic remedies rather than “put poison in my body”. I know those comments came from a place of fear and love for me, but I soon learned to shut out the opinions of other people and march on with the course of treatment my oncologist told me was the only option to kill “the monster.”

No one really knows what it’s like to have cancer, unless they’ve had cancer. That’s the bottom line. We all do what we have to do, individually, to face it, fight it and move on.

On ‘Pinktober’: There seems to be an ever-growing perception (through marketing messages) that we have control over our bodies and can avoid getting cancer. In turn, that translates to many of us as “if you got breast cancer, you must have done something to get it” – ate too much sugar; had a lousy diet; didn’t exercise, etc. There are many of us out here who did everything right (diet, exercise) and got cancer anyway.

I call it The Cancer Crap Shoot. We don’t carry the identified genes and don’t have a family history. So, I think the emphasis needs to be on empowerment: early detection, learning your risk factors and demanding screening (particularly for women 40 and younger if you are at high risk), and even bypassing traditional diagnostics (going straight to MRI or whole-breast ultrasound if you have dense breast tissue).

Yes, diet and exercise are important, however, other physiological factors have been determined to impact risk and women should be educated about them as well (inflammation; keeping your immune system healthy; learning healthy ways of coping with stress).

‘Damage was done to my brain’

Anne Marie, breast cancer patientAnne Marie, New York, New York 

It has been very difficult for me to accept the limitations caused by whatever damage was done to my brain. I was always super organized and could multitask without any issues. Now, I’m lucky if I pay my bills on time.

Realizing I can’t accomplish half of what I could in the past is disappointing, but the fact that I was forced to change directions from office management to writing has been fulfilling in ways I could not have dreamed possible. I try to focus on the fact that I am doing something I love.

On ‘Pinktober’: Breast cancer research has seen many successes over the past decades. Yet, when it is broken down and really examined, we haven’t made the great strides that are hyped, especially during October as we are strangled by pink ribbons.

Treatment is still barbaric. The fact that early detection doesn’t guarantee the disease won’t spread outside the breast is rarely spoken about. The fact that the death rate is substantially unchanged in over 40 years is another problem. Breast cancer is not the great success story it’s hyped to be, it’s just the one that’s been marketed the best.

Many Women whose Tumors Disappear after Chemotherapy Have Mastectomies.


Many women with breast cancer whose tumors disappear after presurgical chemotherapy have a mastectomy instead of breast-conserving surgery, according to a re-analysis of data from the NeoALTTO trial. The results were presented September 30 at the 2012 European Society for Medical Oncology Congress(ESMO).

In the phase III trial, investigators randomly assigned women with HER2-positive breast cancer to receive trastuzumab, lapatinib, or both drugs for a total of 18 weeks prior to surgery. (Both drugs target the HER2 receptor.) After the first 6 weeks, paclitaxel chemotherapy was added to the anti-HER2 treatments.

In 160 of 429 women, the tumors disappeared (a pathologic complete response). But whether a woman had a pathologic complete response did not influence the type of surgery she had later. Although women receiving all three drugs were up to twice as likely to have their tumors disappear as women who received only a single anti-HER2 drug plus paclitaxel, they were no more likely to have breast-conserving surgery than a mastectomy.

Instead, the ultimate choice of surgery type was more strongly influenced by the characteristics of the tumor before chemotherapy, including the initial tumor size and whether the tumor expressed the estrogen receptor, as well as the type of surgery originally planned and whether the cancer was multifocal or multicentric.

One of the main goals of presurgical (neoadjuvant) chemotherapy is to “downstage” larger tumors to allow less-aggressive surgery. Therefore, “there is a need for a clear consensus on the role of breast-conserving surgery, especially in patients who respond to neoadjuvant therapy,” said lead investigator Dr. Carmen Criscitiello, of the European Institute of Oncology in Milan, Italy, at an ESMO press conference.

“This will ultimately translate…into improved breast-conservation rates, [and] could spare more women from receiving radical treatment like mastectomy,” she concluded.

Source: NCI.