31 January 2018

In women who undergo lumpectomy for breast cancer, the likelihood of another cancer developing in the treated breast can range from 0.2 – 1.0% per year, and this rate can be decreased with the addition of endocrine therapy such as tamoxifen or an aromatase inhibitor. The likelihood of developing a contralateral (opposite side) breast cancer is about 0.6% per year, and can also be reduced by endocrine therapy. Prior to making a decision on lumpectomy versus mastectomy, women commonly ask about the possible need for additional biopsies and procedures.

A study published in JAMA Surgery reviewed 2 large insurance databases to determine the frequency of breast biopsy after breast cancer treatment. Over 120,000 cases were analyzed. The researchers found that 15-23% of patients underwent subsequent biopsies during the 10 year period evaluated. 20-30% of these patients underwent additional cancer treatment.  Factors associated with lower biopsy rates included the use of endocrine therapy and older age. The use of partial breast irradiation (brachytherapy) was associated with a higher biopsy rate.

As this was an insurance claims database review (review of billing codes, not actual patient charts or medical records), it is not possible to know if biopsies were performed on the side of initial cancer or the opposite side, except in patients initially treated by mastectomy. In addition, a limitation of all claims database studies is that if the billing and diagnosis codes are not correctly entered, the information obtained will not be accurate. However, given the large number of claims reviewed, this study at least provides an estimate for patients to use when weighing the options of lumpectomy or mastectomy.

1 January 2018

The American Joint Committee on Cancer (AJCC) has recently updated the staging system used for breast cancer. Cancer stage refers to the amount of cancer (size of the main tumor, spread to lymph nodes or other areas). The definitions of each stage vary depending on cancer type. Cancer stage often correlates with outcomes, and treatment recommendations usually take into account stage of disease.

As our knowledge of tumor biology increases, it has become clear that stage is not the only factor that impacts prognosis. Tumor biology and behavior are very important, and in some cases may be more important than stage. A small tumor with aggressive behavior characteristics may may result in worse outcomes compared to a larger, but slower growing cancer. The 8th version of the AJCC staging system for breast cancer now takes into account tumor biology. Factors such as cell grade, ER/PR and Her2/neu status, and even the results of tumor genomic tests will be incorporated into the clinical and pathological prognostic stage. Taking into account these biologic factors means that the stage will have more meaningful prognostic information. Some larger tumors will now be considered stage I, and some smaller lesions will be upstaged based on their biology. In a large validation study performed by researchers at the University of Texas MD Anderson Cancer Center, 31% of patients were upstaged, and 20% of patients were downstaged. The updated prognostic stage performed better (in terms of predicting patient outcomes) than the standard anatomic stage.

The new staging system will take some getting used to. The tables used to help determine clinical and pathologic prognostic stage are 5-6 pages long. However, this new system will give us more meaningful information in terms of prognosis and outcomes. Just please be patient with your physician when you ask “what is my stage?” – it is no longer a simple question!

Additional Information:
American Cancer Society CA Cancer Journal: Breast Cancer – Major Changes in the AJCC 8th Edition

26 December 2017

A study recently published in the Journal of the American College of Surgeons evaluated patient perceptions regarding knowledge about their breast cancer surgery. An online survey was distributed via email to patients who had participated in previous online surveys and had agreed to be contacted again. Enrollment quotas were set for geographic area, insurance status, and income level to try to achieve a varied sample population. In the analyzed sample, 215 patients underwent lumpectomy, 140 underwent mastectomy, and 132 reported that they had undergone both procedures.

The study showed that only 47% of patients who underwent a lumpectomy and 67% who underwent a mastectomy felt fully informed about their treatment choice. About 30% of patients who underwent lumpectomy or mastectomy and about 20% of those who underwent both procedures felt that making a quick treatment decision was more important than thoroughly researching all of the options. The majority of patients reported that they “somewhat” or “strongly” felt that more time would be helpful to make their decision.

60% of patients who underwent lumpectomy obtained a 2nd surgical opinion. 45% of mastectomy and 87% of patients who underwent both procedures obtained a 2nd surgical opinion. Over 50% of women reported receiving additional information from other physicians, websites, and family / friends. A little over 30% of patients sought out information from online blogs and discussion groups.

The study has several limitations, the most important being that a variable amount of time might have elapsed from the time of the patient’s surgery to the time of the survey, and responses may have been influenced by “recall bias”. In addition, the patient population was primarily Caucasian and college-educated. However, this study along with other research clearly shows that we have a long way to go in terms of better informing our patients about their surgical options for breast cancer treatment. This study also shows that patients still feel a sense of urgency to make quick decisions about their treatment.

Physicians are under increasing pressure to see more patients, which limits the amount of time available for each consultation. However, physicians have a responsibility to ensure that patients receive a balanced discussion of their options and need to make themselves available to answer questions. Patients should not feel pressured to make quick decisions, and 2nd opinions can be helpful prior to making a final decision. The authors conclude that “Patients who are completely informed of all their treatment options will make higher-quality shared decisions about treatment and will experience better long-term survivorship outcomes” and I couldn’t agree more.

19 December 2017

Up to 70% of patients treated for breast cancer experience some degree of cognitive dysfunction (more commonly known as “chemobrain”) during and immediately after treatment, and the symptoms may persist in up to 15-25% of patients. The impact on quality of life and ability to work varies; patients may experience forgetfulness, challenges with multitasking, and difficulty finding words and may even struggle to learn new information. Older patients are more likely to be affected but any patient who has been treated with chemotherapy or even endocrine therapy may note changes in mental function. Multiple factors contribute to the development of cognitive dysfunction, including toxicity of the chemotherapy agents specific to the brain and nervous system as well as other medical conditions, genetic factors and aging. The diagram below is from a recent review in the Journal of Oncology Practice (Lange, Joly) and demonstrates the complex interactions:

Persistent cognitive impairment after treatment can have significant negative effects including reduced adherence to oral medications, diminished self-confidence, and negative impacts on personal and work relationships. It can be challenging, especially in older patients, to sort out which symptoms are related to treatment versus aging and possible neurologic disease.

Unfortunately, while there has been an awareness about treatment related cognitive impairment for some time (especially among patients!) this is a relatively new area for research. An editorial accompanying the Journal of Oncology Practice article (Vardy, Dhillon) notes that as the specific mechanisms by which cognitive dysfunction develop are not known, there are few evidence-based recommendations for prevention or treatment. In addition, studies often show little correlation between a patient’s subjective assessment of their cognitive function and performance on a standardized test designed to be more objective. Factors such as anxiety, depression, and fatigue are associated with (patient) perceived cognitive impairment, but are only weakly associated with objective measures of impairment.

Complicating matters further, the authors note that cognitive rehabilitation programs have been shown to improve subjective cognitive function, but the results are mixed regarding improvement in objective measures.

A second editorial (Baer) provided some practical guidance. The author recommended that physicians work with their patients to review and streamline medication lists, eliminating medications for anxiety, pain and sleep if no longer needed. Basic lifestyle patterns such as sleep habits and diet and exercise routines should be discussed. Patients should be encouraged to start a daily exercise program (with physical therapy referral if needed). Laboratory studies to assess for anemia, vitamin deficiencies and thyroid function should also be performed with corrective action taken if indicated. Coordination with the patient’s primary care physician should take place to ensure that other medical problems such as diabetes, hypertension, and sleep apnea are controlled as much as possible. If depression and/or significant anxiety are present, these need to be addressed and treated. Yoga and other meditative practices have also been suggested.

Additional research is certainly needed. In the meantime, patients should should realize first that the changes they are experiencing are real. Patients should be encouraged to discuss their symptoms and possible solutions with their treatment team.

The articles referenced above are behind a “paywall”. If anyone is interested in the full text article please feel free to email me: contact at drattai dot com and I will be happy to provide them.

9 November 2017

In patients with a common form of breast cancer, known as estrogen receptor (ER) “positive”, endocrine therapy is often recommended after other treatments such as surgery, chemotherapy, and radiation are complete. Tamoxifen, most commonly used in pre-menopausal women, blocks the estrogen receptor on the breast cell, so estrogen cannot impact cell growth. In post-menopausal women, aromatase inhibitors (AI) are commonly used – these medications block the production of estrogen in the fat cells – a primary source of estrogen after menopause. Historically, these medications have been used for 5 years after completion of other treatment, although there are some studies suggesting longer courses may benefit certain patients. However, longer courses of therapy are associated with a higher incidence of side effects.

A study just published in the New England Journal of Medicine demonstrated that after 5 years of endocrine therapy, patients have an increasing risk of breast cancer recurrence with long term follow up. The authors evaluated individual patient data from a large database of randomized trials. They found that in patients with stage I tumors (tumor less than 2 centimeters and no lymph node involvement) the 20 year risk of recurrence was approximately 13%. In patients with 4-9 involved nodes, the risk ranged from 34-41% depending on the size of the main tumor.

This study is important as it confirms what many of us see in our practices – that breast cancer can and does recur, even many years after therapy. However, it also raises an important discussion point about our treatments. Studies have estimated that as many as 30% of women prescribed endocrine therapy stop treatment due to side effects which significantly interfere with quality of life such as menopausal symptoms, bone and joint pains, bone loss (osteoporosis) and fracture, and mental status changes (“chemobrain”). Patients should discuss any of these symptoms, especially if they are considering stopping their medication, with their physicians. Lifestyle changes, exercise programs, and medications may be of benefit. It is also important to understand that despite all appropriate treatment, cancer can and does come back – so health maintenance and surveillance are important even long after cancer therapy has ended.

24 October 2017

A national survey performed by the American Society of Clinical Oncology showed that many Americans are unaware of key cancer risk factors, including obesity, alcohol, lack of exercise, tobacco use and sun exposure. While doing “everything right” certainly is no guarantee of a healthy life (for example, many patients who develop lung cancer do not smoke) being aware of the lifestyle factors associated with cancer may lead to better health choices. In addition, all of these lifestyle factors are also associated with a lower likelihood of heart disease, diabetes, and other illness.

An additional finding of the survey was that 27% of respondents noted that either they or an immediate family member (who has / had cancer) took specific actions to decrease treatment costs including skipping appointments, postponed or didn’t fill prescriptions, skipped cancer medication doses, or cut cancer medications in half. We cannot hope to improve cancer outcomes without addressing the issues of cost of care and disparities in access to care.

12 September 2017

A common misconception among patients is that more aggressive surgery for breast cancer leads to better outcomes. In fact, nothing could be further from the truth. The standard operation for breast cancer for years (up until the 1960-70s) was the Halsted radical mastectomy, during which the breast, pectoralis muscle of the chest, and underarm lymph nodes were all removed. Randomized trials then showed that less aggressive surgery, including lumpectomy, resulted in similar survival rates as the more extensive procedure. Axillary lymph node dissection, or removal of a large number of underarm lymph nodes, was also a standard procedure for any patient with breast cancer. Studies performed in the late 1980s reported on the accuracy of the sentinel node biopsy technique, which involves removal of only a few targeted underarm lymph nodes. Adoption of that procedure resulted in decreased rates of arm swelling (lymphedema) and did not negatively impact recurrence or survival rates.

Up until about 10 years ago, it was standard practice to test the sentinel nodes in the operating room and if cancer cells were found, complete axillary dissection would be performed. Published in 2011, the American College of Surgeons Oncology Group Z11 study showed that the addition of axillary dissection did not impact local recurrence (cancer coming back in the underarm) or survival rates. This changed practice immediately – and many more women were spared from undergoing full lymph node removal. The 10 year follow up results to Z11 were just published, and confirm the earlier studies noting similar disease-free and overall survival in patients undergoing sentinel node biopsy alone.

It is important to note that the “Z11 criteria” do not include all patients. Women in the study had early stage breast cancers, were “clinically node negative” (not able to feel any underarm lymph nodes), and only had 1 or 2 involved sentinel nodes. All patients in the study had lumpectomy, followed by chemotherapy and radiation. Patients with more than 2 involved lymph nodes, patients who are being treated by mastectomy, or those who receive chemotherapy or hormonal therapy prior to surgery still may need to undergo the more extensive axillary node dissection. Studies are ongoing to see if we can minimize surgical therapy in these patient populations, because over the years, we have found that more aggressive surgery only leads to more complications, not better outcomes.

Additional Information:
The Atlantic – How Clinical Trials Saved Women With Breast Cancer From Disfiguring Surgery (2013)

18 August 2017

Approximately 15%  of women diagnosed with breast cancer will be found to carry a mutation in one or more genes that significantly increases the risk of developing breast and other cancers. The most common mutations are in the BRCA1 and BRCA2 genes. These genes are tumor suppressor genes – if mutated, they do not function properly and can result in a higher likelihood of cancer development. Most often, we see these abnormal gene mutations in women under the age of 50, and in those with a strong family history of breast and/or ovarian cancer. However, because the mutation may be present in a family member without disease, guidelines recommend testing even without a family history in patients that meet criteria (NCI BRCA1 / BRCA2 Genetic Testing Fact Sheet).

A study recently published in the Journal of Clinical Oncology found that fewer than 1 in 5 women with a history of breast or ovarian cancer underwent genetic testing, and many had not discussed the possibility with their treatment team. Identifying a genetic abnormality can change the surgical recommendations in a patient who has been diagnosed with breast cancer (such as considering double mastectomy due to increased future risk) as well as have implications for family members. Take a few minutes to review the fact sheet linked above, and be aware of your family history. If genetic testing is not offered, ask whether or not it should be considered in your case.

8 May 2017

As a past-president of the American Society of Breast Surgeons I am probably more than a little biased. However, as always, the annual meeting held April 26-30th in Las Vegas was terrific. Topics including the full spectrum of breast disease, including benign and high risk lesions, genetic testing, breast cancer diagnosis and treatment including medical and radiation oncology updates, and metastatic disease.

The press briefing highlighted 3 abstracts which showed that:

  • Modern therapy for inflammatory breast cancer is associated with better outcomes than historically seen
  • Post-treatment lymphedema is related to a combination of treatments including surgery, radiation therapy, and chemotherapy – not just from surgery
  • Patients with DCIS have a 5 year risk of developing a cancer in the other breast of 2.8% and a 10 year risk of 5.6%, and patients should be discouraged from undergoing bilateral mastectomy for this condition. Developing a new cancer in the previously treated breast was twice as likely as developing a new cancer in the opposite breast, and the use of tamoxifen reduced the likelihood of any recurrence.

Dr. Nathalie Johnson moderated a pre-meeting course on Building a Breast Cancer Survivorship Program. I was invited to speak on Traditional Versus Virtual – Options for Patient Support and Education. Just as it can be challenging to choose between cake and ice cream (2 really good things), patients note advantages to both in person and online support and education. It doesn’t have to be one or the other – do what works for YOU! My slides are posted on SlideShare.

During the general sessions, a few topics stood out to me:

Dr. Shelley Hwang from Duke University spoke on DCIS subtyping and overtreatment. She noted that DCIS now comprises over 20% of all mammographically detected breast cancer. It is considered a “non-obligate precursor” of invasive cancer – the rate and likelihood of progression to invasive cancer are not clearly known. However, it is clear that some patients will never exhibit progression to invasive disease, and she discussed this in the context of thyroid and prostate cancer – two situations where we know that treatment in some patients will not provide the patient any benefit. The challenge is to sort out which patients will benefit from treatment and which ones will not. The COMET study is currently enrolling patients with low grade DCIS to in an attempt to help answer these questions.

Dr. Virginia Herrmann from Washington University in St. Louis spoke on non-genetic breast cancer risk factors. This is an important topic and I believe one that doesn’t get covered enough. She noted that hormone replacement therapy does increase risk – although the incremental risk is small and is seen only after about 5 years of use. However, longer term use does result in higher risk. Increased body mass index (BMI) is associated with risk – the risk of breast cancer is 30% higher in patients with a BMI greater than 31 kg/m2 compared to a BMI of 20 kg/m2. She noted that there is a linear relationship between alcohol intake and cancer risk, noting a 10% increase in risk for each 10 gm/day (for wine this is a little over 3 oz) increment in alcohol consumption. The risk is most associated with post-menopausal breast cancer, although in the study she quoted, only alcohol intake during age 50s was associated with an increased risk of postmenopausal breast cancer. She noted the association of ionizing radiation and breast cancer, and young women who received mantle (chest area) radiation for Hodgkin’s lymphoma have a markedly increased risk for developing breast cancer. She noted that breast cancer risk is increased in smokers, correlated with smoking intensity and duration. Finally, she noted the increased risk of breast cancer among soldiers stationed at Camp LeJune related to contaminated drinking water (tetrachloroethylene and trichloroethylene).

Dr. Tiffany Traina, a Memorial Sloan Kettering medical oncologist, gave a brief presentation about triple negative breast cancer: Searching For the Magic Bullet. There are several promising treatment strategies including targeting androgen receptors, the use of PARP-inhibitors in patients who have BRCA gene mutations, antibody-drug conjugates, immune modulating approaches, and targeted therapies based on tumor genomic profiles. Stay tuned – much more to come over the next few years related to this aggressive breast cancer subtype.

Dr. Lisa Newman, from the Henry Ford Health System in Detroit, spoke on Breast Cancer Outcomes: Disparities versus Biology. I have heard her speak on this topic multiple times over the years and always enjoy her excellent presentations. She noted that the incidence of breast cancer in black women is increasing, now close to that in white women. However, mortality rates for black women are higher than those for white women. There is an increased frequency of triple negative breast cancer in black women. She is involved in a research initiative evaluating the association between African ancestry and high risk breast cancer in white American women, African American women, and women in Ghana, including studying novel aspects of tumor biology and breast cancer stem cells – she is asking the question “are there differences in the oncogenic potential of mammary tissue that are associated with ancestry”? She concluded with what I felt was a powerful slide – 60% – 43% – 20%. Those were the survival rates for passengers on the Titanic who were in 1st – 2nd – 3rd class. She noted that healthcare outcomes are often dependent on access to care, and ended with a quote from Dr. Martin Luther King, Jr.: “Of all the forms of injustice, inequality in health care is the most shocking and inhumane”.

Dr. Stephen Edge, from the Roswell Park Cancer Institute, gave an update on the new American Joint Commission on Cancer staging system (AJCC 8th edition). Currently we stage breast cancer based on tumor size and lymph node status. However, it is recognized that that tumor biology plays an important role in prognosis and in some patients it may be more important that tumor size. The new staging system will incorporate tumor grade, Her2/neu status, ER/PR status, and Oncotype Dx status (if available) and should more accurately reflect prognosis. There are 422 lines in the new staging system – it will be impossible to memorize! Thankfully, he noted that the AJCC is working on a staging app.

The last day of the meeting held some great sessions, and the meeting room remained packed up until the very last minute. Dr. Ann Partridge from Dana Farber discussed special considerations in the young breast cancer patient. She noted that the disease is different, the patients are different, and the treatments should be different. Younger women have a higher likelihood to have more aggressive subtypes such as Her2/neu over-expressed and triple negative, and have lower survival rates than older women – even in those with the ER positive breast cancer. However, she cautioned not to over-treat patients based only on age. She noted that young age is not a contraindication for breast conservation, and that there is no clear improvement in mortality in patients who undergo more extensive surgery. She noted the need for improvements in treatment and support, including focused research and guidelines, which should lead to better outcomes.

Dr. Irene Wapnir from Stanford spoke on fertility preservation issues. She noted the various fertility options including medications and procedures. She also reviewed the POSITIVE trial, which will be assessing the risk of breast cancer relapse in patients who temporarily stop endocrine therapy to permit pregnancy, as well as to evaluate factors associated with successful pregnancy after interruption of endocrine therapy. She also stressed that fertility preservation should be discussed with any woman of childbearing age, whether or not she has had a prior pregnancy or a child – physicians won’t know what is important to their patients unless we ask!

Dr. Katherina Zabicki Calvillo from Dana Farber discussed breast cancer in pregnancy. She noted that 0.2-4.0% of breast cancers are diagnosed in pregnant patients – about 1 in 3000 pregnancies. She also noted that given the overall delay in childbearing (and the association of increasing age with breast cancer), the incidence of pregnancy-associated breast cancer will increase. Delays in diagnosis are related to hormonal changes which affect breast tissue making the exam more challenging, and that many patients and physicians assume that masses are related to pregnancy. She stressed that pregnancy termination is usually NOT required, but a multidisciplinary team approach is required. Many of these patients present in more advanced stages, but stage-for-stage, the prognosis is similar to non-pregnant patients with breast cancer. Chemotherapy can be given after the first trimester, but hormonal and Her2/neu targeted therapy should be avoided. She noted that mastectomy should be performed in the first and early 2nd trimester, and discussed the challenges of immediate reconstruction. Breast conservation could be considered in the late 2nd or 3rd trimester with post-lumpectomy radiation planned for after delivery.

Dr. Kevin Hughes from the Massachusetts General Hospital reviewed research studies that have found that in women over the age of 70 with early stage breast cancer, radiation therapy after lumpectomy may not be necessary.  The CALGB 9343 study showed that survival rates were the same whether women received radiation therapy or not. Radiation therapy did reduce the likelihood of cancer returning in the breast (local recurrence) from about 4% in the untreated patients to about 1% in the treated patients (after 5 years of follow up). However it is important to realize that the majority of women in that study were treated with endocrine therapy, which can help reduce the risk of local recurrence. As with many decisions regarding breast cancer treatment, a careful discussion of the risks and benefits of each option is necessary.

Dr. Tina Hieken from the Mayo Clinic gave a very interesting talk on the microbiome and the impact on breast cancer. We normally co-exist with many bacteria – we have ten times the more microbial cells compared to human cells. These microbes carry out metabolic reactions that can be essential to human health. The genetic material (genome) of our microorganisms is called the microbiome. She and her colleagues studied breast tissue from women with and without breast cancer and found that the background breast microbiome is different in women with breast cancer compared to those with benign conditions. She concluded by noting that the future may involve using a microbial pattern to predict breast cancer risk, exploiting the microbiome to enhance treatment response, and that there may also be implications for a cancer prevention vaccine. The Washington Post recently covered her research – definitely worth a read for more information.

Dr. Anthony Lucci from MD Anderson discussed the “Ongoing Saga of Circulating Tumor Cells”. We would all like to see the day when a blood test can tell us with certainty if cancer has developed or returned – but we’re not there yet. After reviewing several studies evaluating both circulating tumor cells (CTC) and circulating “cell free” DNA, he concluded that this information does provide prognostic information in both metastatic and non-metastatic patients, but is not in the current ASCO or NCCN guidelines for guiding treatment. Combining the CTC status with response to preoperative chemotherapy may identify a low risk subset of patients, but noted that additional studies are needed before we can reach the ultimate goal which is improving outcomes by monitoring and responding to CTC and cell free DNA levels.

Dr. Manjeet Chadha from Mount Sinai spoke on repeat lumpectomy after prior lumpectomy and breast radiation. Traditionally, mastectomy has been recommended if cancer returns after lumpectomy and radiation therapy. On average, there is about a 10% risk of “in breast” recurrence after lumpectomy and radiation, but this will vary based on tumor and treatment type. She reviewed several studies evaluating the different types of focused or partial breast radiation that may be used in selected patients who experience recurrence of their breast cancer. She also called for additional studies in this area.

One of the last talks was by Dr. Mehra Golshan from Dana Farber. He spoke about the decision whether or not to operate on patients with breast cancer who present with Stage IV (metastatic) disease. Traditionally, we have not recommended surgery for patients with metastatic breast cancer as these patients were not expected to have long survival, and it was not felt that removal of the main tumor would impact survival. Evaluating existing studies has also been challenging because while some have shown a benefit to removal of the main tumor, the patients who underwent surgery in those studies tended to be younger and healthier. He concluded by noting that surgery in patients with Stage IV breast cancer is not standard of care, but some studies do support this practice. It is recommended that these patients be evaluated in a multidisciplinary forum and that treatment choices be individualized.

 I returned from the meeting exhausted but energized. In addition to the scientific content, the meeting is an opportunity to connect with friends and colleagues across the country. I’m already looking forward to ASBrS 2018!

This post has not been endorsed by the American Society of Breast Surgeons.

20 March 2017

Over 50,000 women in the US are diagnosed every year with ductal carcinoma in-situ (DCIS), also known as Stage 0 breast cancer. DCIS is most often diagnosed on screening mammography and usually presents as a cluster of calcium deposits rather than a lump. In cases of DCIS, malignant appearing cells grow within the milk duct, but do not invade through the wall of the milk duct. DCIS is considered to be a “non-obligate precursor” to invasive breast cancer – it has the potential to develop into invasive disease, but this does not happen in all cases. However, we traditionally have treated DCIS and invasive cancer in a similar fashion – with surgery, radiation therapy and endocrine therapy. It has become clear over the past several years that low grade DCIS is likely a different disease compared to high grade DCIS. Aggressive treatment of low grade DCIS may not improve outcomes but has the potential to cause significant harms.

A new clinical trial has opened for patients with low risk DCIS. The COMET Trial (Comparison of Operative to Monitoring and Endocrine Therapy) is currently enrolling patients under the direction of Dr. Shelley Hwang, a breast surgical oncologist at Duke University. Eligible patients will be randomized to guideline concordant care (standard therapy) versus active surveillance. The primary objective is to evaluate the rate of invasive breast cancer development in the active surveillance group. Secondary objectives include assessments of quality of life and anxiety. In addition, clinical outcomes including mastectomy and breast conservation rates, overall survival and breast cancer specific survival, and ipsilateral (same side) invasive breast cancer rates will be assessed.

The COMET study is not the first to evaluate non-operative therapy for DCIS. The LORIS and LORD trials are already enrolling patients in Europe. A UK-funded initiative known as PRECISION (Prevent Ductal Carcinoma In Situ Invasive Overtreatment Now), headed by the Netherlands Cancer Institute, will collaborate with all three trials.

It is always challenging to go against standard treatment, especially when that means less treatment. It took almost 50 years after the death of Sir William Halsted (“Halsted Radical” mastectomy) for surgeons to accept less invasive surgical procedures. Many patients (and physicians) may feel uncomfortable not removing cells that have been labeled “cancer”. It is important to recognize that lack of surgery does not mean no care – “active surveillance” is now an accepted management strategy for some cases of low grade prostate cancer. Our treatments come with real long term side effects and toxicity. The COMET study is a step in the right direction to help determine which patients may safely avoid aggressive treatment.

Additional Information:
DCISOptions.org
DCIS, Continued…
Slideshare – Are We Overtreating DCIS?
CBS News: Dr. Laura Esserman – When is it OK Not to Treat Cancer?
HealthNews Review Podcast: Dr. Laura Esserman – The DCIS Dilemma
HealthNews Review Podcast: Active Surveillance for Prostate Cancer