Category: Breast Health

Does the Mammography Debate Miss a Key Point?

Posted on by Greg Dennis

Every time the US Preventive Services Task Force issues a recommendation about when women should start getting mammograms – and how often they should have these screenings – it sends shockwaves through the breast-cancer world.

modiglianiThis last time was no different.

But now two influential breast cancer experts assert that – as important as the debate is – it misses an essential point about evaluating a woman’s individual risk of getting breast cancer.

Those experts – Dallas breast surgeon Dr. Peter Beitsch and Nashville breast surgeon Dr. Pat Whitworth – say the key question is how to evaluate “risk.”

The latest recommendations from the task force call for women at “average risk for breast cancer” to begin every-other-year screening at age 50. It casts doubt on the true value of screening beginning at age 40 – citing the high number of false-positive test results in women 40 to 50, plus potential harm from overdiagnosis and unnecessary treatment. Continue reading “Does the Mammography Debate Miss a Key Point?” →

IORT with Oncoplastic Surgery: A Beautiful Combination?

Posted on by Greg Dennis
Julie Reiland SOS 2016 (1)
Julie Reiland, MD, FACS

Breast cancer care continues to see remarkable growth in knowledge of the disease and advances in treatment. That was certainly evident at the recent School of Oncoplastic Surgery (SOS), in Dallas last month.

The school, which was founded by breast surgeon Gail Lebovic, M.D. with a grant from the Mary Kay Ash Foundation, recently had its eighth annual session in Dallas. This year’s session was sponsored by the National Consortium of Breast Centers and the American Society of Breast Disease Clinical Track.

Among the highlights of that three-day training workshop was a talk by Julie Reiland, MD, FACS. An SOS faculty member, Dr. Reiland is a breast surgeon at Avera Medical Group Comprehensive Breast Care, in Sioux Falls, SD. Speaking to a packed room at SOS, Dr. Reiland talked about the convergence of oncoplastic surgery and intraoperative radiation therapy (IORT).

In particular she talked about Continue reading “IORT with Oncoplastic Surgery: A Beautiful Combination?” →

Brighter Days for Ambulatory Surgery Centers with Innovative Breast Care

Posted on by Greg Dennis

Ambulatory surgery centers face plenty of financial (some might even say “existential”) challenges. Among these are a tightening reimbursement environment, competition from hospital systems, and high health insurance deductibles.

Cross in OR - XL-2
Dr. Michael Cross is establishing an international reputation for innovations in breast cancer surgery.

Nonetheless, breast cancer care is emerging as a bright spot for ASCs, including two centers we talked with recently.

In a large New York City surgery center, for example, breast care helps lead the way. In an Arkansas center, transparent pricing and use of a relatively new surgical marker called BioZorb are part of the story.

First, though, let’s talk about those challenges.

“The changes in healthcare have been accelerated with passage of the 2010 Affordable Care Act, a.k.a. Obamacare, the expansion of Medicaid programs, an economy that is improving at a slower than normal rate, and stagnant increases in wages,” Laura Dyrda wrote recently in Becker’s ASC Review, “Reimbursement is in flux for many surgical specialties,” and high-deductible Continue reading “Brighter Days for Ambulatory Surgery Centers with Innovative Breast Care” →

School of Oncoplastic Surgery Shows the Way to Better Breast Cancer Care

Posted on by Greg Dennis
Dr. Gail Lebovic
Dr. Gail Lebovic founded the School of Oncoplastic Surgery

Among the many improvements in the care of women who have breast cancer, one of the most promising is oncoplastic surgery.

This approach combines methods to remove cancer with reconstructive techniques to insure complete tumor control. At same time it achieves better aesthetic outcomes.

This month’s upcoming School of Oncoplastic Surgery will help surgeons develop new skills they can use when performing breast-conserving surgery (lumpectomy) on patients with breast cancer. The three-day course will be held Jan. 22-24, 2016 in Dallas.

The 2016 version of the school is sponsored by the National Consortium of Breast Centers, the Senologic International Society, and the Postgraduate Institute for Medicine.

The course provides a spectrum of skills for attendees. Through a sculpture lab, anatomy lab and interaction with live models, surgeons learn essential tools with hands-on experiences. Panel discussions and case presentations also allow surgeons to openly discuss challenges they face in their practices, and to learn various ways to address complex clinical situations in cancer care.

The founder and leader of the school is Dr. Gail Lebovic. She’s a past president of the American Society of Breast Disease, recipient of several distinguished awards and the inventor of multiple successful medical technologies in women’s healthcare.

Continue reading “School of Oncoplastic Surgery Shows the Way to Better Breast Cancer Care” →

ASCO Meeting Features First Independent Comparison of Breast Cancer Genomic Tests

Posted on by Greg Dennis

The combined MammaPrint and BluePrint genomic tests provide more information about the specifics of breast cancer than does the older, 21-gene test, according to the first independent assessment comparing the assays. That study was among the major new findings about breast cancer molecular diagnostics – also called genomic tests – emerging from this year’s recent annual meeting of the American Society of Clinical Oncology (ASCO).

Brufsky for DD blogAlso featured at ASCO were new insights about breast cancer in African-American women, drawn from research with MammaPrint and BluePrint conducted in the nation’s capital.

Together, the 70-gene MammaPrint and 80-gene BluePrint tests definitively categorize patients as Low Risk or High Risk for breast cancer recurrence and provide additional information about the specific biology of the cancer. The older and less sophisticated 21-gene test, on the other hand, stratifies patients into three risk-recurrence categories: Low Risk, High Risk, and Intermediate. Continue reading “ASCO Meeting Features First Independent Comparison of Breast Cancer Genomic Tests” →

Novel 3-D Marker Is ‘Game Changer’ for Post-Surgical Radiation Therapy

Posted on by Greg Dennis

When most of the business news is about big companies, it’s easy to forgeGreen glove with BZt that there’s still room for a little guy with a great idea. Medical device maker Focal Therapeutics is clearly one of the latter, as a new scientific presentation underlines. The presentation was given at the 2014 Breast Cancer Coordinated Care (BC3) conference, held in February in Washington D.C.

Focal Therapeutics developed the BioZorb™ three-dimensional surgical marker, to help identify the surgical excision site following soft tissue removal, such as breast lumpectomy cavities.  The marker makes it possible for physicians to visualize the surgical region post-surgery. This helps to improve clinical precision for post-operative treatments and follow-up.

To understand the difference this makes, consider a woman who has just had a lumpectomy and now needs post-surgical radiation to prevent her cancer from returning. Once this 3D marker is placed by her surgeon, her radiation oncologist can locate the exact site more precisely, clinicians can better target the radiation (thereby decreasing the volume of tissue that receives radiation minimizing radiation exposure to nearby healthy areas such as the heart and lungs.

The presentation showed BioZorb as an alternative to traditional tissue landmarks such as seroma and clips as well as post-operative density changes seen on CT scans done for treatment planning. The results were dramatic. The device enabled physicians to achieve a greater-than-50% percent reduction in planned treatment volume, according to poster co-author Robert R. Kuske, Jr., M.D. Dr. Kuske is an internationally known radiation oncologist who uses BioZorb in his medical practice at Arizona Breast Cancer Specialists.

What’s more, there appeared to be no downside to using the BioZorb marker. Patients tolerated placement of the device without complications, and cosmetic outcomes were excellent.

With traditional methods, treatment planners have to do a certain amount of guesswork and treat a bigger area because the borders of the area needing treatment aren’t obvious. That can mean a higher radiation dose, more risk to healthy tissue and organs, and negative impacts on the patient’s appearance.

Co-author Linda Smith, M.D. of Comprehensive Breast Care in Albuquerque, N.M. said “It was a revelation to see the surgical edges so clearly with the BioZorb device in place.” Read more about the presentation here.

Dr. Gail Lebovic
Dr. Gail Lebovic

BioZorb’s inventors appear to be true visionaries, because there’s no other device like theirs in the medical marketplace. Unlike other markers, BioZorb defines the treatment area in three dimensions. Its unique open spiral is made of a bioabsorbable material, which means the patient’s body absorbs it slowly over time. That makes surgical removal after completion of therapy unnecessary.

Dowling & Dennis has worked with Focal Therapeutics’ George Hermann, president and CEO, Gail Lebovic, M.A., M.D., FACS, the company’s chief medical officer, as they have created several innovative devices in breasthealth. From all appearances, BioZorb is extending their career-long hot streak.

Wise Foundation Receives Grant from Association for Vascular Access

Posted on by Greg Dennis

One of the pleasures of working in healthcare PR is the opportunity to work with nonprofit organizations. We’ve done this in the fields of breast cancer, prostate cancer and vascular access.

Having worked previously for the Association for Vascular Access (AVA), last year we began supporting the efforts of AVA’s research and education arm, the Wise Foundation.

AVA and the foundation ended the year on a high note, with the announcement of a major grant from AVA to the foundation. The $50,000 grant, given in honor of AVA’s membership, underlines AVA’s support for the foundation’s mission. The grant also strengthens the foundation’s outreach to other major funders.

For more on the grant and the foundation’s work, see Wise Foundation Grant from AVA. Additional info on the foundation and a current grant opportunity available at http://www.wisefoundation.net.

Breast Cancer Media Teleconference

Posted on by Greg Dennis

Shortcomings of the New Study on Breast Cancer Brachytherapy (APBI): What Women Need to Know Now

On December 13, 2011, four of the world’s leading clinical researchers in breast brachytherapy gathered to provide statements and discuss a controversial new study on APBI presented at the 2011 San Antonio Breast Cancer Symposium.

Featuring:
• Robert Kuske, MD, (Scottsdale, AZ) Co-Principal Investigator, NSABP B-39 study comparing five-day APBI to six-week whole breast irradiation
• Peter D. Beitsch, MD, FACS, (Dallas, TX) Co-Principal Investigator of the American Society of Breast Surgeons’ MammoSite Registry
• Jayant Vaidya, MD, (London, U.K.), pioneer of targeted intraoperative radiotherapy (IORT)
• Rakesh Patel, MD, (Pleasanton, CA), Chairman, American Brachytherapy Society

Stream audio of teleconference

Background:
The study was based on Medicare billing claims for more than 130,000 patients over the age of 66 who were diagnosed with early stage breast cancer between 2000 and 2007 and received a lumpectomy and radiation.

Many members of the medical community have spoken out against the study since it was presented. In particular, many physicians object to mastectomy being considered a validated surrogate for local failure, contending that there are many indications for mastectomy unrelated to APBI, such as a new primary cancer or elsewhere failure, and that claims data do not provide sufficient clinical information to draw such conclusions. In addition, the study claimed brachytherapy was associated with higher rates of infection and increased toxicity which is contrary to results of several published clinical trials on brachytherapy.

Read statements of concern from the major medical societies involved in the research and use of APBI – American Society of Breast Surgeons, American Brachytherapy Society (PDF) and American Society of Radiation Oncology.

MD’s Criticize Breast Brachytherapy Study

Posted on by Greg Dennis

A controversial study on breast brachytherapy (APBI) presented last week at the San Antionio Breast Cancer Symposium has prompted deep concern among APBI experts. They worry that breast cancer patients who are good candidates for APBI modalities such as SAVI, MammoSite and IORT will be scared off the therapy, by what the experts say is an inaccurate and misleading study.

Below are statements by three of these internationally know experts, prepared for a Dec. 13, 2011 teleconference they organized to challenge the study findings.

“Shortcomings of the New Study on Breast Cancer

Brachytherapy (APBI): What Women Need to Know Now”

  Robert Kuske, MD, FAACE:

 — Co-Principal Investigator, NSABP B-39 study comparing five-day APBI to six-week whole breast irradiation.

Partial breast irradiation (PBI) was begun in New Orleans in 1991 by myself and colleagues at the Ochsner Clinic, and has been one of the most studied treatments for breast cancer over the past 20 years.  Numerous publications have shown PBI to be safe and effective for select early stage breast cancer patients. As a result of promising phase 2 clinical trials and two favorable randomized prospective clinical trials (scientifically the “Gold Standard”), there has been growing interest in using PBI. Accelerated PBI (APBI) treats only the part of the breast affected by cancer and the treatment time is decreased from several weeks to four or five days. For decades, whole-breast irradiation (WBI), where radiation is delivered every day for five to eight weeks, has been the standard treatment for patients with early breast cancer treated with breast conserving surgery.

APBI has several benefits, including a decreased overall treatment time and a decrease in the radiation delivered to healthy tissue and adjacent organs.  To document its long-term safety and effectiveness compared to WBI, we await the results of the other 7 randomized trials comparing APBI with WBI.

I am concerned about the potential misinterpretation of data presented last week at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium regarding breast cancer patients who received brachytherapy, or accelerated partial breast irradiation (APBI). These data have serious limitations, and should not influence current treatment recommendations for women with early stage breast cancer fitting current eligibility criteria for PBI.

This study, based on Medicare claims data, demonstrated a small 1.8% increase in the rate of mastectomies in patients treated with APBI compared with those treated with conventional whole breast external beam irradiation. Note that the rate of documented recurrences of breast cancer after treatment is not reported.  In either case the rate of mastectomy is still very low (2.2 to 4%), and should be contrasted with the 35 to 40% recurrence rate after lumpectomy without any radiotherapy.

The data presented in San Antonio was drawn from records of patients varying risk factors and stage treated between 2000 and 2007. Doctors choose treatments for their patients based on cancer extent, grade, surgical margins, and other factors such as obesity, diabetes, and age.  This study failed to take these important tumor and patient issues into account, and is therefore biased. This study is a good example of why it is important to be selective in choosing which patients receive the accelerated treatment.

The PBI treatment given in this study is an antiquated balloon catheter with a single channel. Since that time, technology has dramatically improved including the use of newer multichannel applicators with tighter dose constraints. The side effects and toxicity seen with these modern technological advances are far better than the results presented in this study.

This study should encourage enrollment in clinical trials, especially NSABP B-39/RTOG 0413, a National Cancer Institute-sponsored, randomized prospective phase 3 trial. In the meantime, doctors and patients should not limit their options, and should continue to consider a 5-day alternative to conventional 6-7 weeks of whole breast irradiation to conserve the breast.

Peter Beitsch, MD, FACS:

— Co-Principal Investigator of the American Society of Breast Surgeons’ MammoSite Registry.

The study presented by at the San Antonio Breast Cancer Symposium has garnered a tremendous amount of print and Internet media attention. After reading the abstract (paper not in press yet), seeing the talk live in San Antonio, and discussing the study with many colleagues in breast surgery and radiation oncology, I want to try to clarify the data on APBI, and discuss the “information” in the abstract and the hyperbole in the lay press that is distressing our patients.

First and unequivocally, accelerated partial breast irradiation is a safe and effective form of treating the breast after appropriately performed lumpectomy in patients over age 45-50 with early-stage invasive (typically <3cm primaries and lymph node negative) and non-invasive breast cancer.  Numerous retrospective studies and two prospective randomized studies (the gold standard) have shown no difference in survival, local-regional cancer recurrence rates and complications between APBI and whole breast irradiation (WBI).  The American Society of Breast Surgeons’ MammoSite Registry has published more than 16 papers showing the safety and efficacy (comparable to WBI) of MammoSite APBI.

The San Antonio abstract and presentation were drawn from the Medicare claims-SEER database, which is a large database with cancer-patient data linked to Medicare claims data.  The database is managed by the National Cancer Institute and sold to institutions to do research.  The linked database has information about cancer type and treatments, but it has no specific data on margin status, prognostic factors such as estrogen receptor/progesterone receptor (ER/PR) and HER2/Neu receptor — or even local, regional or distant recurrence.

The study stated that “subsequent mastectomy” is a “validated surrogate for local failure,” but I am unaware of any literature that states this.  The “two-fold increased risk for subsequent mastectomy” is misleading and inaccurate. (It s 4.0% for APBI vs. 2.2% for WBI in their study).  Both of these rates are quite small, and it is questionable whether there is any clinical significance between the two.  Not emphasized but equally important are the overall survival rates for APBI vs. WBI, which were equivalent.

The study also stated that infections were higher for APBI (not surprising since it involves the insertion of one or more catheters in the breast), but there is no statement regarding severity (were the APBI patients just placed on prophylactic antibiotics and is that how an infection was defined?).  Fat necrosis and breast pain were also significantly higher in the APBI group, although there is absolutely no uniform definition of what fat necrosis is nor a statement about the severity of the fat necrosis or breast pain.

Lastly, the researchers state there was a 9.6% hospitalization rate for APBI patients vs. 5.7% for WBI patients.  This is puzzling since no diagnosis was given for hospitalization nor was there information on the time period over which patients were hospitalized. Was hospitalization APBI-related (doubtful) or related to first chemotherapy cycle (perhaps) or other unrelated health issues? (It’s worth noting that APBI is often used in older, sicker patients who may not be candidates for six to seven weeks of WBI).

In summary, this retrospective study of an inherently inaccurate database (no data on tumor characteristics and margin status — both known to be significant determiners of local recurrence), with questionable outcomes (admission rate) and non-validated “surrogate endpoints” (subsequent mastectomy=local recurrence) should be looked at with appropriate skepticism in the face of 20 years of retrospective studies and two prospective randomized trials to the contrary.

Jayant Vaidya, MD:

— Pioneer of targeted intraoperative radiotherapy (IORT).

We have performed a prospective randomized phase III trial, which is considered the highest level of scientific evidence.

We have shown with the TARGIT approach (risk-adapted partial breast radiotherapy with a single dose of radiotherapy during breast conserving surgery) that the local recurrence rate is very low (about 1% after 4 years). This rate is non-inferior to the standard approach, which was used in half of the more than 2000 patients.

This supports the concept of PBI in selected (e.g., older) patients with small tumors.

Also important was that the toxicity was not higher with the new approach. The rates of clinically relevant toxicity were about 3% in both treatment arms.  Toxicity is highly dependent on how radiation is delivered, i.e. treatment device, dose, dose rate, fractionation and target volume concept.

– End –