Category: Breast Health

Breast Cancer Alert: Teleconference on 12/13

Posted on by Greg Dennis

Shortcomings & Patient Concerns re: New Study of Breast Brachytherapy (APBI) –

What Women Need to Know Now

Tuesday, Dec. 13, 2011

Noon EST

Call-in number:  1-480-629-9712

Please join us via teleconference to hear statements and discussion by four of the world’s leading clinical researchers in breast brachytherapy (accelerated partial breast irradiation, or APBI).

These experts will highlight their concerns about a controversial — and potentially misleading — new study on APBI presented at last week’s San Antonio Breast Cancer Symposium. They will also provide perspective on what women need to know now about breast cancer radiation therapy.

The teleconference will feature:

Robert Kuske, MD, (Phoenix) Co-Principal Investigator, NSABP B-39 study comparing five-day APBI to six-week whole breast irradiation

Peter D. Beitsch, MD, (Dallas) Co-Principal Investigator of the American Society of Breast Surgeons’ MammoSite Registry

Jayant Viadya, MD, (London, U.K.), pioneer of targeted intraoperative radiotherapy (IORT)

Rakesh Patel, MD, (Pleasanton, Ca.), Chairman, American Brachytherapy Society

This event is open to the first 50 participants, including media and other interested parties.

(Note to media: To ensure your place on the call, please contact Liz Dowling, tel. 415-388-2794; Liz@dowlingdennis.net.)

Problems with New Breast Cancer Radiation Study

Posted on by Greg Dennis

There’s plenty of controversy about – and disagreement with – a new study from MD Anderson (MDA). One expert MD even said the study’s flaws were not trivial, but “huge.”

The study said women who got an older form of breast brachytherapy appear to have slightly higher rates of complications and subsequent mastectomy. Presented at this week’s San Antonio Breast Cancer Symposium, it was a “look-back” at Medicare records.

The MDA conclusions have prompted unusually strenuous objections from physicians who support and perform breast brachytherapy.

Breast brachytherapy, a form of accelerated partial breast irradiation (APBI), is increasingly popular because of its clinical efficacy for appropriate patients, and because it takes just 5 days.

By comparison, the standard course of external-beam, whole-breast irradiation (WBI) takes six or seven weeks. Many early-stage breast cancer patients increasingly express a preference for the far more convenient approach of APBI.

Follow-up radiation is recommended for women who have a lumpectomy as part of breast-conservation therapy. APBI now accounts for an estimated 13% of patients undergoing treatment in 2007, according to MDA’s Dr. Benjamin D. Smith, lead author of the study.

But are the study’s conclusions valid? And what are doctors saying to their patients about breast cancer treatment – especially given that the study data covers a period before more sophisticated APBI became available? (After all, even MD Anderson isn’t changing the way it offers APBI.)

“Criticism of the study surfaced almost immediately,” noted the respected radiology website AuntMinnie.com. “One critique was that the study is based on an analysis of Medicare billing codes rather than actual clinical outcomes.” Medicare claims data is often not a reliable measure of clinical effectiveness.

Also weighing in was the American Society of Breast Surgeons, which represents physicians who place the catheters that deliver breast brachytherapy.

ASBrS maintains a registry of 1440 patients treated by APBI with the balloon catheter device through 2004. It statement said numerous published studies have shown:

— A 5-year local cancer-recurrence rate of <5%, comparable to that of WBI;

— A low rate of other complications with APBI; and

— Good or excellent cosmetic results in approximately 90% of patients.

ASBrS noted that several randomized and nonrandomized studies using another technique of APBI — multiple interstitial catheters — have also seen rates of local cancer recurrence comparable to WBI.

For the record, Dowling & Dennis represents a company that makes one of those multiple interstitial catheters. It’s called SAVI – and it was developed to address the shortcomings of earlier brachytherapy technology, the one examined in the MDA study.

For more information on the experiences of women who’ve had SAVI treatment, see SAVI Sisters. Study data on SAVI is available here. In particular see the peer-reviewed, published results in the respected Red Journal (abstract available here.)

Other concerns about the MD Anderson study include:

— “Patients in this study received antiquated technology,” according to Robert Kuske, M.D., the principal investigator in a landmark trial comparing breast brachytherapy to traditional WBI. “Single-lumen balloons are being replaced with newer multichannel devices that allow much greater control of the radiation dose received by skin or ribs.”

— Said Dr. Frank Vicini, “All this study tells us is that when billing codes are analyzed, there appear to be differences in outcomes based upon billing-code surrogates for clinical outcomes. You can’t turn something nonclinical into clinical.”

Dr. Vicini is a Michigan radiation oncologist who publishes outcomes data comparing 199 APBI patients to 199 patients getting conventional treatment.

“Although the authors acknowledge the flaws in their study, these are not trivial,” he told AuntMinnie. “In my opinion, they are huge.”

So how should women and their families regard the controversial new study?

In urging breast cancer patients to participate in clinical studies when possible, the American Society of Breast Surgeons had this to say:

“The evidence in the MD Anderson study should be considered in pre-surgical counseling — but is not strong enough to preclude the use of APBI in properly selected patients.”

Dr. Attai on New Breast Cancer Report

Posted on by Greg Dennis

A new report in the journal Breast Cancer Research underscores the value of exercising, avoiding obesity and moderating alcohol intake.


Breast surgeon Deanna Attai, M.D. notes that the research points toward these factors and lowering breast cancer risk – even in women with a family history of breast cancer.


Moreover, slimming down helps breast cancer patients themselves. “Women who reduce weight after being diagnosed with breast cancer will reduce their risk of recurrence,” said Dr. Attai.


Yardsticks for the research were the American Cancer Society’s recommendations:


  • At least 20 minutes of vigorous exercise five days a week.
  • Normal body weight or body mass index of 18.5 to under 25.
  • No more than one alcoholic beverage a day.

Dr. Attai, who is also known as a leader in the use of accelerated partial breast irradiation (APBI) and the SAVI applicator, discussed the new research findings on KABC-TV. More on that here: http://tinyurl.com/3ylcgnt.

SAVI Breast Cancer Radiation Highlighted at ASTRO

Posted on by Greg Dennis

The SAVI breast brachytherapy applicator made by Cianna Medical continues to pile up favorable research results. A new study concludes SAVI is the only appropriate brachytherapy solution for patients with small breasts, hard-to-reach lumpectomy cavities, or cavities closed to the skin surface.
Physicist and lead researcher Serban Morcovescu, MS, DABR, presented these findings at the recent annual conference of the American Society for Radiation Oncology (ASTRO).

“The SAVI 6-1Mini applicator is the only implant solution for small lumpectomy volumes,” he said.” Research from Morcovescu, a medical physicist at Texas Oncology Denton, in Denton, Texas, was one of three posters on SAVI presented at ASTRO.

While SAVI comes in several sizes, the SAVI 6-1Mini was specifically designed to deliver radiation to small or hard-to-treat lumpectomy cavities. Unlike other breast brachytherapy devices – including others that have multiple catheters – SAVI is not limited by restrictions on skin spacing or cavity volume. Its design enables physicians to carefully direct and modulate the radiation dose.

SAVI is implemented as part of breast conservation therapy (surgery to remove cancer and follow-up radiation) — in this case, radiation delivered inside the breast by brachytherapy. SAVI treatment is completed in just five days compared to the 6 weeks of treatment, 5 days a week, required by traditional, external-beam radiation.

For more information, call (toll-free) 866-920-9444 or visit http://www.CiannaMedical.com.

EARLY Act on Breast Cancer Gains ACS Support

Posted on by Greg Dennis

The EARLY Act is making progress toward passage in the Congress. To learn more about the bill and register your support with your senators, visit http://earlyactawareness.org. Thanks to recent changes, the bill is now supported by the American Cancer Society.

Dowling & Dennis has been working with the nonprofit Tigerlily Foundation and NeoMatrix, makers of the HALO Breast Pap Test, to get this legislation passed. Among other activities we have:

* Assisted the Tigerlily Foundation with a major Capitol Hill event; and
* Worked with breast surgeon Ernie Bodai, MD, to place his op-ed piece in the Sacramento Bee.
* Done outreach to all the major breast cancer advocacy and clinical organizations;
* Helped create the EARLY Act Website;

This valuable legislation would provide federal funding for educating young women and healthcare professionals about breast cancer in women 45 and younger. That age group accounts for more than 5% of the total breast cancer cases in the US every single year. The bill provides for $45 million in funding over five years.

Along with Tigerlily, NeoMatrix is committed to educating young women about what they can do to avoid breast cancer, and how they can assess their individual risk of getting the disease – thereby taking steps to potentially protect themselves against ever getting breast cancer.

Rep. Debbie Wasserman Schultz, herself a breast cancer survivor, is the original author of the bill. It’s being carried in the Senate by Amy Klobuchar. The EARLY Act has more than 360 cosponsors in the House and more than 30 in the Senate.

For the latest info, check http://earlyactawareness.org.

Excelsior, Novian Added as New Clients

Posted on by Greg Dennis

We’re happy to report that even in the economic downturn, we’ve added two new clients:

* Excelsior Medical is a leading maker of prefilled catheter flush syringes. The company is also launching an exciting new technology called SwabCap™. This product promises to pioneer more effective prevention of potentially deadly catheter-related bloodstream infections.

SwabCap provides passive, verifiable disinfection of the top and threads of luer access valves. These valves are a critical part of providing IV medication and nutrition. Both the Joint Commission and SHEA/IDSA Compendium have new guidelines calling for hospitals to have a specific disinfection protocol– meaning Excelsior expects strong demand for SwabCap as part of the company’s focus on preventing intra-luminal contamination of catheters. http://www.ExcelsiorMedical.com

*Novian Health makes the Novilase™ laser ablation device to treat fibroadenomas of the breast. These non-cancerous lumps are a troubling breast health problem for many women. Novilase provides a minimally invasive alternative to surgical lumpectomy, with no scarring and less infection risk. Novilase is FDA-cleared for treating fibroadenomas. http://novianhealth.com