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Frequently Asked Questions

How many women have been treated with MammoSite Therapy?

Over 50,000 patients in the United States have been treated with MammoSite 5-Day Targeted Radiation Therapy4.

You can hear some of their stories at www.VoicesofMammoSite.com

How do I know if MammoSite Therapy is right for a patient?

MammoSite 5-Day Targeted Radiation Therapy is recommended for women with early-stage breast cancer. The American Society of Breast Surgeons, the American Brachytherapy Society, the American Society for Radiation Oncology and the American College of Radiation Oncology each have published guidelines relating to patient selection.9,10,11,12 have published guidelines relating to patient selection.

To view or print these guidelines, Click here

How long has the MammoSite Radiation Therapy System been available?

The MammoSite Radiation Therapy System received FDA clearance in 2002 and has been used to treat over 50,000 women since then4.

Is there clinical trial data to support use of the MammoSite Radiation Therapy System?

The 5-year results of the initial MammoSite clinical trial involving 43 patients are now available, as is data from other studies.

5-Year Initial Clinical Trial Results (N=43)6

  • No local recurrences
  • 83.3% of patients had good/excellent cosmetic results
  • 100% of patients would recommend MammoSite Therapy to a friend or family member
  • 100% of patients would use MammoSite Therapy if they had to do it over

The American Society of Breast Surgeons MammoSite Registry Trial 513 (N=1440)

44 month follow-up of the first 400 consecutive cases

  • Local recurrence rates between 0 -2.65%
  • Cancer-specific survival of 100.0%

DCIS: Phase II Clinical Study (12 institutions)14

Fifteen-month mean results (n=100)

  • 3.0% local recurrence rate (1 Elsewhere; 2 True Recurrence, Marginal Miss)
  • 95% of patients had good/excellent cosmetic results

Is reimbursement available for MammoSite Therapy?

MammoSite 5-Day Targeted Radiation Therapy is reimbursed by Medicare and a majority of private insurers. In fact, there are over 220 million covered lives for MammoSite Therapy.4 Click here for more details on reimbursement.

How is patient satisfaction for MammoSite 5-Day Targeted Radiation Therapy?

  • 100% of patients in the initial clinical trial would recommend MammoSite Therapy to a friend or family member.6
  • 100% of patients in the initial clinical trial would use MammoSite Therapy if they had to do it over.6

Even qualified candidates may not complete the 5-day therapy due to varying clinical conditions. In that event, it is necessary to advise your patients about alternate treatment options.

Many women who have had MammoSite Therapy are participating in the Voices of MammoSite web community to share their stories so that other women are aware of this radiation treatment option. Click here to learn more: www.VoicesofMammoSite.com.

What is the training process for MammoSite 5-Day Targeted Radiation Therapy?

Web-based training modules are available anytime for convenience of scheduling. Click here to learn more.

In addition, proctor programs are available. Through the proctor programs, you can receive observational training at a proctor’s site or have a visiting proctor on site at your location during initial cases.

For more information on MammoSite training, click here.  

What is the local recurrence rate with MammoSite Therapy?  What is the local recurrence rate with whole breast irradiation?

The MammoSite Radiation Therapy System 5-year initial clinical trial data show no local recurrences.6

The ASBS MammoSite registry demonstrated local recurrence rates between 0 -2.65% at four years in the first 400 consecutive patients.13

In the NSABP-06 trial, the local recurrence rate for whole breast radiation therapy at 5 years was 7.7%.15

How is cosmesis in patients who are treated with MammoSite Therapy?

In the initial MammoSite clinical trial 5-year data, 83.3% of patients had good/excellent cosmetic results.6

What is the infection rate with MammoSite Therapy?

According to a scientific paper published in the American Journal of Surgery in 2004, the expected infection rate for patients undergoing breast conservation therapy ranges between 3.6% and 14.3%.16 Per the clinical study data shown below, MammoSite falls well within this range.

The use of prophylactic antibiotics may help to prevent or minimize infection.

 

ASBS Registry Study17

Initial Clinical Study5

Rush18

# Patients

1419

43

112

Infection rate (%)

8.1

4.7

6.3


Is MammoSite Therapy an appropriate treatment option for women with DCIS?

ASBS Patient Registry: DCIS Subset

  • DCIS patients comprise 13% of enrolled registry study patients

 

# Patients Treated

Follow up

% Local Recurrence 4yr actuarial IBTR

Comment

Jeruss19

169

7.35 mo
1 yr=43

0

Keisch20

192

48 mo

2.45

Three of the failures were true recurrences (1.33% four year actuarial)

Vicini21

194

30.1 mo

0.59 (n=3)


MammoSite Phase II DCIS Study

  • 12 participating institutions
  • 100 patients treated

 

# Patients

Follow up

Recurrence (%)

Other

Benitez22

100 (treated 133 enrolled)

9.5 mo

In Breast: 2 pts
1 TRMM
1 Elsewhere

Both patients have characteristics for high risk of recurrence

Streeter23

100 (treated 133 enrolled)

15 mo

In Breast: 3 pts
2 TRMM
1 Elsewhere

All recurrences 'noninvasive'
Cosmesis: G/E 95%


What is the Cavity Evaluation Device (CED) and when do I use it?

The MammoSite CED is a simple 4–5 cm spherical single-lumen, silicone device. The CED may be used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite RTS applicator. It may be used during surgery to assess skin spacing and conformance. The MammoSite CED may also be left in the lumpectomy cavity as a placeholder until it is exchanged for the MammoSite RTS applicator.

Click on the link below to learn more about the Cavity Evaluation Device. In this video, Peter W. Blumencranz, M.D describes his Surgical Keys to Success Using the MammoSite® Cavity Evaluation Device.

http://www.orlive.com/hol/videos/my-surgical-keys-to-success2

What should I do if a patient has symptomatic persistent seromas with the use of MammoSite Targeted Radiation Therapy?

Physicians must use their clinical judgment to determine the protocol that is best for their particular patient.

Click here to listen to one physician’s experience:

Dr. Alison Laidley talks about her experience with seromas.

Video IconManaging Seromas when they develop

MammoSite Targeted Radiation Therapy: Adobe Flash Player

Who else is using MammoSite 5-Day Targeted Radiation Therapy?

To find out which physicians are using MammoSite 5-Day Radiation Therapy, click here.

My treatment center does not have access to a High Dose Rate (HDR) Afterloader. How do I get one?

A Hologic field representative can put you in contact with the key vendors for HDR units. Click here to be contacted by a representative who can help you.

What are the Advantages of MammoSite Multi-Lumen?

MammoSite Multi-Lumen is a single insertion 4 lumen balloon brachytherapy applicator. It has the ability to shift radiation dose for improved patient outcomes. The multiple offset lumens allow for dosimetric optimization that provide coverage to targeted tissue while minimizing radiation dose to skin surface and chest wall.

When should I use MammoSite Multi-Lumen vs. Single Lumen MammoSite?

Multi-Lumen can be used when there is a need to optimize radiation does relative to skin distance and chest wall proximity.

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