Frequently Asked Questions
How many women have been treated with MammoSite Therapy?
Over 32,000 patients in the United States have been treated with MammoSite 5-Day Targeted Radiation Therapy5.
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 and the American Brachytherapy Society have published guidelines relating to patient selection.12,13 Click here to see these guidelines – you can print them out as well, so you can determine which of your early-stage breast cancer patients can benefit from this treatment.
How long has the MammoSite Radiation Therapy System been available?
The MammoSite Radiation Therapy System5 received FDA clearance in 2002 and has been used to treat over 32,000 women since then5.
Is there clinical trial data to support use of the MammoSite Radiation Therapy System?
5-year clinical trial data7 involving 43 patients show:
- No local recurrences 8
- 82% of patients had good/excellent cosmetic results9
- 100% of patients in the initial clinical trial would recommend MammoSite Therapy to a friend or family member1
- 100% of patients in the initial clinical trial would use MammoSite Therapy if they had to do it over1
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 180 million covered lives for MammoSite Therapy.5 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.1
- 100% of patients in the initial clinical trial would use MammoSite Therapy if they had to do it over.1
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 data7 show no local recurrences.8
In the NSABP-06 trial, the local recurrence rate for whole breast radiation therapy at 5 years was 7.7%.16
How is cosmesis in patients who are treated with MammoSite Therapy?
In the initial MammoSite clinical trial 5-year data7, 82% of patients had good/excellent cosmetic results.9
What is the infection rate with MammoSite Therapy?
|
ASBS Registry Study17 |
Initial Clinical Study6 |
Rush18 |
VCU19 |
# Patients |
1419 |
43 |
112 |
577 |
Infection rate (%) |
8.1 |
4.7 |
6.3 |
7.0 |
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%.20 Per the clinical study data shown above, MammoSite falls well within this range.
The use of prophylactic antibiotics may help to prevent or minimize infection.
Is MammoSite Therapy an appropriate treatment option for women with DCIS?
Treatment efficacy and cosmesis two years after treatment with MammoSite Therapy in patients with DCIS are excellent.21
ASBS Registry Data DCIS (n=194)14
(21-month median follow-up)
- 93% of patients had good/excellent cosmetic results
- 0.9% local recurrence rate
Phase II Clinical Study DCIS - 12 institutions (n=100)16:
(15-month mean follow-up)
- 95% of patients had good/excellent cosmetic results
- 3.0% local recurrence rate (1 Elsewhere; 2 True Recurrence, Marginal Miss)
Radiation therapy in patients with DCIS reduces the risk of recurrence in the ipsilateral breast by up to 60%.22
Findings continue to indicate that lumpectomy plus radiation is more beneficial than lumpectomy alone for women with localized, mammographically-detected DCIS.23
What is the Cavity Evaluation Device (CED) and when do I use it?
The cavity evaluation device is a single-lumen polyurethane balloon catheter that is used to assess the lumpectomy cavity, allowing the surgeon to determine the appropriate MammoSite balloon catheter to be implanted into the lumpectomy cavity.
Dr. Alison Laidley, breast surgeon, speaks about the Cavity Evaluation Device.
 Using the Cavity Evaluation Device
Video Transcript:
The cavity evaluation device, can be placed into the breast in the operating room, at the conclusion of the lumpectomy procedure. It can be placed into the cavity and the surgeon will be able to get an idea about how the MammoSite is going to finally fit in there, and see how the breast tissue will approximate over this balloon. And at the same time, the surgeon can also put in three or four sutures to approximate the breast tissue or the glandular tissue overlying this device and may even be able--and which would facilitate taking a ruler and actually measuring how much fat and how much breast tissue and subcutaneous fat is overlying the CED
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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.
Managing Seromas when they develop
Video Transcript:
A seroma develops at the lumpectomy site in all patients who have breast conservation. When tissue is removed from the breast, fluid builds up into the cavity. Whether you do whole breast irradiation or partial breast irradiation, this is a natural part of healing in the breast. And with time that fluid is absorbed into the body and the seroma goes away. Again the process of absorption of seroma fluid is part of the healing process and very few patients develop seromas that require any medical intervention. When I see the patient for her one week follow up, I tell her to do some breast massage. I am very strong believer in massage for almost any post-operative wound. The physical act of moving the breast even with light massage helps to increase blood flow to tissues and helps with indurated or firm tissues after surgery to soften. It also increases the absorption of the fluid that has developed after the MammoSite was removed. I personally, in the over 100 patients that I have done MammoSite radiation therapy have had no seromas that have required medical interventions, such as aspiration or antibiotic therapy.
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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 Cytyc 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.
