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Discovering North Carolina

October 2005

Options for Local Treatment of Breast Carcinoma

Breast cancer treatment can be broadly divided into local and systemic treatment. Many women receive systemic treatment—hormones and/or chemotherapy—to destroy cancer cells that may be present throughout the body. Treatment of the cancer in the breast is considered local therapy. One treatment involves removing the breast (a mastectomy) while the other treatment involves removing a portion of the breast which contains the lump of tumor (a lumpectomy). The lumpectomy is then followed by radiation to destroy other cancer cells which may be left behind in the breast. This type of treatment is called breast conservation therapy (or BCT). Both local treatments are equally effective in curing the breast cancer.

Following a lumpectomy, the majority of patients in this country receive external beam radiation which treats the entire breast. This type of treatment is considered the standard of care in this country. The treatment involves 25 to 35 treatments delivered over 5 to 7 weeks. The treatments take 10 to 15 minutes and require a daily trip to the radiation therapy center.

For patients with small breast tumors which have not spread to the lymph nodes, doctors have investigated treating a portion of the breast using internal radiation (brachytherapy). It does not treat the entire breast, but treats the area of the breast where a recurrence is most likely. This radiation can usually be delivered in 5 days with two treatments given everyday.

The initial use of brachytherapy involved using multiple catheters (10 to 25 depending on the volume which required radiation) which were implanted around the site of the lumpectomy. Radioactive seeds were then temporarily placed within these catheters to deliver the treatment. Several studies of this technique in North America have shown low rates of recurrence in the breast, similar to whole breast external beam radiation. Several medical centers currently use this type of brachytherapy. One of the disadvantages of this type of brachytherapy is that the placement of multiple catheters is technically difficult, can be uncomfortable and may leave permanent marks in the skin. The MammoSite® Radiation Therapy System (RTS) was developed to deliver radiation to the area of the lumpectomy from the inside out without having to insert catheters. This system of brachytherapy was shown to be safe and was approved for use by the FDA in May 2002. Preliminary data suggests that this system is as effective as the multiple catheter system in preventing recurrences in the breast, but the system has not been used long enough to show this with certainty. To minimize failures using the MammoSite® RTS, patients are carefully selected to try to insure that they are the best candidates for this type of breast radiation. Because the safety and effectiveness of the MammoSite® RTS as a replacement for whole breast irradiation in the treatment of breast cancer has not been established, we would like you to participate in a research study if you elect to be treated with the MammoSite® RTS. This research study will allow us to collect information on the outcome of your treatment.

The MammoSite® Radiation Therapy System (RTS) has the following potential advantages:

1. It places the radiation inside the lumpectomy cavity (the space left when a tumor is removed). The radiation is targeted to the area where cancer is most likely to recur.

2. Radiation is delivered from within the cavity, limiting the amount of radiation to healthy tissue, thereby reducing the potential for side effects.

3. The therapy can be completed in 5 days.

The MammoSite® RTS has been carefully evaluated in a clinical trial. Following treatment, patients did experience minor breast-related side effects such as redness, bruising, and breast pain. Rarely, the skin overlying the catheter developed a temporary ulceration. Some patients also experienced drainage from the insertion site. These are common side effects of breast surgery and/or radiation therapy. They usually last for only a short time. Patient feedback about the MammoSite® RTS was positive. When asked, each of the 19 study patients surveyed said she would choose the MammoSite® RTS again, and all would recommend the MammoSite® RTS to a friend or family member.

Description of Procedure

After lumpectomy, an uninflated MammoSite® RTS balloon is placed inside the tumor resection cavity. The applicator shaft, a tube connected to the balloon, remains outside the breast. The MammoSite® RTS can be inserted either:

• During the lumpectomy procedure (at the same time the tumor is removed)
• In a separate procedure under local anesthesia up to 10 weeks after the lumpectomy (this is the most likely time for insertion)

Once in place, the balloon is inflated with sterile salt water and a contrast agent which are inserted through the applicator. (The contrast agent helps your doctor see the MammoSite® balloon more clearly.) The balloon is filled to fit the edges of the cavity. The balloon remains inflated for the entire time you are receiving radiation therapy (usually 5 days). After the MammoSite® RTS is inserted and inflated, that area of the breast is cleaned and bandaged and you may go home.

Before beginning radiation treatments, a planning session is performed to calculate the dose of radiation and to make sure that radiation can be safely delivered. Rarely, the MammoSite® balloon will be too close to the skin or not positioned correctly, and it may not be possible to treat you with the MammoSite® RTS technique. External beam radiation may be an option if this is the case. If the planning session is satisfactorily completed, you are ready to begin radiation treatments.

Treatment with the MammoSite® RTS is given on an outpatient basis. That is, you do not need to stay in the hospital. When used alone, typical treatment with the MammoSite® RTS would require 2 brief appointments a day, 6 hours apart, for 5 days at the radiation oncology office. This would typically be done on Monday through Friday. If used as a boost with external beam radiation, the MammoSite® RTS will require 2 brief appointments for just 1 day. The position of the balloon will usually be checked prior to each treatment.

On the day of treatment, a tiny radioactive seed which is attached to a wire is passed automatically under computer control from the afterloader machine through the catheter into the inflated balloon. Where the seed goes and how much radiation it releases is carefully determined during the planning session to effectively treat the cancer. After the treatment session is complete, the radioactive seed is automatically withdrawn back into the afterloading machine.

No source of radiation remains in your body between treatments or after the final treatment is over. The tiny radioactive seed is inserted only during appointments and then removed. Neither the MammoSite® RTS, nor the liquid inside, is radioactive in any way.

Once the final session is completed, the balloon is deflated and the MammoSite® RTS is easily removed. You may not even require anesthesia for the removal.

References
Baglan KL, Martinez AA, Frazier RC, et al. The use of high-dose-rate brachytherapy alone after lumpectomy in patients with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys 2001;50:1003-1011.

Initial Clinical Trial Results, FDA Talk Paper, May 6, 2002; http://www.proximatherapeutics.com/mamm/patient/clinical_trial_results/index.htm

Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys 2003;55:289-293.

King TA, Bolton JS, Kuske RR, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is,1,2) breast cancer. Am J Surg 2000;180:299-304.

Pamphlet material modified from http://www.proximatherapeutics.com/mamm/patient/index.htm

Vicini FA, Baglan KL, Kestin LL, et al. Accelerated treatment of breast cancer. J Clin Oncol 2001;19:1993-2001.

Photo Caption: Figure 1. An inflated MammoSite® RTS balloon in the correct position inside the tumor resection cavity. The catheter (A) is attached to the afterloading machine (C). The radioactive seed (B) has been moved into the correct position within the inflated balloon.