Is this for me? If you're having breast-saving surgery (lumpectomy) followed by radiation, this article may interest you.

What question is the study trying to answer? The researchers wanted to know if getting partial-breast irradiation therapy (radiation only to the part of the breast where the cancer was) using the MammoSite device is effective treatment for women with early-stage disease.

Lumpectomy followed by whole-breast irradiation is as effective as mastectomy in treating women with early-stage breast cancer. But some women find it hard to meet the daily demands of a 5- to 7-week radiation treatment schedule. They may live far away from the nearest treatment center or may have a hard time arranging for transportation every day. So they may choose to have mastectomy because they feel they don't have any other choice. Or they may have lumpectomy but not follow it with radiation, which may increase their risk of recurrence.

The MammoSite device is a small balloon at the end of a small tube (the tube is also called a catheter). Your surgeon places the balloon into the empty space where the cancer was. The balloon is inflated with fluid (which stays in there until treatment is done). The tube runs from the balloon to the outside of the breast (through a small hole). The position and shape of the balloon are checked each day.

For each treatment, a radioactive seed is put in the end of the tube and up into the balloon. The seed stays inside the balloon for about 5-10 minutes—just long enough to give off enough radiation to the nearby tissue. Then the seed is removed. Treatments are given twice a day (morning and afternoon) in a treatment center for 5 days. That's 10 treatments total. The time between each daily treatment is about 6 hours. It takes about an hour for each treatment because there is a lot of preparation and checking that has to be done. When your treatment is done, the MammoSite balloon is deflated and removed from your breast. The hole that the tube and balloon come out of is closed with tiny pieces of paper tape.

After treatment, the women returned for follow-up evaluation at 6 months, 1 year, 1.5 years, 2 years, and every year after that. During each visit, doctors looked for possible signs of cancer return in the treated breast or in the nearby lymph nodes. They also looked at the area where the MammoSite device had been to check for healing, infection, fluid buildup (the medical word for this is seroma), and fat necrosis (when some of the fatty tissue around the surgery and MammoSite area dies and becomes hard).

This study was started by a company named Cytyc (then known as Proxima), the maker of the MammoSite device, in 2002 and was taken over by the American Society of Breast Surgeons in 2003.

Study results: Eleven of the 1449 women (0.8%) had the cancer come back in the same breast that was treated. Every 2 years, between 1 and 2 women out of 100 developed a recurrence. Five of 1449 women (0.4%) had the cancer come back in their lymph nodes. This is similar to results for women who have whole-breast irradiation therapy after breast-conserving surgery. However, these results are very early with a very short follow-up. We need a much longer follow-up time to make a fair comparison.

About 93% of the women had good or excellent cosmetic results. This means that the women were pleased with how their breast looked and felt.

Overall, 321 women (22%) had seromas form, but this number decreased over time. At 2 years of follow-up, only 39 women had seromas. More seromas formed in women when the MammoSite device was placed during surgery, rather than implanted after the initial surgery through a small incision. Only 20 women (1.4%) had fat necrosis.

The option of partial-breast irradiation therapy is appealing to many women because of shorter treatment time (1 week versus 6 or 7). And side effects may be reduced because radiation is given directly to a smaller area—just where the cancer used to be.

These results over a very short period of follow-up show a low risk of recurrence after lumpectomy and partial-breast irradiation therapy. While the results are promising, they are only preliminary.

Partial-breast irradiation has no long-term track record. There have been only a small number of women who have been followed for as long as 5 years. And in some of the studies, the women also took tamoxifen or other anti-estrogen medicines to reduce the risk of recurrence. So it's difficult to isolate the benefits of partial-breast irradiation alone. Whole-breast irradiation has been studied for more than 30 years in thousands of women. It has been demonstrated to significantly reduce the risk of the cancer coming back.

The women who participated in this study tended to be older, had small cancers, clear margins, and no lymph node involvement. Therefore, a relatively low risk of recurrence was expected even without partial-breast irradiation. If the low recurrence rate continues to hold up over longer follow-up time, then we can be even more encouraged.

We can't say by how much partial-breast irradiation after lumpectomy lowered the risk of recurrence compared with lumpectomy alone. That's because this study had no control group that had lumpectomy alone. Having a control group like this isn't done these days. Since radiation has been shown to be very effective, withholding it could be considered unethical.

More research is needed to determine if partial-breast irradiation offers the same reduction in recurrence as whole-breast irradiation. Studies are beginning, but, until we have the results from those with longer follow-up, we don't know if the benefits are the same.

It's too early to compare partial-breast irradiation directly with whole-breast irradiation because, so far, there has been no direct comparison between the 2 approaches within 1 study. Right now, there is a randomized study that is looking at this important question: NSAPB B-39.

It was good to see a relatively low risk of side effects and good cosmetic outcome with this form of treatment. Longer follow-up also will be helpful to best understand any possible long-term side effects. It will also help us know if partial-breast irradiation has more, fewer, or different side effects than whole-breast irradiation.

Placing the balloon or catheter in the breast and delivering the radiation requires skill and experience. Doctors and radiation physics experts receive special training to learn how to insert the MammoSite catheter and deliver the radiation. So far, about 700 people have been trained. The position, size, and shape of the catheter must fit properly into the right part of the breast. The radiation treatment centers need a special machine that holds the radioactive seed that goes in and out of the MammoSite, called "high-dose-rate machine." More and more treatment centers are able to perform this technique. To find a center near you, go to mammosite.com .

One great way to pursue partial-breast irradiation is by enrolling in a clinical trial . You can find information about cancer trials run by the National Cancer Institute (NCI) on the Web or by calling the NCI Information Service at 1-800-4-CANCER (1-800-422-6237).

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