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Old 12-01-2006, 09:26 AM   #2
Lani
Senior Member
 
Join Date: Mar 2006
Posts: 4,778
continued

According to Dr. Mendelson, early data (<5 years) has shown similar recurrence rates (<2% to approximately 6%) in whole breast irradiation and lumpectomy.

Catheter-directed PBI was approved by the FDA in 2002. One clear advantage is a treatment time of 5 to 7 days.

Dr. Mendelson described Northwestern's retrospective study of all cases of catheter-directed PBI between May 2002 and April 2006. Investigators reviewed medical records, ultrasounds, mammograms, pathology, and specimen imaging.

During the 4-year period, 75 patients with breast cancer underwent ultrasound for eligibility after lumpectomy, and 44 (59%) met ultrasound eligibility criteria for PBI, with 31 (41%) ruled ineligible. In more than 90% of those who were ineligible, the skin-to-seroma distance was the disqualifying factor, usually related to depth of surgical closure. Nine of the 44 eligible women did not choose PBI. Of the 35 patients in whom balloon catheters were placed, 34 (97%) completed PBI (the sole ineligible patient had been found to have inadequate tissue thickness).

Dr. Mendelson concluded that this study found the procedure safe, sufficient, relatively economical, and minimally invasive, but she noted that the procedure requires careful scanning for eligibility. When compared with surgical placement at the time of lumpectomy, she said that this procedure allows time for a pathologic analysis to be completed to confirm that the margins are disease-free, and it allows the patient time to explore other therapeutic alternatives, including PBI or whole-breast irradiation.

In the Northwestern protocol, the tumor size has to be less than 3 cm (ductal carcinoma in situ) for stage 0 tumors, 2 cm or smaller for stage 1 tumors, and 5 cm or smaller for stage 2. Margins and lymph nodes should be negative.

"The key to eligibility is careful, real-time scanning, in perpendicular planes, to find the minimum thickness between the skin and the top of the fluid collection. That should be at least 6 mm," said Dr. Mendelson. The cavity size should be at least 3 cm.

Dr. Mendelson uses prophylactic antibiotics and local anesthetic (2% lidocaine). A trocar is used to create a tract from the skin to the seroma. The shape of the balloon to be inserted is matched to the shape of the wound.
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