BBI Contributing Editor

ATLANTA, Georgia The American Society of Breast Surgeons (ASBS; Laurel, Maryland) is the fastest-growing surgical society in America, holding its fourth annual meeting here in May with more than a third of its membership in attendance. The mission of the ASBS is to strive together among academia, technology manufacturers and practicing surgeons to advance the study of breast disease, provide a forum for the exchange of ideas and promote the newest advances to the practicing breast surgeon. At this year's meeting, Michael Edwards, MD, president of the society and professor and chairman of the University of Arkansas for Medical Sciences (Little Rock, Arkansas), said, "This is the only medical society that works with industry to determine the direction technology should be going in order to provide the best in patient care."

The current trend in breast disease management is to treat breast cancer in the most efficacious manner while providing the best cosmetic effect. The first procedure that embraced this philosophy was sentinel lymphadenectomy (SL), which is used when possible in lieu of axillary dissection. SL is a minimally invasive staging procedure for patients with breast cancer that is much less extensive, promises less morbidity, and allows for enhanced staging. Up to 55% of patients who undergo axillary dissection experience acute complications. Clive Grant, MD, of the Mayo Clinic (Rochester, Minnesota), conducted a study of 776 women to determine whether sentinel lymph node (SLN) negative patients also need axillary dissection. The findings suggested that axillary dissection may not be necessary for breast cancer patients without SLN involvement and that axillary dissection in these patients would probably produce more complications than benefits. The data supported SLN biopsy (and not axillary dissection) as the staging method of choice for patients with SLN negative breast cancer.

Another aspect of breast disease management that is attempting to provide the best possible therapy with the least amount of scarring is biopsies, or tissue samples of suspicious lesions that were either palpable or identified by mammogram or ultrasound. Several companies have developed minimally invasive techniques to accomplish this. To date, the FDA has not approved any device or system that can remove a suspicious lesion during biopsy, and if positive, not be required to return surgically to insure that all the cancer is gone. Two companies have devices that are entering clinical studies to establish that with their systems the patient can have a biopsy specimen removed and pending clear margins are found by the pathologist, the patient would not be required to return to surgery for more tissue removal even if the lesion is found to be cancerous. Both of these systems are guided by ultrasound in the surgeon's office using local anesthesia.

Neothermia (Palo Alto, California) and Rubicor Medical (Redwood City, California) each have systems that could remove the entire lesion provided that it is not greater than 2.5 centimeters. Neothermia has developed a radiofrequency device with a wire basket at the end of a probe that grips the lesion and then extracts it intact through the tunnel it created upon insertion. It has installed about 30 systems in the U.S. Once deployed, however, the device cannot be used again, costing an additional $700 to $800 for each wand used in the event that the entire sample was not encased during the first pass. Rubicor has an adjustable RF wire with a bag attached to it that encases the lesion in order to remove it without any chance of seeding potential cancer cells upon extraction. It can be passed several times into the lesion space in the event that the entire specimen is not captured initially. These two new devices may appeal to those surgeons who have resisted image-guided biopsy devices because of the "piece removal" methodology associated with their use.

While those studies are being conducted, Mark Gittleman, MD, of Sacred Heart Hospital (Allentown, Pennsylvania), has found another step-saving method of taking those patients with positive biopsies back to the OR for a lumpectomy without having to go first to the radiology suite for placement of a localization wire. Instead, Gittleman places an ultrasound visible marker made by Senorx (Aliso Viejo, California) at the time of the biopsy that later provides a means for the surgeon to perform intraoperative ultrasound-guided localization of the lesion at the time of surgery. Two companies market these devices Senorx and Artemis Medical (Hayward, California). The Senorx product consists of multiple ultrasonically visible, bioresorbable pellets, the central one containing a stainless steel wireform to also provide X-ray visibility. The Artemis product consists of a single collagen resorbable plug containing a titanium clip for long-term follow-up. Gittleman reported that not only is this process more efficient in terms of time, cost and resources, but he also found a 20% lower recision rate when using the marker.

After the biopsy is performed, the next step in the process is to remove the lesion if it is cancerous, or to decide what to do if it is not cancerous. When the lesion is determined to be cancer, 50% or fewer patients in the U.S. receive a lumpectomy as opposed to a mastectomy. However, in Europe the reverse is true, with 70% to 80% of the patients receiving lumpectomies. When the lesion is non-cancerous, there are a variety of treatment modalities available. One study reported that when patients had either a palpable or non-palpable benign lesion, about two-thirds of them elected to have it excised. Other surgeons' experience regarding patient requests for excision of non-palpable, non-cancerous lesions were anywhere from 60% to 95% of the patients wanting the lesion removed (see Table 8).

Half of all women will seek consultation for a breast disorder in their lifetime, with benign breast disorders being the most common reason for presentation to a physician's office. The management of a fibroadenoma (benign breast lump) can be handled in many ways: observation only, open surgical excision, or non-operative therapies including vacuum-assisted biopsies, percutaneous removal or ablation.

Richard Fine, MD, co-director of the Breast Center (Marietta, Georgia), presented data on various methods of removing presumed benign lumps. He reviewed all options and presented the advantage and disadvantages of each of the modalities that would enable removal of a benign lesion (see Table 9 below).

Post-operative radiation therapy is another aspect of breast cancer management where breast surgeons along with oncologists are attempting to deliver the maximum dose necessary to protect the patient from a recurrence while reducing the number of treatments and improve the cosmetic outcome. The conventional approach involves five weeks of fractionated radiotherapy on a linear accelerator, and then a week's intensive course to deliver a boost dose to the estimated position of the tumor bed. For patients living outside of driving distance to a medical center that offers this procedure, it means a prolonged stay at a hotel nearby until the treatments are complete or time-consuming travel to and from the medical center for their treatments. A newer form of treatment, called accelerated partial breast irradiation, promises to reduce the usual treatment period to just four or five days. A high dose of radiation is delivered to the breast region at highest risk for disease recurrence instead of radiating the entire breast. The ASBS recommends that this treatment only be performed by clinicians well versed in this technique and that careful patient selection be followed. Potential partial breast irradiation candidates should be older than 50, have ductal carcinoma, have a total tumor size no greater than 2 cm in diameter and have no axillary/sentinel lymph node disease. The ASBS also suggests that these patients be followed closely afterwards.

One step further down the research road is intra-operative radiation therapy (IORT), where a single boost dose of radiation is delivered to the breast tumor bed during surgery. IORT has been used for pediatric brain tumors where external radiation is not possible, and other places where radiation must be delivered directly to the tumor site. A pilot study is being performed at the department of medical physics at University College London (London), where IORT is being delivered, followed by external beam irradiation to the whole breast for the next five weeks. This study shaves a full week off the normal protocol of six weeks, but future studies hope to eliminate post-operative radiation therapy altogether, using a single high dose during surgery alone. Photoelectron (Lexington, Massachusetts) manufactures the Intrabeam system being used for this study. It is a miniature electron accelerator that can produce and deliver soft X-rays from within the breast. If IORT is found to be as effective as external beam radiation, then it is postulated that there could be a potential decrease in mastectomies by up to 50% because women who don't want to inconvenience their families by being treated for 30 days following surgery near the hospital, now will have another option they can go home.