Medical Device Daily Contributing Writer
BALTIMORE – Besides the various advances in earlier screening for breast cancer presented at the annual meeting of the American Society of Breast Surgeons (Columbia, Maryland), the gathering offered a close look at various innovative developments for treatment.
One clear emphasis seen at the meeting was the forethought for better cosmetic outcomes via smaller incisions to excise and remove a tumor. Even for mastectomies, skin sparing and even areola sparing techniques can be employed so that the reconstructive process actually begins at the same time as surgical removal of the cancer.
Rache Simmons, MD, associate professor of surgical oncology at New York-Presbyterian Weill-Cornell Medical Center's Breast Cancer Center (New York), presented her technique for areola sparing and skin sparing mastectomy procedures which she described as frequently leading to “results that looked much like a cosmetic breast lift rather than a mastectomy.“
A novel concept for those patients whose breast cancer is detected very early – 1 cm or less in size – is that of in situ laser ablation, in which the cancerous lesion is completely ablated with minimal invasion within the breast and left behind for the body to eliminate naturally.
Although this technology has been in development since 1995, clinicians haven't begun, until recently, to consider this a viable option for the future.
However, at Rush Presbyterian-St. Luke's Medical Center (Chicago) Kambiz Dowlat, MD, has performed laser ablation on 70 patients, 54 of whom then had either a lumpectomy or mastectomy one, two or four weeks later. All patients had their cancer confirmed by needle biopsy before laser therapy.
All lumpectomy and mastectomy tissues were examined after they were explanted, and according to Dowlat, “Excluding learning and technical factors during the developmental phases, the success rate of complete cancer destruction was 96%.“
Following the initial 54 patients who had either a lumpectomy or mastectomy, Dowlat has ablated six fibroadenomas and 10 cancer lesions less than 1 cm without performing a follow-up excision.
He has followed these patients using mammography and ultrasound, as well as MRI, if necessary. The longest laser-treated patient is six weeks out without recurrence.
Dowlat also reported that he has “not seen any adverse local or systemic side effect with this treatment and has [had] excellent cosmetic outcomes.“
The prototype system is being tested for final details. He said the final product will include a stereotactic table with attachable 805 nanometer wavelength diode laser and disposable needles that can be used with either ultrasound, X-ray or MRI.
The 15-25 minute procedure is office-based, is done using local anesthesia and with only Tylenol as a post-operative analgesic. Most patients have resumed normal activity and even returned to work the following day.
This alternative to lumpectomy should attract patients who do not want surgical removal of their small tumor or who want their benign fibroadenomas to become less palpable. There are no side effects, no infections, no systemic effects and a perfect cosmetic effect.
And Dowlat said he feels that if his experience is duplicated by other surgeons, this may become a viable treatment option for early breast cancers and fibroadenomas in the office-based setting.
In the same way that surgery is moving towards the least invasive technique, radiation therapy is also increasingly focused on targeting the lesion only and sparing healthy breast tissue.
Accelerated partial breast irradiation (APBI), brachytherapy and intraoperative radiation therapy (IORT) are all being designed to produce the same survival rates but with fewer visits to the hospital for the patient post-operatively. Although external radiation treatment is still used for 90% of all post lumpectomy cases, a movement towards accelerated partial breast irradiation using brachytherapy has begun.
The newest player in breast cancer brachytherapy is Xoft (Fremont, California), a privately held company that has developed a revolutionary miniaturized electronic brachytherapy technology.
Using APBI, a therapeutic dose is delivered directly to the tumor bed from within the lumpectomy cavity, minimizing the radiation exposure of healthy tissue. Like other brachytherapy systems, treatment is reduced to five days vs. seven weeks for whole breast external beam radiation.
Unlike other brachytherapy systems, Xoft does not require radioactive isotopes but instead uses a proprietary miniature X-ray source that mimics the penetration to the 1 cm prescription point and dose rate characteristics of Iridium, the current gold standard.
Xoft received FDA clearance for use in the breast in December of last year (Medical Device Daily, Jan. 11, 2006) and will begin postmarket clinical evaluations at nine centers with 40 patients by the end of summer.
In a poster presentation at the meeting by Darius Francescatti, MD, assistant professor of surgery at Rush Presbyterian-St. Luke's Medical Center (Chicago), the performance of the system in animals was shown as verified and “the electronic brachytherapy system performed as expected.“
The poster concluded: “This animal experience designed to emulate human treatment suggests that integration of electronic brachytherapy into clinical practice of APBI will likely be simpler that for isotope-based systems.“ As always the proof of this pudding will be in human patients – though at this time it appears optimistic.
Pamela Benitez, MD, of William Beaumont Hospital (Royal Oak, Michigan), presented “Preliminary Results and Evaluation of MammoSite Balloon Brachytherapy for Partial Breast Irradiation for Pure Ductal Carcinoma In Situ“ and discussed the preliminary results of this Phase II clinical study. In this research, 12 institutions are studying the use and results of the Mammosite brachytherapy balloon sold by Cytyc Surgical Products (Palo Alto, California) as sole post-lumpectomy radiation treatment for patients diagnosed with disseminated carcinoma in situ.
Her conclusions were similar to other reported studies using the Mammosite balloon in that as long as the surgeon maintained a 7 cm skin spacing, as recommended by the company; the procedure was well tolerated by the patients, long term results were good and there was good cosmetic effect.