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New five-day breast conservation cancer therapy gains acceptance
Wednesday, December 12, 2007
Breast cancer survivor Cathleen Rager was treated with the MammoSite technique, a relatively new five-day treatment.

Margie Miller and Cathleen Rager had a wide choice of treatments when they were diagnosed with breast cancer, including:

• a mastectomy;

• a lumpectomy followed by six to seven weeks of external radiation to the whole breast with ancillary exposure to the other breast and surrounding organs and tissue; or

• a lumpectomy followed by a relatively new treatment called MammoSite, which comprises five days of twice-a-day radiation treatments delivered specifically to the lumpectomy site by a balloon catheter. In some cases, chemotherapy also is part of the treatment.

As far as each woman was concerned, it was no choice at all. Three years apart, Mrs. Miller, of Harmar, and Mrs. Rager, of South Park, both 59, picked MammoSite, albeit for different reasons. Mrs. Rager's treatment includes continuing pill chemotherapy.

A growing number of doctors, including physicians at UPMC facilities and Allegheny General and West Penn hospitals, would applaud their choices and also offer MammoSite 5-Day Targeted Radiation Therapy as an option to their own patients -- as long as they met a fairly rigid set of qualifications laid out by the American Society of Breast Surgeons and the American Brachytherapy Society. Those qualifications include an age of over 45 (ASBS) or 50 (ABS); tumors of 3 centimeters (a little over an inch in diameter) or smaller, and no cancer in the lymph nodes.

The reasons for its increasing popularity are simple: Doctors like the smaller amount of radiation exposure to surrounding parts of the body. They also realize their patients are more likely to undergo radiation for a few days than for several weeks, which might cut down on the number of lumpectomy candidates who have mastectomies instead. The catheter also is easy to insert, and the procedure produces few side effects, mostly some surgical pain and some sunburn-type breast redness.

Dr. Mary Beth Malay, director of Comprehensive Breast Center UPMC Passavant and Mrs. Miller's breast surgeon, is a recent convert to MammoSite.

Since the FDA approved the use of MammoSite in 2002, Dr. Malay has inserted the balloon catheter in the lumpectomy beds of about 20 patients. But, she said, "I've done most of mine in the last six months."

The reason: "The longer I treat the disease and the more cases I see ... for favorable tumors, I've got to believe it's going to be equal [in effectiveness] to whole breast therapy."

So far, that has been the case, though the real test of MammoSite's efficacy will come after recipients have reached the 10- and 15-year survival rate. But the five-year results of the initial, small clinical trial of MammoSite, presented in May at the annual meeting of the American Society of Breast Surgeons, were impressive.

Of the 36 patients followed for a median period of 5.5 years, there were no local recurrences either in the tumor bed or elsewhere in the breast. Nor did any patient develop cancer in the other breast.

In addition, 83.3 percent of the women reported good-to-excellent cosmetic results and 100 percent said they would recommend MammoSite to a friend or use the therapy again if necessary.

"It is easier. It limits radiation to the rest of the breast, ribs, heart, lungs. The potential is for less toxicity, and it's completed in five days," Dr. Malay said.

"Most tumors that recur, recur in the lumpectomy site. Why radiate the whole breast if most tumors occur in the original site?"

But it was the short duration of radiation, coupled with the saving of her breast, that sealed the deal for Mrs. Miller, who underwent her lumpectomy in early October.

Five years ago, Mrs. Miller was diagnosed with Stage 4 colon cancer that had spread to both ovaries and part of her stomach and went through six months of "brutal" chemotherapy.

"I'm a very hands-on person," said Mrs. Miller, who used to own an upholstery business before retiring to enjoy riding her Harley Davidson motorcycle and visiting her sons, daughters-in-law and granddaughter in suburban Phoenix, Ariz. "I said let's try this and get it over with. ...

"One week as opposed to six. Why would anyone choose anything different? I thought that was a good idea. ... I didn't even know anything like that was available. You hear you have breast cancer, all you think of is they're going to cut it off."

Mrs. Miller had her MammoSite treatment soon after surgery and not too long after that headed west in her pickup truck with her Harley in the back to winter with her sons' families. She said Dr. Malay told her to come back in six months.

Mrs. Rager, a retired biology and environmental science teacher at Brentwood High School, was fascinated by the treatment itself when her doctors told her about it three years ago.

"Being that I was a science teacher, I felt if there was something progressive and I felt sure there had been some preliminary tests on its safety, I'd go for it," she said. "They made the facts clear and I made my decision based on the information they had given me."

Mrs. Rager also liked the fact that so much less tissue would be exposed to radiation.

"My skin is very sensitive, and I thought going through a six- to seven-week period might irritate my skin even more so," she said.

As it turned out, Mrs. Rager said she had no side effects for the MammoSite to speak of. "I would recommend it if the person was recommended as a candidate by the physician."

Mrs. Rager's lumpectomy and MammoSite treatment were done at UPMC Magee-Womens Hospital. There, radiation oncologist Dr. Sushil Beriwal reports that the facility has done about 150 MammoSites since shortly after the treatment got FDA approval. That represents "maybe 10 or 15 percent" of the breast cancer cases handled in that period.

"Most people get external therapy," Dr. Beriwal said. "Partial radiation therapy is still not the standard of care because we don't have [long-term research] ... and not everybody is technically suitable for MammoSite."

Still, he added, "All of the results have been as expected. We have not seen any excessive local recurrence."

West Penn, believed to be the first Pittsburgh facility to use MammoSite following its FDA approval, has used the partial breast radiation therapy on 92 patients. "That's approximately one-fourth of the breast cancer patients we've seen since 2002," said radiation oncologist Dr. Victor Onufrey.

"Four of the patients treated have had recurrences, [but] not all of them have been at the site of treatment," he said. "They've been elsewhere, like the lymph nodes, and that kind of goes along with what we'd expect to see.

"That is high [rate of success] but keep in mind that breast cancer is something you have to follow for a long time. We see them at five years but we also want to see what they're doing at 10 years."

Also, Dr. Onufrey noted, only 12 of those patients are five years removed from MammoSite and he didn't have separate data on those 12.

At Allegheny General, the West Penn Allegheny Health System Radiation Oncology Network is making use of MammoSite as well as other kinds of brachytherapy, the formal name for any kind of up-close or internal cancer therapy.

Radiation oncologist Dr. Mark Trombetta said the department has treated about 50 patients with first-time cancers using MammoSite. "It's not enough time to tell, but national preliminary results look like they're going to hold up."

In the meantime, the department also has helped to pave new ground by inserting MammoSite in three women with recurrent tumors instead of doing the standard mastectomy. Its abstract. or prestudy for the results to date, has been accepted for publication. "I don't think it's been published anywhere as used that way before," he said.

Dr. Trombetta also was in the process of authoring a study on the use of another brachytherapy called interstitial radiation for recurring breast cancer. A precursor of MammoSite, it delivers radiation to the cancer site through multiple plastic tubes inserted by hand through layers of tissue.

Allegheny General, Dr. Trombetta said, also is interested in participating in preliminary trials on new MammoSite-type devices that have won FDA approval in the past year or so. They differ from MammoSite in that the external catheter branches off into multiple catheters in the lumpectomy bed.

Multiple catheters make for more flexibility in the delivery of radiation, said Dr. Beriwal at Magee-Womens.

"If the results turn out with long-term success, they'll get their market share," he said. Names of these new devices include Clearpath, Senorex and Savi.

There also is another balloon catheter device called Xoft that makes its own X-rays in the lumpectomy cavity. That means heavy shielding of office walls will be unnecessary and more doctors will be able to offer the convenience of near-to-home therapy.

Convenience also is making breast cancer patients seek out MammoSite, local radiation oncologists say.

"We have women who have come the distance, who have come to West Penn because of MammoSite treatment," Dr. Onufrey said.

"MammoSite is an interesting thing," Dr. Trombetta said. "Since it was written about in the public domain, women come in and request it. ...

"It's been one of the things that's been patient-driven and that's a good thing-bad thing."

It's good women are actively seeking treatment but, "doctors and patients must be careful to settle on one before the long-term test results are in."

What does Dr. Trombetta do if a patient wants it but he finds her an unsuitable candidate?

"We would definitely talk to her about it, but we would do nothing to put a patient at risk," he said. "If it's the right patient, we would offer it to them."


Correction/Clarification: (Published Dec. 15, 2007) The first name of Dr. Victor Onufrey, a radiation oncologist at West Penn Hospital, was incorrect in this story about breast cancer as originally published Dec. 12, 2007.
Pohla Smith can be reached at psmith@post-gazette.com or 412-263-1228.
First published on December 12, 2007 at 12:00 am
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