When Gina Wiest was diagnosed this summer with early-stage breast cancer, she had an array of options to treat it.

One choice was mastectomy, or full breast removal. Another was lumpectomy combined with traditional, full-breast radiation treatments.

A third choice her physician, Dr. Debra Kontny, told her about was lumpectomy combined with a relatively new treatment called MammoSite, which delivers targeted doses of radiation to the area from which the tumor was removed.

The choice, for her, seemed clear.

Wiest didn't want the radical surgery of complete breast removal. The prospect of undergoing radiation treatments for six weeks - and the fatigue and skin burning and irritation that so often come along with them - did not appeal to her. The length of treatment also wasn't something she felt she could afford in her busy life as a mother and director of the Lewis and Clark Humane Society.

The MammoSite therapy takes five days - a fraction of the length of general breast radiation treatments - allowing patients to avoid many of the side effects of full-breast radiation treatments while saving the breast.

But for many in the medical community, the issue is not so cut and dried. Some doctors and medical professional groups have embraced the procedure when used with certain patients. Others, however, feel strongly there is not enough long-term data to prove it is safe.

Medicare and Medicaid - as well as many private insurance companies - cover MammoSite. Many other insurers, including Montana's two largest providers, do not, except under very narrowly defined circumstances.

What is MammoSite?

MammoSite is a type of brachytherapy, a form of radiation therapy in which a radioactive source is placed inside or next to the area requiring treatment rather than generally radiating an affected area.

With MammoSite a balloon is inserted into the cavity left by the removal of a tumor. The balloon is attached to a catheter, through which high-dose-rate (HDR) radiation "seeds" are sent. The patient receives the treatments twice a day for five days.

For a woman to be eligible for MammoSite, she must meet several criteria. Among other considerations, the tumor must be caught in early stage and be smaller than 3 centimeters, there must be no traces of cancer cells in the margins surrounding the tumor and the woman's nodes must be cancer-free.

Wiest had her tumor, which measured 1.1 centimeters, removed on July 1. One week later the balloon was inserted through an incision in her breast.

Wiest described the balloon insertion and its removal as uncomfortable but not painful. In fact, she said, uncomfortable is the word she would use to describe the whole process she went through.

Since there is no HDR brachytherapy system in Helena, Wiest went to Great Falls - one of three Montana cities, along with Missoula and Billings where it's available - for her treatment, where she was hooked up to a machine she said resembles the robot R2-D2 from the "Star Wars" movies.

Is MammoSite safe?

Dr. Kontny, the physician who advised Wiest on her options for treating her cancer, has used MammoSite with success for years, first in her practice in Spokane, Wash., and now at Helena Physicians Clinic, where she has practiced for about a year.

She has no reservations about its safety.

Critics argue that though the FDA approved MammoSite in 2002, the approval process was too quick, with a clinical trial involving only 43 patients.

Some critics decry the FDA approval process for medical devices as insufficient. The FDA has responded that the approval process for medical devices doesn't need to be as exhaustive as it is for drugs, because many are just new ways of delivering the same treatment, as is the case with MammoSite.

One MammoSite detractor is Dr. Robert Bertoli, clinical associate professor of radiation oncology at University of Tennessee Medical Center. Bertoli said that until a randomized clinical trial is finished, it is imprudent to recommend MammoSite as a replacement for traditional radiation therapy. He says the National Comprehensive Care Network is the group most people think sets the standard for treatment, and its recommendation is that it only be used in clinical trials. He said with only five-year data from clinical studies, much still has to be learned about its safety. Trials must be done for at least 20 years, he said, to be sure the recurrence rate for MammoSite is equal to traditional therapy.

"It's not even close," said Bertoli, who along with two of his colleagues wrote a letter to the Knoxville New Sentinel in 2006 warning against MammoSite's use outside clinical trials. "(MammoSite) may be a great thing, I don't know. The problem is it's going to take a long time to get those results."

Dr. Robert Pfeffer, radiation oncologist at St. Peter's Hospital, disagrees. Pfeffer acknowledges that doctors should be cautious in using MammoSite and that patients should be informed that there is not as much historical data on it as there is with traditional therapy.

But he adds that he used MammoSite under what he termed the "conservative guidelines" of the American Brachytherapy Society in his former practice at Cancer Care Network in Spokane. And even though St. Peter's does not have the equipment to offer the treatment, Pfeffer said he would have no hesitation referring the "properly chosen patient" who is interested in receiving it to one of the area medical centers that do offer it.

"You have to realize that the history of partial breast irradiation began years before the the MammoSite balloon was invented," Pfeffer said in an e-mail. "The MammoSite balloon technique is only one way to deliver the dose. Consequently there are a number of articles in the oncology literature showing excellent cancer control and minimal toxicity with a variety of techniques."

Kontny adds that she feels five-year data is sufficient to feel confident in using MammoSite for the right patient, noting that recurrence of breast cancer is most likely in the first two years, and that after five years the recurrence rate is low.

Insurance issues

Wiest was able to receive MammoSite because her husband is insured through Blue Cross Blue Shield of Kansas.

For a large number of Montanans, however, MammoSite is not a real option because their insurance does not cover it.

Blue Cross and Blue Shield of Montana, the state's largest private insurer, considers the treatment investigational and only covers it when it is used as a booster to traditional radiation therapy.

Kontny scoffs at Blue Cross' refusal to cover the treatment, saying MammoSite is proven and well-vetted, citing that the American Society of Breast Surgeons supports its use.

Pfeffer, of St. Peter's, says Blue Cross' position is "bogus" and has written the company a letter telling it so. He says the caveat that it will cover the treatment as a booster for traditional therapy is meaningless.

"Nobody uses it for booster radiation, so they'll never have to cover it," said Pfeffer.

New West, the next largest insurer in Montana, says it covers MammoSite only when used as part of a clinical trial. Dr. Robert Shepard, medical director at New West, cites NCCN's recommendations for the position.

Kontny has problems with New West's stance too. Clinical trials have filled up quickly, she said, and are difficult to get into. And since the studies are randomized, people selected for them have no guarantee they will receive MammoSite.

She also said the NCCN recommendations are only guidelines and should not be used to approve or deny insurance coverage. She adds that part of NCCN's guidelines says that in the absence of a clinical trial, the treatment should only be given to patients with low risk of recurrence and where nodes are free of cancer, which is the policy she uses.

Several insurers that serve Montana do cover MammoSite, including Medicare and Medicaid. According to MammoSite representatives, private insurance companies that cover it include Aetna, Cigna, Humana and Health Net. In addition, more than 40 of Blue Cross' 65 affiliates nationwide cover MammoSite, according to the company.

No time to be sick

According to the U.S. Department of Health and Human Services, the survival rate for women with lumpectomies is equal to the survival rate for those with mastectomies. Still, more than half of women who are candidates for lumpectomy choose to have their breasts removed.

One reason women cite for choosing is they don't want to subject themselves to the six-week radiation therapy.

For Wiest avoiding that process was the chief reason for choosing MammoSite.

"I didn't have time to be sick," she said.

Kontny says rural states like Montana, in which many patients live in remote areas, are an especially good fit for MammoSite. Many women in isolated locations, she said, elect to have unnecessary mastectomies because getting to a hospital for a six-week course of radiation isn't an option.

"This procedure is so meant for Montana," Kontny said.

No regrets

One thing that is clear about the MammoSite debate is that it won't be settled for years, if not decades.

Wiest, however, is certain she made the right choice for herself.

When asked if she had any reservations about choosing MammoSite, she said, "I had reservations about every aspect (of breast cancer). It was scary. But (MammoSite) was the best thing I could have done. The time process was easy. You hear about burns (from radiation). I didn't have any.

"I felt very confident," she continued. "They were very clear. They gave us all the information."

Features editor Joe Menden:

447-4087 or

joe.menden@helenair.com