The article "Quickly Vetted, Treatment Is Offered to Patients" unfairly represents the data supporting an important medical advance that provides excellent breast cancer control with a better quality of life for women diagnosed with early stage disease.

As the original pioneer of this new paradigm for breast cancer treatment, leader of the original FDA trial for MammoSite, the Principal Investigator of the National Cancer Institute sponsored and completed phase II trial, and co-Principal Investigator of the current phase III national trial that has already had over 3200 women participate, we are uniquely qualified to evaluate the evidence for or against Accelerated Partial Breast Irradiation (APBI). Dr. Quiet was the lead physician in entering patients onto the MammoSite trial through the American Society of Breast Surgeons, and is the founder of the Arizona Institute for Breast Health.

The focus of Abelson's report is a critique of the FDA fast tract for clearance of MammoSite's clinical use in 2002. Good points are presented and emotional arguments highlighted in favor of patients being protected from untested devices entering the US market. However, the author did not reveal that APBI was developed in 1991, and has undergone impressive medical scrutiny over the past 17 years. The original concept used time-proven brachytherapy (placement of radioactive seeds inside catheters surrounding a tumor site) that has been successfully implemented against cancers of the cervix, uterus, vagina, prostate, head and neck, and soft tissue sarcomas since the 1920s! This method of radiation delivery actually preceded the current use of high-energy x-ray machines, now considered "the gold standard." World-renown biologists carefully and meticulously calculated the dose of radiation needed to sterilize breast cancer cells. Long-term data is available using 5-day brachytherapy from the Ochsner Clinic in New Orleans and William Beaumont Hospital in Royal Oak, Michigan. These published results compare favorably in every clinical outcome with those of mastectomy or lumpectomy followed by whole breast irradiation over 5 to 7 weeks.

True, the MammoSite device was presented to the FDA in 2002. But the dose of radiation to eradicate breast cancer is exactly the same as the original brachytherapy data from New Orleans and Michigan. Only the affected part of the breast was treated, reducing radiation exposure to the underlying lung, heart, and ribs. A Woman's life outside of breast cancer was less intruded upon, and side effects were reduced. When I presented this information to the FDA in 2002, concerns were minimal because we piggybacked on scientific data that was 11 years mature. Now, MammoSite data is being published every month in peer-reviewed medical journals confirming excellent outcomes in large numbers. Just last month, Dr. Peter Beitsch presented the results of 1440 women treated by MammoSite, with an in-breast recurrence rate of only 2.7% at 3 years, comparable to any published studies with "conventional therapy." My original trial for the FDA was published in Annals of Surgery 2007 by Pamela Benitez, MD with long-term follow-up (median 5.5 years), with no local recurrence and 83% good to excellent cosmetic outcomes. Study after study substantiates the concept that we had back in 1991 that select breast cancers could by effectively treated by a 5-day regimen of APBI with fewer side effects and less danger to internal organs.

So, this is one medical device the FDA approved correctly. In their defense, why should the FDA withhold a treatment that delivers the same calculated tumoricidal dose that has been used for 17 years? The MammoSite is a means for delivering the most time-honored and effective treatment against cancer (radiation), not a "highly experimental" device being foisted upon an unsuspecting public.

Robert R. Kuske, MD
Coral A. Quiet, MD
Radiation Oncologists of Central Arizona
8994 E Desert Cove Ave.
Scottsdale, Arizona 85260
602-240-3506