American Society of Breast Surgeons Release MammoSite Breast Brachytherapy Registry Trial Final Results

BEDFORD, Mass., Oct. 2, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, today announced that the final analysis of the American Society of Breast Surgeons (ASBS) MammoSite Breast Brachytherapy Registry Trial data confirms previously noted "excellent" results and compares favorably with other forms of accelerated partial breast irradiation (APBI) and with outcomes seen in patients treated with whole breast irradiation with similar follow-up.[i] The final analysis was published online in advance of print in the August 22, 2013 issue of the Annals of Surgical Oncology.

The seven year MammoSite Registry Trial followed over 1,400 patients who were diagnosed with early stage breast cancer and underwent breast conserving therapy, which included treatment with Hologic's MammoSite targeted radiation therapy system, between May 2002 and June 2004. By employing MammoSite Therapy, the radiation oncologist can deliver targeted radiation therapy directly to the area where cancer is most likely to recur, allowing a full course of radiation to be delivered in just five days as compared to five to seven weeks. The final analysis demonstrates low rates of local recurrence, long-term cosmesis of greater than 90% and toxicity rates of less than 10%.ⁱⁱ

"The American Society of Breast Surgeons MammoSite Registry Trial continues to represent one of the most pivotal studies available in defining the safety and efficacy of brachytherapy based partial breast irradiation," said Dr. Chirag Shah of Summa Health System and lead author on the paper. "With over 1,400 patients treated and follow-up exceeding five years, it is the only brachytherapy study with over 1,000 patients accrued and five year follow-up available at this time. The final analysis of this trial not only confirmed the efficacy of brachytherapy based partial breast irradiation, but demonstrated that rates of toxicity following treatment remain low and favorable, in line with previously reported toxicity rates using whole breast irradiation." 

"We are pleased that patient outcomes remained strong and comparable to other radiation treatment options throughout the length of the study," said Carter Houghton, Hologic's Senior Vice President and General Manager, Interventional Breast Solutions. "The acceptance of accelerated partial breast irradiation as an effective treatment option for women diagnosed with early stage breast cancer continues to grow worldwide due in part to the favorable results reported throughout this study. Hologic's MammoSite Radiation Therapy is a compassionate treatment option that allows women to return to their daily activities after just five days of treatment, as compared to the conventional five to seven weeks, while minimizing side effects such as skin burning and fatigue."

About MammoSite Targeted Radiation Therapy

By employing MammoSite Therapy, the radiation oncologist can deliver targeted radiation therapy directly to the area where cancer is most likely to recur, allowing a full course of radiation to be delivered in just five days as compared to five to seven weeks. Additionally, targeted therapy of the breast limits radiation exposure to normal, healthy tissue minimizing side effects such as skin discoloration, scarring, burning, fatigue and damage to surrounding organs. With its multi-lumen design, the MammoSite ML system gives radiation oncologists the ability to adjust the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy. First cleared for sale by the FDA in 2002, MammoSite is the most widely utilized and accepted method of APBI in the United States.

About Hologic, Inc

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems, and surgical products, with an emphasis on serving the healthcare needs of women. The Company operates four core business units focused on breast health, diagnostics, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.

Hologic, MammoSite and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statement Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Hologic MammoSite system. There can be no assurance the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the MammoSite system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.

Contacts

[i],[ii] Shah C, Badiyan S, Ben Wilkinson J, Vicini F, Beitsch P, Keisch M, Arthur D, Lyden M. Treatment Efficacy with Accelerated Partial Breast Irradiation (APBI): Final Analysis of the American Society of Breast Surgeons MammoSite(®) Breast Brachytherapy Registry Trial. Ann Surg Oncol. 2013 Aug 22. [Epub ahead of print] PubMed PMID: 23975302

SOURCE Hologic, Inc.