American Society of Breast Surgeons Study
Represents Largest Patient Population to Date
BEDFORD, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Hologic, Inc. (Nasdaq: HOLX) a diversified medical technologies company specializing in imaging systems, diagnostics, and interventional devices dedicated to serving the healthcare needs of women, today announced the publication of a study evaluating the Hologic MammoSite(R) Radiation Therapy System (RTS), one-, two- and three-years after treatment. The study by Frank A. Vicini, M.D., and others, published in the February 15, 2008, issue of Cancer(1), the peer- reviewed professional journal of the American Cancer Society, reports on treatment efficacy, cosmetic results and toxicities of patients enrolled in the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial.
The American Society of Breast Surgeons MammoSite Registry(2) includes a total of 1,440 patients with early stage breast cancer, who were undergoing breast-conserving therapy and were treated with MammoSite RTS between May 2002 and July 2004. Of the total, 87 percent of the patients had invasive breast cancer and 13 percent had been diagnosed with ductal carcinoma in situ (DCIS).
The authors presented a subset analysis of the first 400 cases enrolled in the study with a median follow-up of 37.5 months. The three-year actuarial rate of local or regional recurrence was less than 2 percent in this group. The percentage of breasts with good and/or excellent cosmetic results was 93 percent at 36 months. The authors also reported a three-year actuarial local control rate of 100 percent in the first 48 patients enrolled with DCIS.
An analysis of the overall registry population with a median follow-up of 30.1 months, showed a two-year actuarial rate of local or regional recurrence of 1.0 percent; good and/or excellent cosmetic results of 94 percent at 24 months and a 10.6 percent rate of symptomatic seromas.
The authors note that the MammoSite Radiation Therapy System is "logistically simpler, technically more reproducible, and patient 'friendly'" than other interstitial brachytherapy devices. The authors go on to say that "These results demonstrate that treatment efficacy, cosmesis, and toxicities 2-years and 3-years after treatment with APBI [Accelerated Partial Breast Irradiation] using the MammoSite device in this registry trial are similar to those reported with other forms of APBI with similar follow-up."
"The American Society of Breast Surgeons Registry represents the largest patient population treated with the MammoSite Radiation Therapy System," said Ellen Sheets, M.D., Chief Medical Officer for Hologic. "We are very encouraged by these results and believe they support the clinical benefits of this unique technology."
The MammoSite device is a balloon catheter that is inserted into the cavity created by a lumpectomy (the surgical removal of a breast tumor). MammoSite RTS delivers radiation from inside the lumpectomy cavity over a course of five days. The device targets radiation to the area where tumors are most likely to recur, while reducing exposure to healthy tissue. Since its introduction in 2002, more than 38,000 breast cancer patients have received partial breast irradiation utilizing the MammoSite RTS.
A copy of the study may be downloaded by going to the web site below: http://www3.interscience.wiley.com/cgi- bin/abstract/117880284/ABSTRACT?CRETRY=1&SRETRY=0
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, and mini C-arm for extremity imaging. For more information visit http://www.hologic.com.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves
risks and uncertainties, including statements about the effect of the use
of Hologic's MammoSite Radiation Therapy System on breast cancer patients.
There can be no assurance that the effects demonstrated in the study
described herein will be replicated in any particular manner with respect
to an individual patient as the actual effect of the use of Hologic's
MammoSite Radiation Therapy System on patients with breast cancer can only
be determined on a case-by-case basis depending on the particular
circumstances of the 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 Hologic's
expectations or any change in events, conditions or circumstances on which
any such data or statements are based. Certain factors that could adversely
affect Hologic's business and prospects are described in Hologic's filings
with the Securities and Exchange Commission.
1 Frank Vicini, M.D., Peter D. Beitsch, M.D., F.A.C.S., Coral A. Quiet,
M.D., Angela J. Keleher, Delia Garcia, M.D., Howard C. Snider Jr, Mark
A. Gittleman, M.D., Victor J. Zannis, M.D., Henry M. Kuerer ,M.D.,
Ph.D., Maureen Lyden, Three-year analysis of treatment efficacy,
cosmesis, and toxicity by the American Society of Breast Surgeons
MammoSite Breast Brachytherapy Registry Trial in patients treated with
accelerated partial breast irradiation (APBI), Cancer, 2008;112(4),758
2 The MammoSite Breast Brachytherapy Trial was supported in part by a
grant from Cytyc (Hologic). Co-authors Victor J. Zannis and Maureen
Lyden received support from Cytyc (Hologic).
Frances Doria Jim Culley
Director, Investor Director, Strategic
Hologic, Inc. Hologic, Inc.
Tel: 781.999.7377 Tel: 781.999.7583
|SOURCE Hologic, Inc.|
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