Targeted Intraoperative Radiotherapy (TARGIT) Clinical Trial Outcomes Demonstrate the Potential for Single-Dose Radiation Therapy to Become the New Standard of Care in Breast Cancer Therapy

San Francisco, California, UNITED STATES

CHICAGO, IL--(Marketwire - June 5, 2010) -  TARGIT-A, the largest randomized clinical trial conducted in the field of intra-operative radiotherapy (IORT) for the treatment of breast cancer, has achieved clinical results that may significantly broaden the use of a shorter and easier radiation therapy method for women battling breast cancer worldwide. With up to ten-year follow-up data, the TARGIT-A single-dose IORT clinical trial results will be presented for the first time during American Society of Clinical Oncology's (ASCO's) 46th Annual Meeting. These TARGIT study results have also been published as a fast-tracked paper in The Lancet, now available online at

The TARGIT-A (TARGeted Intra-operative radiation Therapy) multicenter clinical trial1 was launched in 2000 in which 28 centers from 9 countries participated. TARGIT-A trial compared standard whole breast external beam radiotherapy (EBRT) with single-dose targeted intra-operative radiotherapy (TARGIT2,3) using INTRABEAM® after breast conserving surgery in patients > =45 years with invasive ductal carcinoma. Local recurrence was the primary outcome measure1. The original accrual goal of 2232 patients in the TARGIT-A trial, the first randomized clinical trial on partial breast irradiation using intra-operative radiotherapy, was reached in April 2010.

The results4,5 demonstrated the therapeutic equivalence of TARGIT using the INTRABEAM® system: The Kaplan-Meier estimate of local recurrence in the breast was 1.2%(CI 0.53-2.71) for TARGIT versus 0.95% for EBRT (CI 0.39-2.3) at 4 years. The absolute difference in local recurrence in the conserved breast was 0.25% (95%CI -1.04% to 1.54%.) i.e., the absolute difference in local recurrence rate could be at most 1.5% worse or at most 1.0% better with TARGIT than with EBRT. Median age was 63 and 83% patients were below 70 years, median tumor size was 12mm, and 17% of the patients were lymph node positive.

In terms of toxicity, TARGIT performed well in comparison with conventional therapy: The Radiation Therapy Oncology Group (RTOG) grade 3 toxicity (nil grade 4) was only seen in 0.5% patients in the TARGIT group vs. 2.1% patients in the EBRT group, while incidence of seroma requiring aspiration was higher in the TARGIT group (2.1% vs. 0.8%). Overall local toxicity as well as major complication rate was equivalent between the TARGIT group and the EBRT group4.

"It has been a privilege to have the team that came up with these encouraging clinical outcomes and to reveal the results to my colleagues and to the millions of women who will ultimately benefit from advances in breast cancer treatment," said leading British oncologist Michael Baum, Professor Emeritus of surgery at the University College London and chairman of the TARGIT-A trial. "It is the sincere hope of the TARGIT group that these results influence a paradigm shift from conventional radiation approaches to single-dose treatment for eligible patients."

Jayant S Vaidya, MD, PhD, who is a co-inventor of the TARGIT technique and who designed the trial alongside Professor Baum and Professor Jeffrey Tobias added, "These data change two fundamental principles of breast cancer treatment in selected patients. The first is that TARGIT single-dose treatment can replace whole breast radiotherapy approaches which are time-consuming and uncomfortable for the patient. The second is that a much smaller radiation dose can be adequate to achieve similar outcomes, thereby reducing toxicity and eliminating certain side affects, such as cosmetic reactions."

TARGIT single-dose treatment with the INTRABEAM® system provides increased patient convenience: three- to six weeks of radiotherapy may be replaced by a one-day treatment (approximately 30 minute treatment time). This approach may also make radiation therapy available for patients who do not have access today, e.g., in developing countries. Also, in industrialized countries, many women do not undergo recommended breast radiation due to inconvenience or cost. TARGIT single-dose treatment with the INTRABEAM® system is considerably less expensive than conventional radiation therapy4, which it could replace.

"In addition to the profound benefits that TARGIT single-dose treatment offers to breast cancer patients, it can also be performed within any hospital or treatment centre at the time of surgery," added Frederik Wenz, M.D., professor and chairman, Department of Radiation Oncology, Mannheim Medical Center, University of Heidelberg. "We are optimistic that single-dose radiation therapy will become more widely available to patients who do not have acceptable access to treatment today."

About the TARGIT-A trial
Since 1996, the international TARGIT research group has been researching a new method of delivering radiotherapy for breast cancer in which the treatment can be reduced to a single fraction at the time of surgery. In this way, the affected tissue in the tumor bed is irradiated from the inside out. The INTRABEAM® radiotherapy system from Carl Zeiss is used for this purpose. The study is testing whether the single dose can reduce the risk of recurrence of the cancer in the affected breast as effectively as the traditional, three to six week method. On a random basis, one half of the women taking part are offered conventional radiotherapy while the other half are offered to be treated intra-operatively. The results of the study will be presented for the first time during the 2010 annual meeting of the ASCO (American Society of Clinical Oncology) in Chicago from June 4-8. Please visit or for more information.

About The INTRABEAM® System
INTRABEAM®, Carl Zeiss Meditec's ground breaking radiotherapy system, offers the least disruptive treatment method available to patients being treated for early stage breast cancer. The radiation dose of INTRABEAM® is administered to the tumor bed in the operating room.
The system utilizes a miniature X-ray source, a highly flexible support stand and a full range of radiation applicator options. TARGIT has the advantage of precise radiation-dose delivery since the applicator is directly located into the tumor bed. Afterwards the applicator and miniature X-ray source are removed, the surgical site is closed, and the procedure is complete.2,3 In 1999, INTRABEAM® received both FDA clearance and CE mark to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The device is also approved for use in most countries around the world.

1. Vaidya JS, Baum M, Tobias JS et al. Protocol 99PRT/47, Targeted Intraoperative radiotherapy (Targit) for breast cancer. Lancet 1999;
2. Vaidya JS, Baum M, Tobias JS et al. Targeted intra-operative radiotherapy (Targit): an innovative method of treatment for early breast cancer. Ann Oncol 2001; 12(8): 1075-80
3. Vaidya JS, Baum M, Tobias JS et al. The novel technique of delivering targeted intraoperative radiotherapy (Targit) for early breast cancer. Eur J Surg Oncol 2002; 28(4): 447-54
4. Baum M Michael Baum, David Joseph, Jeffrey S Tobias, Frederik K Wenz, Mohammed Keshtgar, Michael Alvarado, Max Bulsara, Wolfgang Eiermann, Norman Williams and Jayant S Vaidya on behalf of the TARGIT Trialists' group. Safety and efficacy of targeted intraoperative radiotherapy (TARGIT) for early breast cancer: First report of a randomized controlled trial at 10-years maximum follow up. Poster Presented at ASCO Annual Meeting; June 7, Chicago, 2010 (LBA517)
5. Vaidya Jayant S, Joseph David J, Tobias Jeffrey S, Bulsara Max, Wenz Frederik, Saunders Christobel, Alvarado Michael, Flyger Henrik L, Massarut Samuele, Eiermann Wolfgang, Keshtgar Mohammed, Dewar John, Kraus-Tiefenbacher Uta, Sutterlin Marc, Esserman Laura, Holtveg Helle M R, Roncadin Mario, Pigorsch Steffi, Metaxas Marinos, Falzon Mary, Matthews April, Corica Tammy, Williams Norman R, Baum Michael. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial., The Lancet, in press 2010

Contact Information:

Media Contacts:
International TARGIT Trial:
Ciara McNulty, Clinical Trials Group
Department of Surgery, Royal Free and UCL Medical School
Centre for Clinical Science and Technology, Clerkenwell Building, Archway Campus
Highgate Hill, London N19 5LW
Tel +44 (0) 20 7034 8890
Fax +44 (0) 20 7288 3969