TARGIT Intraoperative Radiation Therapy: Long Awaited Results of the TARGeted Intraoperative radioTherapy (TARGIT) Trial to Be Announced at American Society of Clinical Oncology 2010

LONDON--(Marketwire - May 26, 2010) - Patients with breast cancer await with interest the outcomes of a study exploring the role of targeted intra-operative radiotherapy using the INTRABEAM® that is to be presented at the American Society of Clinical Oncology’s (ASCO’s) 46th Annual Meeting, taking place June 4-8 in Chicago. The new technique could have enormous implications for both cost-effectiveness and availability of radiation therapy in breast cancer treatment.

A multinational prospective randomized clinical trial (TARGIT-A trial(1)) was launched in 2000 in which 28 centers from 9 countries participated. TARGIT-A trial compared standard whole breast external beam radiotherapy (EBRT) with targeted intra-operative radiotherapy (TARGIT)(2,3) given using INTRABEAM® after breast conserving surgery in patients aged 45 years and over with invasive ductal carcinoma. Local recurrence was the primary outcome measure(1). 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 early this year.

Potential benefits of TARGIT include increased patient convenience: 3-6 weeks of radiotherapy may be replaced by 1 day (approx. 30 min treatment time). TARGIT may also make radiation therapy available for patients, who don’t have access today, e.g. in developing countries. Also, in industrialized countries, many women do not undergo the recommended breast radiation due to inconvenience or cost. Giving TARGIT with INTRABEAM® system is considerably less expensive than conventional radiation therapy(4), which it could replace. If the trial results show that TARGIT is equivalent to conventional external beam radiotherapy, it has the potential to become the new standard of care.

“The TARGIT trial challenges the existing paradigm of the treatment of breast cancer and could also establish a new collaborative team approach between the surgeon and the radiotherapist from the very outset,” said leading British oncologist Michael Baum, Professor Emeritus of Surgery at the University College London and principal investigator of the TARGIT trial.

“If the TARGIT-A trial comes close to our expectations it could change two fundamental principles in the treatment of breast cancer: whole breast radiotherapy could be replaced by TARGIT in a substantial proportion of patients and a much smaller dose of radiation may be adequate,” said Dr. Jayant S. Vaidya, principle investigator of the trial and co-inventor of the TARGIT technique.

Jeffrey Tobias, Consultant in Clinical Oncology at University College London Hospitals and Professor of Cancer Medicine at UCL is one of the original designers of the TARGIT trial, along with Michael Baum and Jayant Vaidya. He said, “Radiotherapy is an essential part of the treatment of most patients with early breast cancer in the western world, but requires repeated visits to Departments of Radiotherapy which are often overstretched. The TARGIT approach could have the potential to change this.”

“TARGIT offers the easiest form of partial breast irradiation for hospitals and for patients, and because of this, it could be performed within any hospital or treatment centre,” added Professor David Joseph, Head of Radiation Oncology at Sir Charles Gairdner Hospital, Western Australia, and co-chairman of the TARGIT steering committee.

About TARGIT
Since 1996, the international TARGIT research group has been researching a new method of radiotherapy for breast cancer in which the treatment can be reduced to a single radiation exposure. The radiation is administered during the surgery directly after removal of the tumor. 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 clarifying whether the single boost can reduce the risk of recurrence of the cancer in the affected breast as effectively as the traditional, 3-6-week method. On a random basis, one half of the women taking part receive conventional radiotherapy while the other half are treated intra-operatively. The initial results of the study will be presented during the next annual meeting of the ASCO (American Society of Clinical Oncology) in Chicago from June 4-8. www.targit-research.org, www.targit.org.uk

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)

1. Vaidya JS, Baum M, Tobias JS et al. Protocol 99PRT/47, Targeted Intraoperative radiotherapy (Targit) for breast cancer. Lancet 1999; http://www.thelancet.com/journals/lancet/misc/protocol/99PRT-47

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. Vaidya JS, Tobias JS, Baum M, et al. Intraoperative radiotherapy for breast cancer. Lancet Oncol 2004; 5(3): 165-73

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