Single-Dose Radiation Treatment Option for Women with Early Breast Cancer

New ground-breaking technology that delivers a targeted, intraoperative radiation treatment directly to the tumor site after lumpectomy was shown to be as effective as traditional radiation for certain women with early breast cancer.

Moffitt Cancer Center (Tampa, Fl, USA) acquired the Intrabeam system, a new radiation platform that is designed to replace as many as six-and-a-half weeks of routine radiation therapy with a single 20- to 30-minute targeted radiation treatment. Moffitt recently acquired the Intrabeam system based on the positive findings of the TARGIT-A international, multicenter clinical trial, which were published June 5, 2010, in the journal, the Lancet.

"This landmark research study will revolutionize the way we treat breast cancer, and the Breast Program at Moffitt is excited to introduce this innovative technology to our patients," said Christine Laronga, MD, FACS, program leader of the Don & Erika Comprehensive Breast Program.

Unlike whole breast radiation treatment, which is administered five times per week for as many as six-and-a-half weeks, the Intrabeam system provides patients with a targeted single-dose radiation treatment delivered intraoperatively after removal of the tumor. Before the surgeon closes the incision, the Intrabeam applicator is positioned in the area of the breast where the tumor was located. This ensures radiation delivery accuracy and minimizes geographical miss. The Intrabeam radiation is applied for 20 to 30 minutes, exposing the affected tissue in the tumor bed from the inside. The surgeon then removes the Intrabeam applicator and closes the incision.

The Intrabeam system was the only radiotherapy device used in the TARGIT-A clinical trial, the largest randomized clinical trial conducted in the field of intraoperative radiotherapy (IORT) for the treatment of early breast cancer. The TARGIT-A trial was launched in 2000, and it enrolled 2,232 patients throughout 28 centers in nine countries. With four-year median follow-up data, the study's findings demonstrate the equivalency of single-dose targeted IORT in comparison to external beam radiation therapy (EBRT) based on local recurrence.

In addition to the convenience of a one-time treatment, the system has been shown to provide additional benefits compared to conventional EBRT. These include less irritation of healthy breast tissues, minimized exposure to the chest cavity and underlying organs, and fewer skin reactions, such as redness, rashes, and irritation. There is also no treatment delay for patients who must also undergo chemotherapy as part of the breast cancer treatment compared to EBRT.

"Intraoperative, single-dose partial breast radiation promises to improve women's access to breast conservation therapy and to significantly improve quality of life for these women, with its dramatically reduced treatment time and decreased side effects from radiation," said Eleanor Harris, MD, clinical director and service chief for the breast and gynecological clinical and research divisions for Moffitt's Radiation Oncology Program.

Currently, eligible candidates for the Intrabeam single-dose treatments include patients with small tumor size, negative excision margins, negative lymph nodes and those who are postmenopausal age. Women who do not qualify for Intrabeam single-dose therapy may still be eligible to receive Intrabeam Boost treatment, which delivers a single dose of radiation directly to the tumor bed during surgery prior to the start of whole breast radiation therapy (WBRT). This can reduce the total radiotherapy treatment regimen duration by five to eight days. Moffitt will be collecting data on a protocol for IORT.

Intrabeam, Carl Zeiss Meditec's (Jena, Germany) radiotherapy system, offers the least disruptive treatment method available to patients diagnosed with early stage breast cancer. The radiation dose of Intrabeam is administered to the tumor bed in the operating room immediately following the surgical excision of the tumor. The system utilizes a miniature X-ray source, a highly flexible support stand, and a full range of radiation applicator options.

In 1999, Intrabeam received both US Food and Drug Administration (FDA) clearance and the CE marking to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The device is also cleared for use in most countries worldwide.

Related Links:
Moffitt Cancer Center
Carl Zeiss Meditec