Feature | April 09, 2014 | Barbara S. Schwartzberg, M.D.

Intraoperative Radiation Therapy for Early Stage Breast Cancer

Intraoperative Radiation Therapy (IORT) procedure in four steps.

The Xoft Axxent Controller, balloon and mini X-ray source assembled to simulate use during IORT.

The current standard of care for treatment of early stage breast cancer is mastectomy or lumpectomy followed by five to seven weeks of daily whole breast radiation therapy (WBRT) treatments. Post-operative accelerated partial breast irradiation (APBI) is slowly replacing whole breast external beam irradiation as an alternative in treatment of early stage lymph node-negative breast cancer. This was originally performed as limited-field breast brachytherapy using multiple interstitial catheters placed post-operatively around the lumpectomy site. Radioactive interstitial wire implants were then placed into the catheters. 

More recently, APBI has been delivered as post-operative intensity-modulated radiotherapy, 3-D conformal radiotherapy or balloon catheter radiotherapy. APBI is usually delivered to the lumpectomy site in 10 post-operative fractions given twice a day, six hours apart, throughout the course of five days. Results to date from all four techniques are favorable, showing good cosmesis and recurrence rates comparable to standard whole breast irradiation.

Trial Studies

Intraoperative radiation therapy (IORT) allows for delivery of a single fraction of radiation to the lumpectomy site while still in the operating room. The use of IORT has been reported in two European studies. The ELIOT trial, published by Veronesi in 2008, reported the results of 1,246 patients treated with intraoperative electron beam radiotherapy using the Sordina IORT Technologies’ Novac 7 and Liac devices.1 Five-year survival was roughly calculated to be 96.5 percent. New primary carcinoma diagnosed in other breast quadrants was 1.3 percent. Four-year follow-up data for another trial, the TARGIT-A trial, was published by Vaiyda in 2010. The Zeiss Intrabeam device was used to treat 1,232 patients.2 Results were considered equivalent to lumpectomy followed by five weeks of standard whole breast irradiation. Five-year follow-up TARGIT-A trial data has been presented for 1,222 patients, showing that IORT still meets non-inferiority criteria when compared to WBRT.3 IORT is now also available using a disposable balloon applicator device as part of the Xoft electronic brachytherapy system. Results of 11 patients receiving a single 20 Gy intraoperative fraction were reported by Ivanov in 2010.4 Mean follow-up was for 12 months. There were no cancer recurrences in this short follow-up time interval. The results of 40 patients using the Xoft System were presented  in 2013.5 There were no recurrences after a mean follow-up of 15 months.

Reduced Treatment Time

Intraoperative radiation therapy using electronic brachytherapy for treatment of early stage breast cancer is currently under investigation. Electronic brachytherapy is delivered using portable equipment that runs conventional electricity over a tungsten or gold crystal to produce radiation. The resultant radiation has a short penetration, allowing for use in the operating room. Leaded bunkered rooms are no longer necessary. The personnel and patients are protected by standard leaded drapes and portable shields. The balloon applicator is placed into the lumpectomy cavity and then attached to a controller. 

Doses, which are individually calculated, are dependent on the size and conformation of the lumpectomy cavity. Most IORT clinical trials include women with a single focus of biopsy-proven invasive ductal carcinoma who have cancer-free lymph nodes. Some trials include women who have been diagnosed with ductal carcinoma in situ (DCIS). If enrolled, patients undergo a standard sentinel lymph node (SLN) analysis and lumpectomy with intraoperative margin evaluation. The SLNs must be cancer-free. Adequate margins are determined radiographically and on gross examination by the pathologist. If cleared by these parameters, a shield is placed against the chest wall to protect the underlying organs. A balloon applicator attached to the Xoft System is placed into the lumpectomy cavity. Intraoperative ultrasound is used to document good apposition of surrounding breast tissue and an acceptable distance between skin and applicator surface. Patients receive a single fraction of electronic brachytherapy through the applicator of 20 Gy. The applicator and shield are then removed and the operation is completed using current standards of care. Final pathology confirms adequate margins and that the SLNs are cancer-free. Additional treatment recommendations follow local medical standards. 

IORT is well tolerated by patients and is usually performed in an outpatient setting. Patients are pleased both with the cosmetic outcome and convenience of the procedure. The cosmetic results are favorable as the radiation is localized to only the lumpectomy site. They are no longer inconvenienced by a five- to seven-week schedule of daily post-operative whole breast irradiation. It is predicted that this will reduce treatment costs.

Promising Alternative

Intraoperative radiation treatment using electronic brachytherapy has shown promise as an alternative to other forms of APBI or whole breast irradiation in the treatment of patients with early stage node negative breast cancer. Clinical trials documenting long-term outcomes are in progress.  

References

1. Veronesi U, Orecchia R, Luini A, et al. “Full dose Intraoperative radiotherapy with electrons (ELIOT) during breast conserving surgery. Experience with 1246 cases.” ECancer Medical Science. Volume: 1 Article Number: 65, 2008.

2. Vaidya JS, Joseph DJ, Tobias JS, et al. “Targeted intraoperative
radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomized,
non-inferiority phase 3 trial.” Lancet 2010; 376 (9735), 91-102.

3. Vaidja JS. San Antonio Breast Cancer Symposium, Dec. 4-8, 2012.

4. Ivanov O, Dickler A, Lum BY, et al. “Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer.” Ann Surg Oncol 2011;18(2): 453-458.

5. Schwartzberg, BS. American Society of Breast Surgeons 14th Annual Meeting, Chicago, May 1-5, 2013.

Barbara Schwartzberg, M.D., is a private practice breast surgeon at Rose Medical Center in Denver, Colo. She received her B.A. in chemistry from Franklin and Marshall College, her M.S. in pharmaceutical chemistry from Purdue University and her M.D. from George Washington University before doing her general surgery residency at the University of Colorado. She enjoys researching new technologies that allow for easier, more targeted treatment of early stage breast cancer.

Related Content

Clinical Data Supports Use of Xoft System for Endometrial Cancer
News | Brachytherapy Systems | August 03, 2017
Researchers presented clinical data supporting use of the Xoft Axxent Electronic Brachytherapy (eBx) System for the...
The ASPIRE Cristalle FFDM system with DBT combines Fujifilm’s state-of-the-art hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow
News | Women's Health | August 01, 2017
Fujifilm Medical Systems U.S.A., Inc. announced that The Mammography Center of Monterey, an ACR-accredited breast...
more healthcare providers and patients are choosing options such as Gamma Knife stereotactic radiosurgery
News | Radiation Therapy | July 31, 2017
Each year, up to 650,000 people who were previously diagnosed with various forms of cancer will develop brain...
Sponsored Content | Videos | Breast Imaging | July 28, 2017
Nancy Cappello, Ph.D., executive director and founder of Are You Dense Inc. and Are You Dense Advocacy, explains how
Radiotherapy Prior to Surgery Reduces Secondary Tumor Risk in Early-Stage Breast Cancer Patients
News | Radiation Therapy | July 24, 2017
Moffitt Cancer Center researchers launched a first-of-its-kind study comparing the long-term benefits of radiation...
Kubtec Launches New Website For Digital Imaging and Irradiation Products
News | Digital Radiography (DR) | July 20, 2017
Kubtec announced the launch a new website focused on the applications of digital X-ray imaging and irradiation for...
Volpara Solutions to Showcase Volpara Enterprise DDP Software at AHRA 2017
News | Mammography | July 11, 2017
Volpara Solutions Inc. will showcase its new Volpara Enterprise DDP software at the Association for Medical Imaging...
Fujifilm Showcases Digital Radiography, Mammography Innovations at AHRA 2017
News | Digital Radiography (DR) | July 06, 2017
Fujifilm Medical Systems U.S.A. Inc. will present its comprehensive portfolio of digital radiography (DR) and...
Feature | Breast Density | July 05, 2017 | By Nancy M. Cappello, Ph.D.
Two decades of research on the masking risk of dense breast tissue by mammography screening is indisputable. As the...
Elekta’s MR-linac integrates an advanced linear accelerator and a 1.5T magnetic resonance imaging (MRI) system

Elekta’s MR-linac integrates an advanced linear accelerator and a 1.5T magnetic resonance imaging (MRI) system. Combined, these systems will allow for simultaneous radiation therapy delivery and high-field MR tumor monitoring.

Feature | Radiation Oncology | July 05, 2017 | By Jeff Zagoudis
Image-guided radiation therapy offers great potential to improve the efficiency of treating cancer patients by more...
Overlay Init