Loma Linda University Medical Center Expands Clinical Trial Eligibility for Proton Beam Treatment for Breast Cancer

<0> Sandra Levy, 562-391-1516 </0>

Enrollment has been expanded in a clinical trial taking place at Loma Linda University Medical Center in which initial results have shown proton beam therapy to be an effective weapon with virtually no side effects for fighting early stage breast cancer.

Results of the Phase II clinical trial conducted by researchers at LLUMC Department of Radiation Medicine have indicated that partial breast radiotherapy delivered with appears to provide excellent disease control within the breast with minimal risk of side effects. Apart from being less toxic to the patient, the treatment reduces the amount of radiation treatment time to two weeks instead of the typical seven weeks.

The study, which began in 2004, has been expanded to include slightly more advanced tumors; and additional patients are actively being recruited to participate in this phase of the clinical trial.

Disease-free survival rates at five years for the patients who took part in the study was over 90 percent, while overall survival rate was close to 100 percent. The study results were initially presented at the American Society for Radiation Oncology (ASTRO) meeting in 2010, and were published in the peer-reviewed scientific journal last year.

“The study results show that we are able to offer early stage breast cancer patients a treatment program that is less risky and can be completed in less time,” said Dr. David Bush, vice-chairman of the Department of Radiation at Loma Linda University Medical Center and one of the study’s principal investigators. “We have expanded the study to include slightly more advanced tumors so that more women could benefit from this groundbreaking treatment and we could add more participants to the trial.”

At present most women diagnosed early with breast cancer would undergo surgery to remove the tumor from the breast. Radiation treatment is then performed over the entire breast. The study looked at treatment results by using proton beam radiation to just the area where the tumor was located instead of the whole breast.

“The size of the radiation area is reduced significantly, lessening radiation exposure to the heart, lungs and other parts of the body. Proton beam allows us to do this better than any other type of radiation treatment,” Dr. Bush said.

A high-definition quality video discussing the therapy and clinical trial is available and may be viewed at: ().

Proton therapy is a precise form of radiation treatment that uses machines to generate beams that penetrate the body from the outside and destroy cancerous tumors and cells with minimal damage to surrounding tissue and organs. It was two decades ago when Dr. James Slater turned Loma Linda University Medical Center into the first hospital in the world to offer proton radiation treatment to treat prostate, brain and other types of cancer. Over 16,000 patients have since been treated at the at Loma Linda University Medical Center.

Ann Hughes, of Highland, CA, maintained an active lifestyle as a semi-retired hairdresser when she was diagnosed with breast cancer in 2006. After having the tumor removed by surgery, she sought out more information and signed up to participate in the Loma Linda clinical trial after overhearing a client talk about it at the salon. “The hope that I wouldn’t have to have chemotherapy was very appealing,” she said.

Ms. Hughes said she was glad not to lose her hair and feel nauseous during the treatment. Six years after the proton beam treatment, she remains cancer free and is able to lead an active life. “Cancer is a very scary word, but once you get to the point that it doesn’t have to be a death sentence, then you can think more clearly and be open to all the options,” she said.

The breast cancer clinical trial investigated the safety and efficacy of utilizing proton beam radiotherapy to deliver partial breast radiotherapy following lumpectomy for early stage breast cancer.

Initially, 50 patients who had invasive (non-lobular) carcinoma and had undergone a lumpectomy were enrolled in the clinical trial. The patients had invasive breast cancer with primary tumors that were three centimeters or less and the cancer had not yet metastasized. During treatment the patients were made to lie in a prone position in a customized foam mold and, over a two-week course, received daily proton beam treatment.

The study completed enrollment of 100 patients, and the second phase of the trial will add an additional 100 patients. The treatment currently is available for breast cancer patients at the James M. Slater Proton Treatment and Research Center at Loma Linda University Medical Center. Individuals who want to inquire about enrolling in the trial are encouraged to call 1-800-PROTONS.

Established in 1990, Loma Linda University Medical Center Proton Treatment and Research Center was the first hospital-based proton therapy center in the world. Today the center uses proton beam technology for many types of cancers and has treated more patients than any other proton treatment center in the world. The center is part of LLUMC’s comprehensive health system, which is widely respected as a healthcare leader pioneering work in such areas as organ transplants, proton treatment for cancers, cardiac care, physical rehabilitation, acute pediatric and adult care as well as treatments for chemical dependence and other behavioral disorders. The health system – which includes Loma Linda University Medical Center and Children’s Hospital, LLUMC – East Campus, Behavioral Medicine Center, Heart and Surgical Hospital, LLUMC-Murrieta and physician clinics – collectively sees over 30,000 inpatients and about 750,000 outpatient visits a year. Visit us online at .