Saint John’s first in the nation to treat glioblastoma patient with revolutionary radiation therapy

Using the Xoft Axxent Electronic Brachytherapy System, the landmark procedure may help extend progression free survival and improve quality of life for those battling deadly form of cancer

SANTA MONICA, CA – A team of multidisciplinary specialists at the Pacific Neuroscience Institute (PNI) became the first in the nation to treat a patient with recurrent glioblastoma — an aggressive form of cancer in the brain — with electronic interoperative radiation therapy during a procedure in November at Providence Saint John’s Health Center.

The therapy, known as IORT, allows radiation oncologists and surgeons to work together to deliver radiation treatment to the patient during the same surgery meant to remove the tumor, and substantially accelerates the access to radiation treatment that would normally start several weeks after surgery.

“Treating a patient suffering from glioblastoma with IORT is an incredible achievement for everyone involved, especially for PNI and our Saint John’s Cancer Institute, which work tirelessly to push the boundaries of innovation in the medical field,” Providence Saint John’s Chief Executive Michael Ricks said.

During the procedure, the Saint John’s team of highly skilled surgeons and radiation oncologists used the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®. Once the tumor was surgically removed, Xoft’s flexible balloon shaped applicator and Xoft’s miniature X-ray source were placed temporarily into the tumor cavity. After the applicator was fitted into the cavity, a single dose of radiation was delivered directly to the tumor bed. Both the applicator, as well as the X-ray source, were removed after the radiation treatment.

“Xoft Brain IORT is a novel approach that may offer patients quality-of-life benefits, compared to traditional treatment,” said Garni Barkhoudarian, M.D., a fellow of the American Association of Neurological Surgeons and assistant professor of neurosurgery and neuroscience at the Saint John’s Cancer Institute. “By reducing radiation treatment times from weeks to just one day, Xoft not only offers a more convenient treatment option, it also may result in fewer side effects and complications, compared to other treatments.”

The procedure also was part of the international multi-center GLIOX trial[i] led by principal investigator and world-renowned neuro-oncologist Santosh Kesari, M.D., who currently serves as chairman and professor of the Department of Translational Neurosciences and Neurotherapeutics at PNI.

The GLIOX trial is designed to compare Xoft IORT plus Avastin® (bevacizumab) to the investigational arm of RTOG-1205 (EBRT plus bevacizumab). Researchers hope this study will validate the intriguing initial results from a prospective two-center comparative study at the European Medical Center in Moscow, which evaluated 15 patients with recurrent glioblastoma (GBM) who were treated with maximal safe resection and Xoft IORT, and 15 patients treated with maximal safe resection and other modalities (control group), from June 2016 and June 2019.

As of March 2021, patients treated with Xoft Brain IORT lived without recurrence of glioblastoma for a range of up to 54 months after treatment, whereas patients in the control group had a recurrence of glioblastoma within 10 months and lived for a range of up to 22.5 months after treatment. Researchers also found there were fewer complications, such as radionecrosis in the IORT group. Radionecrosis refers to the breakdown of normal body tissue near the original tumor site after radiation therapy. One patient from the IORT group was still alive in fall 2021, whereas none of the patients in the control group survived.

The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses the world’s smallest X-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, which targets cancer cells while minimizing the risk of damage to healthy tissue in nearby areas of the body. For the treatment of certain types of tumors —including brain cancers — IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of post-operative external beam radiation therapy with a single fraction of radiation.

“Patients with this type of cancer have extremely limited treatment options, and recurrences are unfortunately quite common. Xoft Brain IORT may offer patients and their families new hope for an additional treatment option that can target the area immediately after the cancer is removed, instead of weeks after surgery,” said Stacey Stevens, president and incoming CEO of iCAD, Inc., Xoft’s parent company. “It is our hope that this study will contribute to the body of data that supports IORT with the Xoft System for the treatment of various types of tumors, including recurrent GBM.”

Glioblastoma is the cancer that killed U.S. Sen. John McCain, R-Arizona, U.S. Sen. Ted Kennedy, D-Massachusetts and Beau Biden, son of President Joe Biden. It is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months.[ii]^,[iii] Worldwide, 308,102 new cases of brain and nervous system tumors were diagnosed in 2020.[iv]

“The initiation of a clinical trial under normal circumstances is no small feat, but the COVID pandemic presented additional challenges that had to be overcome,” said Naveed Wagle, MD., the local principal investigator of the study and associate professor of Neurosciences at the Saint John’s Cancer Institute. “It truly was an enormous achievement, and we are excited that we can now offer it to patients.”